PHARMACEUTICAL INDUSTRIAL TRAINING REPORT .pdf

Internship at Laborate Pharmaceuticals Panipat in 7th semester in b pharmacy. Training report

1. I

INDUSTRIAL TRAINING REPORT
ON
‘PRODUCTION OF TABLETS’
AT LABORATE PHARMACEUTICALS LTD.

Submitted in partial fulfillment of the requirement for the award of degree of
Bachelors of pharmacy
Session 2019-2023


Under the supervision of: Submitted by:
Mr. Shambu Nath Jha Ronak Bhambri
(Head Chemist) B Pharmacy
Laborate Pharmaceuticals India LTD. BPH_1925
E-11 Industrial Area, Regn. No: 19-GIPN-27
Panipat-132103
Haryana



Geeta Institute of Pharmacy Naultha, Panipat
(Affiliated to pt. B.D. Sharma University, Rohtak)

2. II

DECLARATION
I _____________________________, hereby declare that work presented in the industrial
training report entitled in INDUSTRIAL TRAINING PERFORMED AT Laborate
Pharmaceuticals Panipat. is an authentic record of work carried out by me during
_______________ to _______________ at Laborate Pharmaceuticals Panipat under the
guidance of Dr. Sunil Jawla (principal of geeta institute of pharmacy). Is being submitted for
partial fulfilment of the requirement for the award of bachelor degree in B. pharmacy. This has
not been submitted anywhere else for the award of any other degree/diploma.





________________________________
Signature of head of the department
Mr. Shambu nath Jha
Production chemist

3. III

TRAINING CERTIFICATE

4. IV

ACKNOWLEDGEMENT
It is a matter of pleasure and happiness to make and submit this industrial training report during
the course of the completion of this industrial work. Many of the persons have offered their
valuable and enormous support. I’m thankful to all my teachers of Geeta institute of pharmacy
Panipat. For their blessings and encouragement. I would like to express my special thanks and
gratitude to Laborate Pharmaceuticals and Mr. Shambu nath jha (production chemist) for
providing all the essential facilities which were required for this training. Finally, I express my
regards to my beloved parents who inspired me throughout my studies and completion of this
training
I am highly grateful to my project guide Dr. Sunil jawla (principal geeta institute of
pharmacy) for their inspiring presence and blessing for going ahead and fulfilling the project
report.
Lastly I thank faculty and staff members of GIP , Panipat which gave me an opportunity
regarding training purpose and helped me in building some experience in my career


Date: _______________________

Place: ________________________

Student name: ________________________

5. V

INDEX
s.no. content Pg.no.
1 Introduction 1
2 Product list 2
3 Tablet formulation process 3
4 Sizing 4
5 Powder blending 5
6 Granulation 6
7 Drying 7
8 Tablet compression 8
9 Tablet coating 9
10 Physical features of compressed tablets 12
11 Packaging 13
12 Evaluation of tablets 16
13 My learning at laborate pharmaceutical 18
14 Conclusion 22
15 Reference 23

6. VI

LIST OF FIGURES
s.no. Content Pg.no.
1 Ultra king tablets 2
2 Augulab 625 tablets 2
3 Tablet formulation process 3
4 Ribbon blender 5
5 Double cone blender 5
6 Types of tablets 12
7 Kind of packaging 14
8 Blister packs 14
9 Bottle packaging 15
10 Ampoules packaging 15
11 Vials packaging 15
12 Sachet packaging 15

LIST OF TABLES
s.no. content Pg.no.
1 Defects in tablet coating 11
2 Physical features of compressed tablets 12

LIST OF FLOW CHARTS
s.no. content Pg.no.
1 Heat transfer modes of dryers 7

7. 1


INTRODUCTION
ABOUT LABORATE PHARMACEUTICALS
Laborate Pharmaceuticals is one of the fastest growing pharmaceutical companies in India.
Over the years, we have been awarded and recognized for our endeavor to manufacture
premium quality products and sell it for economical price. We believe that healthcare is not a
privilege but a right of every citizen. Thus, we are taking giant strides in making good quality
products available in rural as well as urban areas. We manufacture an extensive range of
products. Currently, our range of over 1000 products varies from Generic Pharma Products to
Ayurvedic and Personal Care Products
Quality Control and Quality Assurance
Ever since our inception in 1985, Quality Control and Quality Assurance has been at the core
of our business operations. We understand our duty towards the society for manufacturing only
premium quality products. Therefore, we have set up an independent department for Quality
Control and Assurance. Moreover, our ultra-modern testing facility is equipped with GC, FTIR,
HPLC, UV and other techniques complying with international Pharmacopoeia requirements
Awards
Over the years, our good work has been recognized by several reputed organizations, and they
have bestowed us with important awards. Here’s a list of few of them:
• ‘Emerging India Award’ by ICICI and CNBC, 2008
• ‘Udyog Rattan Award’
• ‘Excellence Award’ by Institute of Economic Studies (IES), 2008
State of the art Infrastructure
Our 3 world class manufacturing facilities are approved by WHO GMP and FDA of 35 other
countries, and are made as per the guidelines of US-FDA and UK-MHRA. Our multipurpose
plants can manufacture sterile and nonsterile products. We also have exclusive dedicated
blocks for β-lactam and non β-Lactam antibiotics.
Take a look at our daily production capacity:
•Liquid Injections: 200,000 vials and 300,000 ampoules
•Ophthalmic: 300,000
•Dry Injections: 300,000
•Topical Preparations: 200,000 tubes
•Tablets: 15 Million units
•Capsules: 2 Million units
•Dry Syrup: 100,000 Bottles

8. 2

PRODUCT LIST
1. ABIDE ABIDE 400mg Tablet 1's
2. ACEFEN MR Acefen MR Tablet 10'S
3. AMILABAMILAB 500 Injection 1's
4. ASTOZYME Astozyme Syrup 200ml
5. AUGULABAUGULAB 625mg Tablet 10's
6. BECLOLAB NCBECLOLAB NC Cream 15gm
7. CAL D3CAL D3 500mg Tablet 10's
8. CAL D3 Tablet 15's
9. CEFLOX LEFLOX 250 mg Tablet 10's
10. CEFLOX Eye/Ear Drops 10ml
11. CEFLOX CFCEFLOX CF Cream 15gm
12. CEFLOX D E/CIPLOX D Eye/Ear Drops 10ml
13. CEFLOX DEE OPTICCEFLOX DEE OPTIC Eye/Ear Drops 10ml
14. GENTACORT D'GENTACORT D Eye/Ear Drops 10ml
15. GENTALABGENTALAB 40 Injection 30ml
16. GENTALAB Injection 2ml
17. GENTALAB Gentalab Eye/Ear Drops 10ml
18. HUNGREE Hungered Syrup 200ml
19. HUNGREE pineapple flavor HUNGREE PINEAPPLE FLAVOUR Syrup 200ml
20. Hungree Elaichi Flavor HUNGREE ELAICHI FLAVOUR Syrup 200ml
21. Hungree Mango Flavor HUNGREE MANGO FLAVOUR Syrup 2 00ml
22. ITROZOLEITROZOLE 100mg Capsule 4's
23. KT 5 DERMOT 5 DERM Cream 15gm
24. LABCHLOR LABCHLOR Capsule 10's
25. LABDIC RELIEF LABDIC RELIEF Gel 30gm
26. LABOCOF Labocof Tablet 10'S
27. LABOCORTLABOCORT 100 Injection 1's

FIG. NO. 01 FIG. NO. 02
ULTRA KING TABLETS AUGULAB-625 TABLETS

9. 3

CHAPTER-1
TABLET FORMULATION PROCESS
The manufacture of oral solid dosage forms such as tablets is a complex multi-stage process
under which the starting materials change their physical characteristics a number of times
before the final dosage form is produced.
Traditionally, tablets have been made by granulation, a process that imparts two primary
requisites to formulate: compatibility and fluidity. Both wet granulation and dry granulation
(slugging and roll compaction) are used. Regardless of whether tablets are made by direct
compression or granulation, the first step, milling and mixing, is the same; subsequent steps
differ.
Numerous unit processes are involved in making tablets, including particle size reduction and
sizing, blending, granulation, drying, compaction, and (frequently) coating. Various factors
associated with these processes can seriously affect content uniformity, bioavailability, or
stability.
Tableting is a method of pressing medicine or candy into tablets. Confectionery manufacture
shares many similarities with pharmaceutical production.
A powder or granule mixture is prepared, a dye mold is filled, and then the mixture is
compressed and ejected. While drug tablets are constrained to shapes and sizes that can be
swallowed easily, candy tablets are designed to be chewable and can take a wider variety of
shapes and sizes.

FIG. NO. 03
TABLET FORMULATION PROCESS

10. 4

CHAPTER-2
SIZING
Sizing (size reduction, milling, 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 the 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 color and/or active ingredient dispersion in tablet excipients
 Uniformly sized wet granulation to promote uniform drying
The following problems may arise if the process is not controlled properly:
 A possible change in polymorphic form of the active ingredient, rendering it less or totally
inactive, or unstable
 A decrease in bulk density of active compound and/or excipients, which may cause flow
problem and segregation in the mix
 An increase in surface area from size reduction may promote the adsorption of air, which
may inhibit wettability of the drug to the extent that it becomes the limiting factor in
dissolution rate
Various types of machine may be used for the dry sizing or milling process, depending on
whether gentle screening or particle milling is needed. The range of equipment employed for
this process includes:
 Fluid energy mill
 Colloidal mill
 Ball mill
 Hammer mill
 Cutting mill
 Roller mill
 Conical mill

11. 5

CHAPTER-3
POWDER BLENDING
The successful mixing of powder is more difficult than mixing liquid, as perfect homogeneity
is difficult to achieve. Another 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
may be blended at the 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 speed must be evaluated. Blending prior to
compression is normally achieved in a simple tumble blender. This be a fixed blender into
which the powders are charged, blended and discharged. It is now common to use a bin blender
from which the container (bin) can be removed and brought directly to other processing
steps.
[1]
In special cases of mixing a lubricant, overmixing should be particularly monitored.
The various blenders used include the "V" blender, oblicone blender, container blender,
tumbling blender, and agitated powder blender.
Nowadays, to optimize the manufacturing process, particularly in wet granulation, various
improved pieces of equipment which combines several processing steps (mixing, granulation
and/or drying) are used. These are the mixer granulator and high shear mixing machine.

FIG.NO. 04 FIG.NO. 05
Stainless Steel Industrial Ribbon Blender Double Cone Blender
Mixer, Capacity: 100-200 Kg Per Hours

12. 6

CHAPTER-4
Granulation
The granulation process is "any process whereby small particles are gathered into larger,
permanent masses in which the original particles can still be identified." This definition is of
course particularly appropriate to a pharmaceutical granulation where the rapid breakdown of
agglomerates is important to maximize the available surface area and aid in solution of the
active drug. The granulation process of size enlargement used within the pharmaceutical
industry has its roots in ancient times. The practice of delivering medicinal powder by hand
rolling into a pill by using honey or sugar has been used for centuries.
It is still the practice to deliver the botanical and herbal extract in homoeopathic and Ayurveda
branches of medicine, which are still practiced in India along with allopathic medicine. The
term "granulated" material is derived from the Latin word”," meaning grained. The granular
material can be obtained by direct size enlargement of primary particles, or size reduction from
dry compacted material in modern times, granulation technology has been widely used by a
wide range of industries, such as coal mining, and agrochemical These industries employ
agglomeration techniques to reduce dust, provide a case of handling, and enhance the material's
ultimate utility.
The development of pharmaceutical granulation was driven by the invention of the tablet press
by W. Brockedon in 1843. Subsequent improvements in the tablet machinery were patented in
the United States by J. A. Mc. Ferran (1874), T. J. Young 1874), and J. Dunton (1876). The
demands on the granulation properties were further enhanced in the 1970s as high-speed tablet
and capsule filling machines with automated controls were introduced. The continuous
refinements in the regulatory requirements such as low-dose products requiring blend
uniformity/content uniformity necessitated knowledge and technology to produce the required
granule characteristics.
The high-speed compression and capsule filling machines require a uniform flow of material
to the dies or filling stations that produce pharmaceutical dosage form.
Granulation is an example of particle design. The desired attributes of the granule are controlled
by a combination of the formulation and the process.
Granulation methods can be divided into two major types: wet methods which utilize some
form of liquid to bind the primary particles, and dry methods which do not utilize any liquid
1-Receive the raw material as BMR from Raw material store
2-Shiting of raw material (API & EPI) in sifter

13. 7

CHAPTER-5
DRYING
Drying is an important step in the formulation and development of a 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 the fluidized-bed dryer,
vacuum tray dryer, microwave dryer, spray dryer, freeze dryer, turbo-tray dryer, and pan dryer.
Drying is the process of removing the presence of solvents (i.e. water or other liquids) in a
formulation with the presence of heat. The final product of this unit operation is a dry solid
mass or powders. This process is widely used in the pharmaceutical field, from research and
development phase until large -scale manufacture.

It is important to have a good understanding of this process’ impact on the quality attributes of
the active pharmaceutical ingredient (API) in order to guarantee it will not have any adverse
impact on the drug’s safety and efficiency, thus, providing high quality final products.

All drying processes of relevance to pharmaceutical manufacturing involve evaporation or
sublimation of the liquid phase and the removal of the subsequent vapor.

Drying of Wet Solids: Convective Drying of Wet Solids: This method utilizes dynamic
convective dryers (e.g., Fluidized-bed dryer) to obtain good contact between the warm drying
air and wet particles in the fluidized-bed dryer.
The fluidized-bed dryer was developed for the process of fluidization to improve the efficiency
of heat transfer and vapor removal, as compared with the older static tray dryers. This fluidized-
bed dryer also allows the efficient transfer of the latent heat of evaporation from the air and
into the drying solid.
Advantages of fluidized-bed drying:
o Shortens drying time via the efficient heat and mass transfer, allowing high product
output with small footprint.
o Minimizes heat challenge to thermolabile materials
o The turbulence in a fluidized bed causes some gnaws the surface of the granule, thus,
producing a more spherical free-flowing product.

FLOWCHART NO. 01
HEAT TRANSFER MODES OF DRYERS

14. 8

CHAPTER-6
TABLET COMPRESSION

Tablet press
After the preparation of granules (in wet granulation) or sized slugs (in dry granulation) or
mixing of ingredients (in direct compression), they are compressed to get the final product. The
compression is done either by a single-punch machine (stamping press) or by a multi-station
machine (rotary press). The tablet press is a high-speed mechanical 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.

Stage 1: Top punch is withdrawn from the die by the upper cam. Bottom punch is low in the
die so powder falls in through the hole and fills the die.
Stage 2: Bottom punch moves up to adjust the powder weight. It raises and expels some
powder.
Stage 3: Top punch is driven into the die by upper cam. Bottom punch is raised by lower cam.
Both punch heads pass between heavy rollers to compress the powder.
Stage 4: Top punch is withdrawn by the upper cam. Lower punch is pushed up and expels the
tablet, which is removed from the die surface by surface plate.
Stage 5: Return to stage 1.

Tablet testing
The physical properties of a tablet are tested either by manual or automated sampling and IPC
testing (in-process control). Tablet "hardness", also called "breaking force", is tested to assure
that the tablet's strength will survive all further processes, such as dedusting, coating and
packaging. The hardness value of a tablet gives an early indication of the tablet's disintegration
time. Further measured parameters are weight, thickness, diameter, disintegration time,
friability, and abrasion.

Friability and abrasion testing is performed in rotating testing drums, designed according to
the pharmacopeia. The measured parameter is weight loss before and after testing and tumbling
the tablets at a particular time and speed. In the friability test drum tablets are being carried up
by a "shovel" and dropped. Tablets are also not allowed to fall apart during the test. In the
abrasion test, drum tablets are not falling/dropping, but rolling on the ground of the test drum
and losing weight due to the friction between tablets.

Tablet deduster
In almost all cases, tablets coming out of a tablet machine have excess powder on their surface
which is removed by passing them through a tablet deduster.

Fette machine
The Fette machine chills the compression components to allow the compression of low-melting
point substances such as waxes, thereby making it possible to compress products with low
melting points.

15. 9

CHAPTER-7
TABLET COATING
Tablet coating is the process where coating material is applied to the surface of the tablet to
achieve the desired properties of dosage form over the uncoated variety. The advantages of
coating are listed below.
•Improving taste, odor, and color of the drug
•Improving ease of swallowing by the patient
•Improving product stability
•To protect against the gastric environment
•To improve mechanical resistance of the dosage form
•Modifying release properties

There are three main processes for tablet coating: sugar coating, film coating, and enteric
coating. Various classes of pharmaceutical coating materials used in tablet coating depending
on the phase of coating are reached. Coating materials can be categorized as follows:
•Binders (acacia, gelatin, cellulose derivatives)
•Fillers (calcium carbonate, titanium dioxide, talc)
•Colorants (dyes, iron oxides, titanium dioxide)
•Antiadhesives (talc)

Sugar coating
Unlike film coating, sugar coating is a more laborious multistep process, leading to final tablet
weight increases of up to 30%–50%, significantly increasing tablet size. The process of sugar
coating involves various steps, i.e., sealing, subcoating, smoothing, coloring, and polishing.

Sealing
A seal coat is applied over the tablet core to protect against water penetration into the tablet
from the sucrose coatings to follow. Hence, it offers good stability of product and can also
strengthen the tablet core. Sealing coat consists of Shellac, cellulose acetate phthalate (CAP),
polyvinylacetate phthalate (PVAP), hyroxylpropyl cellulose, hyroxypropyl methylcellulose
(HPMC), and Zein (a corn protein derivative). Shellac was previously used as a sealant.
However, this has largely been replaced by zein CAP and PVAP due to polymerization
problems. The amount of sealing coat material depends on tablet porosity and batch size; hence,
optimizing the quantity of sealing coating applied is very important to ensure tablet cores are
sealed effectively.

Subcoating
Subcoating is performed to round the tablets edges. In this process, there is a significant
increase in tablet weight. Generally, lamination process and suspension process methods are
used for subcoating. In lamination process, the subcoat mixture consists of sucrose and binder
solution such as acacia or gelatin, which is applied over the tablet surface followed by powder
containing materials such as calcium carbonate, titanium dioxide, calcium sulfate, and talc.
Finally, drying air is applied in order to evaporate the water. During the suspension process, a
suspension of fillers in gum solution is applied. After that, sucrose solution is applied followed
by drying. Suspension process is suitable for automatic methods.

Smoothing
Smoothing process is applied in order to smooth out subcoated rough surfaces and to increase
tablet bulk to desired size. Smoothing syrup generally consists of 60%–70% sugar solid. In
some cases, however, syrup also comprises acacia, gelatin, pigments, starch, or opacifier.

16. 10

Smoothing is performed many times (about 10 cycles), until tablets are suitable for the next
(coloring) phase.

Coloring
Coloring phase is a significant step in sugar-coating process, which gives the tablet improved
appearance and stability. Sugar-coating solution consists of 70% syrup and other coloring
pigments. Previously water-soluble dyes (coloring agents) were mainly used as for sugar-
coated tablets. However, water-soluble dyes are generally associated with color migration
problems, and dyes usually transfer to the surface of the tablets during drying. Hence, the use
of water-insoluble pigment (lakes) has now replaced the dyes, which provides even tablet color
and maintains batch-to-batch color uniformity.

Polishing
Generally sugar-coated tablets are dull in appearance; polishing gives the characteristic surface
shine and tablet elegance. Polishing is performed in polishing pan using the beeswax, carnauba
wax, and candelila wax mixture.

Film coating
Film coating is single-stage coating process and needs a relatively short time and so is favored
over sugar coating. Film coating is the deposition of a thin film of polymer (between 20 and
100 μm) applied mainly to tablets; in addition, film coating can also be applied to hard and soft
gelatin capsules and multiparticulate system. Film-coating formula generally consists of
polymers, plasticizer, colorants/opacifiers, solvents, etc. Table 5 depicts commonly used film-
and enteric-coating materials.

17. 11


TABLE NO. 01
DEFECTS IN TABLET COATING

18. 12

CHAPTER-8
Physical features of compressed tablets

Compressed tablets can be round, oblong, or unique in shape; thick or thin; large or small in
diameter; flat or convex; unscored or scored in halves, thirds, or quadrants; engraved or
imprinted with an identifying symbol and/or code number; coated or uncoated; colored or
uncolored; one, two, or three layered.
Tablet diameters and shapes are determined by the dies and punches used in compression. The
less concave the punches, the flatter the tablets; conversely, the more concave the punches, the
more convex the resulting tablets. Punches with raised impressions produce recessed
impressions on the tablets; punches with recessed etchings produce tablets with raised
impressions or monograms. Logos may be placed on one or on both sides of a tablet, depending
on the punches.

TABLE NO. 02
PHYSICAL FEATURES OF COMPRESSED TABLETS

FIG.NO. 06
TYPES OF TABLET

19. 13

CHAPTER-9
PACKAGING

Tablets must be packaged before they can be sent out for distribution. The type of packaging
depends 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 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.

Pharmaceutical packaging plays a number of important roles when shipping sensitive and
tightly regulated products. Not only must it protect the contents from physical damage, but
should ensure zero alteration is made to the chemical composition. Which is often achieved
through primary, secondary and tertiary packaging. With a wide range of pharmaceutical
products available on the market, both standard and bespoke packaging can be manufactured
to meet product demands. From temperature controlled solutions, to tamper evident tape and
customs labelling, even the most delicate medicines can be shipped safely.
Here, we explore types of pharmaceutical packaging and the benefits they have for your
products.

Primary, secondary and tertiary packaging
When breaking down the types of pharmaceutical packaging available, this can be done
through primary, secondary and tertiary packaging. We can then dive into these types further
and explore the products used within.

Primary pharmaceutical packaging: Whether it be a drug, medicine, or other formulation,
primary pharmaceutical packaging is used in direct contact with the product to protect its
chemical composition.
Let’s take a look at some examples:
 Vials – A glass or plastic container used to contain liquid, solid or a powder dosage form.
 Ampoules – Similar to vials, ampoules are smaller glass containers (sometimes plastic)
used for packaging liquids.
 Blister packaging – A thermoformed plastic with cavities for tablets or capsules, sealed on
the open side with plastic or aluminum foil.
 Strip package – Formed around the tablet or capsule, each content is protected individually
for an increased shelf life. An alternative form of blister packaging.
The type of primary packaging used all depends on the form and chemical composition of your
product. Capsules and tablets are often secured in blister and strip packages, while liquids are
usually placed in vials or ampoules.

Secondary pharmaceutical packaging: The main purpose of secondary packaging is for
brand awareness as well the display and handling of products. As an example, secondary
packaging would be the branded boxes used to display products in supermarkets.

20. 14

Secondary packaging also plays a vital role in the distribution and protection of
pharmaceuticals. Think of it in this way, secondary packaging is used to protect the primary
packaging, which is protecting the product. A glass vial wouldn’t last long if packed directly
into a shipping case would it?
Secondary packaging is typically found in the form of bespoke cartons. Not only are they easily
customizable, helping with brand awareness, but offer good protection and can be recyclable
too.
The benefits of secondary packaging
When tackled properly, secondary pharmaceutical packaging can have major benefits on your
business, these include:
 Building your brand
 Increasing sales
 Simplifying your shipping process
 Reducing damaged
Tertiary pharmaceutical packaging: Tertiary packaging comes into play with the need for
transportation. It’s designed to absorb any physical impacts, as well as any moisture and dust
problems along the way.
Put simply, tertiary solutions are used to protect both the product and packaging that sits
beneath it during transportation. This may include:
• Cardboard boxes
• Shrink film
• Stretch wrap
• Wooden and plastic pallets
The benefits of tertiary packaging
An optimized tertiary packaging solution should look to combine products as tightly and
compact as possible, while using minimal materials and without causing strain or damage to
products. This helps to:
• Increase pallet stability
• Decrease CO2 emissions
• Lower transport costs
• Save on material waste
• Protect the product

FIG. NO. 07
KIND OF PACKAGING
FIG.NO. 08 Blister Packs:

21. 15



FIG.NO. 09 FIG.NO. 10
Bottle Packaging Ampoules Packaging

FIG.NO.11 FIG.NO.12
Vials Packaging Sachet Packaging

22. 16

CHAPTER-10
Evaluation of Tablet:
 General Appearance: The general appearance of a tablet, its identity and general
elegance is essential for consumer acceptance, for control of Lot-tolot uniformity and
tablet-to-tablet uniformity. The control of general appearance involves the
measurement of size, shape, colour, presence or absence of odour, taste etc.
 Size & Shape: It can be dimensionally described & controlled. The thickness of a
tablet is only variable. Tablet thickness can be measured by micrometre or by other
device. Tablet thickness should be controlled within a±5% variation of standard
 Unique identification marking: These marking utilise some form of embossing,
engraving or printing. These markings inchide company name or symbol, product
code, product name etc.
 Organoleptic properties: Colour distribution must be uniform with no mottling. For
visual colour comparison compare the colour of sample against standard colour.
 Hardness and Friability: Tablet requires a certain amount of strength or hardness
and resistance to friability to withstand mechanical shakes of handling in
manufacture, packaging and shipping
 Friability: Friability of a tablet can be determined in the laboratory by Roche . This
consists of a plastic chamber that revolves at 25 rpm, dropping the tablets through a
Distance of six inches in the , which then operates for 100 revolutions. The tablets are
reweighed. Compressed tablets that lose less than 0.5 to 1.0% of the Tablet weight
are considered acceptable.
Drug Content and Release:
 Weight Variation test: Take 20 tablets and weigh them individually. Calculate average
weight and compare the individual tablet weight to the average. The tablet passed the
U.S.P. test if no more than 2 tablets are outside the percentage limit and if no tablet
differs by more than 2 times the percentage
 Content Uniformity Test: Randomly select 30 tablets. 10 of these were assayed
individually. The Tablet passes the test if 9 of the 10 tablets must contain not less than
85% of the labelled drug content and the 10th tablet may not contain less than 75% and
more than 125% of the labelled content. If these conditions are not met, remaining 20
tablets assayed individually and none may fall outside of the 85 to 115% range.
 Disintegration Test: The U.S.P. The device to test disintegration uses 6 glass tubes
that are 3" 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 "C
such that the tablet remains 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. According
to the test 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. distance
of 5-6 cm at a frequency of 28 to 32 eyelets per minute. Floating of the tablets can be
prevented by placing perforated plastic dishes on each tablet. Disintegration time:
Uncoated tablet: 5-30 minutes Coated tablet: 1-2 hours

23. 17

 Dissolution Test:
Two set of apparatus:
o Apparatus-1: A single tablet is placed in a small wire mesh basket attached to the bottom
of the shaft connected to a variable speed motor. The basket is immersed in a dissolution
medium (as specified in the monograph) contained in a 100 ml flask. The flask is cylindrical
with a hemispherical bottom. The flask is maintained at 37-0.5°C by a constant temperature
bath The motor is adjusted to turn at the specified speed and samples of the fluid are
withdrawn at intervals to determine the amount of drug in solution.
o Apparatus-2: It is the same as apparatus-1, except the basket is replaced by a paddle. The
dosage form is allowed to sink to the bottom of the flask before stirring. For dissolution
test U.S.P. specifies. the dissolution test medium and volume, type of apparatus to be used,
rpm of the shaft, time limit of the test and assay procedure for. The test tolerance is
expressed as a % of the labelled amount of drug dissolved in the time limit.

24. 18

MY LEARNING AT LABORATE PHARMACEUTICALS
The overall objective of industrial training is to involve student in practical studies which are
ongoing process prevailing in pharmaceutical industry. I had gone through my industrial
training at laborate pharmaceuticals, Panipat. There I was employed at tablet production
department as a trainee where particularly production of different tablets taking place I
performed my industrial training in the following procedure
 At very first day my industrial training, I observed that how raw material are kept and stored
I learned how each raw material that I used for formulating our dosage form must undergo
various quality checks.
 At next day of my training, we received our quality report of our raw material that taught
me how a drug is assayed before manufacturing to get assure about quality and maintaining
the standards.
 At day three I carried out weighing of chemicals for the manufacturing and then we started
the procedure of manufacturing of havax fort tablet whose batch no. was 22hx07(b) having
batch size of 5 lack tablets. All raw materials was dispensed according to batch formula.
 Next day sizing or grinding of all raw materials was carried out to ensures the uniformity
size of the excipient and active pharmaceutical drugs using fluid energy mill.
 Then it is transferred to ‘v’ cone blender for successful mixing of excipients with APIs.
 Havax fort tableting is carried out by dry granulation using a roll compaction machine by
compacting primary particles into larger granules and formation of slug takes place.
 Then proper residual moisture level is maintained using fluidized-bed dryer.
 Next I preformed tableting process by using multi-station machine. It squeezed the
ingredients into the required tablet shape with extreme precision
 It is a continuous process until the required quantity of tablets are produced. I also
preformed quality assurance parameter to check the physical parameter of the tablets which
are record in the following pages
 Then after the production quality control department carried out various quality parameter
and issues the report of the quality levels
 Then after the report sugar coating of tablet is carried out in pan coating machine.
 After that dried tablets are processed for packaging mostly blister packs are used for
packing materials and the required information are also printed on it.
 Than our worthy chemist sir has taught us how sample was to be checked and finally the
product left for storage area.
 At last I want to tell you that learned that industrial training has provide me a great
knowledge and how many effort and knowledge are to be used to prepare a good and a
safer pharmaceutical product.

25. 19

26. 20

27. 21

28. 22

CONCLUSION
Through this Industrial Training I gained lots of knowledge about the Pharmaceutical Industry
and its inevitable role in society.
This one month helps me to understand the provisions to manufacture the sterile solid dosage
preparations, like tablets and its analysis and all about the production to a certain extent within
this short period.
Also helps me to understand the GMP requirements that should be complied by the
pharmaceutical Industry and its significance for the maintenance of quality of the formulations.
These 31 days gave me lots of field work experiences in the Industry.

29. 23

Reference
● Mehta R.M. Pharmaceutics 2nd edition Vallabh Prakashan, Page no:-246252
● Lachman, L., Lieberman, H. A., and Kanig. J. L. (1986). The Theory
and Practice of Industrial Pharmacy, 3rd ed., Philadelphia: Lea & Febiger.
● Allen L. V and Ansel H. C. (2014). Ansel's Pharmaceutical
Dosage Forms and Drug Delivery Systems. Philadelphia: Lipincott Williams
and Wilkins.
● Dash, A. (2014). Solid Dosage Forms. In A. Dash, S. Singh and J.
Tolman (Eds). Pharmaceutics: Basic Principles and Application to Pharmacy.
(pp.161-180), USA: Elsevier Inc.
● Gendre C., Genty M., César da Silva J., Tfayli A., Boiret M., Lecoq O.,
Baron M., Chaminade P., Péan J-M., Comprehensive study of dynamic curing
effect on tablet coating structure, Eur. J. Pharm. Biopharm., 81 (2012), 657-665
● ugar Confectionery Manufacture (1999) by E. B. Jackson, chapter 11.
● Hans-Jürgen Bässler und Frank Lehmann : Containment Technology:
Progress in the Pharmaceutical and Food Processing Industry. Springer, Berlin
2013, ISBN 978-3642392917