RDS COLLEGE OF PHARMACY, JAUNPUR

INDEX

Sr.no Contents Page.no.

.

1. Introduction 1

2. Capsule Manufacturing Defects 4

3. Hard Gelatin Capsule 6

4. Components of Hard Gelatin Capsule 6

5. Capsule Size and Shape 7

6. Raw Material For Hard Gelatin Capsule 7

Shell Manufacturing

7. Manufacturing of Hard Gelatin Capsule 9

8. Manufacturing of Empty Hard Gelatin 10

Capsule

9. Filling of Hard Gelatin Capsule 10

10. Soft Gelatin Capsule 13

11. Composition Of Soft Gelatin Capsule 14

12. Vehicles Used in Soft Gelatin Capsule 14

13. Basic Components of Soft Gelatin Capsule 15

14. Manufacture of soft Gelatin Capsule 17

15. Conclusion 19

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CAPSULE
Introduction :
In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage
forms techniques used to enclose medicines in a relatively stable shell known as
a capsule, allowing them to, for example, be taken orally or be used as
suppositories. The two main type of capsules are:

 Hard gelatin capsule, which are typically made using gelatin and
contain dry, powdered ingredients or miniature pellets by e.g. processes
of extrusion or spheronisation. These are made in two halves: a lower
diameter “body” that is filled and then sealed using a higher diameter
“cap”.
 Soft gelatin capsule, primarily used for oils and for active ingredients
that are dissolved or suspended in oil.

Both of these classes of capsule are made from aqueous solutions of gelling
agents, such as animal protein (mainly gelatin) or plant polysaccharides or their
derivatives (such as carrageenans and modified forms of starch and cellulose).
Other ingredients can be added to the gelling agent solution including
plasticizers such as glycerin or sorbitol to decrease the capsule’s hardness,
coloring agents, preservatives, disintegrants, lubricants and surface treatment.

Capsule Manufacturing Process

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Advantage Of Capsules
1. Ease of use due to fact that it is smooth, slippery and easy to swallow.
2. Suitable for substance having bitter taste and unpleasant odor.
3. As produced in large quantities it is economic, attractive and available in
wide range of colors.
4. Minimum excipients required.
5. Little pressure required to compact the material.
6. Unit dosage form.
7. Easy to store and transport.

Disadvantage Of Capsules

1. Not suitable for highly soluble substances like potassium chloride,

potassium bromide, ammonium chloride, etc.
2. Not suitable for highly efflorescent or deliquescent material.
3. Special conditions are required for storage.

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Capsule Manufacturing Defect

1. Lumpy or mis-shaped capsules :

Sometimes capsules shells form lumps called lumpy or mis-

shapencapsuleprevented by maintaining empty shell in temperature range
15°-30°Crelative humidity range 45-55°C avoid exposing to direct sun
light or heat.

2. Improper rectification :

In proper rectification capsules are not oriented properly.

3. Failure to separate :

Sometimes cap and body fails to separate due to vacuum generation. Can
be overcome by applying extra vacuum.

4. Dented capsules :

Dents can form on the dome of the cap and /or body this is due to
improper setup of machine or due to overfilling.

5. Telescoping :

This is due to mis-alignment of cap and body, body splits and a portion of
body covers the cap. Rectified by maintaining proper alignment of cap
and body.

6. Popping :

Popping is capsule opening after filling. It is due to overfilling or due to

weak locking machine.

7. Brittleness :

When capsule lose moisture they become brittle (due to poor storage
condition). Filled capsule have hygroscopic substances cause brittleness.

8. Other defects :
 Colour deviation
 Short or long body and cap
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 Damaged printing
 Dots / specks on capsule
 Holes / scratch
 Bubbles on capsule shell

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HARD GELATIN CAPSULE

Hard gelatin capsules also known as hard-shell gelatin capsules or two-piece
capsules are solid dosage forms in which one or more medicinal agents and/or
inert materials are enclosed within a small shell. They are a well-established
dosage form that provides solutions to many of today’s drug delivery and
nutraceutical formulation challenges.

A hard gelatin capsule shell consists of two prefabricated, cylindrical sections (a

cap and a body) each of which has one rounded, closed-end and one open end.
The body has a slightly lower diameter than the cap and fits inside the cap.

Hard gelatin capsule shells are fabricated and supplied empty to the

pharmaceutical industry by shell suppliers and are then filled in a separate

operation. During the capsule filling unit operation, the body is filled with the
drug substances and the shell is closed by bringing the body and the cap
together.

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Capsule shells showing features

Components of hard gelatin capsules

Hard gelatin capsule shell is composed largely of gelatin. Other than gelatin, it
may contain materials such as plasticizer, colourants, opacifying agents, and
preservatives which either enable capsule formation or improve their
performance. Hard gelatin capsules also contain 12–16% water, but the water
content can vary, depending on the storage conditions.

Capsule sizes and shapes

Empty hard gelatin capsule shells come in a variety of sizes ranging from an
arbitrary numbering of 000 to 5 with 000 being the largest size and 5 being the
smallest. The shape has remained virtually unchanged since its invention except
for the development of the self-locking capsule during the 1960s when
automatic filling and packaging machines were introduced.

The size of hard gelatin capsule selected for use is determined by requirements
of the formulation, including the dose of the active ingredient and the density
and compaction characteristics of the drug and other components. The first step
to estimating the optimal capsule size for a given product is to determine the
density of the formulation using tapped density for powders and bulk density for
pellets, minitablets, and granules. The appropriate capsule size may then be
calculated using the measured density of the formulation, the target fill weight,
and capsule volume. The fill weight for liquids is calculated by multiplying the
specific gravity of the liquid by the capsule body volume multiplied by 0.9.

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To accommodate special needs, some intermediate sizes (‘elongated sizes’) are

produced. These capsule sizes typically have an extra 10% of fill volume
compared to the standard sizes e.g. elongated size 00 capsules (00el), elongated
size 0 capsules (0el), elongated size 1 capsules (1el), elongated size 2 capsules
(2el) etc. The table below shows capsule volumes and typical fill weights for
formulations with different tapped densities.

Capsule volumes and typical fill weights for formulations with

different tappeddensities

Raw materials for hard gelatin

capsule shell manufacturing
Hard gelatin capsule shell is composed largely of gelatin. Other than gelatin, it
may contain materials such as plasticizer, colourants, opacifying agents, and
preservatives which either enable capsule formation or improve their
performance. Hard gelatin capsules also contain 12–16% water, but the water
content can vary, depending on the storage conditions.

A. Gelatin
Gelatin is by far the most common and most well-known material used to
produce hard capsule shells. It is a generic term for a mixture of purified protein
fractions obtained from irreversible hydrolytic extraction of collagen obtained
from the skin, white connective tissue, and bones of animals.

Depending on the source of the collagen and the method of extraction, two
types of gelatin can be produced – type A gelatin and type B gelatin. Type A
gelatin is made from pork skin via acid hydrolysis and has an isoelectric point
between 7.0 and 9.0. Type B gelatin is prepared by alkaline hydrolysis of
bovine bones and has an isoelectric point between 4.8 and 5.0. Because of this

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difference in isoelectric points, both gelatins show solubility differences at

different pH values.

Traditionally capsules may be manufactured by using both types of gelatin, but

combinations of pork skin and bone gelatin are often used to optimize shell
characteristics because bone gelatin contributes firmness, whereas pork skin
gelatin contributes plasticity and clarity.

Gelatin derived from Gelatin grade is further specified by bloom strength. This
is measured in a Bloom gelometer which determines the weight in grams that is
required to depress a standard plunger in a 6.67% w/w gel under standard
conditions.

Gelatin is stable in air when dry but is subject to microbial decomposition when
it becomes moist.

B. Plasticizer
Plasticizers are added to gelatin to reduce the rigidity of the polymer and make
it more pliable. Common examples of plasticizers are glycerine and polyhydric
alcohol. Water is also a good plasticizer and is naturally present in the gelatin.

C. Colourants
Most frequently, hard gelatin capsules are coloured to enhance the aesthetic
properties and also to act as a means of identifying the product. Colorants used
must meet the regulatory requirements of those countries where the product will
be sold. Examples of commonly used capsule colourants include synthetic dyes
such as azo dyes and xanthene dyes. Iron oxide pigments are also used.

D. Opacifying agents
Opacifiers (e.g., titanium dioxide) may be included to make clear gelatin
opaque. Opaque capsules may be employed to provide protection against light
or to conceal the contents.

E. Preservatives
Preservatives (often parabens esters) were formerly added to hard capsules as an
in-process aid in order to prevent microbiological contamination during
manufacture. Manufacturers operating their plants to Good Manufacturing
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Practice (GMP) guidelines no longer use them. In the finished capsules, the
moisture levels, 12–16% w/ v, are such that the water activity will not support
bacterial growth because the moisture is too strongly bound to the gelatin
molecule.

Manufacture of Hard Gelatin Capsules

The sequence of two-piece hard gelatin capsule shell manufacture

Manufacture of empty hard gelatin
capsules
Hard gelatin capsules are manufactured using a dip-coating method and the
various stages involved are as follows:

Step 1: Preparation of the gelatin solution (dipping solution)

Step 2: Dip-coating the gelatin solution on to metal pins (moulds)
Step 3: Rotation of the Dip-coated pins
Step 4: Drying of the gelatin-coated pins
Step 5: Stripping and trimming
Step 6: Joining of the trimmed capsule shell
Step 7: Printing

Filling of hard gelatin capsules:

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The filling of hard gelatin capsules is an established technology, with equipment

available ranging from that for very small-scale manual filling (e.g., Feton
capsule filling machine), through intermediate-scale semi-automatic filling to
large-scale fully automatic filling. Hard gelatin capsules can also be hand-filled
one at a time, as done in a compounding pharmacy. The difference between the
many methods available is the way in which the dose of material is measured
into the capsule body.

The basic steps in filling hard gelatin capsules include:

1. Rectification of capsules (placing empty gelatin capsules on the

removable plate with bodies facing downward).
2. Separation of caps from bodies.
3. Dosing of fill material (The body is filled with the formulation manually
using a plastic spatula, and the excess powder is removed).
4. Replacement of caps/ closing capsule shells and
5. Ejection of filled capsules

Filling of powder formulations into hard

gelatin capsules
Hard gelatin capsules can be filled by hand for research or experimental
purposes or when filling a small number of capsules in the pharmacy. This is
done by placing the powder to be filled on a sheet of clean paper or on a pill tile
or porcelain plate and pressing the open end of the capsule downward until it is
filled. The cap is then placed to close the capsule.

On a small-scale manufacture, hard gelatin capsules can be filled manually

using a manual or a hand-operated capsule machine. This is done by directly
filling the powder into the capsule shell and relying on the bulk/tapped density
of the powder to get the correct dose for the volume of the capsule shell used.
The various types of hand-operated capsule machines have capacities ranging
from 24 to 300 capsules and, when efficiently operated, are capable of
producing about 200 to 2,000 capsules per hour.

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13The dosator device uses an empty tube that dips into powder bed, which is
maintained at a height approximately two-fold greater than the desired length of
the plug. The dosator piston’s forward movement helps form the plug, which is
then transferred to the body of the capsule, and released.

Dosator filling
principles
Filling of

liquids/semisolid formulations into hard gelatin

capsules
As drug discovery continues to yield poorly water-soluble molecules, there is an
increasing need for formulation techniques that can improve drug solubility.
One such approach is the use of liquid-based formulations containing lipids,
solvents, or surfactants, usually in combination, to improve drug solubility and
bioavailability. The final formulation may be filled through piston pump
systems into hard gelatin capsules as a room temperature liquid, or as a molten
semisolid.

The filling of a liquid or semi-solid formulation is dependent on the viscoelastic

properties of the formulation and the need to fulfil certain characteristics at the
filling temperature. As a general rule, the formulation should have a viscosity of
between 50 and 1000 Centipoise (cP) (although formulations of much higher
viscosity can be suitable for manufacturing) and should not exceed 70 °C.

The particle size in suspension should ideally be less than 20 µm and

formulations should be such that no stringing, dripping, splashes or
solidification of the formulation should occur at the dosing nozzle. Unless a hot-
melt is filled that completely solidifies below 40 °C, hard capsules are
recommended to be band or fusion sealed using separate band sealing or Liquid
Encapsulation Microspray Sealing (LEMS®) sealing equipment. For research

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purposes, a machine that is capable of filling and sealing 1500 capsules an hour
(e.g. CFS® 1500) has been developed.

Note: If hard gelatin capsules cannot be used because of any formulation,

preference, or cultural reason, alternative materials such as polymer-based
shells or hypromellose may be used.

Examples of hard gelatin capsules :

Examples of solid-filled hard gelatin capsules

 Cinobac – Cinoxacin (Eli Lilly and Co.)
 Amphetamine and dextroamphetamine – Adderal XL (Shire
Pharmaceuticals)
 Methylphenidate hydrochloride – Ritalin LA (Novartis)
 Didanosine – Videx EC (Bristol Myers)
Examples of liquid- or semi-solid-filled hard gelatin
capsules

 Vancomycin – Vancodin (Lilly)

 Captopril – Captopril-R (Sankyo)
 Ibuprofen – Solufen (SMB Ivax)
 Piroxicam – Solicam (SMB)

SOFT GELATIN CAPSULE

Soft gelatin capsules, also known as softgels or soft elastic capsules, are
hermetically sealed one-piece capsules containing a liquid or a semisolid fill
without a bubble of air or gas. They are made from a more flexible, gelatin film
plasticized by the addition of glycerine, sorbitol, or a similar polyol.

As with hard gelatin capsules, soft gelatin capsules are predominantly

administered orally. Some can be formulated and manufactured to produce a
number of different drug delivery systems such as

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a. Chewable softgels where a highly-flavoured shell is chewed to release

the drug liquid fill matrix
b. Suckable softgels which consist of a gelatin shell containing the
flavoured medicament to be sucked and a liquid matrix (or just air inside
the capsule)
c. Twist-off softgels which are designed with a tag to be twisted or snipped
off, thereby allowing access to the fill material and
d. Meltable softgels designed for use as pessaries or suppositories.

Schematic diagrams illustrating different shapes of soft gelatin

capsules

Soft gelatin capsules have grown in popularity in recent years because they
enable administration of liquids in a solid dosage form with a bioavailability
advantage over other commonly used solid dosage forms (e.g., tablets). They
are available in a variety of sizes, shapes, and colours that may be specific to the
manufacturer.

Composition of soft gelatin capsule shell

The major components of soft gelatin capsule shell are gelatin, plasticizer and
water. Besides these three components, soft gelatin capsule shell may contain
other ingredients such as colourants and/ or opacifiers for visual appeal and/or
reducing the penetration of light for the encapsulation of photosensitive drug
substances.

Flavours and sweeteners may be added to improve palatability. Preservatives

e.g., potassium sorbate, and methyl, ethyl, and propyl hydroxybenzoate are
added to prevent the growth of bacteria and mould in the gelatin solution during
storage.

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Acid-resistant polymers when present in the capsule shell formulation are used
to impart enteric release characteristics. They can also be used to formulate
chewable soft gelatin capsules e.g., ChildLife’s Pure DHA chewable 250 mg
softgel capsule.

Typical content (%
Component Function
w/w)
Gelatin Polymeric base 66.3
Glycerine Plasticizer 33.0
Methylparaben + propylparaben
Preservative 0.1
(80/20 ratio)
Colour Colourant 0.1
Titanium dioxide Opacifier 0.5
Water Solvent/process aid q.s. (0.7–1.3 × of gelatin)

Typical composition of a soft gelatin capsule shell

Types of vehicles used in soft gelatin capsules :

Softgels are prepared to contain a variety of liquid, paste, and dry fills. Liquids
that may be encapsulated into soft gelatin capsules include the following:

1. Water-immiscible volatile and non-volatile liquids such as vegetable and

aromatic oils, aromatic and aliphatic hydrocarbons, chlorinated
hydrocarbons, ethers, esters, alcohols, and organic acids.
2. Water-miscible non-volatile liquids, such as polyethylene glycols, and
nonionic surface-active agents, such as polysorbate 80.
3. Water-miscible and relatively non-volatile compounds such as propylene
glycol and isopropyl alcohol, depending on factors such as concentration
used and packaging conditions

Note: Liquids that can easily migrate through the capsule shell are not suitable
for soft gelatin capsules. These materials include water above 5% and low
molecular weight water-soluble and volatile organic compounds such as
alcohols, ketones, acids, amines, and esters.

Basic components of soft gelatin capsule shell

The various components of the soft gelatin capsule shell are as
follows:

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A. Gelatin
Similar to hard gelatin capsule shells, the basic component of soft gelatin
capsule shell is gelatin. A large number of different gelatin shell formulations
are available depending on the nature of the liquid fill matrix. Most commonly,
the gelatin is alkali- (or base-) processed (type B) gelatin and it normally
constitutes 40% of the wet molten gel mass. Type A acid-processed gelatin can
also be used. The properties of gelatin shells are controlled by the choice of
gelatin grade and by adjusting the concentration of plasticizer in the shell. The
physicochemical properties of gelatin are controlled to allow

1. Adequate flow at desired temperatures to form ribbons of defined

thickness, texture, mechanical strength, and elasticity.
2. Ribbons to be easily removed from the drums, stretch during filling, seal
the temperature below the melting point of the film, and dry quickly
under ambient conditions to an adequate and a reproducible strength.

Physicochemical properties of gelatin important to capsule formation include

gel strength, viscosity, change in viscosity with temperature and shear, melting
point, settling point (temperature), settling time, particle size (affects time to
dissolve), and molecular weight distribution (affects viscosity and strength).

B. Plasticising agents
Plasticizing agents are added in a soft gelatin capsule formulation to ensure
adequate flexibility. They interact with gelatin chains to reduce the glass
transition temperature (Tg) of the gelatin shell and/or promotes the retention of
moisture (hygroscopicity). The most common plasticizer used for soft
gelatin capsules is glycerol. Sorbitol, maltitol, and polypropylene glycol can
also be used in combination with glycerol.

Glycerol derives its plasticizing ability primarily from its direct interactions
with gelatin. In contrast, sorbitol is an indirect plasticizer because it primarily
acts as a moisture retentive agent. Compared to hard gelatin capsules and tablet
film coatings, a relatively large amount (20 -30% w/w) of plasticizers are added
in a soft gelatin capsule formulation to ensure adequate flexibility. The amount
and choice of the plasticizer contribute to the hardness of the final product and
may even affect its dissolution or disintegration characteristics, as well as its
physical and chemical stability.
C. Water

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Water usually accounts for 30-40 % of the wet gel formulation and its presence
is important both during the manufacturing process (to facilitate manufacture)
and in the finished product to ensure that the capsule is flexible. The desirable
water content of the gelatin solution used to produce a soft gelatin capsule shell
depends on the viscosity of the specific grade of gelatin used. It usually ranges
between 0.7 and 1.3 parts of water to each part of dry gelatin.

After the capsule is formed, most of the water is removed from the soft gelatin
capsules through controlled drying. The finished soft gelatin capsules contain
13–16 % w/w water, which represents the proportion of water that is bound to
the gelatin in the soft gel shell. This level of water is important for good
physical stability, because in harsh storage conditions softgels will become
either too soft and fuse together, or too hard and embrittled.

D. Preservative
Preservatives are often added to prevent the growth of bacteria and mould in the
gelatin solution during storage. Examples of commonly used as preservatives
include potassium sorbate, and methyl, ethyl, and propyl hydroxybenzoate.

E. Colorant and/or opacifier

A colourant (soluble dyes, or insoluble pigments or lakes) and/or opacifier (e.g.,
titanium dioxide) may be added to the shell for visual appeal and/or reducing
the penetration of light for the encapsulation of a photosensitive drug. The
colour of the capsule shell is generally chosen to be darker than that of its
contents.

F. Other excipients
Other, infrequently, used excipients can include flavouring agents and
sweeteners to improve palatability. Acid-resistant polymers are used to impart
enteric release characteristics. They can also be used to formulate chewable soft
gelatin capsules. A chelating agent, such as ethylene diamine tetracetic acid
(EDTA), can be added to prevent chemical degradation of oxidation sensitive
drugs catalysed by free metals in gelatin, such as iron.

Manufacture of Soft Gelatin Capsules

Softgels are manufactured using the following methods

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1. Plate process
2. Rotary die process
3. Reciprocating die process
4. Accogel process
5. Seamless process

Plate process
This is the oldest commercial process used in the manufacture of soft gelatin
capsules. In this process, a warmed sheet of plain or coloured plasticized gelatin
is placed over a die plate having a number of depression or moulds or numerous
die pockets. By applying vacuum, the sheet is drawn into these depressions or
pockets to form capsule wells. The capsule wells are then filled with
medication-containing liquid. A second sheet of gelatin is carefully placed on
top of the filled wells followed by the top plate of the mould. Pressure is then
applied to the combined plate to form, seal and cut the capsules into individual
units. This method is used for small scale preparation of soft gelatin capsules
and capsules formed generally, had one flat side.

The major problems with this method of manufacturing softgels were the lack
of dosage uniformity, high manufacturing losses, and its labour-/cost-
intensiveness. This equipment is no longer available.

Rotary Die Process

Most soft gelatin capsules are prepared by the rotary die process, a method
developed and perfected in 1933 by Robert P. Scherer. This process almost
eliminated all the problems associated with the plate process and produced soft
gelatin capsules with improved uniformity and high standards of accuracy.

In this process, two plasticized gelatin ribbons (prepared in the rotary-die

machine) are continuously and simultaneously fed with the liquid, semiliquid or
paste fill between the rollers of the rotary die mechanism. The forced injection
of the feed material between the two ribbons causes the gelatin to swell into the
left- and right-hand die pockets which govern the size and shape of the softgels
as they converge. As the die rolls rotate, the convergence of the matching dies
pockets hermetically seals and cuts out the filled capsules.

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Softgel formation mechanism (rotary die mechanism)

The precise and extremely low clearance of the rotating parts demands
continuous lubrication of the machine to avoid even a slight build-up. The
lubrication oil should, therefore, be a GRAS (generally recognized as safe)
material. Immediately after manufacture, the formed capsules automatically
undergo volatile solvent washing to remove any traces of lubricating oil from
the exterior of the capsules. The capsules are then conveyed to a drying station
and dried on trays, either in air or under vacuum, to equilibrium moisture
content to about 6 – 10 % with forced conditioned air of 20% – 30% relative
humidity at 21°C–24°C. The drying technique may proceed with an infrared
drying step to speed up the process.

After drying is complete, capsules are then be transferred to the inspection

station and sampled for release, after performing the required quality control
tests for sizes sorting, colour sorting, and packaging. Depending on the
manufacturer, additional finishing operations such as off-line print can be
performed.

CONCLUSION
Thus at the end I have reach at conclusion that during my one month training in
Ultra Drugs Pvt. Ltd .I have understand the environment of industry and how
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much company’s staff do the hard work in the production of such a bulk number
of product and how one can cope with the problem while working. A
pharmaceutical manufacturing unit is placed where not only been best possible
formulation are prepared to serve the social surrounding but also industrial
training program carried out to prepare technically skilled manufacturing
chemist and analysts.

In this industry both the above two functions are carried out under the
supervision of well skilled experienced and technical persons with complete
attention and honesty that improves not only the growth profile of industry but
also produce best chemist and analysts in future.

I wish for a sharp growth profile of the industry in the coming days and I also
admire it to be one of the best places for producing better chemists and analysts
beyond the formulation.

My opinion about industry is best places are occasionally been noted by

someone this is one of them noted by me.

I like the environment, staffs and head of departments and heartily wish to work
with them ever when an opportunity is given to me.

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