A REPORT ON INDUSTRIAL TRAINING AT ALKEM LABORATORIES how to create a report on industrial training,

1. A REPORT ON INDUSTRIAL TRAINING
AT
ALKEM HEALTH SCIENCES, UNIT III
(A UNIT OF ALKEM LABORATORIES)
SAMARDUNG, SIKKIM
PRESENTED BY
PANKAJ KUMAR
REG. NO. 19109161059
(B.Pharm, Final Year, 7TH
Semester)
NIBHA INSTITUTE OF PHARMACEUTICAL SCIENCE,
KARIMPUR, RAJGIR

2. ACKNOWLEDGEMENT
I am very thankful to production manager of alkem health science, unit 3, samardung, Sikkim
(A unit of Alkem labotories ltd.) pharmaceutical company for giving me permission for the
training.
I want to give a lot of thanks to Mr. Ashok kumar (production), Mr. Omprakash Singh (Quality
Control), Mr. Ajit Singh (Quality Assurance) and Mrs. Anjana Thakur (EHS), who supervised
me for my future.
I am very thankful to my principal Dr. MA Jahangir (NIPS, Rajgir) for their blessings and
encouragement.
I have clean information about every instrument, manufacturing procedure and analytical
methods.
I owe deep gratitude to the Mr. Abhishek Karua (HR) for their support and guide to carry out
the tasks assigned to us while we are in the training. At last, I am greatly thankful to all my
guidance in alkem health science for extending their constant cooperation which went a long
way towards the completion of this Training and Report.
Thanking You
Pankaj Kumar
Final Year, B. Pharm
(Semester – 7th
)

4. INDEX
SR.
NO.
NAME OF CONTENT
1 Training Certificate
2 About Alkem
3 Introduction
4 List of products
5 EHS
6 Quality Control
7 Production i. Injection
ii. Tablet
iii. Dry Syrup
8 Quality Assurance
9 Conclusion

5. TRAINING CERTIFICATE

7. About Alkem Laboratories Ltd.
Fifty years ago, Late Mr. Samprada Singh and Mr. Basudeb Narain Singh, the two brothers decided to
change the world by disrupting Indian Pharmaceutical Market that was dominated by international
organizations, their bold step redefined the potential of the Indian pharmaceutical companies.
Today, we are honoured to be part of this historic moment and bring gratitude to the founders
for their dedication, vision and hard work over the last 50 years. Alkem Laboratories Limited is an
Indian pharmaceutical company based in Mumbai, Maharashtra, India. Established in 1973, We have
state-of-the-art facilities that employ cutting-edge manufacturing techniques for producing best-in-class
products. Alkem has an extensive manufacturing footprint which has a total of 21 manufacturing
facilities, out of which 19 are in India and 2 are in the United States. We have various manufacturing
facilities at Daman, Baddi, Indore and Sikkim. These possess regulatory approvals from agencies such
as USFDA, MHRA - UK, TGA - Australia, ANVISA - Brazil, WHO - Geneva, TPD - Health Canada,
PPB - Kenya, NDA - Uganda, MOH - Sudan, INVIMA - Colombia, TFDA - Tanzania, Zimbabwe,
BfArM-Germany, SAHPRA-South Africa, & Other Africa, Asian & CIS Countries.
They are routinely audited to ensure compliance with Current Good Manufacturing Practices
(cGMP). Our Production Team has over 3,000 capable individuals, who work in tandem with the
Quality Team to deliver top-quality products. Our management furnishes adequate resources to ensure
quality deliverance. All manufacturing units are equipped with Quality Control Units that assure quality
at each stage.
In the year 2000, Alkem launched a separate division- Alkem Generic dedicated solely for the
marketing of trade generic drugs.Currently under the Alkem Generics cluster there are four divisions-
Futura, Maxxio, Novokem & Alkem Healthcare. Futura, the flagship division of the Generic cluster is
well known for creating iconic brands like Omee, Almox, Alkof and Aldigesic spanning varied therapies
like gastro, ant-infectives, cough & cold and pain and fever.
Launched in 2013, Maxxio division too has made its mark in the generic market and brands
like Lycolyfe, Ketokem and Pamagin are well known across the country.
Novokem division launched in 2017 has carved a niche for itself in the OTC-Trade Generics
space. Brands like Pregakem, Playgard, Orogard have garnered huge consumer acceptance.
Alkem Heathcare launched in 2021 is the latest addition to the Alkem Generic cluster. The
division has a wide range of injectables and Derma products. Brands like Diclokem, Alkem Genta &
Alkem Dexa have done well in the launch year itself.
Alkem Laboratories Limited Contact Details
Head office Training address
Alkem Laboratories Limited Alkem Health Science Ltd.
Devashish Building, Alkem House, Samardung Plant, Namthang, Sikkim
Senapati Bapat Road, Lower Parel, 737126, India
Mumbai - 400 013. Phone :+91 83439 15551
E-mail: contact@alkem.com, Website: www.alkemlabs.com
Tel: +91 22 3982 99 99

8. INTRODUCTION
Location - Alkem Health Science Ltd.
Samardung Plant, Namthang, Sikkim, 737126, India
Phone: +91 83439 15551
Website: www.alkemlabs.com
VISION
“Our vision is to be a leading pharmaceutical company in India and to become a significant
global player by providing high quality, and affordable innovative solutions in medicine and
treatment.
MISSION
“We will discover, develop and successfully market pharmaceutical products to prevent,
diagnose, alleviate and cure diseases. We shall provide total customer satisfaction and achieve
leadership in chosen markets, products and services across the globe, through excellence in
technology, based on world-class research and development. We are responsible to the society.
We shall be good corporate citizens and will be driven by high ethical standards in our
practices.”
SOCIAL RESPONSIBILITY
At Alkem, we believe that contributing back to the society is not only a RESPONSIBILITY
but a COMMITMENT. Our little value added to the betterment of society is a part of our
mission, in line with our commitment to human health. Through the years, Alkem has strived
to make the world around it a better place. Corporate Social Responsibility (CSR) is not just
an integral part of our business but devotion; the promise of a brighter future for every life we
touch. We consider it our duty to contribute a share of our earnings towards health benefits to
the less privileged, rural welfare to make life easier for rural poor and several charitable
activities to do our part towards the welfare of society as a whole.
Blood Donation
With a highest population in the world, there is the tremendous requirement of blood for patient
care. Unfortunately, there is an endemic shortfall of this precious item. Every year we organize
a blood donation drive at all our locations for our team members to contribute to this noble
cause. And every year on 31th may celebrate World No Tobacco Day.

9. List of products
Quality and Alkem are synonymous! For us patient centricity is the foundation on which the
organisation rests. Our every action is triggered by empathy for patients and the unflinching
commitment to fulfil their unmet needs. This helps us create apex quality products to address
the needs of patients. To aid this, we have a wide range of products spanning across multiple
Therapeutic Area (TA) such as Anti-infective, Gastroenterology, Pain Relief/Analgesic, Anti-
diabetic, Cardiology, Dermatology, Neurology/Central Nervous System (CNS) and Vitamins,
Minerals & Nutrients.
Alkem manufactures all of its more than 800 products, but when I was in Alkem Health Science
Unit 3, they only manufactured antibiotics.
But i explored some products, they are mention in below -
Injection
1. TAXIM INJECTION - 125MG,250MG, 500MG, 1GM, 2GM.
2. XONE INJ. – 125MG, 250MG, 500MG, 1GM, 2GM.
3. XONE XP INJECTION – 1.125GM.
4. XONE SB INJ. – 1GM
5. SWICH XP – 1GM.

10. 6. MEROSURE INJ. – 125MG, 250MG, 500MG, 1GM, 1.5MG.
7. ZAXTER INJ. – 125MG, 250MG, 500MG, 1GM.
8. ZAXTER XP INJECTION
TABLET
1. TAXIM O – 200MG TABLET
2. SWICH O - TABLET
DRY SYRUP
1. TAXIM O - DRY SYRUP FOR PAEDIATRIC USE (SUSPENSION)
2. SWICH DROPS FOR PAEDIATRIC USE

11. Environment, Health and Safety (EHS)
The Environmental, Health, and Safety (EHS) Guidelines are technical reference documents
with general and industry specific examples of Good International Industry Practice (GIIP).
When one or more members of the World Bank Group are involved in a project, these EHS
Guidelines are applied as required by their respective policies and standards. These industry
sector EHS guidelines are designed to be used together with the General EHS Guidelines
document, which provides guidance to users on common EHS issues potentially applicable to
all industry sectors. For complex projects, use of multiple industry-sector guidelines may be
necessary.
The EHS Guidelines for Pharmaceuticals and Biotechnology Manufacturing include
information relevant to pharmaceuticals and biotechnology manufacturing facilities. They
cover the production of active pharmaceutical ingredients and secondary processing, including
intermediates, formulation, blending, and packaging, and related activities research, including
biotechnology research and production.

12. Effluent Treatment Plants (ETP)
Also known as ETP is a waste water treatment process (WWTP) that is used to treat waste
water. It's mostly used in industries like pharmaceuticals, textiles, and chemicals where extreme
water contamination is a possibility. It plays a significant role in the treatment of industrial
waste water as well as domestic sewage. Organic matter, inorganic matter, heavy metals, oil &
grease, suspended particles, and other contaminants are treated in the wastewater treatment
process of an ETP plant. Chemical treatment, biological treatment, a combination of chemical
and biological treatment, and thermal treatment are the several types of wastewater treatment
plants.
Different processes involved are:
EQUALISATION: The equalization tank's purpose is to balance the raw effluent from various
processing units. The wastewater is collected in an existing mixed effluent tank and pumped to
an existing aeration tank, which also functions as an equalisation tank. The floating aerator is
used to homogenise the effluent before it is pumped to the neutralization tank for treatment.
pH CONTROL: The pH value of effluent should be between 5.5 and 9.0, according to the
Bureau of Indian Standards (BIS).pH neutralization is used to modify the pH of waste water.
For waste that is acidic (low pH): Bases are used to modify the pH of a solution.
In the case of alkali waste (high pH): Acids are used to modify the pH of a solution.
COAGULATION: Coagulation is a technique that involves adding liquid aluminium sulphate
to untreated water. This causes tiny dirt particles to stick together after mixing. This collection
of particles combines to generate larger, heavier particles that are easily removed through
settling and filtration.
SEDIMENTATION: Water travels slowly in this process, causing the heavy particles to settle
to the bottom. Sludge is the term for the particles that gather at the bottom of a container.
FILTRATION: Filtration is the process of passing water through a filter that removes
particulates. The filters are made out of sand and gravel layers. Backwashing is required to
clean these filters on a regular basis.
DISINFECTION: Before entering the distribution system, water is disinfected. Chlorine is
used to disinfect and decontaminate water.
SLUDGE DRYING: Sedimentation collects and settles down solids, which are then transported
to drying beds. when the sludge thickness reaches around 300 mm, the sludge charging should
be stopped, and the bed should be segregated to allow natural evaporation to dry it off. This
takes approximately ten days.
ETP PARAMETER
Capacity of Aerotion tank - 40KL, Online monitoring - Axis Nano
Capacity of MBR - 100KL, Volute press capacity - 15kg/hr
Conset Status - 1035 SPCB, Bio Assay Test - Fish Pond

13. Quality Control
The practice of checking goods, products, etc. during and after the production process to make
sure that they are of the expected standard. Before consuming any type of medicine, they need
to be tested and approved for consumption in prepared pharmaceutical laboratories, so that they
can be sold and consumed by the population. Each person who works in quality control in the
Pharmaceutical Industry, must be qualified according to their area of expertise to perform their
duties. Academic qualifications are extremely important, but there are also training courses for
each function, equipment and rule applied in the sectors that the company must provide to
employees.
Analyses are performed according to what each drug requires and depending on the phase this
drug is in. In the physical-chemical laboratory, controls of all types are carried out, from the
simplest to the most complex. We can mention as simple analyses the product’s appearance,
hardness, density and pH. As more complex, we can mention the most used method today in
the largest pharmaceutical industries in the world, the content of the product (dosage), carried
out in a device called HPLC (High Performance Liquid Chromatography). There are some
laboratories that are designed in such a way that separate compartments are provided for Wet
Chemical Analysis, Instrumental Analysis, Storage for glasswares, chemicals, control samples
and documentation.
Each product goes through a production process and in a physico-chemical laboratory it is
analysed from the raw material, passing through the initial product, final product and stability
study. Each phase requires special attention in its tests,
Raw Material
Raw material means any substance, active or not, and whatever its origin, used in the
production of medicine, whether it remains unchanged or changes or disappears during the
process. Raw materials thus include excipients and active substances.
Intermediate Product
Intermediate product is the partially processed mixture of the raw material with the necessary
inputs in their due measures that must be subjected to subsequent manufacturing steps before
becoming a bulk product.
Finished Product
Finished product is any product that has gone through all the stages of production of the
medicine before the packaging process is completed. Sterile products in their primary
packaging are considered bulk products.
Stability
A stability study is the monitoring of each medication or pharmaceutical input from time to
time to ensure that it maintains or does not lose a large percentage of its effectiveness. It is also
carried out in the laboratory, as well as the other phases of the product, and can provide
evidence on how these substances may vary over time from the influence of environmental
factors such as temperature, light and humidity. It is very important that each information,

14. activity and deviation is properly registered and identified by the quality control. An
unrecorded activity is seen as an unfulfilled activity.
A list of the instruments we explore in the wet lab's quality control section
1. Deep freezer
Make- Remi Electronics ltd.
Model – RQVD- 200
2. Centrifuge
Make – Remi Electronics ltd.
Model – R-4C
3. Magnetic stirrer
Make - Remi Electronics ltd.
Model – 5ML PLUS
4. Hardness tester
Make – Sotex
Model – MT50
5. Dissolution Test Appratus
Make – ElectroLab
Model – EDTO8LX

15. 6. Dis-integration test apparatus
Make – ElectroLab
Model – ED25APO
7. MILLI-Q WATER SYSTEM
Make – Merck
Model – Integral 10
8. Ph Meter
Make – LabIndia
Model – Pico plus
9. KF Titration
Make – Metrihm
Model – 888titration
10. Tap density apparatus
Make – ElectroLab
Model – EDT1020
11. Friability apparatus
Make – ElectroLab
Model – EF-2N

16. 12. UV Vis-Spectrophotometer
Make – SHIMADZU
Model – UV-1900
13. CILLER SONICATOR
Make – PCi
Model – 20L400
14. Analytical balance
Make – Mettler Toledo
Model – XSE205DV
15. Polarimeter
Make – Rudolph Research
Analytical
Model – auto Pol. V.
16. LPC (Liquid Particulate Counters) Apparatus
17. High Performance Liquid Chromatography (HPLC)

17. Production
The main area of the pharmaceutical facility which is responsible for manufacturing of the
pharmaceutical products. Some common points to be considered are:
1. The products of different categories (such as antibiotics, beta-lactum, steroids etc.)
should be manufactured in different area which eliminates the risk of the cross
contamination.
2. The premises should be designed in such a way in production area that the flow of the
material is justified.
3. The area specified for the production should be hard, smooth, impervious which
allows to handle the dangerous materials and also makes the cleaning and sanitization
easy.
4. Adequate light fittings, pipe work, ventilation and other services should be provided
in the production area.
5. Drainage system of production area should be of adequate size, sufficient in number
and suitably located to prevent the backflow.
6. Ventilation of the rooms should be proper by using HVAC systems and depending
upon the type of pharmaceutical product being manufactured.
7. Manufacturing area such as filling, punching of tablets should be segregated from the
packaging lines to avoid the cross contamination.
8. Also, in production area the primary packaging area should be different from the
secondary packaging areas to avoid mix ups.
9. The light should be proper in production areas specially in the region where the visual
checks are performed. For example: checking of ampoules for particles against the
white or black background.
Alkem Health Science, unit 3 has three production departments;
1. Dry powder injection (DPI) manufacturing and packaging
2. Tablet manufacturing and packaging
3. Dry Syrup manufacturing and packaging

18. INJECTION
An Injection is a preparation intended for parenteral administration and/or for constituting or
diluting a parenteral article prior to administration.
Parenteral articles are prepared thoroughly by methods designed to ensure that they meet
Pharmacopoeial requirements for sterility, pyrogens, particulate matter, and other contaminants
and where appropriate, contain inhibitors of the growth of microorganisms. Injectable product
manufacturing facilities are the most sophisticated and difficult to design, build, qualify, and
operate, especially since the products manufactured in these facilities are rendered sterile and
ready to inject directly into a human when finished. As a result, when designing such a facility,
special care has been taken.
The four most frequently used types of injection are:
Intravenous (IV) injections - An IV injection is the fastest way to inject a medication and
involves using a syringe to inject a medication directly into a vein. IV infusions allow a set
amount of medication to be administered in a controlled manner over a period of time. Eg -
antimicrobials, anticonvulsants, diuretics, steroids and analgesics
Intramuscular (IM) injections - IM injections are given deep into a muscle where the
medication is then absorbed quickly by surrounding blood vessels. Eg - Antibiotics and
contraceptive hormones, other hormones such as testosterone, Botox, steroids,
Subcutaneous (SC) injections - SC injections are injected into the innermost layer of the skin
called the subcutis or hypodermis, which is made up of a network of fat and collagen cells.
These injections work more slowly than an IV or IM injection because the area does not have
such a rich blood supply.
Eg- Insulin and other medications for diabetes
Intradermal (ID) injections - ID injections are given directly into the middle layer of the skin
called the dermis. This type of injection is absorbed more slowly again than IV, IM or SC
injections. Eg - Botox, steroids, and the tuberculosis (TB) vaccine.
Other types of injections include:
Intra-articular injections - into a joint
Peri-articular injections - into the soft tissue close to a joint
Intraosseous injections - into the bone marrow
Intradetrusor injections - into the muscle in the wall of the bladder
Intraocular (intravitreal) injection - into the jelly-like fluid in the eye
Intraperitoneal injections - given within the abdominal cavity
Intracardiac injections - into the muscle or ventricles of the heart
Intracavernous injections - into the base of the penis.

19. DRY POWDER INJECTION
There are certain drugs that seem to be extremely sensitive and unstable in an aqueous
environment. Even the slightest span of exposure can cause much damage to these drugs.
Hence, they require the manufacturing, packaging, storage, and shipping, to be done in the state
of powder or lyophilized form, in order to keep the product safe and stable during its shelf life.
MANUFUCTURING
The injectable dry filling area is a completely stenle area of the company that is a strictly
controlled area. The high-level alertness is mandatory to main the atmospheric condition in the
filling area of the dry powder filling area of Injectable. Every step in the production area
requires a written SOP. It is very important to check the relative humidity and temperature of
the filling room to avoid any quality issues with the product. The best way to address the
requirement of conditions an approved SOP for dry powder filling operation should be
followed.
Powders for injection (PIs) constitute an important category of dosage forms for active
molecules. Because of their instability in the aqueous environment, Pls cannot be marketed as
ready-to-use injectables
(1). Instead, they are marketed as dry powders to be reconstituted with a suitable vehicle just
before administration. The final form after reconstitution may be either a solution or a
suspension.
(2). Beta-lactam antibiotics, cephalosporins, and acyclovir. A few ready-to-use infusion
products are marketed as frozen solutions in plastic bags for these molecules. However, the
low temperature required for their shipment and storage makes these products an unviable
option, especially in countries in which a cold chain from manufacturing to the point of
consumption is difficult to establish. Depending on their formulation strategy, Pls can be
categorized into any of the classes Two strategies can be adopted for the formulation and
manufacture of Pls The first strategy of lyophilizing the primary pack allows the formulation
of drugs that are thermolabile or unstable in aqueous solution. However, lyophilization
normally yields an amorphous or partially amorphous product, which leads to solid-state
instability.
(3). A more stable crystalline stage can be obtained by crystallization in aseptic conditions, and
it can be maintained by directly filling the sterile dry-powder drug into presterilized vials,
Strategy
PROCESS OF MANUFUCTURING OF DPIs
VIAL DECARTOONING
VIAL WASHING TUNNEL/DEPYROGENATION FILLING SEALING
VISUAL INSPECTION
LABELING
PACKAGING
TRANSTER TO FG

20. INSTRUMENTS
1. VIAL WASHING MACHINE
NKP Pharma offers automatic linear vial washing machine
to make the surfaces of vial free from any dust or foreign
particles. The cleaning of vial is an important procedure in
order to make it suitable for further pharmaceutical
applications. Our state of the art manufacturing facilities
makes us produce optimum quality washing machines for the
vial.
Vial washing machine supplied by NKP Pharma has a simple structure with a left to right
working direction. The vial washer is offered in two variants- NKLVW 150H / 250H and
NKAC 120.
Linear vial washing machine NKLVW 150H / 250H has the capability of attending up to 120
and 240 vials per minute respectively. The vial size can vary from 2 ml. to 100 ml. and the
conveyor height can be adjusted from 850 to 900 mm. This makes the machine suitable for a
wide variety of applications.
2. TUNNEL
Conventional 3 zone for steady and standard
containers with safeties and simplicity
Contemporary Multi Zone configurations for novel
containers and Isolator compatibility
Proprietary Air-Turbines that have proven to work for
decades
High Temp HEPA filters that are industry benchmark
Automated slide gates for zone management
Environmental monitoring and control
Special interface for third party interface
On board fans, filters, heating and cooling systems
3. FILLING MACHINE
Automatic vial filling machine is a very efficient machine used for filling up the dry powder in
to the vials. The vial filler machine also places a rubber stopper on the top of the vial, once it
is filled with the powder. Injectable dry powder filling machine with rubber stopper makes use
of vacuum/pressure dosing system that helps achieve good accuracy and precision levels even
with the micronized powders for long, non-stop production cycles. It accommodates rubber
stopper size of 20 mm with the operation attaining of +/- 1%.

21. Injectable powder filler production rate depends upon the number of doses. For single dose, it
is 120 Vial/min, whereas for double dose, 60 vial/min can be achieved. When it comes to triple
dose, the production rate is 40 fills/min and for four dose, it is 30 vial/min. The vial filling
machine (vial filler) requires an electric supply of 5 HP with fill capacity ranging from 50 mg
to 1.5 gm for single dose and 1.5 gm to 6 gm for double, triple, and four dose.
Production Rate
Up to 120 Fills/Min. for single dose.
Up to 60 Fills/Min. for double dose.
Up to 40 Fills/Min. for triple dose.
Up to 30 Fills/Min. for four dose.
Fill Capacity
50 Mg to 1.5 Grms. single dose (with help of
change parts).1.5 Grms. to 6 Grms. double, triple
and four dose. Fill range depending upon vial
opening and bulk density of powder.
Accuracy
± 1% depending upon consistency and the
uniformity of bulk density of injectable powder
under controlled level of humidity (i.e., 25%).
4. VIAL SEALING MACHINE
An Automatic single head vial sealing machine is used for capping vials and provide hermetic
seals to protect the integrity of the drug inside the container. These drugs hold great medicinal
value and thus it must be made sure that the contents remain unadulterated.
NKP Pharma Pvt. Ltd. brings to you single head vial sealing machine that
performs the operation of sealing very effectively. Vial sealing machine
has a production rate of up to 50 to 60 vials per minute. Vial sealer
machine requires 3 HP of electric supply to operate and has a
single sealing head. The range of vial size that can be
accommodated in this machine is between 2 ml to 100 ml. Single
head vial sealer machine can allow seal sizes of 13mm, 20mm,
28 mm, & 32mm. The conveyor height is adjustable with the
height capable of being changed between 900 and 950 mm.

22. 5. PACKAGING
PRIMARY PACKAGING
A. Vial Inspection Machine - For Inspection of
Vials after Sealing
Automatic visual vial inspection machine ensures
that the vials, after being sealed, for any defects
regarding breakage, filling, or any other problems. This
vial inspecting equipment helps with the detection of
defective vials and hence can be rectified ensuring
minimum loss. The inspection machine checks for the
condition of vials and its content whether they are safe for practical applications.
In a visual inspection machine, the checking of vials is done with very little human
intervention. It requires very little maintenance and performs the operation quite effectively.
N.K.P. Pharma Pvt. Ltd. offers visual vial inspection machine in two variants- NKINS – 120
and NKINS – 250. The direction of the operation of these machines is from left to right. The
electric supply required for NKINS-120 is 1.0 HP whereas the NKINS – 250 require 1.5 HP.
Both the machines are capable of inspecting the inputs having the capacity ranging from 5 ml
to 30 ml. The machines are very rigid in construction and ensure that they have a longer life
without being damaged.
B. Vial Labelling Machine
it shoots up to 240 vials/min. Both these variants of self adhesive
vertical labelling machine require 2 HP of electric supply in order
to ensure that the operations performed by them are an
efficient one. The vial labeler machine is capable of
applying label for all the lengths starting from 12mm. It
can incorporate containers having their diameter in the
range of 20 mm to 90 mm.
These vial labellers use wrap around mechanism for labeling, which is
predominantly the most preferred method. Self-adhesive labeling machine is a type of vial
labelling machine that is employed for labeling the round containers by partially or fully
wrapping it around. Number of containers per hour can be labelled using this self adhesive
labeler machine. It is also one of the most user friendly equipments that one will ever come
across.
SECONDARY PACKAGING
Equipment for secondary packaging: -
1. Autocartonator machine 3. Cotdot printer
2. Checkweigher machine 4. Collating and Wrapping machine
5. Final product (weighing and shifting)

23. TABLET
Tablets are solid dosage forms that are taken orally and are manufactured with a combination
of various ingredients Active ingredients are mixed with excipients to manufacture the tablets,
Quantity and type of excipients are selected according to the type of tablets. The process of
tablet manufacturing has several steps including granulation, compression, and coating.
A. Active Ingredients: ornidazole IP, Folic acid, pantoprazole sodium, tranexemic 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.
There are three methods of preparing tablet granulations. Such as:
(a) Wet granulation,
(b) Dry granulation (also called "slugging"),
(c) Direct compression.
(a) WET GRANULATION PROCESS
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.

24. (b) DRY GRANULATION PROCESS
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.
(c) DIRECT COMPRESSION PROCESS
1. Milling of drugs and excipients.
2. Mixing of ingredients.
3. Tablet compression.
EQUIPMENTS IN THE SECTION OF TABLET MANUFUCTURING
1. GRANULATION
2. COMPRESSION
3. COATING
4. PACKAGING
FBD(FLUID BED DRYER) :-
Its main role includes drying granules produced by the wet
granulation process. If you’re not familiar with this process,
it simply involves agglomerating small powder particles
together by using a granulating liquid solution.
the fluid bed dyer’s working principle, you must know its
parts. There are three systems, really:
1. Air handling unit (AHU)
2. Main stainless steel tower
3. Exhaust system
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.

25. Multi-mill
This is a hammer mill that uses a high speed rotor to which a
number of 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 hammers.
DOUBLE CONE BLENDER
The Double Cone Blender is an efficient and versatile machine for mixing dry powder and
granules homogeneously. All the contact parts made out of
stainless steel of required grade by customer. Two third of the
volume of the Cone Blender is filled to ensure proper mixing. It
can be used for Pharmaceutical, Food, Chemical and Cosmetic
products etc.
Working of Double Cone Blender:
The powder is filled up to 2 or 3rd of the volume of the blender
to ensure proper mixing. The rate of rotation should be 30 to 100
RPM, and on rotation, mixing occurs due to the tumbling motion.
The Finally mixed Material is discharged from the bottom of the
equipment. the mixing tank can be slanted freely at an angle of
0° to 360° for material discharging and cleaning purposes.
Pharmaceutical Applications:
In the pharmaceutical industry, it is used for the homogeneous
mixing of dry powder and granules for tablets and capsules.
It is used in the preparation of spices, flavors, cake mixes, and other solid ingredients.
In the chemical industry, it is utilized for blending chemicals, creating dry powdered detergents,
manufacturing glass or ceramic products, and producing fertilizer.

26. DOUBLE ROTARY COMPRESSON MACHINE
Cadpress IV is a Double Rotary Excellence highly preferred for high batch production. The
machine is extremely reliable and trusted since last more than 20 years of its inception and
incorporates many of the proven features of the Cadpress family of pharma manufacturing
machines.
TECHNICAL SPECIFICATION
No. of station 45
Type of tooling D
Rated output (tablets / hour)* 65,000 to 324,000
Rated output (tablets / hour)* 65,000 to 324,000
Max. Compaction force-Pre (kN) 10
Max. Tablet diameter (mm) 25
Max. Depth of die fill (mm) 20
Max. Tablet thickness (mm) 8
Upper punch penetration-Main comp. (mm) 3 to 6
Power supply 220 / 380 / 415 / 480 V +10%, 3 Ph., 50 / 60 Hz
Principle of Tablet Compression Machine:
In the tablet compression machine main principle is compressing of the upper and lower punch
in a die hole, the hydraulic pressure plays a key role. This pressure is transmitted unreduced
through the static fluid. Any externally applied pressure is transmitted via static fluid to all the
direction in same proportion. It also makes it possible to multiply the force as needed. If we
increase the hydraulic pressure more compressing force on tablet then it becomes more hard.
Tablet compressing stage
Filling - Formulation is overfilled at the compressing station
Metering - Overfill is removed
Compression - Tablet is formed by pressure of punches within die
Ejection - Tablet is ejected from die

27. 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.
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 subcoat 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:

28. (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.
EQUIPMENT OF TABLET COATING
1. AUTOMATIC COATING MACHINE WITH STIRRER
Auto coater or automatic coating machine is an apparatus that is used to coat surfaces of small
particles with a thin film of coating substance.
In pharmaceutical industries the auto coater is used to coat the tablets. The tablets are sprayed
with a coating as the tablets move on in a device and then hot filtered air is passed so that the
applied coat dries immediately to form a thin layer of
coating on the tablet surface.
It is the application of coating solution to the rotating bed
of tablets with the application of hot air to facilitate the
evaporation.
Applications
Auto-Coater is used in pharmaceutical industries for
coating of tablets.
In food industries candies are coated with sugar using auto coater.
Various types of coating are possible like film coating with an organic solvent, enteric coating,
and aqueous coating.
Film coating to cover the unpleasant taste of tablets.

29. 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 25◦C and RH 45 % is
maintained.
This area has an inspection table where deformity and contamination are checked against
black and white background.
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 load that packs tightly into containers.
PROCESS OF PACKAGING
1. BQS MACHINE (BLISTER
QUICK SERVO)
ACG Pam-Pac presents servo technology
enabled flat-forming, flat-sealing,
continuous motion blister packing
machine - BQS (Blistering Quickly
through Servo).
Servo adds precision to blister packing by
synchronizing the different movements.
With servo, BQS achieves precision
power, speed and position control.
Synchronization of different movements in blister packing machines can be achieved by
mechanically linking the movement of the different axes. This is traditionally done by chain
and sprocket or timer belt and pulley or by using gears.
This design leads to a lot of changeover activities besides mechanaical maintenance.

30. Features High output machine for both PVC/PVdC(600 blister/minute) and Alu/Alu (280
blisters/minute).
Servo technology enables user friendly operationwith quick change over.
Flat forming, flat sealing continuous motion machine for high speeds.
Unique drum feeding systems for Alu/Alu ensure reliable feeding of high speeds.
Edge-to-edge cutting for 'Print Registered' products gives saving in foil consumption.
Tool-less change over for both PVC/Alu and Alu/Alu.
"Pick and Place" system for direct link up with cartoning machine without conveyor.
2. AUTOCARTONING
3. Check weigher
4. Automatic collating and wrapping machine
5. Weighing system
6. Bopp tapping machine

31. DRY SYRUP
“Dry pharmaceutical syrup may be defined as a Finely divided insoluble particle ranging
from0.5-5 μ, which Is to be distributed in a suitable vehicle”. Dry syrups are the solid dosage
form that can be reconstituted by theaddition of water to administer by the oral route. Mostly
antibiotics, some moisture sensitive and pediatric Drugs are available in the form of dry syrup.
Major application - paediatric therapy: taste masking:
Oral Route of administration is the route of choice for administration of medicines in children.
Theonly hurdle for dosage form designing for pediatric patients is the patient’sacceptance of
the dosage form. Pediatric Patients tend to become uncooperative during the administration of
oral medication; the most common reason being the taste of the oral formulationadministered
among the children. Most of the drugs administered as granules for oral suspension under
pediatric therapy are Antibiotics, which when administered orally as any other dosage
formhave a bitter taste making it unpleasant for Children to consume the medication
Advantages of dry Syrup:
• There is accurate single dosing as the dose is packed in single dose sachets.
• Drug dose is comparatively independent of any physical factors like temperature,
sedimentationrate and liquid flow properties.
• The packaging of the powder mixture is done in sachets making the formulation easy to carry.
•The enhanced convenience of the single dosage regimen.
• Colored, flavored, sweetened formulation is advantageous for administration to the paediatric
population.
• Stable on storage and when reconstituted with an ingestible liquid for administration, the
corresponding liquid suspension is stable for the duration for which the therapy is required.
Disadvantages of Dry Syrup:
• It is a bulk formulation, so there are chances of inaccuracy in single dosing.
• Drug dose depends on various physical factors of the dosage form such as the temperature of
storage, sedimentation rate of the formulation, liquid flow properties like viscosity, pourability,
redispersion, flocculation and content uniformity.
• Stability of the liquid largely depends on the temperature of storage.
• Caking occurs upon storage.
Condition for manufacturing Dry Syrup:
For manufacturing of dry syrup following conditions should be maintained.
Relative humidity: Not more than 60%.
Temperature: Below 25°C
All relevant materials are removed
Equipment is cleaned

32. Process of Dry Syrup Manufacturing and Packaging
MACHINE IN DRY SYRUP
1. AIRJET CLEANING MACHINE (AIR RINSER)
The Airjet Cleaning Machine applies compressed air through jets and also sucks through
vacuum. Machine can be used to clean Glass/Plastic/Pet Bottles, Jars etc. Machine is suitable
for cleaning of non-sterile products like Dry Syrups and Bulk Packing of Tablets & Capsules.
Machine with Built with Turn Table which feeds container in vertical position through
conveyor to cleaning station, where cleaning heads grip the container through cup holder and
starts the compressed air and then vacuum to clean the bottles.
Working Principle of Airjet Cleaning Machine
Containers are fed on to infeed turn table of the
machine from where they are transferred on to
conveyor of the machine. Once bottles reaches to
the Cleaning Station, proximity sensor provide
pulse to the machine and pneumatic bottle stopper
stops four bottles. Intermittent motion nozzles
come down onto bottles. Vacuum mouth holder
hold bottles firm and start air purging and vacuum
suction operations. Vacuum suction unit suck
impurities from the bottle. Air and vacuum both
done on same time to take out impurities from the bottles. After cleaning the bottle,
pneumatic bottle stopper deactivates and bottles moves further on to conveyor for next
operation.
Granulation
Bottle Decartoning
Bottle wash & visual inspection
Filling
Sealing
Packaging
Stored – quarantine room
Capping Weighing Inspection
Wrapping
Stored in warehouse

33. 2. POWDER FILLER DRY SYRUP
Features
» Fully Automatic machine.
» Vacuum pressure filling system. Powder moves from hopper to powder wheel under vacuum,
this ensures uniform powder slugs. The slugs are then pushed out by air/nitrogen pressure in
the funnel.
» Funnel moves with container and during this period powder
is dispensed to container
» Special feature of vibrator, turret in 4 piece, nitrogen
purging and bottle lip cleaner is available ( Better GMP)
» Very quick changeover of the changeparts.
» Very high dosing accuracy.
» Low maintenance machine
» Parts can be easily declamped/clamped for quick cleaning and changeover
» Fully fail-safe design
3. AUTOMATIC EIGHT SCREW CAPPING MACHINE
Features
» Very fast changeover of the changeparts.
» Pick and place mechanism
» Magnetic adjustable torque clutch in the
capping head ensures no wear and long life.
» Special chucks to reduce damage/marks on
caps
» Very high accuracy for Screwcap placing
» Planet gear mechanism for torque
application
» No bottle no cap
» Completely Fail safe design
Accessories
» Cap loader
» Pre/post inspection device
» Tagger detection mechanism
» Cap rejection device
» Bottle rejection device
» Cap diameter:- 20 mm to 50mm
» Cap Height :- 12 mm to 30mm
» Bottle diameter:- 30mm to 80mm

34. Quality Assurance
Quality assurance professionals within this industry are responsible for the consistency,
reliability, and safety of drug products for public release. These professionals use testing
procedures and guidelines to evaluate the quality of the products made, protecting the
integrity of the drug and the company manufacturing the product.
QA professionals evaluate the product development processes in the research,
development, and manufacturing stages.
Quality Assurance Department Functions are listed below
1. Ensuring proper warehousing practices
For Incoming components (Active Pharmaceuticals Ingredients)-
APIs
Excipients,
Packaging Materials,
containers and closures
labels with proper storage conditions which is required for drug stabality, etc QA department
is responsible for the proper storage of API and other excepiants and segregation of the material
in the warehouse
2. Manufacturing process and critical process checks -
This is one of the most critical activity performed by the QA department For this Activity
special team is assigned named as IPOA (In Process Quality Assurance) Which keep a eye on
all door activities related to the Storage of RM to the final product dispatch, Defore starting
any manufacturing process the IPGA person ensure the paperwork and physical condition of
the area.
3. Process monitoring and Process controls -
• During the manufacturing of the product the whole process is monitored by the QA
department and ensure that all the steps followed for the manufacturing of the product are
validated and as per SOP
• If the QA person is found any alteration in the method of manufacturing of the product then
the appropriate action is taken to ensure the quality of the product
4. Batch Record Review :-
All the data which is generated during the manufacturing of the Pharmaceutical product is
recorded in a file (soft copy/Hard copy).
• Which tell us about the all essential data related to product manufacturing (eg Timing of
process, ingredients,environmental conditions, person involve etc), in the end of the
manufacturing process.
5. Final release of Drug Products for distribution and sale:

35. When the Pharmaceutical product is manufactured and Packed then the role of QA comes to
• ensure that the product is safe for market or not,
• all the QC test reports are attached with batch record
• all the calculation related to that batch are correct, and
• several other parameters are checked and after ensuring the product safety then the QAperson
allow to distribute the product in the market.
6. Stability testing and evaluation of shelf-life of products: -
QA department is responsible for the stability testing of the pharmaceutical product
manufactured in there factory. And ensure that the shelf life of the product is same as per the
study and mention on the product to avoid the market complains
7. Ensuring proper warehousing of finished products: -
Storage condition plays an important role in the stability of the Pharmaceutical products so the
QA person ensures.
Other Quality Assurance functions:
To achieve the objectives of Quality Assurance, below functions of the department has been
classified but are not limited to this.
• Plan and manage all the activities of Quality Assurance Dept to assure the quality of all
products manufactured by the Company.
• Co-ordinate with manufacturing department in controlling their process and products at every
stage of manufacturing to meet the established specifications through testing, auditing and
reporting.
• Review the adequacy and relevance of specifications & analytical procedures in co-ordination
with Quality Control Dept. and K&D
• Coordinate technical audits of the Quality Control Laboratory to determine the analytical
Quality Systems are yielding the highest quality information and to ensure that the analytical
instrumentation is functioning properly and calibration and servicing is as per schedule.
• Monitor the production environment and services to the production operation
• Products are stored handled and distributed in a way to maintained product quality throughout
their shelf life
• Maintenance of Quality Control records of manufacturing procedures for each batch
manufactured
• all the parameters which are required to prevent the product decontamination during the
storage.

36. • Maintenance Records of Release, Quarantine or rejection of components and finished
products, Containers, closures and labels based on Quality Control test results Routine "Good
Manufacturing Practices Auditing" of manufacturing process, control and related areas
• Suggest and organize training programmers' fer development of technical and administration
skills of all the employees to meet with cGMP regulations on continuous baris, co-coordinating
with Plant and Quality Head
• Establish guidelines and procedures en cGMP and Standard Operating Procedures of overall
Quality Assurance activities. To review pretocols related to Method, Process, Cleaning,
Analytical Method Validation etc.
• Overall renews of non-conformance, failure investigations, analyzing the Quality trends,
investigations of market complaints,
• batch failure investigations,
• deviations,
• verification of change control procedures,
• updating the specifications,
• test procedures,
• manufacturing processes etc.

37. 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 our training period, we had seen the various instruments in the industry. The
highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. We could acquire a lot of information regarding the latest instruments and their
working procedures.
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 Alkem Health science
Unit 3, samardung, Sikkim. It helped us to acquire knowledge on punctuality, regularity and
working environments in industries.
The friendly working environment in Alkem Health science Unit 3, samardung, Sikkim
will remain in our mind in near future. Hence, we can say that our goal of attending the
industrial training is fulfilled. We acknowledge the great help “Alkem Health science Unit
3”.
PANKAJ KUMAR