A PROJECT REPORT ON INDUSTRIAL

TRAINING

A Dissertation submitted to the

HIMACHAL PRADESH TECHNICAL UNIVERSITY,

HAMIRPUR, HIMACHAL PRADESH
In partial fulfillment of the requirement for the degree of

BACHELOR OF PHARMACY
Submitted by

ANMOL SINGH THAKUR

(ROLL NO. 21013514010)

Under the guidance of Mrs. Kumari Shilpa Sharma

(Assistant professor)

AAKASH INSTITUTE OF MEDICAL SCIENCES, NALAGARH,

HIMACHAL PRADESH- 174101
 INDUSTRIAL TRAINING REPORT

DECLARATION
I Anmol Singh Thakur, hereby declared that the work presented in the industrial report entitled in A Project
report on industrial training.

It is an authentic record of work carried out by me during 19-06-2024 to 18-07-2024 at GLENMARK

PHARMACEUTICALS Ltd. under the guidance of Aakash institute of medical sciences, Nalagarh. Is being
submitted for partial fulfillment of requirement for the award of bachelor’s degree in B.Pharm. It has original
piece of work. This is not being submitted anywhere else for the award of any other degree/diploma.

Anmol Thakur
(21013514010)

ACKNOWLEDGEMENT

2
 INDUSTRIAL TRAINING REPORT
I considered it a great privilege & honor to have had the opportunity to undergo the industrial training work in
GLENMARK PHARMACEUTICALS Ltd. I am greatly indebted to Prof. (Dr.) MUNISH GOYAL
Principal of Aakash institute of medical sciences, Nalagarh for enabling us the chance of industrial training.

I convey heartiest thanks to Mr. Gaurav Gupta (Manager), for their most valuable suggestion, constant
encouragement, and affectionate guidance during the period of this training.

I would like to thanks all trainees and staff, who help me very much and without whom support and guidance
it was impossible for me to complete the project successfully.

Finally, I express my regards to my beloved parent who inspired me throughout my studies and completion of
this training.

...Anmol Thakur

PREFACE

3
 INDUSTRIAL TRAINING REPORT
Pharmacy is a profession which is concerned with the art and science of the preparing suitable and convenient
material for distribution and use in treatment and prevention of disease, so it is fully technical profession
where practical knowledge is much more important along with theoretical knowledge.

According to curriculum of a four-year integrated degree course of BACHELOR OF PHARMACY each

student has to undergo practical training for a period of one month in any of pharmaceutical industry in India.

I was directed to undergo at “GLENMARK PHARMACEUTICALS Ltd.” and this report contains a brief
description of the above pharmaceutical industry which was observed during the training program.

4
 INDUSTRIAL TRAINING REPORT

COMPANY PROFILE
 Sai healthcare is established as a sole proprietorship firm. Sai healthcare is leading manufacturing of a
wide range of pharmaceuticals tablet, capsule, dry syrup.
 They are engaged in manufacturing of pharmaceuticals product for acute care market, etc.
 They are leading group of companies that is headed by an experienced management involved in the
diverse field of pharm industries to grow.
 They possess an image of a wide recognized manufacture of dry syrup.

MISSION

 Honor our pledge to continuously improve strive toward the highest quality standards in all aspect of
our business.
 Optimize the talent of our employees within a learning organization with an environment that reward
commitment, creativity, and performance
 Value teamwork among our employees, business associates etc.

Vision

 Our vision is to become a technological –based Indian pharmaceutical company & to emerge out as a
strong player in the domestic and international market
 To keep improving the quality of life by offering value added novel product that are technologically
innovative, cost-effective and of superior quality.

Social responsibility

At Glenmark, we believe that contributing back to society is not only a RESPONSIBILITY but a
COMMITMENT. Our little value added to betterment of society is a part of our mission, in line with
our commitment to human health. Corporate social responsibility is not just an integral part of our
business but devotion; the promise of brighter future for every life we touch.

List of products

5
 INDUSTRIAL TRAINING REPORT

1. magnesium zinc vitamin D3 & B12 tablet

2. Calcium carbonate, vitaminD3, methylcobalamin, L-Methyl folate Calcium

&pyridoxal-5-phosphate tablets

3. Aceclofenac, paracetamol & serratiopeptidase tablets

6
 INDUSTRIAL TRAINING REPORT

4. Azithromycin tablets

TABLE OF CONTENTS

7
 INDUSTRIAL TRAINING REPORT
Sr. No. Topic Page No.
1. Industrial Training Certificate 1

2. Profile of Organization 2-5

3. Raw Material Store 6-7

4. Tablet Section 8-16

5. Capsule Section 17-21

6. Liquid Section 22-24

7. Quality Control and Quality Assurance Section 25-28

8. Finished Good Section 29

9. Engineering Section 30-31

10. Conclusion 32

SECTIONS IN COMPANY

➢ Raw Material Store

➢ Tablet Manufacturing Section
➢ Capsule Manufacturing Section
➢ Liquid Manufacturing Section
➢ Quality Control and Quality Assurance Section
➢ Microbiology Section
➢ Finished Goods Section
➢ Engineering Section

8
 INDUSTRIAL TRAINING REPORT

RAW MATERIAL STORE

A raw material also known as a feedstock or most correctly unprocessed material, is a basic material
that is used to produce goods, finished products, energy or intermediate materials which are
feedstock for future finished products. As feedstock, the term connotes these materials are bottleneck
assets and are highly important with regards to producing other products.

Pharmaceutical raw materials comprise substrates or elements that are used for manufacturing
different types of drugs e.g. endocrine disorder drugs, musculoskeletal system drugs, anti-infective
drugs viz. cephalexin, penicillin, ampicillin, cephalin, etc. Pharmaceutical excipients and ingredients
or raw materials used to manufacture drugs are extracted from different sources. These sources could
be natural or synthetic. Recently, many of the raw materials previously derived from natural sources
are being produced synthetically in part or even biotechnologically. This is so because manufacturing
them artificially is economical, safer and much quicker. Pharmaceutical raw materials are
manufactured using different types of acids, alcohols, esters, phenomes, pyridines, etc.

Pharmaceutical raw materials are essential to producing pharmaceutical drugs and include active
pharmaceutical ingredients (APIs) also known as bulk active are pharmaceutically active and have
desired pharmacological effects on the body e.g. alvimopan, pefloxacin, sapropterindihydrochloride,
lanreotideacetate, nicotinic acid, etc. In contrast pharmaceutical excipients are the pharmaceutically
inert substances which help in delivering the active ingredients.

e.g. anti-adherents, binders, coatings, disintegrants, fillers, etc.

Fig.1 – Raw Material Store

9
 INDUSTRIAL TRAINING REPORT

STEPS INVOLVE IN RM STORE

➢ Receiving
➢ Sampling
➢ Storing
➢ Dispensing

Receiving
➢ Raw material is supplied by vendors by placing order.
➢ After receiving the raw material check he “Observation on pack”.
➢ Segregate the raw material according to batch number.
➢ Pre entry cleaning of raw material by vacuum cleaner ➢ Weighing of the raw material.

Sampling
➢ Before sampling get line clearance by QA person.
➢ OC person test the sample of raw material under LAF by different tests and fill it in
“Observation on sampling and pack” and “Certificate of analysis.”

➢ Warehouse operators will paste the labels of “Approved label” and “Sampled label.”
➢ Next sent raw material for storing.

Storing
➢ The raw material is stored at 3 different temperature zones – Ambient:
Not more than 35 0C; Controlled temperature room: 15 – 25 0C; Cold
room: 2 – 8 0C.

Dispensing

➢ Raw material is picked for dispensing according to “Material pick list for process order” and
dispensed according to BMR prepared by QA personnel.
➢ Selection of raw material is done according to “First expiry first dispenses”.
➢ Raw material is dispensed from dispensing booth under LAF to the production area.

PRODUCTION SECTION

General Instructions and Precautions –

➢ Ensure area and equipment cleanliness before starting the manufacturing operations.
➢ Check and ensure that all manufacturing equipment and other required accessories are cleanready
for use.
➢ Wear gloves and nose mask during all manufacturing process.
➢ Counter check the weights of all ingredients before using in the batch.
➢ Get line clearance from QA for manufacturing.
➢ Air handling unit (AHU) system should be kept ON throughout the manufacturing process.

10
 INDUSTRIAL TRAINING REPORT
➢ Temperature should be kept between 25 0C + 2 0C and relative humidity should be kept
between50 + 10%.
➢ Ensure that QC approval purified water is being used for manufacturing purpose.
➢ Always transfer solution to the manufacturing vessels through 20 meshes.
➢ During the preparation of product, no other product processing should be done in the same area.
➢ Whenever sifting through SS mesh is involved; check the mesh integrity before and after use.
➢ All critical aspects during manufacturing like temperature, duration of mixing, weight, etc. must
be checked and recorded by the supervisor.
➢ Supervisor to ensure completion of all in-process records during various stages of manufacturing
operations till completion of the batch.
➢ Release from QA should be taken from all in-process tests mentioned in batch manufacturing
record.
➢ No over writing is allowed in batch manufacturing record. If initial data is wrong entered, cancel
the data by single stroke arrow and put initials. Record reasons for change as footnote on the
same page.
➢ All details whatever is necessary should be recorded in batch manufacturing record (BMR).
➢ Send a test request to QC after manufacturing is completed.
➢ Check all polyethylene bags before and after material loading for black particles and sealing.
➢ Check calibration of respective equipment/machine before use.

TABLET MANUFACTURING SECTION

Tablet Components and Additives

A. Active Ingredients: ornidazole IP, Folic acid, pantoprazole sodium, tranexamic acid,
azithromycin, cefixime, metformin, vitamin B6, etc.

B. Non-active Ingredients: six major excipient categories

a. Diluents: lactose, starch, mannitol, Sorbitol.
b. Binders: Acacia, Gelatin, Tragacanth, starch.
c. Lubricants: stearic acid, magnesium stearate, calcium stearate. and talc.
d. Disintegrants: Starches are the most common disintegrating agents.
e. Colors: D&C and FD&C dyes and lakes, and
f. Flavors and Sweeteners: mannitol, lactose, sucrose, saccharin and dextrose.

Unit Operations
There are three methods of preparing tablet granulations. Such as:

(a) Wet granulation,

(b) Dry granulation (also called "slugging"), and (c) Direct compression.

➢ Each of these methods has its advantages and disadvantages.

➢ Each individual operation of the process is known as a unit operation.

11
 INDUSTRIAL TRAINING REPORT
WET GRANULATION
1. Milling of drugs and excipients.
2. Mixing of milled powders.
3. Preparation of binder solution.
4. Mixing binder solution with powder mixture to form wet mass.
5. Coarse screening of wet mass using 6- to 12- mesh.
6. Drying moist granules.
7. Screening dry granules with lubricant and disintegrants.
8. Mixing screened granules with lubricant and disintegrants.
9. Tablet compression.

DRY GRANULATION
1. Milling of drugs and excipients.
2. Mixing of milled powders.
3. Compression into large, hard tablets called slugs.
4. Screening of slugs.
5. Mixing with lubricant and disintegrating agent.
6. Tablet compression.

DIRECT COMPRESSION
1. Milling of drugs and excipients.
2. Mixing of ingredients.
3. Tablet compression.

EQUIPMENTS
1. SIFTER
An instrument used to sieve the ingredients of a tablet with a replaceable mess ware. In this
technique, particles of power mass are placed on a screen made of uniform aperture. The sifter is
attached with a vibrator that helps in sieving the materials through the meshwork. The mechanism of
action is to loosen the packing of the particle in contact with screen surface, permitting entrapped sub
sieve particles to the screen surface.

Fig 2. Sifter Fig 3. Planetary Mixer

12
 INDUSTRIAL TRAINING REPORT

2. Planetary Mixer
For wet granulation a planetary mixer is used. Solutions of the binding agent are added to the mixed
powders with stirring. The powder mass is wetted with the binding solution until the mass has the
consistency of damp snow. The planetary mixer can mix a material of 100kg. The beater of the
planetary mixer revolves 2-4 times for each revolution of the head, providing double mixing action.

3. Mass Mixer
This is also mixing equipment used to mix dry as well is wet ingredients. The mixer has blades that
are alternately arranged and is allows uniform mixing. The mass mixer is emptied by inverting it and
scrapping off its ingredients. The planetary mixer can mix a material of 100kg.

4. Multi-mill
This is a hammer mill that uses a high-speed rotor to which several swinging hammers are fixed. The
unit is enclosed with chamber containing a grid or removable screen through which the material can
pass. The material is fed from the top and ground by impact of hammers or against the plates around
the periphery of the casing. The materials are enough pass through the screen that forms the lower
portion of the chamber.

The fragments are swept downward against the screen where they undergo additional hammering
action until they are reduced to a size small enough to pass through the openings and out. Oversize
particles are hurled upwards into the chamber where they also undergo further blows by the
revolving hammer.

5. Fluidized bed dryer

In a fluidized bed dryer, the fluidized air stream is introduced by a fan or blower mounted at the top
of the apparatus. The air is heated to the required temperature in an air heater and flows upwards
through the wet materials, which remains in a drying chamber fitted with a wire mesh supported at
the bottom. By this process, the material is suspended and agitated in a warm air stream while the
granulation is maintained in motion.

13
 INDUSTRIAL TRAINING REPORT

Fig 4. Fluidized Bed Dryer Fig 5. Tray dryer

6. Tray dryer
It consists of a chamber, containing horizontal arrangements of trays on which granules are dried.
The drying process is accomplished by a gust of hot air driven by or blower through an electric
heater and heat exchange. In this method, the wet materials are placed over paper sheets and finally
placed over the trays and the drying operation is carried out. These dryers are mainly useful for
materials that contain alcoholic solutions and where slow drying for better granule characteristic is
necessary.

7. Compressor
For increased production, Rotary machines offer a great advantage. A head carrying a number of sets
of punches and dies revolves continuously while the tablet granulation runs from the hopper, through
a feed frame and into the dies placed in a large, steel plate revolving under it. This method promotes
a uniform fill of the die and therefore an accurate weight for the tablet. Compression takes place as
the upper and the lower punches passes between a pair of rollers. This action produces a slow
squeezing effect on the material in the die cavity from the top and bottom and so gives a chance for
the entrapped air to escape.

TABLET PRESSES
➢ The basic unit of any tablet press is a set of tooling consisting of two punches and a die which is
called a station.
➢ The die determines the diameter or shape of the tablet; the punches, upper and lower, come
together in the die that contains the tablet formulation to form a tablet.
➢ There are two types of presses: single-punch and rotary punch.
➢ The single-punch press has a single station of one die and two punches, and is capable of
producing from 40 to 120 tablets per minute depending on the size of the tablet. It is largely used
in the early stages of tablet formulation development.

14
 INDUSTRIAL TRAINING REPORT
➢ The rotary press has a multiplicity of stations arranged on a rotating table in which the dies are
fed the formulation producing tablets at production rates of' from a few to many thousands per
minute.
➢ There are numerous models of presses manufactured by a number of companies, ranging in size,
speed, and capacity.

Tablet presses consist of

1) Hoppers, usually one or two, for storing and feeding the formulation to be pressed.
2) Feed frame(s) for distributing the formulation to the dies.
3) Dies for controlling the size and shape of the tablet.
4) Punches for compacting the formulation into tablets.
5) Cams (on rotary presses) that act as tracks to guide the moving punches. All other parts of the
press are designed to control the operation of the above parts.

Fig 6. Rotary tablet press coating

➢ Tablet coatings perform one or more of the following functions. They may: mask the taste of
unpalatable drugs, protect the drug from deterioration due to light, oxygen or moisture, separate
incompatible ingredients, control the release of medicament in the gastrointestinal tract, and
provide an elegant or distinctive finish to the tablet.

➢ The materials used for coating may largely comprise sucrose (sugar coating), water soluble film
forming polymers (film coating) or substances which are soluble in the intestinal secretions but
not in those of the stomach (enteric coating).
➢ These types of coating can all be applied by the pan or fluid-bed processes; the compression
coating technique is suitable for sugar and enteric coatings, but not for film coating.

15
 INDUSTRIAL TRAINING REPORT

TYPES OF COATING:
1) SUGAR COATING
2) FILM COATING
3) MODIFIED RELEASE COATING

1) SUGAR COATING: This traditional coating imparts a smooth, rounded, elegant appearance to
the tablet. Stephenson and Smith (1951) have given a detailed discussion on the composition of
sugar coatings.

➢ The sugarcoating process involves building up layers of coating material on the tablet cores as
they are tumbled in a revolving pan by repetitively applying a coating solution or suspension and
drying off the solvent.
➢ Before sugarcoating, the core is coated with a sealing coat of shellac, PVP*- stabilized types of
shellac, or other polymeric materials, such as cellulose acetate phthalate and polyvinyl acetate
phthalate.
➢ The next stage is to build up a sub coat that will provide a good bridge between the main coating
and the sealed core, as well as round off any sharp corners. This step is followed by smoothing or
grossing.
➢ The finishing stage is accomplished by again applying one or two layers of clear syrup. The
tablets are then left for several hours before being transferred to the polishing pan.
➢ The polish is a dilute wax solution (e.g., carnauba or beeswax in petroleum spirit) applied
sparingly until a high luster is produced.

2) FILM COATING: Film coating has increased in popularity for various reasons.

➢ The film process is simpler and, therefore, easier to automate. It is also faster than sugarcoating,
since weight gains of only 2 to 6% are involved, as opposed to more than 50% with sugarcoating.
➢ Two major groups of film coating materials may be distinguished:
(a) Those that are non-enteric and, for the most part, cellulose derivatives, and
(b) Those that can provide an enteric effect and are commonly esters of phthalic acid.
➢ Films may contain a plasticizer that prevents the film from becoming brittle with consequent risk
of chipping.
➢ Until recently, alcohols, esters, chlorinated hydrocarbons, and ketones have been among the most
frequently used types of solvents. However, because of increasing regulatory pressures against
undesirable solvents, there has been a pronounced trend toward aqueous film coating.

3) MODIFIED-RELEASE COATINGS: A coating may be applied to a tablet to modify the release

pattern of the active ingredient.

➢ Two general categories, enteric coating and controlled-release coating, are distinguished.
➢ the former are insoluble in the low pH environment of the stomach but dissolve readily in the
small intestine with its elevated ph.
➢ They are used to minimize irritation of the gastric mucosa by certain drugs and to protect others
that are degraded by gastric juices.

16
 INDUSTRIAL TRAINING REPORT

Fig 7. Tablet Coating Machine Fig 8. Automatic Coating Machine

PACKAGING AND LABELLING OF TABLETS

 Packaging and Labeling of tablets are done in Packaging and Labeling area.
 In this area concurrently three actions i.e. visual checking for contaminant or deformity, Labeling
and Packing are taking place.
 This room is fitted with air-conditioners and a temperature of about 270C is maintained.
 This area has an inspection table where deformity and contamination are checked against black
and white background.
 The minimum luminosity required in the inspection zone is 500 lacs. ➢ The inspection table is
fitted with stainless steel conveyors.
 The equipment is attached with a motor of 1 H.P. and a reduction gear box with adjustable
pulley.
 It is sometimes convenient to categorize packages by layer or functions – 1) Primary Packaging
2) Secondary Packaging
3) Tertiary Packaging

Primary Packaging – It is the material that first envelope the product and holds it. This usually is
the smallest unit of distribution or use and is the package which is in direct contact with the
content.

Secondary Packaging – It is outside the primary packing and may be used to prevent pilferage or to
group primary packages together.

Tertiary Packaging – These are used for bulk handling, warehouse storage and transport shipping.
The most common form of palletized unit loads that packs tightly into containers.

17
 INDUSTRIAL TRAINING REPORT

Fig 9. Blister Packaging Machine

TYPES OF PACKAGING

1) BLISTER PACKING
2) STRIP PACKING
1) Blister Packing: This is useful for packaging of unit dose of pharmaceuticals. This packing mode
has been used extensively for several good reasons. It is a packaging configuration capable of
providing excellent environmental protection, coupled with an aesthetically pleasing and
efficacious appearance. It also provides user functionally in terms of convenience, child
resistance and now temperature resistance.
Blister packing consists of two principals’ components: -

1) A formed base web creating the cavity inside which the product fit.

2) The lidding foil for dispensing the product out of the pack.

2) Strip packing: The blister package is formed by heat softening a sheet of thermoplastic resin and
vacuum drawing the softened sheets of plastic into a contoured mould. After coming, the sheet is
released from the mould and proceeds to the filling station of the packaging machine. The semi-
rigid blister previously formed, is filled with the product and lidded with a heat sealable backing
material. The backing material can be either a push through or peelable type. For a push through
type of blister, the backing material is usually heating seal coated aluminum foil. The packaging
of the final product is done in paper cartons, manually, and is finally sealed using an automatic
sealer. The machine can seal cartons.

18
 INDUSTRIAL TRAINING REPORT

Fig 10. Blister Packaging

Fig 11. Strip Packaging

CAPSULE MANUFACTURING SECTION

➢ Capsule is the most versatile of all dosage forms.

➢ Capsules are solid dosage forms in which one or more medicinal and inert ingredients are
enclosed in a small shell or container usually made of gelatin.
➢ The process of manufacture of capsules is known as Encapsulation.

Types of Capsules
1) Hard Gelatin Capsule
2) Soft Gelatin Capsule

➢ The hard capsule is also called “two pieces” as it consists of two pieces in the form of small
cylinders closed at one end, the shorter piece is called the “cap” which fits over the open end of
the longer piece, called the “body.”
➢ The soft gelatin capsule is also called as “one piece.” Capsules are available in many sizes to
provide dosing flexibility.
➢ Unpleasant drug tastes and odors can be masked by the tasteless gelatin shell.
➢ The administration of liquid and solid drugs enclosed in hard gelatin capsules is one of the most
frequently utilized dosage forms.

19
 INDUSTRIAL TRAINING REPORT

INDUSTRIAL FILLING OF HARD GELATIN CAPSULES

a) Removal of caps
b) Filling of the bodies
c) Replacement of caps
d) Ejection of filled capsules

➢ Capsules are delivered into the perforated capsule filling ring.

➢ The ring is rotated on a turntable, and a vacuum pulls the bodies into the lower half of the ring,
leaving the caps in the upper half of the ring.
➢ The top & bottom halves of the filling ring are separated manually, and the cap half of the ring is
set aside.
➢ The body half of the ring is then moved to another turntable where it is rotated mechanically
under a powder hopper.
➢ The hopper contains an auger which feeds the powder into the bodies.
➢ When the capsule bodies are filled, the cap and body rings are rejoined.

FILLING OF POWDER IN CAPSULE SHELL

Filling of powder is generally done by the different machines. The equipment’s used for filling of
powder in capsule shell types –

1) Hand Operated Capsule Filling Machine.

2) Semiautomatic Capsule Filling Machine.

3) Automatic Capsule Filling Machine.
1) HAND OPERATED CAPSULE FILLING MACHINE
The machine is designed for filling a wide variety of formulation suitable for all classes of
pharmaceutical industry. The machine is simple to operate with no variation. The machine is fully
made out of stainless steel 304 quality except harden and lubricant parts.

Fig 12. Hand Filling Capsule Machine

20
 INDUSTRIAL TRAINING REPORT

Features
➢ Low investment.
➢ Benefit ration simple to operate can be handled by UN skilled labor.
➢ All the loading plates are made of s.s.304 quality.
➢ Easily dismantle and reassembled even by unskilled labor.

Output
➢ 8000 Capsule per/hour from 300 holes machine.
➢ 4500 Capsule per/hour from 200 holes machine.
➢ 2000 Capsule per/hour from 100 holes machine.

Working
➢ It consists of a bed having 200-300 hole, a loading tray having 200-300 holes, a power tray, a pin
plate having 200-300 pins, a sealing plate having a rubber top, a lever, a cam handle.
➢ The empty capsules are filled in the loading tray and it is placed over the bed. ➢ The cam handle
is operated to separate the capsule caps form their bodies.
➢ The power tray is placed in a proper position and filled with an accurate quantity of power with
scraper.
➢ The excess of the powder is collected on the platform of the powder tray.
➢ The pin plate is lowered and the filled powder is pressed by moving the pin downwards.

21
 INDUSTRIAL TRAINING REPORT
After pressing the pin plate is raised and the remaining powder is filled into the bodies of the
capsules.

➢ The powered tray is removed after its complete filling.

➢ The cap holding tray is again placed in position.
➢ The plate with the rubber top is lowered and the lever is operated to lock the caps and bodies.
➢ The loading tray is then removed and filled capsules are collected.

2) SEMI AUTOMATIC CAPSULE FILLING MACHINE

The Semi-Automatic Capsule filling machine is a user-friendly machine available with advanced
features.

Fig 13. Semi Automatic Filling Capsule Machine

Features
➢ Fill weight accuracy
➢ Formulation yields
➢ Maintenance free operation
➢ Operator ease and safety

Innovative features
➢ Automation of loading station - This eliminates the need for continuous operator attention as
solid state control circuitry provides automatic stoppage of the loading table after completion of
one cycle, each of 60 strokes.

22
 INDUSTRIAL TRAINING REPORT
➢ Automation of filling station - This, again, is a revolutionary feature that eliminates the need for
continuous operator attention. Motorized. swing-in and swing-back of the drug hopper after one
filling cycle results in reduced operator fatigue.
➢ Pneumatic closing station - This utilizes an electronic sensor which activates a pneumatic
cylinder to carry out the closing operation resulting in ease of operation and reduced operator
fatigue.
➢ Filled capsule output capacity can be increased using our ring loading station. This allows
existing SA-9 installations to be upgraded for extra production.

Output

Capsule Size 00 0 1 to 5
No. of Holes/ Loading Ring 360 420 480
Output Per hour 21,600 25,200 48,960
With ring loading 36,700 42,840 48,960
system Output per
hour

3) AUTOMATIC CAPSULE FILLING MACHINE

➢ High Speed Automatic Capsule Filling machines are suitable for filling powders and pellets. These
are versatile machines with several outstanding features both functional and mechanical.
➢ The machines have capabilities to give an output of 40,000 capsules and 90,000 capsules per hour
with high filling accuracy and can accommodate capsule sizes.
➢ Capsule fillers are used to fill hard gelatin and non-gelatin capsules with pre-determined quantity of
liquids, powders, pellets, tablets.
➢ Capsules are normally fed into the machine, the filler then align, opens and accurately fills each
capsule and recloses.

Fig 14. Automatic Filling Capsule Machine

23
 INDUSTRIAL TRAINING REPORT
Fillers generate minimum dust with lowest level of product loss. Non-separated, double loaded
capsules and improperly inserted capsules are automatically rejected by machines to maintain the
consistency in the quality of product.

➢ Most capsule fillers are characterized with fast changeover time to accommodate a variety of
capsules in terms of shapes and size.
➢ High Quality Capsule Filling Machine requires minimal maintenance and easy to clean.
➢ Another important feature is the installation of speed adjusting equipment and automatic
counters ensuring the right quantity of capsules being filled and packed.
➢ Model - A 40 40,000 capsules per hour for powder & 30,000 capsules per hour for pellets.
➢ Model - A 90 90,000 capsules per hour for powder & 70,000 capsules per hour for pellets.

POLISHING OF CAPSULE
CAPSULE POLISHING MACHINE
➢ This polishing machine is used after capsules were filled for cleaning the powder attached on the
capsules surface, through mechanically rotating brush and attraction of vacuum to take out the
external powder.
➢ As the chamber is made of stainless steel is installing with filter cloth and nylon brush as the
capsule are subjected to roll travel from one end of the brush to other end between nylon bristles
and filter cloth and the capsule get polish an get glossy finish.
➢ This part of the machine compatible with two stainless Steel chambers installed with filter cloth,
a revolving variable speed spiral nylon brush stainless Steel powder collector and a vacuum dust
collector.
➢ The capsules travel from one end to another end. During this travel they are subjected to roll in
between the nylon bristles and filter cloth.
➢ In this course the powder on the capsules and at the edge are removed and sucked by the dust
collector.

Features
➢ Fill weight accuracy.
➢ Formulation yields.

24
 INDUSTRIAL TRAINING REPORT

LIQUID MANUFACTURING SECTION

➢ The Liquid Manufacturing Plants are ideal tools for the pharmaceutical industry
to produce Oral Liquids.
➢ It is specially designed to take care of two critical factors which directly affect
the quality of the Liquids.
➢ Minimum manual handling of Liquid.
➢ Effective cleanness during manufacturing.
➢ It also provides the benefits of the effective manpower utilization.

LIQUID MANUFACTURING PLANT CONSIST THE

FOLLOWING EQUIPMENTS AND ACCESSORIES
➢ Sugar Syrup Vessel
➢ Manufacturing Vessel
➢ Storage Vessel ➢ Control Panel
➢ Product Piping
➢ Working Platform

SALIENT FEATURES OF THE LIQUID MANUFACTURING

PLANT ARE AS FOLLOWS
➢ The Plant is designed to be operated only by one operator and one helper.
➢ All material transfers are done by vacuum or by transfer pumps
➢ All the vessels are CGMP (paint free construction)
➢ The gaskets used are of silicon (food grade).
➢ All contact parts are of S.S. 304 quality material (SS316 provided on demand)
& finished to class4B (Mirror) finish and are crevice free.
➢ The entry of stirrer & high-speed emulsifier is from top. In-line Emulsifier (as
per customer choice) provided on demand. (Optional)
➢ All vessels are suitable for internal pressure of 1 Kg. / Sq. cm. and hence can be
sterilized.

PROCESS CONTROL
This system consists of a closed-circuit manufacturing facility from feeding
of Sugar / Water Phase to loading the Volumetric Liquid Filling Machine.

25
 INDUSTRIAL TRAINING REPORT

➢ The Sugar and Water, are load with vacuum system or by mechanical system or
manually.
➢ The Sugar Syrup Vessel is supplied with high-speed stirrer & electrical heating
(In small model) /steam heating facility (In bigger size model).
➢ The sugar syrup is prepared at required temperature & is transferred to
Manufacturing Vessel by vacuum or by transfer pump.
➢ The product during emulsion formation is re-circulated through In-Line
Homogenizer or Liquid Transfer Pump.

LIQUID FILLING MACHINES

1. AUTOMATIC LIQUID FILLING MACHINE

➢ Automatic anti-pressure liquid filling machine adopting the ways of vacuum filling
to fill all several of overflow products with high accuracy and versatility ensure
filling without leakage, no foam and damaged bottle is no incorporated.
➢ Automatic speed variation adjustment makes operation more convenient and
reliable.

2. SEMI AUTOMATIC VOLUMETRIC LIQUID FILLING MACHINES

➢ Semi-automatic volumetric liquid filling machines is two head, table top, fully
GMP model used to fill variety of liquids.
➢ Semi-automatic volumetric liquid filling machine can be used for different types
of glass, Plastic, Metal containers.
➢ Semi-automatic volumetric liquid filling machine works on volumetric principle
and is fitted with two syringes on the sides.
➢ The motor and gear box are covered in a SS cabinet. The desired volume can be
adjusted by increasing or decreasing the eccentricity. Bottles are kept bellow the
nozzles manually.
➢ Output bottles per minute depending on type of liquid and fill size with the help
of three speed pulley arrangement.

Fig 15. Semi-Automatic Liquid Filling Machine

26
 INDUSTRIAL TRAINING REPORT

3. ROTARY BOTTLE WASHING MACHINE

➢ The washing machines are ideal for washing injection bottles, infusion bottles,
ampoules, cartridges and syringes. It is designed to clean various types of glass
bottles or plastic, metal containers either round or odd shaped, subjecting it to a
series of distinct processing operations.
➢ On washing machines, containers are fed individually and considerately through
several stations: flooding, washing (with or without ultrasonic support), blowing
out and transfer to a downstream sterilizing tunnel.
➢ The bottles are loaded on rotating platform where bottles are getting cleaned in a
series of operations. The bottles are placed in an inverted position in cups.

4. HIGH SPEED AUTOMATIC BOTTLE FILLING & CAP

SEALING MACHINE

➢ High Speed Automatic Bottle Filling & Cap Sealing Machine can be adapted to a wide
variety of bottle shapes and liquids properties and can be used in various Industries
such as Pharmaceuticals, Cosmetics, Agrochemicals, Chemicals, Etc.
➢ This unit is fully automatic unit and can be coupled with an un-scrambler to feed the
bottles to the in feed conveyor of this machine.
➢ This machine achieves the complete operation of filling the bottles automatically and
accurately.

27
 INDUSTRIAL TRAINING REPORT

QUALITY CONTROL AND QUALITY

ASSURANCE SECTION
Quality control is the part of GMP concerned with sampling, specification and testing
and with organization; documentation and release procedures which ensure that
necessary and relevant tests are carried out and that materials are not released for sale
or supply, until their quality has been judged satisfactory.

Quality Control (QC) laboratory ensures that the products are pure, safe and effective
and are released only after thorough analysis as per stringent specifications, methods
and procedures developed according to international guidelines viz. EU cGMP,
MHRA, WHO, TGA, etc.

One of the most important elements in QC laboratory program is the quality and
assurance of the standard which are used. The standard can be broadly defined into
two categories –

Different types of tests are performed for different material. The types of
tests performed for each material are as follows – 1. Size and Shape test

2. Color test
3. Hardness test
4. Friability test
5. Weight Variation test
6. Disintegration test
7. Dissolution test
8. HPLC

1. Size and Shape – Thickness is + 5% of standard value control to facilitate

packaging. Shaped tablet requires slotted punches because of the non-uniformity
force during compression.

2. Organoleptic Property – Color of product must be uniform. Non-uniformity of

color on the tablet is called Mottling.

3. Hardness - Tablet requires a certain amount of strength or hardness and resistance

to friability to withstand mechanical shakes of handling in manufacture, packaging,
and shipping.

➢ Hardness generally measures the tablet crushing strength. The strength of a tablet
was determined by following ways;

28
 INDUSTRIAL TRAINING REPORT

(a) By cracking the tablet between 2nd and 3rd fingers with the thumb acting as a
fulcrum. If there is a sharp snap, the tablet is an acceptable strength.

➢ Generally used Hardness testers are:

a) Monsanto Tester
b) Pfizer Tester

➢ Hardness for compressed tablet is 5 to 8 kg.

Fig 16. Monsanto tester

4. Friability

➢ Friability of a tablet can determine in laboratory by Roche friabilator.

➢ This consist of a plastic chamber that revolves at 25 rpm, dropping the tablets
through a Distance of six inches in the friabilator, which is then operate for 100
revolutions.
➢ The tablets are reweighed. Compress tablet that loses less than 0.5 to 1.0 % of the
Tablet weigh are consider acceptable.

Fig 17. Roche Friabilator

29
 INDUSTRIAL TRAINING REPORT

5. Weight Variation test (U.S.P.)

➢ Take 20 tablets and weighed individually.

➢ Calculate average weight and compare the individual tablet weight to the
average.
➢ The tablet passes 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
limit.

6. Disintegration Test (U.S.P.) ➢ The U.S.P. 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 0C 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.
➢ Disintegration time: Uncoated tablet: 5-30 minutes
➢ Coated tablet: 1-2 hours

Fig 18. Disintegration Test Apparatus

7. Dissolution Test (U.S.P.)

30
 INDUSTRIAL TRAINING REPORT

➢ 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 monograph)
contained in a 100ml flask.
➢ The flask is cylindrical with a hemispherical bottom.

8. HPLC
➢ Most widely used separation technique
➢ Broad applicability – organic & inorganic

Chromatography can be described as a mass transfer process involving adsorption

using a non- polar stationary phase and a mobile polar phase titrating through the
column. The active component of the column, the sorbent or the stationary phase, is
typically a granular material made of solid particles (e.g. silica, polymers, etc.), 2-50
μm in size. High performance liquid chromatography (HPLC) is a chromatographic
technique used to separate a mixture of compounds in analytical chemistry and
biochemistry with the purpose of identifying, quantifying or purifying the individual
components of the mixture.

Fig 19. HPLC

FINISHED GOODS SECTION

➢ Finished goods are goods that have completed the manufacturing process but
have not yet been sold or distributed to the end user.
➢ A good purchased as a “Raw material” goes into the manufacture of a product.
➢ A good only partially completed during the manufacturing process is called
“work in process”.

31
 INDUSTRIAL TRAINING REPORT

Procedure
➢ Receive the finished good transfer ticket from production duly authorized by
production supervisor and checked by QA.
➢ Following is to be made in finished good transfer ticket after received from
production –
➢ Name of product.
➢ Manufacturing Date.
➢ Expiry Date.
➢ Verify the received goods against transfer with above details.
➢ Ensure the all details are complete as per our requirements.
➢ In case of any observation, intimate to production department and get it
corrected.
➢ Enter the physically verified quantity in SAP system.

ENGINEERING SECTION
➢ Electricity Unit
➢ Water softening unit
➢ Water Treatment System
➢ Chilling unit

Electricity Unit
➢ Generation of electricity in Elfin is from three sub-stations red, yellow and blue (RYB).

Light arrester – A lightning arrester is a device used on electrical power system

and systems to protect the insulation and conductors of the system from the
damaging effects of lightning.

Transformer – Step down unit, this transformer converts high voltage, low
current power into low voltage, high current power. The larger gauge wire used in
the secondary winding is necessary due to the increase in current.

Water Softening Unit

➢ It is the removal of calcium, magnesium and certain other metal cations in hard
water.
➢ The resulting soft water is more compatible with soap and extends the lifetime of
plumbing.

32
 INDUSTRIAL TRAINING REPORT

Fig 20. Water Softening System

CONCLUSION
Industrial training is very much essential for Pharmacy Students. It is also a great
opportunity to acquire practical knowledge. During my training period, in the
industry I acquired lots of experiences in Pharmaceutical Production and Production
management. This will help me to clarify my theory knowledge. I hope and pray that
it will help me much in my future profession.

During my training period, I had seen the various instruments and apparatus in the
industry. The highly sophisticated instruments that work precisely must be operated
with intense care for optimum use. We acquire a lot of information regarding the
latest instruments and their working procedure.

It was taught to us that; the cGMP guidelines are to be strictly followed in the
industries in each and every section. And the similar guideline was seen followed in
Glenmark Pharmaceuticals Ltd. Baddi, Solan Himachal Pradesh. It helped us to
acquire knowledge on punctuality, regularity and working environments in industries.

I was successfully able to complete my short venture of training and got a lot of
knowledge.

33
INDUSTRIAL TRAINING REPORT

…. ANMOL SINGH THAKUR

34
INDUSTRIAL TRAINING REPORT

35
INDUSTRIAL TRAINING REPORT

36
INDUSTRIAL TRAINING REPORT

37