Pasteur laboratories PVT. LTD.

It is a Project on Industrial Vocational Training at Pasteur laboratories PVT. LTD. It mainly comprises of the Management overviews of a Pharmaceutical as well as a production eligible industry. Workplace training, also known as trade or industry training, involves learning and earning money while you work. Apprenticeships are one type of workplace training. You can do workplace training in a range of hands-on industries. Workplace training usually combines on-the-job and off-the-job training. You'll have to:
1. attend all courses that are part of the industry training – these may be block courses, evening courses or day release classes, and are offered by a polytechnic or other education provider
2. Complete on-the-job assessments to show you are competent doing practical tasks, and to work towards your national certificate
3. Complete off-the-job assessments to work towards completing your qualification.
The Industry Training Authority is a provincial government agency in the province of British Columbia, Canada. Established in 2004, to replace the Industry, Training and Apprenticeship Commission (ITAC), its mandate is to facilitate training in the trades and industry occupations in the province.
We are thankful to Pasteur laboratories Pvt. Ltd., for conducting this training program during our undergraduate course in pharmacy & also for their precious knowledge & guidance throughout the training.
We are highly grateful as this knowledge would be an enormous help to our career in future days.
I, Diptarco Singha from GURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE & TECHNOLOGY, PANIHATI, KOLKATA is representing this project after successfully completing our vocational training at Pasteur Laboratories Pvt. Ltd.
I am highly grateful to Pasteur Laboratories Pvt. Ltd. for complete guidance and supervision. It was a treat to work and learn under the guidance of Mr. Tuhin Saha. His vast knowledge regarding the subject was immensely helpful and gave a clear view about the path in future.

1. INDUSTRIAL VOCATIONAL TRAINING AT PASTEUR LABORATORIES PVT. LTD.

1 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

2. INDUSTRIAL VOCATIONAL TRAINING AT PASTEUR LABORATORIES PVT. LTD.

2 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology




Pharmacy is the art, practice of profession of preparing, preserving, compounding, & dispensing a substance or drug
meant for social and pharmacological welfare.
The pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals for use as medications.
Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of
laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. The government started to
encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970.
However, economic liberalization in 90s by the former Prime Minister P.V. Narasimha Rao and the then Finance Minister, Dr.
Manmohan Singh enabled the industry to become what it is today. This patent act removed composition patents from food
and drugs, and though it kept process patents, these were shortened to a period of five to seven years.
In a word, the pharmaceutical industry is responsible for the development, production and marketing of medications. Thus,
its immense importance as a global sector is evident.

Workplace training, also known as trade or industry training, involves learning and earning money while you work.
Apprenticeships are one type of workplace training. You can do workplace training in a range of hands-on industries.
Workplace training usually combines on-the-job and off-the-job training. You'll have to:
1. attend all courses that are part of the industry training – these may be block courses, evening courses or day release
classes, and are offered by a polytechnic or other education provider
2. Complete on-the-job assessments to show you are competent doing practical tasks, and to work towards your national
certificate
3. Complete off-the-job assessments to work towards completing your qualification.
The Industry Training Authority is a provincial government agency in the province of British Columbia, Canada. Established in
2004, to replace the Industry, Training and Apprenticeship Commission (ITAC), its mandate is to facilitate training in the
trades and industry occupations in the province.
We are thankful to Pasteur laboratories Pvt. Ltd., for conducting this training program during our undergraduate course in
pharmacy & also for their precious knowledge & guidance throughout the training.
We are highly grateful as this knowledge would be an enormous help to our career in future days.

3. INDUSTRIAL VOCATIONAL TRAINING AT PASTEUR LABORATORIES PVT. LTD.

3 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology




I, Diptarco Singha from GURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE & TECHNOLOGY, PANIHATI, KOLKATA is
representing this project after successfully completing our vocational training at Pasteur Laboratories Pvt. Ltd.
I am highly grateful to Pasteur Laboratories Pvt. Ltd. for complete guidance and supervision. It was a treat to work and learn
under the guidance of Mr. Tuhin Saha. His vast knowledge regarding the subject was immensely helpful and gave a clear view
about the path in future.
I would like to express my gratitude to all the members of Pasteur Laboratories Pvt. Ltd. For their kind co-operation,
encouragement and a friendly environment that helped me to complete my project.


We would especially like to thank the following people without whom it wouldn’t have been possible to complete this
project.
 Late Mr. M.C. Law (Director, Manufacturing)
 Mr. K. Law (Director, Administration & Finance)
 Mr. D. Law (Director, Sales & Marketing)
 Mr. S. Law (Director, Research & Development)
 Mr. A. K. Nandi (Factory Manager)
 Mr. Tuhin Saha (quality Assurance Manager; Unit I)
 Mr. S. Das (Quality Control In Charge; Unit I)
 Mr. T.K. Pal (Quality Control Chemist; Unit I)
 Mrs. Mousumi Bhattacharya (Production Supervisor; Unit I)
 Mr. U. Chowdhuri (Manufacturing Chemist; Unit I)
 Mr. R. Sikdar (Manufacturing Chemist; Unit I)
 Mr. S.k. Mondal (In Charge; Unit II)
 Mr. P. Simlai (Quality Control Chemist; Unit II)
 Mr. T. Dey Mondal (Factory Superintendent)

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4 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology






Serial No. Contents Page No.
01 About the Company
02 Industrial Hazards & Safety Measures
03 Environmental impact of Pharmaceutical & Personal Care
04 Demineralization (D.M) Plant & Waste Water Treatment
Plants

05 Calibration
06 Validation
07 Qualification
08 Management
09 BCG Analysis or BCG Matrix
10 SWOT Analysis
11 Schedules
12 Quality Control & Quality Assurance
13 Apparatus in Q.C Department
14 Apparatus in Microbiology Department
15 Preparation of Tablet
16 Preparation of Ointment
17 Machineries for Production at Unit I
18 Machineries for Production at Unit II
19 Products
20 Conclusion

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5 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology





PASTEUR LABORATORIES PVT. LTD.
WITH THE ENTHUSIAM OF A GROUP OF EXPERTS HEADED BY LATE MC.LAW PASTEUR LABORATORIES PVT. LTD.
WAS ESTABLISHED WAY BACK ON 19
TH
OF MARCH 1947AT IT’S PRESENT ADDRESS OF KOLKATA.
THE SOLE IDEA OF FORMIMING THE COMPANY WAS TO MAKE THE MEDICINES AVAILABLE TO COMMON PEOPLE
AT A REASONABLE PRICE AS WELL AS TO UTILIZE THE EXPERTISE OF A GROUP OF PERSONS AVAILABLE TO OUR
FOUNDER MANAGING DIRECTOR LATE MC .LAW FROM THE VERY BEGINNING THE COMPANY HAD INTRODUCED
AND CONCENTRATED ON VARIOUS DERMATOLOGICAL PREPARATIONS & TRANSFUSION FLUIDS ALONG WITH
OTHER INJECTABLE AND ORAL PREPARATIONS.
THOUGH IT IS A SMALL SCALE COMPANY BUT FROM THE INCEPTION IT WAS ESTABLISHED AS A PIONEER
COMPANY IN MANUFACTURING OF TRANSFUSION FLUIDS AND DERMATOLOGICAL PREPARATIONS.
TODAY BY INFLUX OF TIME, THE COMPANY HAS ACQUIRED GMP CERTIFICATION & HAS CONCENTRATION IT’S
PREPARATIONS. ESPECIALLY ON DERMATOLOGICAL RANGE ALONG WITH OTHER PREPARATIONS.
PRESENTLYWITH A GROUP OF STRONG SALES FORCE BACKED BY MODERN LABORATORYTHEY ARE MARKING
OUR PRODUCTS TO A LARGE SEGMENT OF OUR COUNTRY. WITH THE BACKDROP THE COMPANY IS MARCHING
AHEAD NEW PRODUCTS , MODERN IDEAS FOR A BRIGHT FUTURE.

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6 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology




Introduction: Industrial Hazard is a term associated with a substance that is likely to cause an injury in a given
environment or situation. Industrial hazard may be defined as any condition produced by industries that may cause injury or
death to personnel or loss of product or property. Industrial hazard may also be defined as any condition produced by
industries that may cause injury or death to personnel or loss of product or property. Safety in simple terms means freedom
from the occurrence of risk or injury or loss. Industrial safety refers to the protection of workers from the danger of industrial
accidents.

Accidents:
Human factor is the contributing cause of accidents in most situations. For people who are likely to have accidents, the
treatment is divided into three main categories
 Medical assistance- in 13 percent cases
 Personality readjustment- in 22 percent cases
 Operating defects- the remaining 65 percent cases

Accident reduction:
Accident proneness is acceptable to a certain extent; it does not mean that nothing can be done to reduce the number of
accidents
Accidents can be reduced by two approaches
 Actuarial approach- It involves studying the statistics to determine accidents based on actual data . The factors
related to the accident frequency should be identified. The violations of safety rules must be clearly identified.
 Safety educational campaign -Safety education must be conducted by management to the employee groups.

Types of Industrial Hazards:
1. Chemical hazards
2. Physical hazards
3. Biological hazards

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7 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

 Chemical Hazard: A chemical hazard is any substance that can cause harm, primarily to people.
Chemicals of all kinds are stored in our homes and can result in serious injuries if not properly handled. Household
items such as bleach can result in harmful chlorine gas or hydrochloric acid if carelessly used.

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Hazard pictographs are a type of labeling system that alerts individuals efficiently at a quick glance if there are
hazardous chemicals present. The symbols help identify if the chemicals that are going to be in use may potentially
cause physical harm or hard to the environment. The symbols are distinctive as they are shaped like a diamond
with red borders. These signs can be divided into:
1. Explosive (exploding bomb)
2. Flammable (flame)
3. Oxidizing (flame above a circle)
4. Corrosive (corrosion of table and hand)
5. Acute Toxicity (skull and crossbones)
6. Hazardous to environment (dead tree and fish)
7. Health Hazard/ Hazardous to the ozone layer (Exclamation mark)
8. Serious Health Hazard (Cross on a human silhouette)
9. Gas Under Pressure (Gas cylinder



Chemical safety is the application of the best practices for handling chemicals and chemistry processes to minimize risk,
whether to a person, facility, or community. It involves understanding the physical, chemical, and toxicological hazards of
chemicals.
Physical hazard means a chemical for which there is scientifically valid evidence that it is a combustible liquid, a compressed
gas, explosive, flammable, an organic peroxide, an oxidizer, pyrophoric, unstable (reactive) or water-reactive.
 Flammable Liquids and Combustible Liquids.
 Examples: Ethanol, Acetone.
 Compressed Gases

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9 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

Management of over-exposure
Management of over-exposure to chemicals performed by:–
 Removal from exposure- Prompt removal of person to exposure site, air respirators and lifelines are mandatory first
aid.
 Decontamination- A victim whose skin or clothing has been contaminated requires immediate removal of garments
and shoes.
 Symptomatic Treatment- like dehydration arrhythmias.
Dust Explosion:-
A dust explosion is the rapid combustion of fine particles suspended in the air,
often but not always in an enclosed location. Dust explosions can occur where
any dispersed powdered combustible material is present in high enough
concentrations in the atmosphere or other oxidizing gaseous medium
such as oxygen.

Other Hazards include:-

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10 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology


Most Effective Hazard Controls: -
The best way to protect workers is to remove or eliminate the hazard from the workplace using the
following hazard control methods: Substitution. Substitute dangerous chemicals, equipment or work methods with
safer and less hazardous ones to eliminate the hazard altogether.


Other Requirements:-
 Building Constructions,
 Exit point,
 Fire alarm,
 Sprinkler System


Special Safety Protection Equipment:-
 For protection of Head & Eyes:- Goggles, Helmets or Covers, Hooks, Masks.
 For protection of Hands, Arms, Legs & Feet:- Rubber Gloves, Rubber Boots, Aprons & other clothing, Shoes.
 For prevention of breathing of poisonous gases:- Respirative Protective Devices.
Safety programs involves:-

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11 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

As the population increases, use of water also have increased and creating a corresponding rise in waste quantity. This
increased water use and process wastewater generation requires more efficient removal by products and pollutants that
allows for effluent within established environmental regulatory limits.
The determination of wastewater quantity set forth in environmental permits has been established since the 1970s in a series
of laboratory tests focused on four major categories:
1. Organics- A determination of the concentration of Carbon-based (i.e. organic) compounds aimed at establishing the
relative strength of wastewater (biological oxygen demand [BOD], chemical oxygen demand [COD], Total organic carbon
[TOC], oil and grease[O&G]).
2. Solids-A measurement of the concentration of particulates solids that can dissolved or suspend in wastewater (e.g. Total
solid [TS], Total suspended solid [TSS], Total dissolved solid [TDS], Total volatile solids [TVS], Total fixed solids [TFS]).
3. Nutrients- A measurement of the concentration of target nutrients (e.g. nitrogen, phosphorus) that can contribute to the
acceleration of eutrophication (e.g. temperature, colour, turbidity, odour).
4. Physical property and other impact of the parameters- Analytical test designed to measure a varied group of constituents
directly impact wastewater treatability (e.g. temperature, colour, turbidity, and odour).
Information pertaining to the transport and fate of these hormones and their metabolites in the dairy waste disposal is still
being investigated, yet research suggest that the land application of solid wastes is likely linked with more hormone
contamination problems. Not only does the pollution from PPCPs affect marine ecosystems, but also those habitats that
depend on this polluted air.
There are various concerns about the effects of pharmaceuticals found in surface waters and specifically the threats against
rainbow exposed to treated sewage effluents.
Routes into environment:-
Pharmaceutical residues may reach the environment by a number of different routes. It is a generally assumed that the
production of pharmaceuticals in industrialised countries is well controlled and unharmful to the environment, due to local
legal res. The major route for pharmaceutical residues to reach the aquatic environment is most probably by excretion from
patients undergoing pharma treatment. Since many pharmaceutical substances are not metabolised in the body but they may
be excreted in biologically active form, usually via the urine. Furthermore, many pharmaceutical substances are not fully
taken up from the intestine into their blood stream. The fractions not taken up into the blood stream will remaining in the gut
and eventually excreted via the faces. Hence, both urine and faces from treated patients contain pharmaceutical residues.

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12 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

ENVIRONMENTAL
While the full effects of most PPCPs on the environment are not understood, there is concern about the potential they have
for harm because they may act unpredictably when mixed with other chemicals from the environment or concentrate in the
food chain. Additionally, some PPCPs are activate at very low concentration and are often released continuously in large
quantities. Because of the high solubility of PPCPs, aquatic organisms are especially vulnerable to their effects. Researchers
have found that a class of antidepressant may be found in frogs and can significantly slow their development. The increased
presence of oestrogen and synthetic hormones in waste water due to birth control and hormonal therapies has been linked
to increased feminization of exposed fish and other aquatic organisms. The chemicals within these PPCP products could
either affect the feminization or masculinization of different fishes, therefore impacting their reproductive rates. In addition
to being found only in waterways, the ingredients of some PPCPs can also be found in the soil . Since some of these
substances take a long time or cannot be degraded biologically, they make their way up the food chain.
Fate of pharmaceuticals in the sewage treatment plants
Sewage treatment plants may offer a variety of techniques for diminishing the amount and harmful activity of its biological
contents. Usually the sewage treatments plants are equipped with an initial mechanical separation of solid particles (socks,
underwear, 12holera articles etc.)Appearing in the incoming.
Following this there may be filters particles either occurring in the incoming water.
Or water with flocculating agents. Many STPs also include one or several steps of biological treatment. By stimulating the
activity of various strains of microorganisms physically their activity may be promoted to degrade the organic content of the
sewage by up to 90% or more. In certain cases more advanced techniques are used as well . Such techniques may comprise
UV treatment of the water, or addition of ozone. In either case, these methods will degrade organic material not taken care
of by the microorganism. Optimal treatment with such methods may destroy up to 80% or more of pharma residues in the
water. A final step with 13holera13d carbon may eliminate possible reactivate degradation products from the UV or ozone
treatment. Several research projects are running to optimize the use of advanced sewage treatment techniques after
different conditions. The advanced techniques will increase the costs for the sewage treatment substantially.
It is therefore important to define best available technique before extensive infrastructure investments are introduced on a
wide basis. The fate of incoming pharmaceutical residues in the STP is unpredictable. Some substances seem to be more or
less completely eliminated. While others pass the different steps in the unaffected. There is no systematic knowledge at hand
to predict how and why this happens. Pharmaceutical residues that have been conjugated before being excreted from the
patients may undergo de-conjugation in the STP, yielding higher levels of free pharmaceutical substance in the outlet from
the STP than in its incoming water. Some pharmaceutical with large scale volumes have not been detected in the incoming
water to STP, indicating that complete metabolism and degradation must have occurred already in the patient or during the
transport of sewage from the household to the STP.

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Demineralization is the process of removing mineral salts from water by using the ion exchange process.
Demineralized water is water completely free (or almost) of dissolved minerals as a result of one of the following
processes:
 Distillation
 Deionization
 Membrane filtration( reverse osmosis or Nano filtration)
 Electrodyalisis
 Or other technologies
Demineralized water also known as Deionized water, water that has its mineral ion removed. Mineral ion such as cations of
sodium, calcium, iron, copper etc. and anions such as chloride, sulphate, nitrate etc. are common ions present in water.
Deionization is a physical process which uses specially-manufactured ion exchange resins which provides ion exchange site
for the replacement of the mineral salts in water with water forming H+ and OH- ions. Because of the majority of water
impurities are dissolved salts, deionization produces high purity water that is generally similar to distilled water.
Demineralization is the proven process for treatment of water. A DM water system produces mineral free water by operating
on the principles of ion exchange, degasification and polishing. Demineralized water system finds wide application in the field
of steam, power, process and cooling.
PRINCIPLE
Raw water is passed via two small polystyrene bead filled (ion exchange resin) beds. While the cations get exchanged with
hydrogen ions in first bed, the anions are exchanged with hydroxyl ions in the second one.

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14 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology



Biochemical oxygen demand (BOD) (also called biological oxygen demand) is the amount of dissolved oxygen needed (i. e.,
demanded) by aerobic biological organisms to break down organic material present in a given water sample at certain
temperature over a specific time period.
 The term also refers to a chemical procedure for determining this amount. This is not a precise quantitative test,
although it is widely used as an indication of the organic quality of water.
 The BOD value is most commonly expressed in milligrams of oxygen consumed per liter of sample during 5 days of
incubation at 20 °C and is often used as a robust surrogate of the degree of organic pollution of water.
 BOD5 is calculated by: ( Dilution method )
Unseeded: BOD5 = (DO – D5)
P
Seeded: BOD5 = (DO-D5) – ( B0 – B5 )F
P
 where: DO is the dissolved oxygen (DO) of the diluted solution after preparation (mg/l); D5 is the DO of the diluted
solution after 5 day incubation (mg/l); P is the decimal dilution factor ; B0 is the DO of diluted seed sample after
preparation (mg/l) ; B5 is the DO of diluted seed sample after 5 day incubation (mg/l) ; F is the ratio of seed volume
in dilution solution to seed volume in BOD test on seed.

Test Procedure:-
1. 5 beakers were labelling with A, B, C, D and E.
2. 100 mL of pond water are collected and pour into beaker A.
3. The D.O probe was placed in the beaker A to read the initial D.O Concentration directly.
4. The result was recorded in Data Logger Spread sheet Program.
5. Steps 1 to 4 were repeated by using different samples of water which are drain water, distilled water, aquarium
water and pipe water which the samples of water is poured into beaker B, C, D and E respectively.
6. The samples were let until 5 days and D.O probes were placed again in these samples to read the final D.O
concentration.

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15 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

7. BOD value was determined by the following formula:

B.O.D value = Final D.O – Initial D.O
p
*Note that, before put the sensor into the next sample of water, rinse the sensor with distilled water.

Results if plotted gives:-

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16 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

What is DO (Dissolved Oxygen)?
Dissolved oxygen (DO) refers to microscopic bubbles of gaseous oxygen (O2) that are mixed in water and available to aquatic
organisms for respiration—a critical process for almost all organisms. Primary sources of DO include the atmosphere and
aquatic plants.
DO Flow:-









COD (Chemical Oxygen Demand):-
In environmental chemistry, the chemical oxygen demand (COD) test is commonly used to indirectly measure the amount of
organic compounds in water. Most applications of COD determine the amount of organic pollutants found in surface water
(e.g. lakes and rivers) or wastewater, making COD a useful measure of water quality. It is expressed in milligrams per liter
(mg/L), which indicates the mass of oxygen consumed per liter of solution. Chemical Oxygen Demand (COD) is a measure of
capacity of water to consume Oxygen during the decomposition of organic matter and the oxidation of inorganic chemicals
such as ammonia & nitrite.
 It is expressed in milligrams per liter (mg/L) also referred to as ppm (parts per million), which indicates the mass of
oxygen consumed per liter of solution.
 The following formula is used to calculate COD:
COD= {8000(b-s) n}/ Sample volume

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17 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

 Where b is the volume of FAS used in the blank sample, s is the volume of FAS in the original sample, and n is the
normality of FAS. If milliliters are used consistently for volume measurements, the result of the COD calculation is
given in mg/L.
 The COD can also be estimated from the concentration of oxidizable compound in the sample, based on its
stoichiometric reaction with oxygen to yield CO2 (assume all C goes to CO2), H2O (assume all H goes to H2O), and
NH3 (assume all N goes to NH3), using the following formula:
 COD = (C/FW)(RMO)(32)Where C = Concentration of oxidizable compound in the sample,FW = Formula weight of the
oxidizable compound in the sample, RMO = Ratio of the # of moles of oxygen to # of moles of oxidizable compound in
their reaction to CO2, water, and ammonia. For example, if a sample has 500 wppm of phenol:
 C6H5OH + 7O2 → 6CO2 + 3H2OCOD = (500/94)(7)(32) = 1191 wppm

TOC (Total Organic Carbon):-

Total organic carbon (TOC) is the amount of carbon found in an organic compound and is often used as a non-specific
indicator of water quality or cleanliness of pharmaceutical manufacturing equipment.

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 The theory of constraints (TOC) is a management paradigm that views any manageable system as being limited in
achieving more of its goals by a very small number of constraints.
 Total Organic Carbon (TOC) is an indirect measure of organic molecules present in water and measured as carbon.
Organic molecules are introduced into the water from the source water, from purification, and from distribution
system materials. TOC is measured for both process control purposes and to satisfy regulatory requirements.
 One approach used to measure TOC involves subtracting the measured inorganic carbon (IC) from the measured total
carbon (TC), which is the sum of organic carbon and inorganic carbon: TOC = TC – IC.

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Calibration is the set of operations that establish, under specified conditions, the relationship between values indicated by a
measuring instrument, a measuring system or values represented by a material measure, and the corresponding known
values/standard value of a measurement.
Steps:-
1. Identify instruments/glassware
2. Identify sources of calibration facility/procedures
3. Calibration procedure
4. Documentation
5. sources of error
6. correction
The set of operations which establish under specific conditions, the relationship between values indicated by measuring
instrument or measuring system or value represented by a material measure or a reference material, and the corresponding
value of a quantity realized by a reference standard.

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Need of Calibration:-
The main objectives of calibration services are:
 To maintain quality control and quality assurance in production.
 To comply with requirements of global trade.
 To meet the requirement of ISO guides.
 To promote international recognition.
 For tracking back measurement results to national standards.

Benefits of Calibration:-
 It fulfills the requirements of traceability to national / international standards like ISO 9000, ISO 14000 etc.
 As a proof that the instrument is working.
 Confidence in using the instruments.
 Traceability to national measurement standard.
 Interchangeability.
 Reduced rejection, failure rate thus higher return.
 Improved product and service quality leading to satisfied customers.
 Power saving.
 Cost Saving.
 Safety.

The Basic Requirements for Calibration:-
 Reference / Calibration Standards & other instruments / equipments
 Controlled Environment Conditions.
 Competence of Calibration Lab personnel.

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 Traceability of Reference / Calibration standards.
 Documentation.

Serial No. Name Of Instrument Calibration Frequency
01 Thermometer Every 6 Months
02 Digital Balance Every Time on usage
03 Ph. meter Every day
04 Karl Fisher Every Time on usage
05 Polari meter Every 3 months
06 Friabilator Every month
07 Conductivity meter Every 15 days
08 Hardness tester Every year
09 Disintegration apparatus Every month
10 Dissolution apparatus Every 3 months
11 U.V Spectrophotometer Every 3 months


Sources of error in calibration:-
• Stabilization
• Normal position
• Avoid sources of interference
• Avoid traces of leftover
**Calibration accuracy should be 3 to 10 times the accuracy required for the measurement

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Concept of Validation:-
GMP- definition is the validation of “establishing documented evidence that establishes a high degree of certainty that a
particular process will consistently a product that provides the previously established specifications & quality attributes are
available.
 The collection and evaluation of data, from the process design stage through commercial production, which
establishes scientific evidence that a process is capable of consistently delivering quality products. (FDA)

 Documented evidence which provides a high degree of assurance that a specific process will consistently result in a
product that meets predetermined specifications and quality characteristics. (WHO)
 The documented evidence that the process, operated within established parameters, can perform effectively and
reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.(EMA)
Types of process validation and dossier requirements:-

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Documentations associated with Validation:-
 SOP (Standard Operating Procedures),
 Specifications,
 Validation Master Plan(VMP),
 Validation Protocols & Reports


Validation Protocol Standards:-
The following method of construction must be used. The over-all protocol standards are shown in the SOP’s for the different
protocols, here we are concerned about the testing element alone. All testing must be detailed and pre-approved by a
qualified person to ensure the system under test has been adequately tested. Each test must comprise of;

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Main Sub-headings in Test Script:-
 A Rationale; giving the reason and or object of the test.
 A detailed Test Method.
 Detailed Acceptance criteria; that the tests must produce.
 A Test Result; confirming whether the test result, satisfied the acceptance criteria.
General details that must be adhered to:-
 The test result must be initialed (or signed) by the person executing the tests, on completion or at each significant
stage.
 Each test must be designed to verify an element of the equipment functionality.
 Each test must a have a result that is clear, unambiguous and known.
 The test method must call up for the recording of the test result parameters. (No ticks or tick boxes, no generalities).
 Each test must be witnessed or the results must be reviewed by a competent person.
 The overall test results must be approved by a competent person.
Standard Protocol Inter-relationships:-

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Action of providing & documenting that any premises, systems & equipment are properly installed, &/or work correctly &
lead to expected results.
Qualification is often a part (the initial stage) of validation, but Qualification alone do not constitute process validation.
Qualification is a part of validation
 According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence
which provides a high degree of assurance that a specific process will consistently produce a product meeting its
predetermined specifications and quality attributes.”
 It is a requirement for Good Manufacturing Practices and other regulatory requirements.
Types of Qualification:-
Validation is broken down into 5 main phases,
 Design qualification (DQ).
 Installation qualification (IQ).
 Operational qualification (OQ).
 Performance qualification (PQ).
 Maintenance Qualification (MQ)
 Component qualification (CQ).
Vendor Time Line:-

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Quality Management equipment qualification:-















Equipment Qualification:-
It is a basic requirement of good analytical chemistry that balances and other analytical instruments must be suitable for the
purpose for which they are used and that they must be appropriately calibrated. As a consequence, Equipment Qualification
is gaining more and more importance in ensuring the validity of results. Regulatory bodies also seem to be turning their
attention increasingly to this area, and manufacturers of analytical equipment are forced to play a significant role in the
various steps of Equipment Qualification.
The 5 steps of Equipment Qualification:-

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Step 1: Design Qualification (DQ) defines the functional and operational specifications of a balance or instrument.

Step 2: Installation Qualification (IQ) ensures that a balance or instrument is received as designed and specified. It
documents the installation in the selected user environment.

Step 3: Operational Qualification (OQ) demonstrates that a balance or instrument will function according to its operational
specification in the selected environment.

Step 4: Performance Qualification (PQ) demonstrates that a balance or instrument consistently performs according to a
specification appropriate to its routine use.

Step 5: Maintenance Qualification (MQ) describes and documents any maintenance required on the equipment.
Design qualification (DQ):-









Installation Qualification (IQ):-

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Installation qualification (IQ) is the process of checking the installation, to ensure that the components meet the approved
specification and are installed correctly, and to see how that information is recorded. The purpose is to ensure that all
aspects (static attributes) of the facility or equipment are installed correctly and comply with the original design.
All of the instrumentation components are identified and checked against the manufacturer’s component listing.
The working environment conditions are documented and checked to ensure that they are suitable for the operation of the
instrument.
Installation Qualification establishes that the instrument is received as designed and specified, that it is properly installed in
the selected environment, and that this environment is suitable for the operation and use of the instrument.

Before installation:
- Obtain manufacturer's recommendations for installation site requirements.
- Check the site for the fulfillment of the manufacturer's recommendations (utilities such as electricity, water and gases plus
environmental conditions such as humidity, temperature, vibration level and dust).
- Allow sufficient shelf space for the equipment itself, related SOPs, operating manuals, logbooks and software.

Operation Qualification (OQ):-

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Operational qualification (OQ) is the process of testing to ensure that the individual and combined systems function to meet
agreed performance criteria and to check how the result of testing is recorded. The purpose is to ensure that all the dynamic
attributes comply with the original design. Each of the instrument’s function are checked to ensure that they conform to the
manufacturer’s specifications.
This includes the use of certified, traceable electrical simulators and standards to verify that the equipment is processing
input signals correctly.
Performance Qualification (PQ):-

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Performance qualification (PQ), also called process qualification, is the process of testing to ensure that the individual and
combined systems function to meet agreed performance criteria on a consistent basis and to check how the result of testing
is recorded. The purpose is to ensure that the criteria specified can be achieved on a reliable basis over a period of time.
The performance of the equipment for its routine analytical use is checked to ensure that this complies with its specification.
 The temperature sensor readings are compared with a certified reference thermometer. After calibration, the
conductivity sensor readings are compared using certified, traceable control standards.
 Control Standards of similar values to the intended test samples must be used for PQ.
 Performance Qualification (PQ) is the process of demonstrating that an instrument consistently performs according
to a specification appropriate to its routine use.
 Important here is the word consistently. The test frequency is much higher than for OQ. Another difference is that PQ
should always be performed under conditions that are similar to routine sample analysis.
 PQ should be performed on a daily (or at least a weekly) basis, or whenever the instrument is used. The test
frequency depends not only on the stability of the equipment but also on everything in the system that may
contribute to the analysis results.

1. Define the performance criteria and test procedures.
2. Select critical parameters.
3. Define the test intervals
Maintenance Qualification (MQ):-

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The MQ describes and documents any maintenance required on the equipment. This includes routine servicing and any
repairs necessary. Details of any maintenance contracts are also documented in this section, together with a list of
authorized service engineers. In addition, the MQ includes the routine cleaning of the equipment and also its ultimate
disposal.
Component qualification (CQ):-
 Component qualification (CQ) – is a relatively new term developed in 2005. This term refers to the manufacturing of
auxiliary components to ensure that they are manufactured to the correct design criteria. This could include
packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these
components must have some type of random inspection to ensure that the third party manufacturer's process is
consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
Instrument Re-Qualification:-
 Instrument Validation should not be viewed as a one-off event – confidence in analytical results is required for the
whole of the instrument’s working life.
 To ensure that this confidence is retained, the instrument validation process should be repeated at regular intervals
during the instruments operational life.
 The difference between Installation Validation and Re-Qualification is that IQ is omitted for the Re-Qualification
 Re-Qualification should be performed at least annually and should be performed more frequently for applications
whose test results have critical implications



Management in business & organizations s the function that coordinates the effort of people to accomplish goals &
objectives by using available resources efficiently & effectively.
Management includes planning organization, staffing leading or directing & controlling an organization to accomplish the
goal. Resourcing encompasses the development & manipulation of human resources, financial resources, technological
resources & natural resources. Management is also an academic discipline, a social science whose objective is to study
social organization.

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Management Key Concepts:-
Organizations: People working together and coordinating their actions to achieve specific goals.
Goal: A desired future condition that the organization seeks to achieve.
Management: The process of using organizational resources to achieve the organization’s goals
Resources are organizational assets and include:
Man,
Machinery,
Materials,
Money
Managers - to meet its goals.
Organizational Performance:-
Managers use resources effectively and efficiently to satisfy customers and to achieve goals.
Efficiency: A measure of how well resources are used to achieve a goal.
Effectiveness: A measure of the appropriateness of the goals chosen, and the degree to which they are
achieved.
Characterization:-
 One of the most important human activities is managing.
 Managing has been essential to ensure the coordination of individual efforts.
 Task of managers has been rising in importance.
CONCEPT OF MANAGEMENT:-
The term management is used in three alternative ways:
• Management as a discipline,
• Management as a group of people, and
• Management as a process.

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WHAT IS MANAGEMENT?
1. Field of Study -Management principles, techniques, functions, etc.-Profession
2. Team or Class of people-Individual who performs managerial activities or may be a group of persons
3. Process-Managerial activities -planning, organizing, staffing, directing, controlling.
 Different context of defining management:
There are four such orientations have been adopted in defining management process:
• Production-or efficiency-oriented,
• Decision-oriented,
• People-oriented, and
• Function-oriented.
NATURE AND SCOPE OF MANAGEMENT:-
The nature of management can be described as follows:
• Multidisciplinary
• Dynamic nature of principles
• Relative, not absolute principles
• Management: Science or Art
• Management as profession
• Universality of management
IMPORTANCE OF MANAGEMENT:-
The importance of management may be traced in the following contexts:
• Effective Utilization of Resources
• Development of Resources
• To incorporate Innovations
• Integrating Various Interest Groups
• Stability in the Society

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Functions of Management:-
The following are the functions of management:
 Planning,
 Organizing,
 Staffing,
 Directing or Leading and
 Controlling.



The growth–share matrix (aka the Product Portfolio Matrix, Boston Box, BCG-matrix, Boston matrix, Boston Consulting
Group analysis, and portfolio diagram) is a chart that was created by Bruce D. Henderson for the Boston Consulting Group in
1970 to help corporations to analyze their business units, that is, their product lines. This helps the company allocate
resources and is used as an analytical tool in brand marketing, product management, strategic management, and portfolio
analysis. Some analysis of market performance by firms using its principles has called its usefulness into question.
To use the chart, analysts plot a scatter graph to rank the business units (or products) on the basis of their relative market
shares and growth rates.
 Cash cow is where a company has high market share in a slow-growing industry. These units typically generate
cash in excess of the amount of cash needed to maintain the business. They are regarded as staid and boring, in a
"mature" market, yet corporations value owning them due to their cash generating qualities. They are to be "milked"
continuously with as little investment as possible, since such investment would be wasted in an industry with low
growth.
 Dogs, more charitably called pets, are units with low market share in a mature, slow-growing industry. These units
typically "break even", generating barely enough cash to maintain the business's market share. Though owning a
break-even unit provides the social benefit of providing jobs and possible synergies that assist other business units,
from an accounting point of view such a unit is worthless, not generating cash for the company. They depress a
profitable company's return on assets ratio, used by many investors to judge how well a company is being
managed. Dogs, it is thought, should be sold off.
 Question marks (also known as problem children) are businesses operating with a low market share in a high
growth market. They are a starting point for most businesses. Question marks have a potential to gain market share
and become stars, and eventually cash cows when market growth slows. If question marks do not succeed in
becoming a market leader, then after perhaps years of cash consumption, they will degenerate into dogs when
market growth declines. Question marks must be analyzed carefully in order to determine whether they are worth
the investment required to grow market share.

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 Stars are units with a high market share in a fast-growing industry. They are graduated question marks with a
market or niche leading trajectory, for example: amongst market share front-runners in a high-growth sector, and/or
having a monopolistic or increasingly dominant unique selling proposition with burgeoning/fortuitous proposition
drive(s) from: novelty (e.g. Last.FM upon CBS Interactive due diligence), fashion/promotion (e.g. newly
prestigious celebrity branded fragrances), customer loyalty (e.g. Greenfield or military/gang enforcement backed,
and/or innovative, grey-market/illicit retail of addictive drugs, for instance the British East India Company's, late-
1700s opium-based Qianlong Emperor embargo-busting, Canton System), goodwill (e.g.monopsonies)
and/or gearing (e.g. oligopolies, for instance Portland cement producers near boomtowns), etc. The hope is that stars
become next cash cows.
Stars require high funding to fight competitions and maintain a growth rate. When industry growth slows, if they remain a
niche leader or are amongst market leaders they have been able to maintain their category leadership stars become cash
cows, else they become dogs due to low relative market share.

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Benefits of the BCG matrix:-
The key benefits of the BCG matrix are:
 It is very simple to use and explain, as there are only two dimensions and four quadrants
 It is a reputable and long-standing strategic model that has proved to be robust over time and significant changes in
the competitive environment
 Usually the measurements required – market growth and relative market share – are available to the company, along
with competitive measures, making it relatively easy to execute and prepare
 Clear guidance is provided for each quadrant in terms of the approach to investment and support of business units
(or brands or products) – perhaps with the exception of the question mark quadrant (please see discussion of the
question mark quadrant)
 It is an important model for allocating resources for firms pursuing market share goals and seeking experience curve
benefits
 The firm has a basis for allocating resources across its business units, based upon competitive position and market
opportunity – making for a more strategic based decision
 Although the matrix is developed based upon historical/current position, the four quadrants of the BCG matrix
provide some strategic guidance for the future
 The matrix is more beneficial for large-scale manufacturing operations where experience curve benefits can be
realized – that is, where they is a strong correlation between market share profitability
 For students, it provides a good understanding of the concept of aligning competitive strengths with market
opportunities in the development of a suitable strategy for the organization.

Limitations of the BCG-Matrix:-
 It neglects the effects of synergies between business units.
 High market share is not the only success factor.
 Market growth is not the only indicator for attractiveness of a market.
 Sometimes Dogs can earn even more cash as Cash Cows.
 The problems of getting data on the market share and market growth.
 There is no clear definition of what constitutes a “market”.
 A high market share does not necessarily lead to profitability all the time.

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 The model uses only two dimensions – market share and growth rate. This may tempt management to emphasize a
particular product, or to divest prematurely.
 A business with a low market share can be profitable too.
 The model neglects small competitors that have fast growing market shares.

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What Does A SWOT Evaluate?










What are Strengths?
Strengths:
 What advantages (for example, skills, education or personal industry connections) do they have that others don’t
have?
 What do they do better than anyone else?
 What personal resources do they have access to?
 What do other people (and their superiors in particular) see as their strengths?
 In looking at your employees strengths, think about them in relation to the other employees
Example: if an RSM is making call attainment and the other employees around them are not, then this is likely to be
strength in their current role.

What are Weaknesses?
 What should they avoid?
 What could your employees improve?

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 What things are the people around them likely to see as weaknesses? (qualities that the employee may be
unaware of) Do co-workers consistently out-perform them in key areas?
 It is best to be realistic now, and help them face any unpleasant truths if possible.
 Examples – unorganized binders, too casual dress, poor rapport, poor time management.

What are Opportunities?
Opportunities:
 A useful approach to looking at opportunities is also to look at employees’ strengths and ask you whether these
open up any opportunities.
 Alternatively, look at their weaknesses and ask whether they could open up opportunities by eliminating them.
Changes in technology, markets and our company on both a broad and narrow scale
 Changes in the company’s need for future managers – having managerial skills or wanting to improve their
management skills (Fast Track Candidate)
 Changes in social patterns, population profiles, lifestyle changes, etc.

What are Threats?
Threats:
 What obstacles do they face?
 What are the people around them doing?
 Is their job (or the demand for the things they do) changing?
 Is changing technology threatening their position?
 Could their weaknesses seriously threaten them? Today’s standard of technical competence will be tomorrow’s
level of incompetence. The technological landscape requires constant upgrading of skills and proficiencies.
 Example: RSM can’t send in success stories by e- mail and is not trying to learn how to improve computer skills

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SWOT Analysis Worksheet for an RSM:-
Strengths:
• Has management experience in driving results and promotions
• Very good selling skills & analytical abilities
• College degree & recent new hire
• Speaks two or more languages
Weaknesses:
• Dresses too casually
• Perceived as Career not important / unmotivated
• Books and Bag not organized
• Lacks professionalism in the business
Opportunities:
• Possible Fast Track candidate
• Instruct on how to improve communication skills
• ASM career opportunities if skills continue to be tutored
• International management opportunities
Threats:
• Has no previous outside marketing/sales experience
• Has limited Excel, Word, PowerPoint, or e-mail skills
• Large territory requires overnights and extensive driving
• Competitive job markets – career vs. money $
Private Personal Issues (not criteria):
• Retirement Age
• Member of Rotary Club
SWOT Analysis

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• Has small children at home
• Prior medical conditions or issues


Use of SWOT Analysis:-
A SWOT (strengths, weaknesses, opportunities and threats) analysis looks at internal and external factors that can affect your
business. Internal factors are your strengths and weaknesses. External factors are the threats and opportunities. If an issue or
situation would exist even if your business didn't (such as changes in technology or a major flood), it is an external issue.
 Strategic planning, brainstorming and decision making
 Building on strengths
 Minimizing weaknesses
 Seizing opportunities
 Counteracting threats
 Addressing individual issues

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What is Quality?
 In manufacturing, a measure of excellence or a state of being free from defects, deficiencies and significant variations. It is
brought about by strict and consistent commitment to certain standards that achieve uniformity of a product in order to
satisfy specific customer or user requirements.
The totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs.
(ISO 8402-1986)
Quality is fitness for use
• Quality is meeting customers’ expectations
• Quality is exceeding the customers’ expectations
• Quality is superiority to competitors
Quality Control (QC)
The standard(s) to which the construction or assembly of a building component has been
incorporated into the project’s design.
• Quality control is concerned with the operational activities and techniques that
are used to fulfil the requirements of quality.
• The quality control process includes the activities which ensure a high quality
product. These activities focus on identifying defects in the actual product being
produced.
Quality control functions start once the project work has begun. Quality control is a reactive approach and helps you find
defects in deliverables.
Quality Assurance (QA)
• Are all those planned and systematic actions necessary to provide adequate
confidence that an entity will fulfil requirements for quality
• Quality assurance is a process based approach whose prime objective is to
prevent defects in deliverables in the planning process itself to avoid the
rework, which costs a lot.

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• Quality assurance is a proactive process, and it starts at the very beginning of the project to understand the product’s
stated and non-stated requirements and expectations, and then develop the plan to meet these requirements and
expectations.
• Quality audit is an example of a quality assurance process. Other examples of quality assurance are training, process
definition, selection of tools, etc.
The Difference between Quality Assurance and Quality Control:-











The Benefits of Quality Assurance and Quality Control:-
• It gives you a high quality output.
• It increases the efficiency of operations.
• It brings customer satisfaction, which affects your brand and helps you grow your business.
• If your product is of good quality, you will not need much rework and there will not be much after-sale support
required. This will help you save a lot of money.
• A high level of confidence and a motivated team.

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Apparatus in pharmaceutical Quality control:-
Muffle Furnace:-
A muffle furnace (sometimes, retort furnace) in historical usage is a furnace in
which the subject material is isolated from the fuel and all of the products of
combustion, including gases and flying ash.
Today, a muffle furnace is (usually) a front-loading box-type oven or kiln for
high-temperature applications such as fusing glass,
creating enamel coatings, ceramics and soldering and brazing articles. They are
also used in many research facilities, for example by chemists in order to
determine what proportion of a sample is non-combustible and non-volatile
(i.e., ash). Some digital controllers allow RS232 interface and permit the
operator to program up to 126

segments, such as ramping, soaking, sintering,
and more. Also, advances in materials for heating elements, such as
molybdenum silicide, can now produce working temperatures up to 1,800
degrees Celsius (3,272 degrees Fahrenheit), which facilitate more sophisticated
metallurgical applications.
A muffle furnace is also called a retort furnace.
Disintegration apparatus:-
 For a drug to be readily available to the body, it must be in solution.
 For most tablets, the first important step toward solution is break down of the tablet
into smaller particles or granules, a process called disintegration.
The U.S.P. device to test disintegration uses 6 glass tubes that are 3 inches long; open at the
top and 10 mesh screens at the bottom end. To test for disintegration time, one tablet is
placed in each tube and the basket rack is positioned in a 1-L beaker of water, simulated
gastric fluid or simulated intestinal fluid at 37 ± 2
0
C such that the tablet remain 2.5 cm below
the surface of liquid on their upward movement and not closer than 2.5 cm from the bottom of
the beaker in their downward movement. Move the basket containing the tablets up and down
through a distance of 5-6 cm at a frequency of 28 to 32 cycles per minute. Floating of the
tablets can be prevented by placing perforated plastic discs on each tablet.
 To be in compliance with USP standards, the tablet must disintegrate and all particles
must pass through the 10 mesh screen in the time specified. If any residue remains, it must
have a soft mass with no hard core.

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 Complete disintegration is a state in which any residue remains is a soft mass having no palpable firm core except
fragments of insoluble coating remaining on the screen of the apparatus.
 Procedures are stated for running disintegration times for uncoated tablets, plain coated tablets, enteric coated
tablets, buccul tablets and sublingual tablets.
 Uncoated USP tablets have disintegration time as low as 5 minutes, but the majority has max. Disintegration time of
30 minutes.
 Disintegration test: we start with 6 tablets ( each tablet in each tube) , if one or two tablets failed to disintegrate
completely, test should be repeated for additional 12 tablets , the requirement met if not fewer than 16 of the total
18 are disintegrated.
 Enteric coated tablets are similarly tested. Except that the tablets are tested in simulated gastric fluid for one hour ,
after which no sign of disintegration , cracking or softening must be seen. They are immersed in simulated intestinal
fluid for the time specified in the monograph, during which time the tablets disintegrate completely for a positive
test.
Photoflurometer:-
A fluorimeter or fluorimeter is a device used to measure parameters of fluorescence: its
intensity and wavelength distribution of emission spectrum after excitation by a certain
spectrum of light. These parameters are used to identify the presence and the amount of
specific Fluorescence analysis can be orders of magnitude more sensitive than other
techniques. Applications
includechemistry/biochemistry, medicine, environmental monitoring. For instance,
they are used to measure chlorophyll fluorescence to investigate entry of Light
sources for fluorometers are often dependent on the type of sample being tested.
Among the most common light source for fluorimeter is the low-pressure mercury
lamp. This provides many excitation wavelengths, making it the most versatile.
However, this lamp is not a continuous source of radiation. The xenon arc lamp is used
when a continuous source of radiation is needed. Both of these sources provide a suitable spectrum
of ultraviolet light that induces chemiluminescence. These are just two of the many possible light sources.
Glass and silica cells are often the vessels in which the sample is placed. The scientist must be very careful to not leave
fingerprints or any other sort of mark on the outside of the cell.

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Tablet Hardness Tester:-
Tablet hardness testing, is a laboratory technique used by the pharmaceutical industry to test the breaking point and
structural integrity of a tablet "under conditions of storage, transportation, and handling before usage" The breaking point of
a tablet is based on its shape. It is similar to friability testing but they are not the same thing.
Tablet hardness testers first appeared in the 1930s. In the 1950s, the Strong-
Cobb tester was introduced. It was patented by Robert Albrecht on July 21,
1953. and used an air pump. The tablet breaking force was based on arbitrary
units referred to as Strong-Cobbs. The new one gave readings that were
inconsistent to those given by the older testers.

Later, electro-mechanical testing
machines were introduced. They often include mechanisms like motor drives,
and the ability to send measurements to a computer or printer.
There are 2 main processes to test tablet hardness: compression testing and 3
point bend testing. For compression testing, the analyst generally aligns the
tablet in a repeatable way, and the tablet is squeezed by 2 jaws. The first
machines continually applied force with a spring and screw thread until the tablet
started to break. When the tablet fractured, the hardness was read with a sliding
scale.
There are several devices used to perform this task:
 The Monsanto tester was developed 50 years ago. The design consists of "a barrel containing a compressible spring
held between 2 plungers". The tablet is placed on the lower plunger, and the upper plunger is lowered onto it.
 The Strong-Cobb tester forces an anvil against a stationary platform. Results are viewed from a hydraulic gauge. The
results are very similar to that of the Monsanto tester.
 The Pfizer tester compresses tablet between a holding anvil and a piston connected to a force-reading gauge when
its plier-like handles are gripped.
 Erweka tester tests a tablet placed on the lower anvil and a weight moving along a rail transmits pressure slowly to
the tablet.
 The Dr.Schleuniger Pharmatron tester operates in a horizontal position. An electric motor drives an anvil to compress
a tablet at a constant rate. The tablet is pushed against a stationary anvil until it fractures. A reading is taken from a
scale indicator.
Karl Fischer:-
Karl Fischer titration is a classic titration method in analytical chemistry that
uses coulometric or volumetric titration to determine trace amounts of water in

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a sample. It was invented in 1935 by the German chemist Karl Fischer. Today, the titration is done with an automatized Karl
Fischer titrator.

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Polarimeter:-
A Polarimeter is a scientific instrument used to measure the angle of
rotation caused by passing polarized light through an optically
active substance.
Some chemical substances are optically active, and polarized
(unidirectional) light will rotate either to the left (counter-clockwise) or
right (clockwise) when passed through these substances. The amount
by which the light is rotated is known as the angle of rotation
Other apparatus are:-
Dissolution apparatus,
Potentiometric titrimeter,
pH Meter,
Spectrophotometer etc.






1. Hot Air Oven for Sterilization:
It is used for sterilization of glassware’s, such as test tubes, pipettes and petri dishes. Such dry sterilization is done only for
glassware’s. Liquid substances, such as prepared media and saline solutions cannot be sterilized in oven, as they lose water
due to evaporation.
The glassware’s are sterilized at 180°C for 3 hours. An oven (Figure 3.2) has a thermostat-control, using which the required
constant temperature can be obtained by trial and error. The thermostat dial reading is approximate and the exact
temperature is read by introducing a thermometer into the oven or on a built-in L-shaped thermometer.

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In a modern oven (Figure 3.3), there is a digital temperature display and automatic temperature controller to set the desired
temperature easily. Time is set by a digital timer. After loading the glassware’s, the door is closed and oven switched on.

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The required temperature is set. After the oven attains the set temperature, the required time of sterilization is set on the
timer. The oven switches off automatically after the set time. The oven is opened, only after its temperature comes down
near to room temperature. Otherwise, if the door is opened, while the inside of the oven is still very hot, cold air may rush in
and crack the glassware’s.
2. Drying Oven:
For preparation of certain reagents, the glassware’s, after proper cleaning and rinsing with distilled water, are required to be
dried. They are dried inside the drying oven at 100°C till the glassware’s dry up completely.
3. Autoclave:
Autoclave is the nucleus of a microbiology laboratory. It is used not only to sterilize liquid substances such as prepared media
and saline (diluents) solutions, but also to sterilize glassware’s, when required.
It has the same working principle as a domestic pressure cooker. The maximum temperature that can be obtained by boiling
water in an open container is 100°C (boiling point of water).
This temperature is sufficient to kill only the non-spore formers, but it is difficult to kill the spore-forming bacteria at this
temperature, as they escape by forming heat resistant spores. It takes very long time to kill the spores at this temperature.
On the other hand, when water is boiled in a closed container, due to increased pressure inside it, the boiling point elevates
and steam temperature much beyond 100°C can be obtained. This high temperature is required to kill all the bacteria
including the heat resistant spore-formers. Steam temperature increases with increase in steam pressure (Table 3.1).
Table 3.1: Temperatures attainable at different steam pressures:
In operating a standard vertical autoclave, (Figure 3.4) sufficient water is poured into it. If water is too less, the bottom of the
autoclave gets dried during heating and further heating damages it.

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If it has in-built water heating element, (Figure 3.5) water level should be maintained above the element. On the other hand,
if there is too much water, it takes long time to reach the required temperature.

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The materials to be sterilized are covered with craft paper and arranged on an aluminium or wooden frame kept on the
bottom of the autoclave, otherwise if the materials remain half-submerged or floating, they tumble during boiling and water
may enter. The autoclave is closed perfectly airtight only keeping the steam release valve open.
Then, it is heated over flame or by the in-built heating element. Air inside the autoclave should be allowed to escape
completely through this valve. When water vapour is seen to escape through the valve, it is closed.
Temperature and pressure inside goes on increasing. The pressure increase is observed on the pressure dial. Usually
sterilization is done at 121 °C (a pressure of 15 pounds per square inch i.e. 15 psi) for 15 minutes. The required time is
considered from the point, when the required temperature-pressure is attained.
Once required temperature-pressure is attained, it is maintained by controlling the heating source. After the specified time
(15 minutes), heating is discontinued and steam release valve slightly opened. If fully opened immediately, due to sudden fall
in pressure, liquids may spill out from the containers.
Gradually, the steam release is opened more and more, so as to allow all steam to escape. The autoclave is opened only after
the pressure drops back to normal atmospheric pressure (0 psi). The autoclave should never be opened, when there is still
pressure inside. The hot sterilized materials are removed by holding them with a piece of clean cloth or asbestos- coated
hand gloves.
In case of a steam-jacketed horizontal autoclave, a boiler produces the steam (Figure 3.6). It is released at a designated
pressure, into the outer chamber (jacket). Air is allowed to escape and then its steam release valve is closed.

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The hot jacket heats the inner chamber, thereby heating the materials to be sterilised. This prevents condensation of steam
on the materials. Now, steam under pressure is released from the jacket into the inner chamber and air is allowed to escape
from it.
Then, its steam release valve is closed. The steam under pressure in the inner chamber reaches temperatures in excess of
100°C, which can sterilise the materials kept inside it. The autoclave also has automatic shutting system i.e. unless
temperature and pressure comes down near to room conditions, the door cannot be opened.
Besides the pressure dial, it also has separate temperature dial to indicate the temperature inside the inner chamber.
Moreover, the autoclave maintains the temperature and pressure automatically and switches off after the set time of
sterilization.
4. Microbiological Incubator:
Profuse growth of microbes is obtained in the laboratory by growing them at suitable temperatures. This is done by
inoculating the desired microbe into a suitable culture medium and then incubating it at the temperature optimum for its
growth.
Incubation is done in an incubator (Figure 3.7), which maintains a constant temperature specifically suitable for the growth of
a specific microbe. As most of the microbes pathogenic to man grow profusely at body temperature of normal human being
(i.e. 37°C), the usual temperature of incubation is 37°C.

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The incubator has a thermostat, which maintains a constant temperature, set according to requirement. The temperature
reading on the thermostat is approximate. Accurate temperature can be seen on the thermometer fixed on the incubator.
Exact temperature, as per requirement, is set by rotating the thermostat knob by trial and error and noting the temperature
on the thermometer.
Most of the modern incubators (Figure 3.8) are programmable, which do not need trial and error temperature setting. Here,
the operator sets the desired temperature and the required period of time.

The incubator automatically maintains it accordingly. Moisture is supplied by placing a beaker of water in the incubator
during the growth period. A moist environment retards the dehydration of the media and thereby, avoids spurious
experimental results.

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5. BOD Incubator (Low Temperature Incubator):
Some microbes are to be grown at lower temperatures for specific purposes. The BOD low temperature incubator (Figure
3.9), which can maintain temperatures from 50°C to as low as 2-3°C is used for incubation in such cases.

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The constant desired temperature is set by rotating the knob of the thermostat. Rotation of the thermostat knob moves a
needle on a dial showing approximate temperature. Exact required temperature is obtained, by rotating the knob finely by
trial and error and noting the temperature on the thermometer fixed on the incubator.
Most of the modern BOD incubators (Figure 3.10) are programmable, which do not need trial and error temperature setting.
Here, the operator sets the desired temperature and the required period of time. The incubator automatically maintains it
accordingly.

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6. Fridge (Refrigerator):
It serves as a repository for thermo labile chemicals, solutions, antibiotics, serums and biochemical reagents at cooler
temperatures and even at sub-zero temperatures (at less than 0°C). Stock cultures of bacteria are also stored in it between
sub-culturing periods. It is also used for the storage of sterilized media, so as to prevent their dehydration.
7. Deep-fridge:
It is used to store chemicals and preserve samples at very low sub-zero temperatures.
8. Electronic Top-pan Balance:
It is used for weighing large quantities of media and other chemicals, where precise weighing is not of much importance.
9. Electronic Analytical Balance:
It is used to weigh small quantities of chemicals and samples precisely and quickly.
10. Double-pan Analytical Balance:
It is used to weigh chemicals and samples precisely. Weighing takes more time, for which it is used in emergency only.
11. Distilled Water Plant:
Water is used in the preparation of media and reagents. If the media are prepared using tap water, the chemical impurities
present in it may interfere with the growth of the microorganisms in the media. Moreover, the higher is the bacteria content
of the media, the longer is the time required for their sterilization and greater is the chance of survival of some bacteria.
Distilled water, though not bacteria- free, contains less number of bacteria. That is why; it is preferred in the preparation of
microbiological media. It is also used in the preparation of reagents, because the chemical impurities present in tap water
may interfere with the proper functioning of the reagent chemicals.
As manufacture of distilled water by Liebig condenser is a time-taking process, in most laboratories, it is prepared by ‘distilled
water plants’. Usually a distilled water plant is made of steel or brass. It is also called distilled water still.
It has one inlet to be connected to the water tap and two outlets, one for distilled water to drop into a container and the
other for the flow out of hot cooling water into the sink. The still is installed on the wall. It is heated by in-built electric
heating elements (immersion heater).
The still works efficiently, when the water in-flow is so adjusted that, the temperature of the cooling water flowing out from
the still into the sink is neither too high nor too low i.e., warm water should flow out. The distilled water may contain traces
of metals corroded from the steel or brass container.
To get metal-free distilled water, glass distillation apparatus is used and still better is quartz distillation apparatus. However,
for a microbiology laboratory, a steel or glass distillation apparatus is sufficient. For precision analyses, double- or triple-
distilled water is used.
12. Ultrapure Water Purification System:

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For precision analytical works, now-a-days, instead of using double- or triple-distilled water, micro- filtered water is used. In
case of distilled water, there is chance that, few volatile substances present in the water get volatilized during heating of the
water and subsequently get condensed into the distilled water collected.
Thus, there may be traces of such substances in the distilled water. To overcome this, ultrapure water is used. Here, water is
allowed to pass through very fine microscopic pores, which retain the microscopic suspended particle including the microbes.
Then, the water passes through two columns of ion exchange resins. The anion exchange resin adsorbs the captions present
in the water, while the caption exchange resin adsorbs the anions. The water that comes out is extremely pure.
13. Homogenizer:
For microbiological analysis, liquid samples are directly used, whereas solid samples have to be mixed thoroughly with a
diluents (usually physiological saline), so as to get a homogenous suspension of bacteria. This suspension is assumed to
contain bacteria homogenously.
The mixing of solid samples and diluents is done by a homogenizer, in which a motor rotates an impeller with sharp blades at
high speed inside the closed homogenizer cup containing the sample and the diluents. It has a speed regulator for controlling
the speed of rotation of the impeller.
In some laboratories mixing is done manually by sterilized pestle and mortar. In modern laboratories, a disposable bag is
used, inside which the solid sample and liquid diluents are put aseptically and mixed mechanically by peristaltic action of a
machine on the bag. This machine is called stomacher.
14. pH Meter:
A pH meter is an instrument for determining the pH of liquid media, liquid samples and buffers. It has a glass pH electrode.
When not in use, it should be kept half immersed in water contained in a small beaker and preferably be covered by a bell jar
to avoid dust accumulation in the water and loss of water through evaporation.
Before use, the meter is calibrated using two standard buffers of known pH. Usually buffers of pH 4.0, 7.0 and 9.2 are
available commercially. The instrument is switched on and left for 30 minutes to warm up. The temperature calibration knob
is rotated to the temperature of the solutions whose pH is to the measured.
Then, the electrode is dipped into the buffer (pH 7.0). If the reading is not 7.00, the pH calibration knob is rotated till the
reading is 7.00. Then, the electrode is dipped in another buffer (pH 4.0 or 9.2).
If the reading is same as the pH of the buffer used, the instrument is working properly. Otherwise, the electrode is activated
by dipping in 0.1 N HC1 for 24 hours. After calibration, the pH of samples is determined by dipping the electrode into them
and noting the reading.
Every time, before dipping into any solution, the electrode should be rinsed with distilled water. The samples should not
contain any suspended sticky materials, which may form a coating on the tip of the electrode and reduce its sensitivity.
The old model pH meters have double electrodes (one of them acting as reference electrode), while new models have single
combined electrode. Moreover, to overcome the problem of temperature correction, now pH meters with automatic
temperature correction are available.

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Here, another ‘temperature electrode’ is also put into the solution along with the pH electrode, which measures the
temperature of the solution and automatically corrects the influence of temperature variations.
Sophisticated pH meters have single gel electrode. Such electrodes have very little chance of breakage, as they are almost
completely enclosed in a hard plastic casing except at the tip. The tip has both pH and temperature sensors.
Moreover, they are easy to maintain, as they do not require constant dipping in distilled water, because the electrode tip is
closed with a plastic cap containing saturated solution of potassium chloride, when not in use. However, in preparation of
microbiological media, pH is determined by narrow-range pH papers and is adjusted to the required pH by adding acids or
alkalis as required.
15. Hot Plate:
Hot plate is used to heat chemicals and reagents. The hot plate is made of an iron plate, which gets heated by an electric
heating element from below. The required degree of heating is obtained by a regulator.
16. Shaking Water Bath:
Sometimes, heating at very precise temperatures is required. Such precise temperatures cannot be obtained in an incubator
or oven, in which temperature fluctuates, though slightly. However, precise temperatures can be maintained in a water bath,
which provides a stable temperature.
A water bath consists of a container containing water, which is heated by electric heating elements. The required water
temperature is obtained by increasing or decreasing the rate of heating by rotating the thermostat by trial and error.
In a shaking water bath, the substance is heated at the required temperature and at the same time, it is shaken constantly.
Shaking is done by a motor, which rotates and moves the containers to and fro in each rotation. The rate of shaking is again
controlled by a regulator. Shaking agitates the substance and enhances the rate of the process.
Most modern water baths are programmable and do not need trial and error temperature setting. A desired water
temperature can be maintained over a desired period of time by programming accordingly. It is used for cultivation of
bacteria in broth medium at a specific temperature.
17. Quebec Colony Counter:
In enumeration of bacteria in samples, it is assumed that a single bacterium gives rise to a single visible colony, when grown
on a plate of solidified nutrient medium. Thus, by counting the number of colonies, the number of bacteria in a sample can be
estimated.
Sometimes, colonies are very small and too much crowded making it difficult to count. Counting becomes easy, when a
mechanical hand counter, called Quebec colony counter (Figure 3.11), is used. It divides the plate into several square
divisions and the colonies are magnified 1.5 times by a magnifying glass, which makes counting easy.

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18. Electronic Colony Counter:
Electronic colony counter is of two types:
(1) Hand-held electronic colony counter and
(2) Table-top electronic colony counter.
The hand-held electronic colony counter is a pen-style colony counter with an inking felt-tip marker. For counting of colonies
of bacteria grown in a petri dish, it is kept in an inverted position, so that the colonies are visible through the bottom surface
of the petri dish.
The colonies are marked by touching the glass surface of the petri dish with the felt-tip of the colony counter. Thus, each
colony is marked by a dot made by the ink of the felt-tip on the bottom surface of the petri dish. In a single motion, the
electronic colony counter marks, counts and confirms with a beep sound.

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The cumulative count of colonies is displayed on a four-digit LED display. In case of table-top electronic colony counter, the
petri dish containing the colonies of bacteria is placed on an illuminated stage and the count bar is depressed. The precise
number of colonies is instantly displayed on a digital read out.
19. Magnetic Stirrer:
In the preparation of solutions, certain chemicals require stirring for long time, to be dissolved in certain solvents. Magnetic
stirrer is used to dissolve such substances easily and quickly. A small teflon- coated magnet, called ‘stirring bar’, is put into a
container containing the solvent and the solute.
Then, the container is placed on the platform of the magnetic stirrer, below which a magnet rotates at high speed by a motor.
Attracted by the rotating magnet, the teflon-coated magnet rotates inside the container and stirs the contents. Now, the
solute dissolves quickly.
The teflon coating prevents the magnet from reacting with the solution, which comes in contact with it. After complete
dissolution, the teflon-coated magnet is removed from the solution by mean of a long retriever, called ‘stirring bar retriever’.
20. Sonicator:
It is used to rupture cells using high frequency waves.
21. Vortex Mixer:
It is an instrument used for thorough mixing of liquids in test tubes. It has a rotor, whose speed can be controlled. On the tip
of the rotor is a foam-rubber top. When the bottom of a test tube is pressed upon this foam-rubber top, the rotor starts
rotating, thereby rotating the bottom of the test tube at high speed.
Due to centripetal force, the solution gets mixed thoroughly. It is particularly helpful during serial dilution in enumeration of
bacteria, which needs homogenous suspension of bacteria cells.
21. Laminar Flow Chamber:
It is a chamber (Figure 3.12) used for aseptic transfer of sterilized materials, as well as for inoculation of microbes. Dust
particles floating in the air harbour microbes. These microbe-laden dust particles may enter into the sterilized media and
contaminate them, when they are opened for short periods of time during inoculation of microbe or transfer from one
container to another.

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To overcome this, when inoculation is done in open air, the air of the small inoculating area is sterilized by the flame of a
bunsen burner. The heated air becomes light and moves upwards, thereby preventing the dust particles from falling on the
media during the short opening process.
To further reduce the chance of contamination by the microbe-laden air, a laminar flow chamber is used. It is a glass-fitted
cuboidal chamber. An air blower blows air from the surrounding and passes it through a HEPA filter (High Efficiency
Particulate Air filter), so as to make it dust free (microbe-free).
This microbe-free air passes through the chamber in a laminar manner and comes out from the chamber through the open
front door. This laminar flow of microbe-free air from the chamber to outside through the open door prevents the outside air
from entering into the chamber.
Thus, the chamber does not get contaminated with the microbes present in the outside air, though the door is kept opened
during inoculation or transfer of media. An UV lamp fitted inside the chamber sterilizes the chamber before operation.
It has a stainless steel platform with provision for gas pipe connection for a bunsen burner. Before use, the platform is
cleaned and disinfected with lysol, the bunsen burner is connected and then the glass door is closed.
The UV light is switched on for 10 minutes to sterilise the environment inside the chamber and then switched off. The glass
door should never be opened when the UV light is on, because UV light has detrimental effect on skin and vision. The blower
is switched on and then the glass door is opened.
Now, the bunsen burner is lighted and media transfer or inoculation is carried out in the chamber aseptically. If extremely
hazardous microbes are to be handled, a laminar flow chamber with gloves projecting into the chamber from the front glass
door is used, as inoculation has to be done keeping the front door closed.
22. Electronic Cell Counter:
It is used to directly count the number of bacteria in a given liquid sample. An example of electronic cell counter is the
‘Coulter counter’. In this equipment, a suspension of bacteria cells is allowed to pass through a minute orifice, across which
an electric current flows.
The resistance at the orifice is electronically recorded. When a cell passes through the orifice, being non-conductor, it
increases resistance momentarily. The number of times resistance increases momentarily is recorded electronically, which
indicates the number of bacteria present in the liquid sample.
23. Membrane Filtration Apparatus:
Certain substances like urea disintegrate and lose their original properties, if sterilized by heat. Such substances are sterilized
by membrane filtration apparatus. In this apparatus, the solution of the substance to be sterilized is filtered through a
membrane filter, which does not allow bacteria cells to pass down. Filtration is done under suction pressure to increase the
rate of filtration (Figure 2.19, page 30).
24. Microscopes:
Different types of microscopes are used for visual observation of morphology, motility, staining and fluorescent reactions of
bacteria.

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25. Computers:
Computers are generally used for analysis of results. They are also used for identification of bacteria easily within few hours.
Otherwise, identification of bacteria is a tedious process and takes days together to identify one bacteria species.
The computers used for identification of bacteria are Apple II, IBM PC and TRS-80 and their modern variants. Each research
personnel of the laboratory should be provided with a computer, along with internet facility.
26. Spectrophotometer:
It is an instrument for measuring the differences in color intensities of solutions. A beam of light of a particular wavelength is
passed through the test solution and the amount of light absorbed (or transmitted) is measured electronically.
A simple visible spectrophotometer can pass light with wavelengths within visible range, whereas a UV-cum-visible
spectrophotometer can pass light with wavelengths in ultraviolet as well as in visible range. In microbiology lab, it is used for
direct counting of bacteria in suspension as well as for other purposes.
27. Electrical Devices:
A fluctuation of electric voltage in the laboratory is one of the most important reasons, which reduces the longevity of the
equipments and sometimes damage them. Therefore, all the voltage-sensitive equipments should be provided with voltage
protection devices like stabilizers, servo stabilizers or constant voltage transformers (CVT) as per the recommendations of the
manufacturers of the equipments.
Computers, balances and some sophisticated equipments should be connected through uninterrupted power supply (UPS), as
any breakdown in the electric power supply during their operation may severely damage some of their sensitive components.
The laboratory should have a high capacity generator to supply electric current to the whole laboratory in case of power
failure. This is because, power failure not only brings the activities of the laboratory to a standstill, it also brings about
undesirable irreversible changes in the samples stored in the deep-fridges and refrigerators.
28. Automatic Bacteria Identification System:
It is an instrument used for automatic computer-assisted identification of bacteria (Figures 3.13 and 3.14). The conventional
method of identification of bacteria is very lengthy and cumbersome.

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It mainly involves staining, motility test, cultural characteristics, a series of biochemical tests and finally searching the name of
the bacteria in ‘Bergey’s Manual of Determinative Bacteriology’ by matching the results with those available in the manual.
The automatic bacteria identification system automatically identifies the bacteria in very short time.
The system, like VITEK 2 (Figure 3.14) uses disposable cards. One card is required for the identification of one bacteria. The
system can accommodate a series of cards, which can be arranged on a cassette, thus enabling the identification of several
bacteria at a time.

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Each card has several rows of wells. Usually there are 8 rows of 8 wells each (8X8 =64 wells). The wells contain different
dehydrated media required for different biochemical tests. A capillary tube is fixed to each card, which sucks the suspension
of bacteria to be identified and dispenses into all the wells.
The dehydrated media in the wells become hydrated by the suspension liquid, thereby allowing growth of the bacteria. After
a prescribed period of incubation, the colour changes in all the wells are recorded automatically in the system.
The results of the color changes go to a computer attached to the system. The computer automatically compares the results
with those available in its library for different bacteria and finally gives the name of the bacteria with a definite probability.
For identification, the given bacteria, grown as isolated colony on a plate or as pure culture grown on a slant are taken. A
lapful of the bacteria is transferred aseptically into sterile saline solution in a test tube and a suspension of the bacteria is
made.
The suspension should contain a prescribed density of bacteria, as determined by a densitometer. The test tube is fixed to the
cassette and a card is fixed near it, such that the tip of the suction capillary tube of the card remains deeply submerged in the
suspension.
Several such test tubes and cards are fixed to each cassette, depending on the number of bacteria to be identified. The
cassette is put in the vacuum chamber of the system. A high vacuum is created inside the chamber, which forces the bacteria
suspension to be sucked into the capillary tubes and dispensed into the wells of the cards.
The cassette is taken out and put inside the incubation and analysis chamber. Here, the capillary tubes are cut and the cut
ends sealed automatically. Then, the incubation process starts at a prescribed temperature for a prescribed period of time,
which is programmed by the control panel. During incubation, in every 15 minutes, each card automatically goes to the color
reader, which reads the color changes in the wells and records them.
The recorded results go to the computer, which automatically compares them with those, available in its library for different
bacteria. Finally, it gives the names of the bacteria with definite probabilities. The used cards fall into the waste disposal
chamber of the system for removal and final disposal after sterilization.
The renowned automatic bacteria identification systems are VITEK 2 and API. While VITEK 2 works on the above principle, the
API (Analytical Profile Indexing) system (Figure 3.13) uses a slightly different method for the automatic identification of
bacteria, which involves manual inoculation and external incubation.
29. PCR Thermocycler, Refrigerated Centrifuge, Ultra-centrifuge, Gas Chromatography (GC), High Performance Liquid
Chromatography (HPLC), Thin Layer Chromatography (TLC), Paper Chromatography, Column Chromatography and
Electrophoresis Unit:
These are instruments used for isolation, purification and identification of biochemical substances, such as bacterial DNA,
plasmids, microbial toxins etc. Polymerase chain reaction (PCR) is an important tool in nucleic acid based methods. It is a
workhorse in modern microbiology and biotechnology laboratories.

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Tablet is defined as a compressed solid dosage form containing medicaments with or without excipients. According to the
Indian Pharmacopoeia Pharmaceutical tablets are solid, flat or biconvex dishes, unit dosage form, prepared by compressing a
drug or a mixture of drugs, with or without diluents

The advantages of the Tablet dosage form are:-
• They are unit dosage form and offer the greatest capabilities of all oral dosage form for the greatest dose precision
and the least content variability.
• Cost is lowest of all oral dosage form.
• Lighter and compact.
• Easiest and cheapest to package and strip.
• Easy to swallowing with least tendency for hang-up.
• Sustained release product is possible by enteric coating. Objectionable odour and bitter taste can be masked by
coating technique.
• Situable for large scale production.
• Greatest chemical and microbial stability over all oral dosage form.
• Product identification is easy and rapid requiring no additional steps when employing an embossed and/or
monogrammed punch face.
Disadvantages of Tablet dosage form are:-
• Difficult to swallow in case of children and unconscious patients.
• Some drugs resist compression into dense compacts, owing to amorphous nature, low density character.
• Drugs with poor wetting, slow dissolution properties, optimum absorption high in GIT may be difficult to formulate
or manufacture as a tablet that will still provide adequate or full drug bioavailability.
• Bitter testing drugs, drugs with an objectionable odor or drugs that are sensitive to oxygen may require encapsulation
or coating. In such cases, capsule may offer the best and lowest cost.

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Different types of Tablets:-
(A) Tablets ingested orally:
1. Compressed tablet, e.g. Paracetamol tablet
2. Multiple compressed tablet
3. Repeat action tablet
4. Delayed release tablet, e.g. Enteric coated Bisacodyl tablet
5. Sugar coated tablet, e.g. Multivitamin tablet
6. Film coated tablet, e.g. Metronidazole tablet
7. Chewable tablet, e.g. Antacid tablet
(B) Tablets used in oral cavity:
1. Buccal tablet, e.g. Vitamin-c tablet
2. Sublingual tablet, e.g. Vicks Menthol tablet
3. Troches or lozenges
4. Dental cone
(c) Tablets administered by other route:
1. Implantation tablet
2. Vaginal tablet, e.g. Clotrimazole tablet
(D) Tablets used to prepare solution:
1. Effervescent tablet, e.g. Dispirin tablet (Aspirin)
2. Dispensing tablet, e.g. Enzyme tablet (Digiplex)
3. Hypodermic tablet
4. Tablet triturates e.g. Enzyme tablet (Digiplex)
Tablet Ingredients:-
In addition to active ingredients, tablet contains a number of inert materials known as additives or excipients. Different
excipients are:
1. Diluent

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2. Binder and adhesive
3. Disintegrents
4. Lubricants and glidants
5. Coloring agents
6. Flavoring agents
7. Sweetening agents
EXCIEPIENTS- functions:-
• Impart weight, accuracy, & volume(its allow accuracy of dose)
• Improve solubility
• Increase stability
• Enhance bioavailability
• Modifying drug release
• Assist pdt identification
• Increase patient acceptability
• Facilitate dosage form design
1. Diluent: Diluents are fillers used to make required bulk of the tablet when the drug dosage itself is inadequate to
produce the bulk. Secondary reason is to provide better tablet properties such as improve cohesion, to permit use of direct
compression manufacturing or to promote flow. A diluent should have following properties:
1. They must be non-toxic
2. They must be commercially available in acceptable grade
3. Their cost must be low
4. They must be physiologically inert
5. They must be physically & chemically stable by themselves & in combination with the drugs.
6. They must be free from all microbial contamination.
7. They do not alter the bioavailability of drug.
8. They must be color compatible.

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Commonly used tablet diluents:-
1. Lactose-anhydrous and spray dried lactose
2. Directly compressed starch-Sta Rx 1500
3. Hydrolyzed starch-Emdex and Celutab
4. Microcrystalline cellulose-Avicel (PH 101and PH 102)
5. Dibasic calcium phosphate dehydrate
6. Calcium sulphate dihydrate
7. Mannitol
8. Sorbitol
9. Sucrose- Sugartab, DiPac, Nutab
10. Dextrose
2. Binders and Adhesives: These materials are added either dry or in wet- form to form granules or to form cohesive
compacts for directly compressed tablet.
• Example: Acacia, tragacanth- Solution for 10-25% Conc.
• Cellulose derivatives- Methyl cellulose, Hydroxy propyl methyl cellulose, Hydroxy propyl cellulose
• Gelatin- 10-20% solution
• Glucose- 50% solution
• Polyvinylpyrrolidone (PVP) - 2% conc.
• Starch paste-10-20% solution
• Sodium alginate
• Sorbitol
3. Disintegrents: Added to a tablet formulation to facilitate its breaking or disintegration when it contact in water in
the GIT.
• Example: Starch- 5-20% of tablet weight.
• Starch derivative – Primogel and Explotab (1-8%)
• Clays- Veegum HV, bentonite 10% level in colored tablet only

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• Cellulose
• Cellulose derivatives- Ac- Di-Sol (sodium carboxy methyl cellulose)
• Alginate
• PVP (Polyvinylpyrrolidone), cross-linked
Superdisintegrants: Swells up to ten fold within 30 seconds when contact water.
4. Lubricant and Glidants: Lubricants are intended to prevent adhesion of the tablet materials to the surface of dies
and punches, reduce inter particle friction and may improve the rate of flow of the tablet granulation.
5. Coloring agent: The use of colors and dyes in a tablet has three purposes:
(1) Masking of off color drugs
(2) Product Identification
(3) Production of more elegant product
6. Flavoring agents: For chewable tablet- flavor oil are used
7. Sweetening agents: For chewable tablets: Sugar, mannitol.
TABLET MANUFACTURING
PROCESS:-

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DISPENSING:-
Dispensing is the first step in any pharmaceutical manufacturing process. Dispensing is one of the most critical steps in
pharmaceutical manufacturing; as during this step, the weight of each ingredient in the mixture is determined according to
dose. Dispensing may be done by purely manual by hand scooping from primary containers and weighing each ingredient by
hand on a weigh scale, manual weighing with material lifting assistance like Vacuum transfer and Bag lifters, manual or
assisted transfer with automated weighing on weigh table, manual or assisted filling of loss-in weight dispensing system,
automated dispensaries with mechanical devices such as vacuum loading system and screw feed system. Issues like weighing
accuracy, dust control (laminar air flow booths, glove boxes), during manual handling, lost control of each ingredient,
material movement into and out of dispensary should be considered during dispensing.

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SIFTING AND SIZING:-
The sifting and sizing (size reduction, milling, and crushing, grinding, pulverization) is an important step in the process of
tablet manufacturing.
In manufacturing of compressed tablets, the mixing or blending of several solid pharmaceutical ingredients is easier and more
uniform if the ingredients are about the same size. This provides a greater uniformity of dose. A fine particle size is essential
in case of lubricant mixing with granules for its proper function.
Advantages of smaller tablets are as follows:
Increased surface area, which may enhance an active ingredient's dissolution rate and hence bioavailability
Improved tablet-to-tablet content uniformity due to a larger number of particles per unit weight
Controlled particle size distribution of dry granulation or mix to promote better flow of mixture in tablet machine
Improved flow properties of raw materials
Improved Colours and/or active ingredient dispersion in tablet excipients
Uniformly sized wet granulation to promote uniform drying
GRANULATION:-
Following particle size reduction and blending, the formulation may be granulated, which provides homogeneity of drug
distribution in blend. This process also is very important and needs experience to attain proper quality of granule before
tableting, quality of granule determines the smooth and trouble free process of tablets manufacturing. Please keep in mind, if
one cannot have experience of granulation, can make great troubles for tableting press operator.

Process Critical Parameters During Process:-

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DRYING:-
Drying is a most important step in the formulation and development of pharmaceutical product. It is important to keep the
residual moisture low enough to prevent product deterioration and ensure free flowing properties. The commonly used
dryers include Fluidized – bed dryer, Vacuum tray dryer, Microwave dryer, Spray dryer, Freeze dryer, Turbo - tray dryer,
Pan dryer, etc.
Process Critical Parameters during Process:-






BLENDING:-
The successful mixing of powder is more difficult than mixing liquid, as perfect homogeneity is difficult to achieve. A further
problem is the inherent cohesiveness and resistance to movement between the individual particles. The process is further
complicated in many systems by the presence of substantial segregation influencing the powder mix. This arises from the
difference in size, shape, and density of the component particles. The powder/granules blending are involved at stage of pre
granulation and/or post granulation stage of tablet manufacturing. Each process of mixing has an optimum mixing time, and
longer mixing may result in an undesired product. The optimum mixing time and mixing speed must be evaluated. Blending
prior to compression is normally achieved in a simple tumble blender. The blender may be a fixed blender into which the
powders are charged, blended and discharged. It is now common to use a bin blender.
LUBRICATION:-
In special cases of mixing a lubricant, over mixing should be particularly monitored. The various blenders used include "V"
blender, Octagonal blender, Oblicone blender, Container blender, tumbling blender, Agitated powder blender. But nowadays
to optimize the manufacturing process particularly in wet granulation the various improved equipment which combines
several processing steps (mixing, granulation and/or drying) are used. They are the "Mixer granulator" and "High shear mixing
machine".
COMPRESSION
After the preparation of granules (in case of wet granulation) or sized slugs (in case of dry granulation) or mixing of
ingredients (in case of direct compression), they are compressed to get final product. The compression is done either by
single punch machine (stamping press) or by multi station machine (rotary press). The tablet press is a high-speed mechanical

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device. It 'squeezes' the ingredients into the required tablet shape with extreme precision. It can make the tablet in many
shapes, although they are usually round or oval. Also, it can press the name of the manufacturer or the product into the top
of the tablet. .
Each tablet is made by pressing the granules inside a die, made up of hardened steel. The die is a disc shape with a hole cut
through its centre. The powder is compressed in the Centre of the die by two hardened steel punches that fit into the top and
bottom of the die. The punches and dies are fixed to a turret that spins round. As it spins, the punches are driven together by
two fixed cams - an upper cam and lower cam. . The top of the upper punch (the punch head) sits on the upper cam edge.
The bottom of the lower punch sits on the lower cam edge.
Process Critical Parameters during Process:-














PACKAGING:-
Tablets must be packaged before they can be sent out for distribution. The type of packaging will depend on the formulation
of the medicine.
Blister packs are a common form of packaging. They are safe and easy to use and the user can see the contents without
opening the pack. Many pharmaceutical companies use a standard size of blister pack. This saves the cost of different tools

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and changing the production machinery between products. Sometimes the pack may be perforated so that individual tablets
can be detached. This means that the expiry date and the drug's name must be printed on each part of the package. The
blister pack itself must remain absolutely flat as it travels through the packaging processes, especially when it is inserted into
a carton. Extra ribs are added to the blister pack to improve its stiffness.




• Semisolid preparations intended for external application to the skin or mucous membranes.
• Semisolid plastic flow characteristics
• Definite yield value
• Resistance to flow drops as application continues
Ointment Bases
• Oleaginous Bases
• Absorption Bases
• Water-Removable Bases
• Water-Soluble Bases
Preparation of Ointments
• Incorporation
• Fusion
Compendia Requirements for Ointments
• Microbial Content
• Minimum Fill
• Packaging, Storage, and Labeling
• Additional Standards
Oleaginous Bases
• Water insoluble

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• Not water washable
• Can’t absorb water
• Oily, occlusive, lack cosmetic appeal
Examples:
• Hydrocarbons (mineral oils, petrolatum, paraffin, waxes)
• Animal fats/vegetable oils (castor oil, cottonseed oil, olive oil)
• Synthetic esters (glyceryl monostearate, butyl stearate, isopropyl lanolate, stearyl alcohol)
• WHITE PETROLATUM
• WHITE OINTMENT
Absorption Bases:
• Water insoluble
• Not water washable
• Can absorb water
• Anhydrous
• Oily, occlusive, lacks cosmetic appeal
Examples:
• Hydrophilic petrolatum
• Aquaporin
• Aqua base
Cream / Ointment Manufacturing
Equipments Include:
 Mixing and Homogenizing Equipment
 1000 Kg / 500 Kg Manufacturing Tanks
 Aqueous Phase Tank
 Oil Phase Manufacturing Tank
This unit is equipped to take batch sizes for 300 Kg to 1000 Kg. Transfer of material from

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vessel to vessel is through vacuum. Wax is melted outside and transferred after weighing. These equipments are having on-
line homogenizers.
Filling Area
Filling area contains double and single head filling machine with online bar code reader. It
is equipped to fill products from 3 gm to 100 gm. Jar filling machine having filling capacity
of 10 g to 500 g.

Packing Area
Cartonators are of Wimco and Subnil with on-line printing.
Lotion Manufacturing
Mixing and Homogenizing Equipment
This contains 1000 Liter SS316 jacketed manufacturing tank with propeller stirrer.
Filling Area
Four head filling machine with pre and post gassing can fill from 3 ml to 100 ml.
Packing Area
Online pressure sensitive labeling machine
Capacity
 Cream Compounding up to 1500 Kgs. per shift
 Solution Compounding up to 1000 Kgs. per shift
 Cream Filling up to 150,000 units per shift
 Solution Filling up to 30,000 units per shift
The plant can run full three shifts.
QC Equipments
The Company has a well-equipped quality control laboratory. The equipments in the laboratory are validated and calibrated
at regular intervals as per the SOPs. Major equipments includes:
 21 CFR compliant Agilent HPLC with temperature-controlled auto sampler
 Agilent Gas Chromatograph (GC)

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 Mettler balance
 UV Spectro photometer
 Karl Fischer Titrator
 Burst Strength tester
 Lacquer porosity test apparatus
 Steam sterilizer with online temperature recorder
 Incubators for microbiology laboratory
 Dedicated autoclave for media destruction
 Deep freezer for storage of microbial cultures



CALAMINOL
(Liminent Calamine)
Composition :

Calamine I.P. 5% w/v
In an oil in water emulsion base agreeably
perfumed
Action and Use:
CALAMINOL is a soothing astringent liniment, containing Calamine I.P. which is basically Zinc Oxide having
properties of precipitating protein of the tissue and serous exudate. It has mild antiseptic and anti-pruritic
properties with soothing action and thus it gives relief from irritable conditions of skin due to diverse
etiology.
Indications:
As a soothing antipruritic and astringent, CALAMINOL is used in dry eczema, urticarial, nappy rash and all

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forms of dermatitis and various irritable conditions of the skin.
It is also indicated for the prevention of roughness on the skin due to sunburn and extreme cold.
CALAMINOL can also be safely used for removal of blemishes from the face or any other part of the body.
Often skin becomes defatted and loses its normal texture on keeping the fractured bone covered for some
time with plaster. After removal of plaster, on application of CALAMINOL on the skin, the normal texture
and auppleness are restored within a short time.
Mode of Application:
CALAMINOL is to be applied on the affected skin with a piece of Cotton wool three times a day or more till
the normal texture of the skin is restored.
Presentation :
50 ml. & 100 ml. Phial
CALACREME
(Calamine in Cream Base)
Composition :

Calamine I.P. 5 % (w/w)
Liquid Paraffin I.P. 25% (w/w)
In cream base
Action & Use :
CALACREME is a soothing astringent in cream base containing Calamine which is basically Zinc Oxide having
properties of precipitating protein of the tissue and serous exudate, it is antipruritic with soothing action
on the skin.
Indications :
CALACREME is indicated as a soothing antipruritic and emollient cream for dry eczema, urticaria and
dermatitis as well as in various irritable conditions. It produces an instant soothing effect on skin in
sunburn and makes the skin soft and supple. CALACREME can be safely applied on the tender and soft skin
of babies and children. It can also be used in defatted and chapped skin as well as to protect from the
adverse effect of cold.
Mode of Application :

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CALACREME is to be applied gently on the skin twice a day or more frequently for better and faster relief
from such complaints.
Presentation :
15 gms. Tube
CALAMYL
(Liminent Calamine)
Composition :

Calamine I.P. 10% w/v
Emulsion Base ( Oil & water )
Action & Use :
CALAMYL is a soothing astringent liniment, containing Calamine which is basically Zinc Oxide having
properties of precipitating protein of the tissue and serous exudate. It acts as mild antiseptic and
antipruritic with soothing action and therefore gives relief from irritable conditions of the skin.
Indication :
As soothing antipruritic and astringent CALAMYL is used in dry eczema, urticaria and all forms of dermatitis
and various irritable conditions of the skin.
It is indicated for the prevention of roughness on skin caused by sunburn and extreme cold. It also removes
blemished on the face or other parts of the body. As it has higher percentage of calamine, it can be used
specially in refractory cases.
Often skin becomes defatted and loses its normal texture on keeping the fractured bone covered for some
time with plaster. After removal of plaster, on application of CALAMYL on the skin, the normal texture and
suppleness are restored within a short time.
Mode of Application :
CALAMYL is to be applied on the affected skin with a piece of Cotton wool three times a day or more till
the normal texture of the skin is restored.
Presentation :
100 ml. Phial

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AQUAMINOL
( Calamine lotion in aqueous base )
Composition :

Calamine I.P. 10% (w/v)
In aqueous base
Action & Use :
AQUAMINOL is a soothing astringent lotion in aqueous base containing Calamine which is basically Zinc
Oxide having properties of precipitating protein of the tissue and serous exudate. Thus it stops secretion
from the oozing surface. As it has a mild antipruritic and sedative action on the skin it gives relief from
irritable condition of the skin due to diverse etiology.
Indication :
As a soothing astringent, AQUAMINOL is used in Urticaria, Weeping Eczema, Atopic Dermatitis, Allergic
Dermatitis, Contact Dermatitis and Occupational Dermatitis or any other irritable conditions of the skin.
Mode of Application :
AQUAMINOL should be applied on the affected area with a piece of cotton wool three times a day or more
frequently for better and faster relief.
Presentation :
50 ml. & 100 ml. Phial.

HISTACALAMINE
( An Astringent Lotion with Antihistamine )

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Composition :
Calamine I.P. 15% ( w/v )
Chlorpheniramine Maleate U.S.P. 0.4 % (w/v)
In aqueous base
Action & Use :
HISTACALAMINE is a soothing astringent in aqueous base containing Calamine which is basically Zinc Oxide
having properties of precipitating protein of the tissue and serous exudate and prevent secretion from
oozing surface. It also contains Chlorpheniramine Maleate a potent anti histamine which gives prompt
relief from pruritus and irritable allergic conditions.
Indications :
HISTACALAMINE is indicated in Urticaria, Allergic Dermatitis, Contact Dermatitis, Drug Dermatitis etc.
Mode of application :
HISTACALAMINE should be applied on the affected part with the help of cotton wool three or four times a
day until the oozing conditions and irritation subside.
Presentation :
50 ml. & 100 ml. Phial
EPHYTOL PAINT / EPHYTOL OINTMENT
AN ANTI TINEA PAINT & OINTMENT
PAINT
Composition :
Phenyl Mercuric Nitrate I.P -0.25%(W/V)
Salicylic Acid I.P -6.2%(W/V)
Carbolic Acid I.P -6.2%(W/V)
Glacial Acetic. Acid I.P -6.2%(W/V)
Tincture Benzoin Compound I.P - Q.S
OINTMENT :
Composition :
Salicylic Acid I.P 6% W/V
Benzoic Acid I.P 6% W/V

Causative Organism :
Ringworm is caused by group of fungi. In the tropics. Tricophyton rubrum. Tricophyton Mentragrophyts
and E.flucosum are responsible for causing the disease. They Cause ringworm of the inguinal region (Tinea
cruris)or other parts of the body(Tinea corporis), Athlets foot (Tinea pedis), is a persistent interdigital

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affeation of the foot in which the fungus forms a nidus of infection there etc.
Action and Use :
Salicylic Acid :
A useful Keratolytic agent having a fungicidal and antibacterial properties. It is particularly effective in
various Tinea infections. It promotes painless removal of dead cells of the epithelium which allows to reach
and destroy both the fungi and bacteria by its antifungal and antibacterial action.
Benzoic Acid :
It has also antifungal action. Combination of these two compounds effectively shed the infected epidermal
layer by virtue of its Keratolytic action which allows it to reach and destroy the infection caused by the
fungi and bacteria.Thus it is effective in local mixed infections caused by fungi and bacteria.
Phenyl Mercuric Nitrate :
It has Pronounced action against Ringworm Fungi & Bacteria. Page No 1118(3) Martindale- Pharmacopocia.
Carbolic Acid:
It has Antiseptic & disinfectant Properties & active against some viruses. Page No 1090(1) Martindale.

Glacial Acetic Acid :
It has bacterial & Anti fungal with astringent properties. Page No:1373(2) Martindale.
Compound of Benzoic Tincture :
Having Local Antiseptic Astringent properties. Page No:1121(2)Martindale.
Indication :
Ephytol either as paint or ointment is applicable to ringworm of all kinds but the ointment is specially
recommended for affection in soft skin such as Inguinal Tinea Cruis and Interdigital regions whereas paint
is indicated in Tinea cruis. .Tinea Corporis and on those areas where skin has become hard and thick.
Mode of application :
The paint is to be applied on the affected area not more than once a day till recovery. This however is to be
avoided on tender skin and also on the broken skin. For better result Ephytol ointment is to be applied at
night. In the soft skin only ointment is to be applied.
Presentation:
Paint 15ml. Phial
Ointment 20 gm. Tube.

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CLOMAZOLE CREAM / CLOMAZOLE LOTION
( A Broad Spectrum Antifungal Cream and Lotion )
Composition :
CREAM : Clotrimazole I.P. 1%
LOTION : Clotrimazole I.P. 1%

Action & Use :
Clotrimazole is a broad –spectrum Antifungal Drug for topical use. It is also active against yeast and
dermatophytes. It alters permeability of fungal cell wall through inhibition of ergosterol synthesis. It has a
very little systemic absorption yet it penetrates the epidermic layer and thereby prompt action is assured.
Indication :
It is effective in wide range of Fungi like Tinea Cruris, Tinea Barbae, Tinea Corporis, Pityriasis Versicolor,
Tinea Capitis, Tinea Pedis, Paronychia , Fungal Nappy Rash, Candidiasis or any other superficial fungal
infection.
Mode of Application :
The preparations to be applied 2 to 3 times daily and to be continued 2 weeks more after disappearance of
the symptoms of total eradication of the infection.
Presentation :
CLOMAZOLE CREAM – 15 gm Tube
CLOMAZOLE LOTION – 15 ml. Phial

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THIOSOL
(A REMEDY FOR TINEA VERSICOLOR)
Composition :
Zinc sulphate I.P 2.5%w/v
Pot. Sulphurate B.P.C 2.5%w/v
Alcohol I.P 2%

Pharamacologilcal Properties :
Sulphur is know to possess antiseptic Properties when used locally. For this reason sulphur has been found
to be effective in controlling acne and other parasitic infection. Lotion of potassium sulphurate is often
prescribed with Zinc Sulphate as a lotion for skin disease. This produces nascent Hydrogen Sulphide which
rapidly kills Pitryrosporum ovale causative fungus of seborrhoeic dermatitis and also Pityiriasis versicolor
caused by Pityrosporum furfur.
Indications :
Seborrhoeic dermatitis, Acne Vulgaris, Pityriasis versicolor.
Mode of Application :
It is to be applied two times a day on the affected part with cotton or sponge. In case of depigmentatrion
Thiotar ointment is to be applied at the night time to restore the normal complexion promptly.
Presentation :
100 ml phial.

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THIOSOL FORTE
(A REMEDY FOR TINEA VERSICOLOR)
Composition :
Zinc Sulphate I.P 4% w/v
Postassium Sulphurate B P C 4% w/v
Sodium Thiosulphate I.P 1% w/v

Action and Uses :
The blemishes on the face and trunk are often caused by fungal infection e.g. Pityrosporum ovale
Pityrosporum furfur and whereas acne is a bacterial infection.
Sulphur is known to possess antiseptic properties when used locally. For this reason sulphur has been
found to be effective in controlling acne and other parasitic infection. Lotion of Potassium Sulphurate is
used in acne, eczema, often prescribed with Zinc Sulphate as a lotion for skin diseases. This produces
nascent Hydrogen Sulphide which rapidly kills pityrosporum ovale , the causative fungus of seborrhoeic
dermatitis and P. furfur Higher concentration of both the salt helps act particularly in refractory conditions.
Sodium Thiosulphate is also a sulphur containing salt. This also helps to improve the action of other
Sulphur containing salts and thus the infections caused by the fungi are promptly controlled.
Indications :
Seborrhoeic Dermatitis Acne vulgaris and Pityriasis versicolor. It is also very useful for refractory
conditions.
Mode of Application :
The lotion is to be applied with a cotton or sponge twice daily on the affected parts till the affected areas
are free from infection. In case there is depigmentation Thiotar Ointment is to be applied on the affected
part at bed time to restore the normal colour of the skin.

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Presentation :
60 ml Phial.





CASTELLANI’S PAINT
(A remedy of Tinea Infections)
A modified of Castellani’s Paint with phenyl Mercuric Nitrate
Composition :
Basic Fuchsin B.P.C. 1%
Carbolic Acid I.P. 5%
Boric Acid I.P. 1%
Resorcin I.P. 10%
Acetone B.P.C’ 68 5%
Phenyl Mercuric Nitrate I.P 0.1%
Alcohol I.P. 10%

Causative Organism :
Ringworm of the nail (T. Unguim), interdigital ringworm (Tinea pedis,Tinea interdigitale) commonly know
as Bengal Rot, Mango toe. athlete’s foot, are the most intractable condition which often recur frequently.
These diseases are caused by Trichophyton rubrum. T. mentagrophytes. Epidermophyton floccosum.
Common medicines cannot penetrate sufficiently so as to render the fungicidal action of the drug. On the
other hand Castellani’s Paint can penetrate into the deeper layer and effectively control those infections as
this preparation is specific against interdigital ringworm and ringworm of the nail.
Action and Use :
Boric Acid has got Bacterio-static, Fungistatic & Astringent properties & is also an emulsifier.
Carbolic Acid is an Antiseptic & Disinfectant agent. It has Bactericidal action and removes itching.
Resorcin is Antipruritic , Antifungal and Keratolytic agent and effective in seborrhoeic dermatitis.
Basic Fuchsin is effective against grampositive bacteria & some dermatophytoses & also effective in
impetigo.
Phenyl Mercuric Nitrate has antibacterial and anti fungul Properties.

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Acetone as a solvent takes care of inflammatory conditions.
Indication :
Tinea Infections – Nail Fungus- Intedigital Rigworm.
It is indicated specially in Tinea unguium and also in Tinea infections of all kinds including refractory tinea
infections.
Mode of Application :
The affected part of the nail is to be scrapped thoroughly and the paint is to be applied twice daily till the
infection disappears completely.
Presentation:
20 ml phial.
FLORET TABLET
PAINT
Composition :
Each Tablet contains
Fluconazole: 150 mg.

ACTION & USE :
Fluconazole is a bis-triazole antifungal drug and is structurally related to imidazole derivatives. It is
fungistatic in action and exerts its antifungal activity by altering cellular membranes resulting in increased
membrane permeability, leakage of essential elements and impaired uptake of precursor molecules of
DNA. It is used as a systemic broadspectrum anti- fungal and highly effective against both yeasts and molds
with minimum side effect.

INDICATION :
Floret is a broad spectrum antifungal agent administered by mouth.
It is indicated in:
= Superficial mucosal candidiasis & for any other fungal skin infections.
= Systemic fungal infections including systemic candidiasis.
= Coccidiosis
= Cryptococcosis.
= Blastomycosis and chromoblastomycosis.

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= Histoplasmosis.
= Vaginal candidiasis.
= Anti-fungal treatment of AIDS Patients.

DOSES :
Candidiasis- floret- 150 mg 1 tablet weekly for1 to 2 weeks.
Pityriasis versicolor- 400 mg- 400 mg , single dose, or 150 mg 1 tablet for 4-6 weeks.
Paronychia or Onychomycosis- 150 mg 1 tablet weekly for 6-12 months.
Tinea infections: 150 mg 1 tablet weekly for 4-6 weeks.
Oropharyngial candidiasis- 150 mg – 200mg. 1 tablet daily for 2 weeks.
AIDS related fungal infections- 150 mg – 200 mg, 1 tablet daily for 2-3 weeks.
PRESENTATIONS :
1 tablet of floret 150 in a box.

HISTACID TABLET
Composition :
Each tablet contains
Cetirizine B. P. 10 mg.

ACTION :
Histacid (Cetirizine) is a potent and highly selective antagonist of the peripheral histamine H1 – receptor.
Even at high concentration there is no effect of setrotoninergic, muscarinic, dopaminergic, D2 and alpha-
adrenergic receptors. Histacid also has no effect at calcium channels and H2 –receptors. So it is used as a
potent non – sedating antiallergic drug with less side effects.
INDICATIONS :
Seasonal and Perennial Allergic Rhinitis.
Chronic idiopathic Urticaria.
Allergic Conjunctivitis.
Atopic Dermaitis.
Pruritus

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Adjunct in Asthma Management or
Any other Allergic condition.
DOSAGE :
Histacid 10 mg tablet once or twice daily.
Child (over 6 years) 5-10 mg once daily.
(2-5 years) 2.5-5mg . once daily.
ADVERSE DRUG REACTION :
Mild and transient side effects such as headache, dizziness, drowsiness, agitation, dry mouth and gastro-
intestinal discomfort. Occational hypersensitivity has been reported.
PRESENTATION :
Box of 10x10’s in strips.
PASTON Syrup
Composition :
Each 5 ml. Contains :
Ferric Ammonium Citrate I.P. 159.99mg
Folic Acid I.P. 0.501mg
Cyanocobalamin I. P. 7.5mg

ACTION & USE :
Ferric ammonium citrate is used as a rich source of iron for iron deficiency anemia. It is given by month and
is frequently used in liquid dosage form and helps improving hemopoetic factors.
Folic Acid is a member of Vitamin B group, acting as a co-enzyme for various metabolic process. Folic acid is
used in the treatment and prevention of anemic conditions. It is also used in women of child –bearing
potential and pregnant women to protect against neural tube defects in their offspring.
Cyanocobalamine (Vit B12) deficiency leads to megaloblastic anemia and other neurological damage. A
specific anemia know as pernicious anemia develops in patients with disturbed absorption of Vitamin B12
from dietary sources. It is also closely involved with folic acid, important metabolic pathways.
INDICATION :
Iron deficiency anemia, chronic blood loss, post operative anemia convalescene perid, during pregnancy
and lactation and other forms of anemia.

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DOSAGE :
Adult –3 teaspoonful (1 tablespoonful) – twice daily with the principle meals.
Children – Proportionately less, or as advised by the physician.
PRESENTATION :
200 ml. bottle.
EVERA Cream
Composition :
ALOE VERA – 10% (w/w)
VITAMIN E ACETATE – 0.5%(w/w)
MOISTURISING CREAM BASE.

ACTION AND USE :
Aloe Vera:
Aloe vera gel is obtained from the leaves of Aloe Vera (A. barbadensis), once all the sap has drained away.
It is widely used in cosmetics for a moisturising and revitalizing action.
Thus aloe is widely used throughtout the world as a complete therapy for dry skin, dermatitis,
hyperpigmentation resulting from chronic exposure to irritants, allergens, environmental, changes, ageing,
stress, hormonal changes or from skin conditions like a) Psoriasis b) Atopic dermatitis, c) Eczema d)
Xeroderma e) Ichthyosis etc. It accelerates wound healing, protects skin from damage due to UV radiation.
Also used to remove scar marks and as an adjuvant therapy with topical corticosteroids and retinoids.
VITAMIN E :
Alpha- tocopherol, an essentital nutrient for humans prevents oxidative damage of lipids (present in the
skin to protect it as sebum) and an essential component to cell membrance and cell stability. So, there are
wide use of Vitamin E topically to prevent skin damage from outer environment and to keep the skin
healthy and moist.
INDICATION :
Evera cream or Lotion indicated as a complete therapy for Dry skin/ Dermatitis, Hyperpigmentation
resulting from chronic exposure to irritants, allergens, environmental changes, ageing, stress, hormonal
changes or from skin conditions like (a)Psoriasis (b)Atopic Dermatitis (c)Eczema (d)Xeroderma (e) Ichtyosis.
Adjurent Therapy with potent corticosteroids & Retinoids Accelerates wound healing

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Protects the skin from damage due to UV radiation post Acne Scars, post pimple scars.
PRESENTATION :
50 gm container
CLINCHEEK- T
Composition :
Each 20 gm collapsible tube contain
Tretinoin – 0.025%
In cream base.

ACTION AND USE :
Clincheek – T (Tretinoin-0.025%) is a retinoid, it is used primarily in the topical treatment of Acne vulgaris
in which comedones, papules and pustules are predominate. It appears to stimulate mitosis and turn over
of follicular epithelial cells and reduce their cohesiveness thereby facilitating the extrusion of existing
comedones and preventing formation of new ones. It is also having mild keratolytic action and appears to
have anti-inflammatory activities.
MODE OF APPLICATION :
The skin should be cleaned to remove excessive oil and dried 15 to30 minutes before application of
Clincheek–T lightly, once or twice daily according to response and reaction. Other topical preparations,
including skin moisturizers should not be applied at the same time with Clincheek – T. Coution is required if
other local irritants are use concurrently. There may be apparent excerbations of the acne during early
treatment and therapeutic response may not be evident for 6-8 weeks. When the conditions has resolved,
maintenance therapy should be less frequent.
INDICATION :
Clincheek-T is a indicated for the topical treatment of mild to severe Acne vulgaris.
ADVERSE EFFECTS :
Tretinoin is skin irritant. Topical application may cause transitory stinging and feeling of warmth and in
normal use it produces some erythema and peeling similar to that of mild sunburn.
PRECAUTION :
Clincheek-T is contraindicated in pregnancy and breast feeding mothers. Contact of Clincheek-T with the
eyes, mouth and other mucous surfaces should be avoided. It should not be applied to eczematous skin,

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sunburn or abraded skin. Exposure to UV radiation, X-ray and sunlight should be avoided.
PRESENTATION :
20 gms collapsible tube.
DESCAB
A Potent Lotion for Remedy of Scabies & Pediculosis.
Composition :
Gama Benzine Hexachloride I.P. – 2%
Cetrimide I.P.– 0.5%

Causative Organism :
Scabies is an infestation of the skin which is caused by Scarcoptes Scabies. It is characterized by itching and
scratching of the affected part . Often this results in secondary infection. In the initial stage of the
infestation a patient does not complain of itching but with the progress of the disease there are complaints
of itching and scratching.
Action & Use :
Gama Benzine Hexachloride : It is a most potent Scabicidal Drug caused by Sarcopties Scabies. The drug is
also highly active in pedienlocide & effective in the Treatment of Pediculosis pubis, Capitis & Corporis.

Cetrimide :
It has Antibacterial Antifungal Properties and is effective in some viruses. Secondary infections caused by
scratching & itching by patients suffering from scabies is taken care by cetrimide
Indication :
= Scabies
= Pediculosis
Mode of Application :
Take soap bath and apply Descab in whole in 3 consecutive days with taking bath. Care to be taken so that
during application eyes are not effected.
Treatment of Pediculosis :

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DESCAB is also effective in Pediculosis & generally one application is enough for control of Lice its eggs.
Presentation :
50 ml, 100 ml & 450 ml phials.
SPASMIGON
Tablets & Drops
COMPOSITION :
SPASMIGON TABLET –
(Each tablet contains)
Dicyclomine hydrochloride B. P. - 20 mg
Paracetamol I. P. 500 mg.
SPASMIGON DROPS -
(Each ml. Contains.)
Dicyclomine Hydrochloride B. P. - 10 mg .
Activated Dimethicone I. P. - 40 mg.

ACTION & USE:
Dicyclomine hydrochloride:
This is a tertiary amine, anti muscarinic with effects similar to atropine with a direct antispasmodic action,
which acts directly on smooth muscle with local anaesthetic action without side effect.
Paracetamol :
A para- aminophenol derivative, has a strong analgesic, antipyretic and anti- imflammatory activity.
Activated Dimethicone :
Lowers surface tension and when administered by mouth causes bubbles of gas in the gastro- intestinal
tract to coalesce, thus aiding their disperson. Thus being a strong antifoaming agent dimethicone reduces
flatulency rapidly.
INDICATION :
Assures prompt relief from biliary colic, gastro-intestinal colic, renal colic, irritable bowel syndrome,
dysmenorrhoea and other spasmodic conditions involving smooth muscles.
Spasmigon Drops: Relieves infants and neonates from spasmodic pain, flatulence, gaseous distension etc.
DOSAGE :
Spasmigon tablet - 1 tablet 3 times a day after food or as directed by the physician.
Spasmigon Drop – 1 ml. 3 times a day upto 3 years, or as a directed by the physician.
Children over 3 years proportionately higher dose is recommended.
PRESENTATION :

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Spasmigon tablet- 10 x 10’s in strip.
Spasmigon Drops- 10 ml. Vial
CLOMAZOLE-S
Composition :
Clotrimazole I.P. 1%
Beclomethasone Dipropionate I.P. 0.025 %

Action & Use :
Clortrimazole is a broad-spectrum anti fungal agent for topical use. It is also active against yeast and
dermatophytes. It alters permeability of fungal cell wall through inhibition of ergosterol synthesis. It has a
very little systemic absorption yet it penetrates the epidermic layer and thereby prompt action is assured.
Beclomethasone Dipropionate is an extremely potent corticosteroid. It is effective in various inflammatory
conditions and steroid responsive Dermatoses.
Therefore CLOMAZOLE –S is anti fungal, anti-inflammatory, anti-exudative and antipruritic preparation.
Indication :
It is effective in Fungal Infections with Inflammation of the skin and also effective against certain gram +ve
& trichomonas species.
It is also effective in Steroid Responsive Dermatosis like Eczema, Psoriasis, and all types of Fungal
Dermatosis.
Mode of Application :
Apply gently CLOMAZOLE – S to the effected area 2 to 3 times daily. When inflammation and irritation
subsides, continue treatment with CLOMAZOLE CREAM or LOTION till primary infection is eradicated.
Presentation :
15 gm Tube

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DICLOTIN
( An antiamoebic preparation with spasmolytic and antiflatulance action )
Composition :
Each Tablet contains :
Tinidazole I.P. 300 mg.
Diloxanide Furoate I.P. 250 mg.
Simethicone U.S.P. 20 mg.
Dicyclomine Hcl B.P. 5 mg.

ACTION AND USE :
Diloxanide Furoate is an antiamoebic compound when taken orally it breaks up into Diloxanide and
Furoate radicals in the system. The free Diloxanide radicals acts directly on the amoeba in the lumen
whereas Furoate radical acts on the amoeba in the liver. Furthermore Diloxanide Furoate acts on the cysts
also.

Tinidazole, a nitro imidazole, derivative is a potent antiprotozoal amoebicidal drug and being soluble it is
effective in Extra Intestinal amoebiasis. Moreover it is also very effective in Giardiasis. Therefore a
combination of Tinidazole and Diloxanide Furoate is effective in intestinal, extra intestinal amoebiasis both
on the trophozoites and cysts and also in Giardiasis.

Simethicone is an antiflatulant whereas Dicyclomine Hcl is an effective spasmolytic compound. Therefore
DICLOTIN is an ideal preparation for intestinal or extraintestinal amoebiasis and giardiasis as it takes care of
all the aspects of the diseases.
INDICATION :
Intestinal Amoebiasis
Extraintestinal Amoebiasis
Giardiasis
DOSAGE :
Adults : Two tablets two times a day for 5 days or as advised by the Physician.
PRESENTATION :
Box of 10x10's in strips.
HYTEN

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Composition :
Each tablet contains:
Atenolol - 50 mg and Atenolol - 100 mg

ACTION AND USE :
Hyten (Atenolol) is a cardio selective beta andrenoceptor blocking agent without membrane stabilizing or
intrinsic sympathomimetic activities. Following oral doses of 50 & 100 mg, both beta blocking and
antihypertensive effects
persists for at least 24 hours, because of its higher lipid solubility.
INDICATIONS :
a.. Essential hypertensions
b.. Anigina pectoris
c.. Cardiac arrhythmias
d.. Left ventricular hypertrophy
e.. Myocardial infarction
DOSAGE :
Adults : 50 mg - 100 mg daily.
CONTRA -INDICATIONS :
Sinus bradycardia, heart block greater than first degree, cardiogenic shock, overt cardiac failure, known
hypersensitivity reaction to atenolol.
SPECIAL PRECAUTIONS :
Renal impairment, pregnancy, diabetes, untreated cardiac failure, sudden withdrawal may excerbate
angina
pectoris, myocardial contractility.
SIDE EFFECTS :
Bradycardia, cold extremities, leg pain, dizziness, tiredness, fatigue & lethargy, skin rashes and/or dry eyes.
PRESENTATION :
10 Strips of 10 tablets of Hyten 50 in a box.
10 Strips of 10 tablets of Hyten 100 in a box.

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SOLU RESORCINOL
(An Ideal Anti Dandruff Lotion)
Composition :
Each 100 ml. Phial Contains :
Resorcin I.P 4.0 gm
Mercuric chloride I. P 0.112 mg
Tinc Cantheridin B.P.C 2 ml

ETIOLOGY OF DANDRUFF :
Dandruff (Seborrhoea Capitis) is a scaly condition of the scalp. It is formed by dried up sebum which
contains dry scales caused by Pityrosporum ovale. The same Fungus owing to its growth at the root of hair
follicles causes baldness of the scalp by eating away the root of the hair. It has been experimentally found
that oil in any form favours the growth of this fungus. Oil is therefore definitely injurious on seborrhocic
baldness.

Mode of Action :
Resorcin is a highly effective not only in controlling fungal infection but it also removes the scales &
Dandruff from the surface on the scalp.

Mercuric chloride being a potent Antibacterial and Antifungal compound, helps to eliminate Bacteria and
fungi or Mixed infection from the root of the hair.

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Tine. Cantheridin enhance blood circulation which helps nutrients to be brought to the root of the hair and
in the process the root is strengthened
SOLU RESORCINOL Provides excellent remedy by removing scales from the surface of the skin & promoties
growth of hair on the head by stimulating & regenerating hair follicles. It prevents growth of pityrosporum
ovale & keep the scalp clean, free from Dandruff & thus prevents premature Baldness.

Indications :
= Dandruff (Seborrhoea Capitis)
= Premature Baldness of Seborrhocic Origin.
= Alopecia Areata.
Mode of Application :
The Scalp should be washed & cleaned with shampoo twice a week. Lotion should be applied &rubbed on
the scalp twice a day in the morning & again in the evening. During therapy application of oil is to be
avoided.
Presentation:
100 ml Phial.


SOLUKEN LOTION
Composition :
Each 100 ml phial contains :
Ketoconazole I. P. 2%

ACTION & USE :
Soluken Lotion is a broadspectrum antifungal agent which is highly effective against yeast and Molds such
as pityrosporum ovale, Candida spp; Dermatophytes etc.
Soluken reduces inflammation associated with Dandruff and seborrhoeic dermatitis. Also it helps in
relieving scaling and pruritus, which are usually associated with Pityriasis versicolor, Seborrhoeic dermatitis

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and Pityriasis Capitis(Dandruff)
INDICATIONS :
Treatment and Prophylaxis of fungal infections like Pityriasis versicolor, Pityriasis capitis, Seborrhoeic
dermatitis, Onychomycosis, Paronychia or any other fungal infections of the skin, hair or nail.
APPLICATIONS :
Dandruff - Once daily on the scalp at bed time, or as directed by the physician.
Other fungal infections of the skin - Once or twice daily in the affected area or as directed by the physician.
PRESENTATION :
100 ml. Phial.

DECONGIN
(DECONGESTANT TABLET)
Composition :
Each tablet Contains:
Phenylephrine Hydrochloride I.P. 10 mg
Paracetamol I.P 500 mg
Chlorpheniramine Maleate I.P 2 mg
Caffeine Anhydrous I.P 30 mg

PHARAMACOLOGICAL ACTION :
PHENYLEPHRINE HCL is a potent vasoconstrictor which opens up clogged nasal passage & thus gives relief
from Nasal Congestion.
PARACETAMOL is a safe effective centrally acting Analgesic & Antipyretic agent which gives prompt relief
from pain associated with fever.
CHLORPHENIRAMINE MALEATE is an effective Antihistamine. It promptly relieves excessive Nasal
Discharge & Sneezing due to Histamine.
CAFFEINE keeps patients wakeful and alert.

Indications :
= Symptomatic relief of Nasal Congestion/ Discharge/ Sinusitis.
= Rhinorrhoea
= Fever associated with Colds and pain

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= Keeps patients wakeful & Alert
Dosage :
One Tablet 3 times a day or as directed by the physician.





PHENIREX SYRUP
Composition :
Each 5 ml. contains :
Chlorpheniramine Maleate I. P. 2mg.
Ammonnium Chloride I.P 125 mg.
Sodium Citrate I. P. 50 mg.
Menthol B. P. 1.25 mg.
Syrup Q.S.

ACTION AND USE :
PHENIREX contains Chlorpheniramine Maleate which reduces excessive bronchial secretion caused by
allergy, infection or irritation. On therapeutic dose Chlorpheniramine virtually does not induce sleep.
Ammonium Chloride and Sodium Citrate in PHENIREX hasten liquification of the tenacious bronchial
viscid mucous which is expelled out by reflex action and thus reduced cough gradually.
Menthol produces soothing and analgesic effect to the inflammed mucous membrane and in the
process stops irritation.
INDICATIONS :
Cough and cold due to variable etiology. It is also effective in productive and non- productive cough and
reduced bronchial spasm in asthma.
DOSE :
Adult : One teaspoonful thrice daily or as directed by the physician.

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Childred: Proportionately less.
PRESENTATION:
100 ml. bottle.

KERASOL
(A lotion to remove Corn Painlessly)
Composition :
Salicylic Acid I.P 10% w/v
Lactic Acid I.P 10% w/v
Alcohol I.P 10% w/v
Solvent Ether I.P 15% w/v
Collodion Flexile I.P 55% w/v

PHERMACOLOGICAL PROPERTIES :
Kerasol has a strong KERATOLYTIC AND EXFOLIATIVE ACTION on the skin. It acts by mechanical and
painless removal of the corn. After application when it gets dried it forms a plaster like layer on the
affected part of skin. This property helps to adhere the cotton wool on the surface of the corn and
ultimately removes the corn painlessly.
ACTION AND USE :
Salicylic Acid is keratolytic agent which causes softening of the horney layers and destruation of the
dead tissue by shedding of scales, It produces this desquamation by solubilishing the intercellular
cement and enhances the shedding of corneocytes by decresing cell to cell cohesion.
Lactic Acid is enhancing the exfoliative activity of Salicylic Acid. It has also a humectant property, which
can hold the water in the skin for a long period and keep the Corn moint and soft.
Colloidoin Flexile acts as a vehicle for Salicylic and lactic acid . when mixed with Alcohol it forms an
adherant film that sticks to the cotton on the skin after drying.

Mode of Application :
The affected part to be cleaned thoroughly with the warm water and allowed to dry. Kerasol is to be
applied drop by drop on a thin layer of cotton wool after placing it on the corn so that cotton gets wet.
The application is to be repeated over the cotton wool three times a day. It is necessary to avoid water
to prevent soaking the cotton wool. After application for about a week the core of the corn can easily
be peeled of with a forcep or pulled out with finger. The process of application may be repeated and

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continued in persistent cases for few more days.
In case of wart the surface is to be rubbed with a mild abrasive . Thereafter Kerasol is to be applied on
the wart carefully and allowed it to dry. The process is to be repeated till it disappears .
Indication :
Kerasol is indicated for painless removal of corn or clavus, and warts.
Presentation:
10 ml phial.
TRIPLE DYE
(EFFECTIVE & SAFE ANTISEPTIC LOTION)
Composition
Acriflavin I.P 0.1 % W/V
Brilliant Green I.P 0.25% . W/V
Gentian Violet I.P 0.25% W/V
Alcohol I.P 3.00% W/V

ACTION :
Gentian Violet & Brilliant green are two Aniline Dyes which have antiseptic action against gram positive
Bacteria & Fungi. Acriflavin is an acridine dye and has got similar action. Combination of these 3 dyes
has got Synergestic Action with an advantage that they do not have any irritation on the skin.
It is highly effective against Staphylococcus SPP. and Candida SPP.
(Extra pharmacopoeia 27th Ed page 516)
It is used in the Treatment of Burns,Boils and Mycotic Infection (B.P.C –1979)
It may be applied with a Swab to the fresh cut cord and periumbilical area to prevent infections. (
Merck Manual 16th Ed. Page - 1924 )
Indications :
CUTS, BURNS, BEDSORE, CANDIDIASIS, BOILS, INTERTRIGO(Caused by Ringworm), FURUNCLES,
BARBER’S ITCH ECZEMA, UMBILICAL CORD DETACHMENT.
Presentation :
20 ml & 450 ml phial

112. INDUSTRIAL VOCATIONAL TRAINING AT PASTEUR LABORATORIES PVT. LTD.

112 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

DINAC-P
(Anti inflammatory and Analgesic Tablet)
Composition:
Each tablet contains-
Diclofenac Sodium 50 mg
Paracetamol IP 500 mg

Action and Use :
DINAC-P is a unique combination of Diclofenac Sodium and Paracetamol in optimum quantity per dose.
Diclofenac Sodium is a potent anti- inflammatory compound with analgesic action. It maintains
optimum balance between clinical efficacy and safety. It inhibits biosynthesis of Prostaglandin,
Prostacyclin and Leucotriene and thus gives relief from pain and inflammation promptly. Diclofenac
Sodium is well accepted for its efficacy for long term use.
Paracetamol on the other hand is a well accepted analgesic and anti-inflammatory compound which
gives prompt relief from body ache and pain.
Therefore DINAC-P is the drug for inflammatory conditions where pain is pronounced and in those
painful conditions where immediate relief is aimed at. In order to reduce gastric intolerance
Dicolofenac Sodium granules are enteric coated.
Indications :
Low back pain, Torticollis, Barsitis, Fibrositis, pain and Inflammation, after tooth extraction, post
operative pain and also other painful conditions of bones and tissues.
Dosage :
Adult One tablet, two or three times a day or as advised by the physician.
Contra indication :
Peptic Ulcer, Hypersensitivity of the compound.
Presentation :
Box of 10 X 10’s in strips.

113. INDUSTRIAL VOCATIONAL TRAINING AT PASTEUR LABORATORIES PVT. LTD.

113 | P a g e Diptarco Singha from Guru Nanak Institute of Pharmaceutical Science & Technology

ALKACIT
(SYSTEMIC ALKALISER)
Composition :
Each 5ml contains
Disodium Hydrogen Citrate I.P = 1.43gms
In a palatable Syrup Base Pleasantly Flavored.

Action & Use :
ALKACIT induces Diuresis & Diaphoresis readily & thus makes Urine alkaline it helps to eliminate Toxic
substances of the body & maintains alkalinity of the blood.
Indications :
ALKACIT is Indicated in
Febrile condition to Cold,
Influenza & Viral infection.
Acidosis associated with Uremia,
Toxemia & Cholemia.
Adjuvant therapy in urinary Tract Infections.
Nephritis and Toxic effects due to Prolonged use of Drugs
Heat exhaustion causing suppression of micturation.
Dosage:
1 to 2 Teaspoonful two or three times a day.
Presentation :
100ml and 450ml phil.