Industrial visit report

To know about the company policy

1. A REPORT OF PROJECT

On

“INDUSTRIAL VISIT REPORT”
at
Ashoka Institute of Technology & Management
SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENT FOR THE
AWARD
OF THE DEGREE OF

BACHELOR OF PHARMACY





MAY, 2022


SUBMITTED TO: SUBMITTED BY:
MR. ANUP KUMAR BRIJESH KUMAR
ASSOCIATE PROFESSOR 1864150015
Bpharm 4
th
year


DEPARTMENT OF BACHELOR OF PHARMACY

2. CONTENTS

Topic Page No

Candidate’s Declaration i
Abstract ii
Acknowledgement iii
About the Ashoka Institute of Technology & Management iv

Capsule
 Characteristics
 Components of Capsules
Types of Capsules
 Soft Gel Encapsulation
 Hard Gelatin Capsules
Capsule Size
 Characteristics
 Additives
Gelatin
 Manufacture of Hard Gelatin Capsule
 Capsules parameter as per I.P.
 Filling Hard Capsules Shells
 Process Capsule Filling
Quality Control
 Quality Assurance & Quality Control in Pharma Industry
 Quality Assurance (QA) Management Procedure
 Quality Control work (Summary)
 Quality Control Department
 Working Of Quality Control
Packaging Section
 Types of packaging
 The purposes of packaging and package labels
 Packaging machines
Conclusion
Reference

3. i | P a g e Ashoka Institute of Technology & Management

ASHOKA INSTITUTE OF TECHNOLOGY AND MANAGEMENT
VARANASI


CANDIDATE'S DECLARATION

I “BRIJESH KUMAR ” hereby declare that I have undertaken a project at “ASHOKA
INSTITUTE OF TECHNOLOGY & MANAGEMENT” during a period of May, 2022
in partial fulfilment of requirements for the award of degree of “Bachelor of
Pharmacy” at ASHOKA INSTITUTE OF TECHNOLOGY AND MANAGEMENT,

VARANASI. The work which is being presented in the training report submitted to Department
of Bachelor of Pharmacy at ASHOKA INSTITUTE OF TECHNOLOGY
AND MANAGEMENT, VARANASI is an authentic record of project work.






Signature of the Student


Dr. Brijesh Singh
(Principal, B.Pharma)













|

4. ii | P a g e Ashoka Institute of Technology & Management
ABSTRACT



Industrial training is an important phase of a student life. A well planned, properly executed
and evaluated industrial training helps a lot in developing a professional attitude. It develop
an awareness of industrial approach to problem solving, based on a broad understanding of
process and mode of operation of organization. The aim and motivation of this industrial
training is to receive discipline, skills, teamwork and technical knowledge through a proper
training environment, which will help me, as a student in the field of Information Technology,
to develop a responsiveness of the self-disciplinary nature of problems in information and
communication technology. Throughout this industrial training, I have been learned new
techniques of packaging, quality control etc related to capsules.

5. iii | P a g e Ashoka Institute of Technology & Management
ACKNOWLEDGEMENT


I have taken efforts in this project. However, it would have been possible without the kind
support and help of many individuals. It is indeed a great pleasure to work on this project and
presenting this report to my department. This project had provided me a good exposure to the
real world problem and also a solution to that.
I would like to pay my heartiest thanks to Dr. Sarika Srivastava, Director of AITM & Dr.
Brijesh Singh, Principal of B.Pharma Department, AITM who provided me such a
wonderful opportunity to pursue my mini project on such an interesting topics. My heartfelt
thanks go to all other faculties who provided valuable suggestions and kind co-operation. I
would like to thanks our project guide Mr. Anup Kumar, for importing his valuable
guidance and support. He has not only provided suggestions but also rectified my problems
whenever I have faced any problems.
I would like to express my special gratitude and thanks to persons who rendered their assistance
directly or indirectly. I would like to express my gratitude towards my parents & friends for
their kind co-operation and encouragement which help me in this project.





BRIJESH KUMAR
Bachelor of Pharma,
AITM

6. iv | P a g e Ashoka Institute of Technology & Management
ASHOKA INSTITUTE OF TECHNOLOGY AND
MANAGEMENT VARANASI



ASHOKA INSTITUTE OF TECHNOLOGY AND MANAGEMENT (AITM) came into
existence on February 22; 2010 located at heart of the holy city Varanasi at the distance of 3.5
km from the Varanasi Cantt Railway Station and is also near to the place of enlightenment of
Lord Buddha, Sarnath (Rishipattan) at the distance of 1.5 km. The institute's location adds
vibrancy of the campus and makes it an ideal place for learning. It is safe, secure and provides
excellent academic environment. It offers B.Tech in six Engineering disciplines (Computer
Science and Engineering, Mechanical Engineering, Electronics and Communication, Electrical
Engineering, Civil Engineering and Biotech), B.PHARMA and MBA in 4 specializations
(HRM, Marketing, Finance, IT). It aims to excel in arena of technical education covering the
objective of imparting superlative skills of teaching hinged on availability of world class
infrastructure.
Institute believes in conveying such qualitative knowledge that enables budding technical
wizards to accept the challenges of posterity. Our sprawling campus studded with plush
facilities will go a long way in giving much needed inputs to students of UP in general and
Purvanchal in particular. Our integrated campus is first of its kind to offer Managerial,
Pharmaceutical and Engineering studies under one umbrella in the competent and dynamic
leadership of top-class academic stalwarts.

7. v | P a g e Ashoka Institute of Technology & Management
The institute also intends to ensure holistic growth of students in order to make them
accountable for societal and national elevation and amelioration. It has already become a trend
setter in professional education in eastern up owing to the strong foundation laid by great
minds, assisted by highly qualified faculties and supported by excellent infrastructure and
amenities. May our students prove themselves as scintillating stars in sphere of scholastic
pursuit of knowledge!
B TECH & MBA courses are approved by ALL INDIA COUNCIL FOR TECHNICAL
EDUCATION (AICTE) and B PHARMA by PHARMACY COUNCIL OF INDIA (PCI) and
the institute is affiliated to Dr. A.P.J. Abdul Kalam Technical University (APJAKTU)
Lucknow.

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CAPSULE SECTION
Capsule

Capsule is solid dosage forms in which one or more medicinal and or inert substances are enclosed within
a small shell or container generally prepared from a suitable form of gelatin. Depending upon their
formulation, the gelatin capsule shells may be hard or soft.
Characteristics:
1. May be swallowed whole by the patient.
2. May be inserted into the rectum for drug release and absorption from the site.
3. The contents may be removed from the gelatin shell and employed as a pre measured medicinal powder,
the capsule shell being use to contain a dose of the medicinal substance.
4. Elegance.
5. Ease of use.
6. Portability.
7. Tasteless shell to mask the unpleasant taste/odor of the drug.
8. Permits physician to prescribe the exact medication needed by the patient.
9. Conveniently carried.
10. Readily identified.
11. Easily taken.
12. tasteless when swallowed.
13. Commonly embossed or imprinted on their surface the manufacturer’s name and product code readily
identified.
Components of Capsules
1. Gelatin.
2. FD & C and D & C colorant.
3. Sugar.

4. Water - 12 to 16 % but may vary depending on the storage condition.
5. Sulfur dioxide (.15%) - prevent decomposition during manufacture.
6. Opaquants/Opacifying agent - titanium dioxide.

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Type of capsule
The two main types of capsules are-
1. SOFT GEL ENCAPSULATION

Cod liver oil soft gel capsules
In 1834, Moths and DeBlanc were granted a patent for a method to produce a single-piece gelatin capsule
that was sealed with a drop of gelatin solution. They used individual iron moulds for their process, filling
the capsules individually with a medicine dropper. Later on, methods were developed that used sets of
plates with pockets to form the capsules. Although some companies still use this method, the equipment is
not produced commercially any more. All modern soft-gel encapsulation uses variations of a process
developed by R.P. Scherer in 1933. His innovation was to use a rotary die to produce the capsules, with the
filling taking place by blow moulding. This method reduced wastage, and was the first process to yield
capsules with highly repeatable dosage.

2. HARD GELATIN CAPSULES


Also referred to as “DFC” Dry Filled Capsule. Manufactured into two sections, the capsule body and a
shorter cap.



Two-part hard gelatin capsule

10. A recent innovation in capsule shell design is the Sna
hard gelatin capsules.
Capsule size










Empty Hard Gelatin Capsule Physical Specifica
INDUSTRIAL VISIT REPORT


p-Fit, Coni-Snap, and Coni Snap Supro













Tions



Size


Height

or

Typical Fill

Weights

Outer Locked Actual Vol.
(mg) 0.70
Diameter (mm) Length (mL)
Powder Density
(mm)
000 9.91 26.14 1.37 960
00 8.53 23.30 0.95 665
0 7.65 21.70 0.68 475
1 6.91 19.40 0.50 350
2 6.35 18.00 0.37 260
3 5.82 15.90 0.30 210
4 5.31 14.30 0.21 145
5 4.91 11.10 0.13 90








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For human use, empty capsules ranging in size from 000 the largest to 5 the smallest.
Generally, hard gelatin capsule are used to encapsulate between 65 mg to 1 gram.

Characteristics
 Usually use in the extemporaneous compounding of Rx.
 Made of gelatin, sugar, and water.
 Clear, colourless and essentially tasteless.
 Coloured with various FD & C and D & C dyes and made opaque by adding agents
such as titanium dioxide.

Combination of colorants and Opaquants to make them distinctive, many with caps and bodies
of different colours.

Plasticizers: -
 The number of plasticizers used to make the capsule to hard or soft.
 The plasticizers are used – Glycerine, Sorbitol.

Preservatives: -
 If included, is generally a mixture of Methylparaben (4part) and Propylparaben
(1part) to the extent of 0.2%.


Flavours: -
 If added, should not exceed 2%.
 Generally the flavours are used- Ethyl vanillin or essential oils.

Sugar: -

 If included, may be up to 5% to give the gelatin shell desirable chewable
characteristics.

Additives: -

a) Diluents: -
 The diluents have to be added to bring the medicament up to a desired bulk.
 The quantities of diluents are related to the dose of the medicament and the capsule
size.

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b) Protective Sorbents: -
 Sometimes some inert materials are included to prevent the absorption of moisture by
hygroscopic substances.
 Materials like – oxides and carbonates of Mg or Ca.
c) Glidants: -
 Glidants become essential when the powders are filled by automated machinery
requiring their regular flow in the capsule bodies.
 Glidants like- Talc, Stearates.
d) Anti-dusting compounds: -
 These are the compounds which prevent the flow of dust particle of the drug in the air
to causes health hazards.
 Anti-dusting compounds like- inert edible oils.
Gelatin
 It is obtained by the partial hydrolysis of collagen obtained from skin, white
connective tissue and bones of animals.
 Available in the form of a fine powder, a coarse powder, shreds, flakes, or sheets.
 Stable in air when dry but when become moist - subject to microbial decomposition.
 HGC contain 13 to 16 % of moisture.
 Extreme dryness- capsules may become brittle and crumble.
Manufacture of Hard Gelatin Capsule
 Manufactured into 2 sections, the capsule body and the shorter cap.
 The 2 parts overlap when joined, with the cap fitting snugly over the open end of the
capsule body.
 Shells are produced by chemical dipping of pins or pegs of the desired shape and
diameter into a temperature-controlled reservoir of melted gelatin mixture.
 The pegs made of manganese bronze, are affixed to plates, each capable of holding up
to about 500 pegs.
 Each plate is mechanically lowered to the gelatin bath, the peg submerges too the
desired depth and maintained for the desired period to achieve the proper length and
thickness of coating.
 The plate and the pegs are slowly lifted from the bath and the gelatin dried by a gentle
flow of temperature-and humidity-controlled air.
 When dried, each capsule part is trimmed mechanically to the proper length and
removed from the pegs, the capsule bodies and caps are joined.

13. Capsules parameter as per I.P.
INDUSTRIAL VISIT REPORT


Product Dose Conversion (m.g.) Drug content Dissolution
(m.g.) (%) (%)
Amoxicillin 250 285 90-110 80
Ampicillin 250 287 92.5-104.5 75
Trihydrate
Cephalexin 250 270 90-110 75
Monohydrate
Doxycycline 100 116 90-120 65
Rifampicin 150 165 92.5-107.5 70

Filling Hard Capsules Shells
1. Use Punch Method
 powder is placed on a sheet of a clean paper or porcelain plate.
 using spatula - formed into a cake having a depth of approximately one-fourth to
one-third the length of the capsule body.
 then empty capsule body is held between the thumb and forefinger and
punched vertically into the powder cake repeatedly until filled.

2. Feton Capsule Filling
 With empty capsule in the loader tray, the tray placed on top of the filler unit.
 The loader inserts the capsules into the filling unit and is removed, and the top plate is
lifted to separate the caps from the bodies.
 The powder is placed on the unit and the capsule bodies filled.
 The top plate is returned to the unit and the caps placed on filled capsule bodies.

Process Capsule Filling
1. Milling /Sieving of all Ingredients.
2. Blending Powder Blender / Empty Capsules.
3. Capsule Filler.
4. Capsule cleaner.
5. Capsule injection screen.
6. Capsule check-weighing system/reject.

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7. Finished capsules.






ProFill 100 - The ProFill 100 Capsule Filling Machine utilizes an advanced design for fool-
proof manual filling of two-piece capsules. With the Pro Fill 100 machine, there is no need for
expensive capsule filling equipment and electrical/vacuum connection.

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Capsule Filling Machine: -





Finishing: -
Semi-Automatic Capsule Filling Machine

The filled the sealed capsules necessitate finishing operation before inspection, bowling or
packing in strips and labelling. The following steps are involved in the finishing process-
a) Pan polishing.
b) Cloth dusting.
c) Brushing.
d) Sealing.
e) Inspection (ROTOSORT).

Evaluation of capsules: -

1. Uniformity of weight.
2. Content of active ingredients in capsules.

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3. Disintegration.
4. Dissolution.


U.P.D.PL.Product list (Capsules & powder)

S.N. Capsules & Powder
1 Amoxicillin Trihydrate capsules IP 250 mg
2 Amoxicillin Trihydrate capsules IP 500 mg
3 Ampicillin Capsules IP 250 mg
4 Ampicillin Capsules IP 500 mg
5 Cephalexin Capsules IP 250 mg
6 Cephalexin Capsules IP 500 mg
7 Doxycycline Hydrochloride capsules IP 100 mg
8 Tetracycline capsules IP 250 mg
9 Tetracycline capsules IP 500 mg
10 Oral Rehydration’s Salt citrate 270gm IP

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QUALITY CONTROL


Quality Assurance & Quality Control in Pharma Industry
QA: It is the sum total of the organized arrangements with the objective of ensuring that
products will be of the quality required for their intended use.
GMP: Is that part of Quality Assurance aimed at ensuring that products are consistently
manufactured to a quality appropriate to their intended use.
QC: Is that part of GMP concerned with sampling, specification & testing, documentation
& release procedures which ensure that the necessary & relevant tests are performed & the
product is released for use only after ascertaining its quality.

Quality Assurance (QA) Management Procedure
1. How to write Standard Operating Procedure:
 SOP describes standard SOP format that you can use immediately for your quality
procedure.
 SOP has instructions on how to write a formal operating procedure for your systems
which your people can follow every day.
2. Quality Documentation Management and Change Control:
 This SOP describes how to generate new quality documents or change control of
existing documents, review of quality documents, satellite file management, and role
of document author, approver, document control officer and satellite file
administrator.
3. Documentation Rule for GMP Documents:
 This SOP describes the principles to be followed in GMP documents, entry of data
and information, signature requirements and correction technique of incorrectly
entered data or information.
4. Quality Documentation-Control, Tracking and Distribution:
 In this SOP you will find mainly the role of document control officer during the
initiation, creation, circulation and approval of new quality related documents.
 It also describes the procedure of modification and review of existing document using
a documentation database.
 Management of existing and superseded documents is also a part of this procedure.
 You will see all the forms referred during the instruction are attached at the end of the
procedure.
5. Shelf Life of Product:
 This simple SOP describes the meaning of shelf life and provides on how to interpret
shelf lives and storage conditions for your raw materials from the Certificate of
Analysis, determining expiry date for your finished products by use of raw material
date of manufacturing and their shelf lives.

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Quality Control work (Summary)

Sampling of active pharmaceutical ingredients, Excipients, finished product & packing
material etc.
1. Testing of API (Active Pharmaceutical Ingredients).
2. Testing of excipients.
3. Testing of sample process.
4. Testing of finished products.
5. Testing of packing material.
6. Stability studies of finished product.
7. Maintenance and calibration of instruments.
8. Procurement of chemicals and glass ware.
9. Procurement of reference standard.
10. Procurement of maintenance of clusters for microbiological testing.
11. To certificate analysis.
12. To study products complaints.
13. To destroy the control sample after six month of the date of expiry.

Quality Control Department

1. Quality control sampling section:
Responsibilities: -

 To draw the sample of RM from store.
 To draw the samples of F.G. from production department.
 To keep control sample for reference & for stability studies.
 Final inspection of each batch.
2. Quality control chemical section:
Responsibilities: -

 Complete analysis of all RM/ process & F.G. sample as per prescribed standard.
 To send report to production, store, Q C office.
 To carry out stability testing etc.
 Instrument maintenance and calibration.

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3. Quality control microbiology section:
Responsibilities: -

 Microbiological analysis of RM/process/FG/sample.
 To send report to production, store, QC office.
 Quality control packaging material test.
 To carry out stability testing.
4. Quality control office:
Responsibilities: -

 To make certificate of analysis of R.M. &finished products.
 To maintain & keep records of analysis & certificate of analysis.

WORKING OF QUALITY CONTROL

21. List of quality control instruments:
INDUSTRIAL VISIT REPORT



S.NO NAME MAKE / MANUFACTURER

1 Tablet disintegration machine Campbell electronics
2 Water bath six hole thermostatic control JSGW
3 pH meter ECIL
4 Magnetic stirrer Reml
5 Friability test apparatus I. Equipment Cors
6 Vacuum pump Tempo
7 Oven SEW
8 B.O.D. JRSC
9 HPLC WATERS (INDIA)
10 Six stage dissolution rate test apparatus Tab machines
11 Melting point apparatus IEC& JSGW
12 Laminar flow Klenzald
13 Flame photometer Systronic
14 Digital balance ATCO
15 Spectrophotometer UV-1601(with CVT) Shaimadzu















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PACKAGING SECTION

Packaging is the science, art and technology of enclosing or protecting products for
distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation,
and production of packages. Package labelling or labelling is any written, electronic, or graphic
communications on the packaging or on a separate but associated label.
Types of packaging:
There are two types of packaging-

1. Primary packaging.
2. Secondary packaging.

1- PRIMARY PACKAGING: -
It is the packing which is in contact with medicament (capsule or tablet).

a) Blister packaging: -

 In this PVC and Al Foil is used for packaging.
 Sometimes Al foil is used wholly for packaging-
• Thickness of Al foil = 0.025mm ± 10%.
• Thickness of PVC = 0.25 mm ±10%.
 The blister package is formed by heat- softening a sheet of thermoplastic resin and
vacuum drawing the softened sheet of plastic into a contoured mold.
 Blister packaging machine consist of-
• Feeder (vibrator).
• A guide tracks.
• A forming dies.
• Forming heater.
• Sealing heater.
• Cutter.
• Printing registration controller.


Blister Packaging

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TEMPRATURE: -
 Forming heater = 140º-170º C.
 Sealing heater = 170º-200º C.

b) Strip packaging: -
The strip package is form by feeding to webs of a heat sealable flexible film through either a
heated crimping roller or a heated reciprocating platen. In this the product is drop into the
pocket formed prior to forming the final set of seals.
Machine: -

 It consists of –
 Hopper.
 Disc.
 Channel (chute).
 Two rollers (for Al foil).
 Cutter (centre cutter).
 Conveyer belt.
 Thermostat.
 Selector.
 When primary (strip & blister) packaging is done. The strips & blisters are subject for
secondary packaging.











Strip Packaging



2- SECONDARY PACKAGING: -

It is the packaging which is in contact with the primary packaging.
It involved –
 Cartoons (printed).
 Corrugated boxes (CB).
 White board box.

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 Corrugated boxes consist of 3 ply or 5 ply or 7 ply as per requirement.

 When secondary packaging is complete a BOPP tape (Bio Oriented Poly Propylene
Tape) is use for sticking.

The Purposes of Packaging And Package Labels
Packaging and package labelling have several objectives:
Physical protection - The objects enclosed in the package may require protection from,
among other things, shock, vibration, compression, temperature, etc.
Barrier protection - A barrier from oxygen, water vapor, dust, etc., is often required.
Permeation is a critical factor in design. Some packages contain desiccants or Oxygen
absorbers to help extend shelf life. Modified atmospheres or controlled atmospheres are also
maintained in some food packages. Keeping the contents clean, fresh, and safe for the intended
shelf life is a primary function.
Containment or agglomeration - Small objects are typically grouped together in one
package for reasons of efficiency. For example, a single box of 1000 pencils require less
physical handling than 1000 single pencils. Liquids, powders, and granules need containment.
Information transmission - Packages and labels communicate how to use, transport,
recycle, or dispose of the package or product. With pharmaceuticals, food, medical, and
chemical products, some types of information are required by governments.
Marketing - The packaging and labels can be used by marketers to encourage potential
buyers to purchase the product. Package design has been an important and constantly evolving
phenomenon for several decades. Marketing communications and graphic design are applied
to the surface of the package and (in many cases) the point-of-sale display.
Convenience - Packages can have features which add convenience in distribution, handling,
stacking, display, sale, opening, reclosing, use, and reuse.
Portion control - Single serving or single dosage packaging has a precise number of
contents to control usage. Bulk commodities (such as salt) can be divided into packages that
are a more suitable size for individual households. It is also aids the control of inventory: selling
sealed one-litre-bottles of milk, rather than having people bring their own bottles to fill
themselves.


Packaging Machines
A choice of packaging machinery includes, technical capabilities, labour requirements, worker
safety, maintainability, serviceability, reliability, ability to integrate into the packaging line,
capital cost, flexibility (change-over, materials, etc.), energy usage, quality of outgoing
packages, qualifications (for food, pharmaceuticals, etc.), throughput, efficiency, productivity.

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High speed conveyor with bar code scanner for sorting transport packages




Label printer applicator applying a label to adjacent panels of a corrugated box


Packaging machines may be of the following general types:
• Blister packs, skin packs and Vacuum Packaging Machines.

• Bottle caps equipment, Over-Capping, Lidding, Closing, Seaming and Sealing Machines.

• Cartooning Machines.

• Box, Case and Tray Forming, Packing, Unpacking, Closing and Sealing Machines.

• Cleaning, Sterilizing, Cooling and Drying Machines.

• Conveyors, Accumulating and Related Machines.

• Feeding, Orienting, Placing and Related Machines.

• Filling Machines: handling liquid and powdered products.

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• Package Filling and Closing Machines.

• Form, Fill and Seal Machines.

• Inspecting, Detecting and Checkweigher Machines.

• Palletizing, Depalletizing, Unit load assembly.

• Product Identification: labelling, marking, etc.

• Wrapping Machines.

28. 21 | P a g e A s h o k a I n s t i t u t e o f T e c h n o l o g y & M a n a g e m e n t
INDUSTRIAL VISIT REPORT

CONLUSION

ABAN PHARMACEUTICAS helped us to imbibe the detailed information about capsule
section & packaging section.
This industrial training provided a valuable learning experience in the carrier exploration
process and gave us unexpected benefit. Now I have evaluated the class room taught facts and
ideas and applied them to the real-life situation. We came to know about many things such as
the GMP (Good Manufacturing Process), the Current Good Manufacturing Process (CGMP).
The basic laboratory requirement for product validation, the variety of machine used in the
large-scale industries of medicine etc.
These and many other factors cause the enhance of my knowledge and have created a lifelong
interest to learning through an exposure to new educational experience.

29. 22 | P a g e A s h o k a I n s t i t u t e o f T e c h n o l o g y & M a n a g e m e n t
INDUSTRIAL VISIT REPORT

REFERENCE

1. https://en.wikipedia.org/wiki/Capsule_(pharmacy)
2. https://en.wikipedia.org/wiki/Capsule_endoscopy
3. https://www.researchgate.net/publication/292539476_Capsule_Manufa
cturing_Technology
4. https://www.slideshare.net/AnkushBiswas/a-project-report-on-
56439227