REPORT ON INDUSTRIAL TRAINING (BP610P)

REPORT ON INDUSTRIAL TRAINING (BP610P)
AT DHANUKA LABORATORIES LIMITED,
GURGAON
For partial fulfillment of Bachelor of Pharmacy 6th
Semester
Session 2021-22
SUBMITTED IN
GOVERNMENT PHARMACY COLLEGE, BRD MEDICAL
COLLEGE, CAMPUS, GORAKHPUR (0937)
to the
DR. A. P. J. ABDUL KALAM TECHNICAL UNIVERSITY
LUCKNOW
2021-22
SUBMITTED TO
Dr. MAHENDRA KUMAR SINGH
(Assistant professor)
SUBMITTED BY
ASHUWANI KUMAR
B. Pharm. 6th
Semester
ROLL No.-XXXXXXXXXX

CERTIFICATE
This is to certify that Mr. ASHWANI KUMAR S/o Mr. MALIKHAN SINGH
Roll no. 200937XXXXX is studying in B. Pharm. Third Year (6th
semester)
during Session 2021-22. He has submitted his Industrial training report (BP610P)
for the partial fulfillment of requirement for the degree of Bachelor of Pharmacy
in Government Pharmacy College, BRD Medical College Campus, Gorakhpur.
Supervisor
Dr. Mahendra Kumar Singh
Assistant Professor
Government Pharmacy College
BRD Medical College Campus
Gorakhpur
Principal
Dr. Ganesh Kumar
Principal In-charge
Government Pharmacy College
BRD Medical College Campus
Gorakhpur
EXTERNAL EXAMINER

DECLARATION
I Ashwani Kumar, hereby declare that work presented in the industrial training report
entitled in INDUSTRIAL TRAINING PERFORMED AT DHANUKA
LABORATORIES LIMITED, GURGAON.
It is an authentic record of work carried out by me during 12.03.2022 to 09.04.2022 at
Dhanuka Laboratories Limited, under the guidance of Dr. A.P.J. Abdul Kalam
Technical University. Is being submitted for partial fulfilment of the requirement for
the award of bachelor degree in B.Pharm. This is not been submitted anywhere else for
the award of any other degree/diploma.
ASHUWANI KUMAR
B.PHARM (6th Sem)
Roll no. 200937XXXXX
Government College of Pharmacy
BRD Medical College Campur,
Gorakhpur

ACKNOWLEDGEMENT
I consider it a great privilege & honor to have had the opportunity to undergo the
industrial training work in Dhanuka Laboratories Ltd. Hence, I would like to offer my
heartiest thanks to Mr. R G Agarwal, (Group Chairman) and Mr. Amit Kumar (HR
Manager)..
I am greatly indebted to Dr. Ganesh Kumar, Principal In-Charge, GPC, Gorakhpur, for
enabling us to have the chance of industrial training and arranging such a nice
arrangement.
I convey my heartiest thanks to Mr. Mahendra Kumar Dhanuka (Manager Director), Jitin
Sadana (Production Manager), S Ajmat Chaudhary (Manager, QC), Namrata Gupta
(Manager, QA), Harsh Dhanuka (Head, Maintenance Section) for their most valuable
suggestions, constant encouragement, and affectionate guidance during the period of this
training.
I have clean information about every instrument, manufacturing procedure and analytical
methods. A special thanks to all staff and workers who cooperate me during the training
period.
Thanking you
ASHUWANI KUMAR
B.PHARM (6th Sem)
Roll no. 200937XXXXXX
Government College of Pharmacy
BRD Medical College Campur,
Gorakhpur

1. COMPANY PROFILE 1-4
2. TABLET SECTION 1-5
3. MANUFACTURING SECTION 7-15
INDEX
Topic Page No.
1.1. About Dhanuka Laboratories Ltd 1-2
1.2. Location 2
1.3. Site Capabilities 2
1.4. Layout of Industry 3
1.5. Industry Logo 3
1.6. Products Manufactured 4
Topic Page No.
2. Tablet 5
2.1. Ingredients Used in Tablet Formulations 5
2.2. Essential properties of tablet 6
Topic Page No.
3. Pharmaceutical Manufacturing Process 7
3.1. Formulation (Cefixime 200) 7
3.2.Granulation Section 8
3.2.a. Wet Granulation 8
3.2.b. Dry Granulation 9
3.2.c. Direct Compression 9-10
3.2.1 Mass Mixer 10
3.2.2. Tray Dryer 10

5. QUALITY CONTROL 16-36
6. PACKING SECTION 37-40
3.2.3 FBD 11
3.2.4 Multi Mill 12
3.2.5. Roll Compactor 12
3.3.Blending Section 13
3.4. Compression Section 14
3.5.Coating Section 15
3.5.a. Objectives 15
3.5.b. Type of Coating 15
Topic Page No.
4. Quality Assurance & Quality Control in Pharma Industry 16
4.1.Quality Assurance (QA) Management Procedure 16
4.2. Quality Control Work (Summary) 17
4.3. Quality Control Department 17
4.4. Working of Quality Control 18
4.5. List of quality control instruments 19
4.6. Introduction 19
4.6.a. Chemical section 20-23
4.6.b. Instrumental Section 23-31
4.6.c. Micro-biological section 32-36
Topic Page No.
5. Pharmaceutical Packaging 37
6.1. Types of Packaging 37
6.1.a.Primary Packaging 37

7. OTHERS 41-42
6.1.b.Secondary Packaging 38
6.2. The purposes of packaging and package labels 39
6.3. Packaging machines 40
Topic Page No.
6. Conclusion 41
7. Reference 42

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Training Report | Dhanuka Laboratories Ltd.
1. COMPANY PROFILE
1.1. About Dhanuka Laboratories Ltd.:
❖ "Dhanuka Group", which has an annual sale of Rs. 1000cr (USD 200 Million). Dhanuka
Group is a three-decade old business house that has been engaged in the business of
Agrochemicals and Pesticides. The group garnered a high reputation by virtue of its
ethics and was able to have Global tie-ups with internationally reputed companies in
Agrochemicals. Having attained a prominence in their core forte, the group decided to
diversify into pharmaceuticals and established Dhanuka Laboratories Ltd. In 1998.
❖ Dhanuka Laboratories Limited is one of the prominent manufacturer and exporter of
ORAL CEPHALOSPORIN APIs based in India. The company has a large capacity to
manufacture various products like Cefixime, Cefdinir, Cefaclor, Cefuroxime Axetil,
Cefpodoxime Proxetil, Cefditoren Pivoxil, Cefprozil in high quality cGMP conditions.
❖ The company strives to maintain high ethical values and customer-centric policy. The
motto of the company is to provide the right product at the right price at the right time to
the customer.
❖ Dhanuka Laboratories Limited is proud to be a WHO-GMP, ISO 9001-2015 certified
company.
❖ The company values intellectual property and hence the company invests regularly in to
Research & Development and generate its own intellectual property rights through filing
of patents regularly.
❖ Right from inception, Dhanuka Laboratories Ltd. has adopted synergistic advantage to
develop and manufacture a range of Cephalosporin’s and their key intermediates. With
age, the company has matured into a formidable contender that has outperformed its
peers in terms of Quality and Reliability.
❖ Dhanuka Laboratories Ltd. Has established itself as a respected vendor of Active
Pharmaceutical Ingredients in the International market, with exports of its products to
more than 20 countries. The company has strived to continuously improve quality
standards, by registering its products in most stringent international markets like
European Union, China, Korea and Japan. The company’s GMP standards have been
audited by many reputed customers in India and abroad, and found to be appropriate.
The company is in the process of getting approvals from EDQM and KFDA.
❖ After establishing in the field of API, Dhanuka Laboratories Ltd aspired to develop into
an Integrated Pharmaceutical company, and this resulted in acquisition of Pharmceutical
Formulations exporting company “Synmedic Laboratories”. Synmedic Laboratories has
a strong global presence with more than 500 product registrations in more than 15
countries. Synmedic has strong presence across therapeutic categories which include
Anti-infectives, cardiovascular, Antiretroviral, Gastroenterology Pain management,
Dermatology and many more.
❖ Dhanuka Laboratories is focused on its mission to deliver excellence in every corner of
its operations and meet its commitments to the many constituencies that it serves. All

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the long-term strategies and short-term actions are molded by a set of core values that
are shared by each and every associate.
❖ The company’s desire to have technical and commercial tie ups in developed and
developing geographies of the world will help it to achieve a wider goal of “Healthcare
for all”. In an integral approach to healthcare that fuses traditional wisdom with
technological sophistication, the company is focused on it larger motto “Life
Enrichment through Science”.
1.2. Location:
Dhanuka Laboratories Limited,
7-KM Old Manesar Road, Village Mohammedpur,
Gurgaon, Haryana, INDIA-122001
1.3. Site Capabilities:
❖ Manufacturing Facility- Vitamins & Minerals Premixes Processing, Primary Packing,
Secondary Packing, and Sachet filling machine
❖ General Tablets Granulation Area, Three Compression cubicles and three packing lines
❖ State of art Quality laboratory-
❖ Qualified and competent staff
❖ Separate Wet and Instrument Lab
❖ Labs are well equipped with latest infrastructure.
❖ WHO-GMP, ISO 9001-2015 certified company.

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1.4. Layout of Industry:
1.5. Industry Logo :

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1.6. Products Manufactured:
S.No. NAME
1. CEFIXIME
2. CEFUROXINE AXETIL(AMORPHOUS)
3. CEFDITOREN PIVOXIL (AMORPHOUS)
4. CEFDINIR
5. CEFPODOXIME PROXETIL
6. CEFTIBUTEN
7. CEFACLOR
8. CEFPROZIL
9. CEFUROXINE AXETIL(AMORPHOUS)
10. CEFDITOREN PIVOXIL (AMORPHOUS)
11. CEFDINIR
12. CEFPODOXIME PROXETIL
13. CEFTIBUTEN
14. CEFACLOR
15. MONTELUKAST
16. PREGABALIN
17. ROSUVASTATIN
18. PHENYLEPHRIN HCL
19. TELMISARTAN
20. LEVETIRACETAM
21. CITICOLINE
22. VILIDAGLIPTIN
23. FAVIPIRAVIR

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2. TABLET
A tablet is a mixture of active substances and excipients, usually in powder form, pressed
or compacted into a solid. The excipients include binders, Glidants (flow aids) and
lubricants to ensure efficient tabletting, disintegrates to ensure that the tablet breaks up
in the digestive tract; sweeteners or flavors to mask the taste of bad-tasting active
ingredients; and pigments to make uncoated tablets visually attractive. A coating may be
applied to hide the taste of the tablet's components, to make the tablet smoother and
easier to swallow, and to make it more resistant to the environment, extending its shelf
life.
Advantage:-
❖ Production aspect
➢ Large scale production at lowest cost.
➢ Easiest and cheapest to package and ship.
➢ High stability.
❖ User aspect (doctor, pharmacist, patient)
➢ Easy to handling.
➢ Lightest and most compact.
➢ Greatest dose precision & least content variability.
➢ Coating can mark unpleasant tastes & improve pt. acceptability.
Disadvantages:-
❖ Some drugs resist compression into dense compacts.
❖ Drugs with poor wetting, slow dissolution, intermediate to large dosages may be difficult or
impossible to formulate and manufacture as a tablet that provide adequate or full drug
bioavailability.
❖ Bitter taste drugs, drugs with an objectionable odor, or sensitive to oxygen or moisture may
require encapsulation or entrapment prior to compression or the tablets may require coating.
2.1. Ingredients Used In Tablet Formulations:
1. Drugs.
2. Fillers, diluents, bulking agent
➢ To make a reasonably sized tablet.
3. Binders
➢ To bind powders together in the wet granulation process.
➢ To bind granule together during compression.
4. Disintegrates
➢ To promote breakup of the tablets.
➢ To promote rapid release of the drug.
5. Lubricants
➢ To reduce the friction during tablet ejection between the walls of the tablet and the
walls of the die cavity.
6. Glidants
➢ Reducing friction between the particles.
➢ To improve the flow properties of the granulations.

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7. Antiadherants
➢ To prevent adherence of the granules to the punch faces and dies.
8. Dissolution (enhancers and retardants)
9. Wetting agents
10. Antioxidants
11. Preservatives
12. Coloring agents
13. Flavoring agents
2.2. Essential properties of tablet:
❖ Accurate dosage of medicament, uniform in weight, appearance and diameter.
❖ Have the strength to withstand the rigors of mechanical shocks encountered in its
production, packaging, shipping and dispensing.
❖ Release the medicinal agents in the body in a predictable and reproducible manner
❖ Elegant product, acceptable size and shape.
❖ Chemical and physical stabilities.

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3. MANUFACTURING SECTION
Pharmaceutical manufacturing is the process of industrial scale synthesis of
pharmaceutical drug by pharmaceutical companies. The process can be brokendown
into a series of unit operations such as milling, drying, compression, and coating.
The primary goals of manufacturing section includes: -
i. To formulate tablets that are strong and hard to withstand mechanical
shockencountered during manufacturing, packing, shipping, dispensing and
use.
ii. To formulate tablets that are uniform in weight and in drug content.
iii. To formulate tablets that are bioavailable according to indication requirements.
iv. To formulate tablets that are chemically and physically stable over a
longperiod of time.
v. To formulate tablets that have elegant product identity which is free from
anytablet defects.
3.1. Formulation For Cefixime 200mg
Brand Name – CEFIX-200 (Cipla)
COMPOSITION:
Ingredients Quantity For 5 Lakh Tablets
Cefixime trihydrate equivalent
to Cefixime
112 Kg
Microcrystalline Cellulose 75.500 Kg
Pregelatinized starch 28 Kg
Collidon Sillicon Dioxide 0.750 Kg
Sodium Lauryl Sulphate 2.250 Kg
Sodium stearyl fumerate 5 Kg
Magnesium stearate 1.500 Kg
Net tablet weight 450 mg

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The manufacturing section have different sub division and these are as described below:
A. Granulation Section
B. Blending Section
C
. Compression Section
D. Coating Section
3.2. Granulation Section:
Granulation is a process of collecting particles together by creating bonds
between them and these bonds are formed by compression or by using a binding agent.
A process whereby small particles gathered into large, permanent masses in which
the original particles can still be identified.
Granulation process will improve flow and compression, characteristics, reduce
segregation, improve content uniformity, and eliminate excessive amounts of fine
particles. The results will be improved yields, reduced tablet defects, increased
productivity, and reduced down time.
There are three methods of preparing tablet granulations. These are
(a) Wet granulation,
(b) Dry granulation (also called "slugging"), and
(c) Direct compression.
3.2.A. Wet granulation:
Wet granulation is a process of using a liquid binder or adhesive to the powder mixture. The
amount of liquid can be properly managed, and over wetting will cause the granules to be too

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hard and under wetting will cause the granules to be too soft and friable. Aqueous solutions
have the advantage of being safer to deal with than solvents.
3.2.B. Dry Granulation:
This process is used when the product needed to be granulated may be sensitive to
moisture and heat. Dry granulation can be conducted on a press using slugging tooling or
on a roller compactor commonly referred to as a chilsonator. Dry granulation equipment
offers a wide range of pressure and roll types to attain proper densification. However, the
process may require repeated compaction steps to attain the proper granule end point. Also
called as “Pre-compression” or “Slugging” method.
3.2.C. Direct Compression:

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The equipment’s used in the process of Granulation are:-
a) Mass Mixer
b) Tray Dryer
c) FBD (Fluidized Bed Drier)
d) Multi-mill
e) Roll Compactor
3.2.1. Mass Mixer:
Mass Mixer is designed to perform smooth operations
for thorough mixing equipped with safety transparent
dust cover & specially designed self-adjusting sealing
arrangement, which ensures the restriction of black
particles enter themixing drum. Mass Mixer is Ideal
for dry & wet uniform mixing of materials.Mass
Mixer is available in sizes ranging from 5 Kg to 300
Kg as per GMP & cGMP models.
Mass Mixer
3.2.2 Tray Dryer:
A dryer used for drying of the wet products like crude drugs, chemicals, powders or the granules,
etc. is known as Tray dryer.
The material which we want to dry is dispersed on the tiers of the trays. The tray, which is used in
this process must have perforated, solid or wire mesh bottoms. Forthe circulation of the air across
the drying materials, we lined the screen trays with paper. A limited amount of heat is provided to
every shelf at that time when the wind passes over it to provide the latent heat of vaporization.
This kind of dryers provides proper control of humidity and temperature.
Tray Dryer

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3.2.3. FBD (Fluidized Bed Dryer)
Fluidized (fluid) bed dryers are used extensively in the pharmaceutical industries to reduce
moisture content of pharmaceutical powder and granules. They have also found use in the
drying of suspension, slurries, solutions, dilute paste or sludges.
A typical fluidized bed dryer consists of the following components.
➢ Air preparatory unit.
➢ Product container.
➢ Exhaust filter.
➢ Exhaust blower.
➢ Control panel.
➢ Air distribution plate.
➢ Spray nozzle.
➢ Solution deliver.
In fluidized bed dryer, hot air is passed at high pressure through a perforated bottom of the
container containing the wet solids. The wet solids are lifted from the bottom and suspended
in a stream of air (fluidized state). The hot air then surrounds every granules. Heat transfer is
accomplished by direct contact between the wet solid and hot gases. The vaporized liquid is
carried away by the drying gasses.
Fluidized Bed Dryer

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3.2.4. Multi-mill:
Multi Mill is used in different functions involving wet &
dry granulation , pulvenisation etc. of Pharmaceutical,
Chemical, Bulk drug, Cosmetic, Colors.Food products etc.
The Industrial Multi Mill consists of stainless steel hopper,
processingchamber with beater assembly, Motor, DOL stater,
three speed pulley, screen and study body.
Multi Mill
3.2.5. Roll Compactor:
Roller Compactors are used to force fine powders between two counter rotating rolls and
presses the raw materials into a solid compact (flakes, sheets, strips). RollCompacters are also
called dry granulators.
Principle: -
A roller compactor generally consists of three major units.
1) A feeding system, which converts the powder to the compaction area between the rolls.
2) A compaction unit, where powder is compacted between two counter rotating rolls to a
ribbon by applying a force.
3) A size reduction unit, for milling the ribbons to the desired particle size.
The most important parameter in the dry granulation process is the force applied on the
powder compacted between two rolls. The applied force is expressed in kN/cm, being the
force per cm roll width.
Roller Compactors

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3.3. Blending Section:
Blending is a process which mixes the API and excipients to ensure there is a homogeneous
mixture of the all ingredients for each manufacturing process.
Blending is a process that can be carried out numerous times within a manufacturing process
when new excipients need to be added.
Blending is carried out by the help of Blender.
Blender

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3.4. Compression Section:
Tablet compression machine makes the tablets by pressing the granules in die with lower and
upper punch.
Different innovations to tablet compression machines are being done to improvethe
production rates and now it is possible to produce more than 500,000 tabletsper hour. A
tablet formation takes place by the combined pressing action of two punches and a die.
The basic principle behind the tablet compression machine is hydraulic pressure. This
pressure is transmitted unreduced through the static fluid. Any externally applied pressure is
transmitted via static fluid to all the directions in the same proportion. It also makes it
possible to multiply the force as needed.
Single Rotary Compression Machine Double Rotary Compression Machine
The basic principle behind the tablet compression machine is hydraulic pressure. This
pressure is transmitted unreduced through the static fluid. Any externally applied pressure is
transmitted via static fluid to all the directions in the same proportion. It also makes it
possible to multiply the force as needed.
The tablet compression procedure that is used in different pharmaceutical companies is
divided into four distinct stages. These are:-
➢ Filling
➢ Metering
➢ Compression
➢ Ejection

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3.5. Coating Section:
Coating is a process by which an essentially dry, outer layer of coating material is
applied to the surface of a dosage form in order to confer specific benefits over
uncoated variety.
Coating may be applied to a wide range of oral solid dosage form, such as
particles, powders, granules, crystals, pellets and tablets. When coating composition
is applied to a batch of tablets in a coating pan, the tablet surfaces become covered
with a tacky polymeric film.
Coating Machine
3.5.A. Objectives:
➢ To makes the taste, odor, or color of the drug.
➢ To provide physical and chemical protection for the drug. To control the release of the
drug from the tablet.
➢ To protect the drug from the gastric environment of the stomach with an acid resistant
enteric coating.
3.5.B. Type of Coating:
➢ Film coating.
➢ Sugar coating.
➢ Press coating.
➢ Functional coatings
o Enteric coating
o Controlled release coating

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4. QUALITY CONTROL:
Quality Assurance & Quality Control in Pharma Industry
QA: It is the sum total of the organized arrangements with the objective of ensuring that
products will be of the quality required for their intended use.
GMP: Is that part of Quality Assurance aimed at ensuring that products are consistently
manufactured to a quality appropriate to their intended use.
QC: Is that part of GMP concerned with sampling, specification & testing, documentation &
release procedures which ensure that the necessary & relevant tests are performed & the
product is released for use only after ascertaining its quality.
4.1. Quality Assurance (QA) Management Procedure:
1. How to write Standard Operating Procedure:
➢SOP describes standard SOP format that you can use immediately for your quality
procedure.
➢SOP has instructions on how to write a formal operating procedure for
your systems which your people can follow every day.
2. Quality Documentation Management and Change Control:
➢This SOP describes how to generate new quality documents or change control of
existing documents, review of quality documents, satellite file management, and
role of document author, approver, document control officer and satellite file
administrator.
3. Documentation Rule for GMP Documents:
➢This SOP describes the principles to be followed in GMP documents, entry of data
and information, signature requirements and correction technique of incorrectly
entered data or information.
4. Quality Documentation-Control, Tracking and Distribution:
➢In this SOP you will find mainly the role of document control officer during the
initiation, creation, circulation and approval of new quality related documents.
➢It also describes the procedure of modification and review of existing document
using a documentation database.
➢Management of existing and superseded documents is also a part of this procedure.
➢You will see all the forms referred during the instruction are attached at the end of
the procedure.
5. Shelf Life of Product:
➢This simple SOP describes the meaning of shelf life and provides on how to
interpret shelf lives and storage conditions for your raw materials from the
Certificate of Analysis, determining expiry date for your finished products by use
of raw material date of manufacturing and their shelf lives.

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4.2. Quality Control work (Summary):
Sampling of active pharmaceutical ingredients, Excipients, finished product & packing
material etc.
1. Testing of API (Active Pharmaceutical Ingredients).
2. Testing of excipients.
3. Testing of sample process.
4. Testing of finished products.
5. Testing of packing material.
6. Stability studies of finished product.
7. Maintenance and calibration of instruments.
8. Procurement of chemicals and glass ware.
9. Procurement of reference standard.
10.Procurement of maintenance of clusters for microbiological testing.
11.To certificate analysis.
12.To study products complaints.
13.To destroy the control sample after six months of the date of expiry.
4.3. Quality Control Department:
1. Quality control sampling section:
Responsibilities: -
➢ To draw the sample of RM from store.
➢ To draw the samples of F.G. from production department.
➢ To keep control sample for reference & for stability studies.
➢ Final inspection of each batch.
2. Quality control chemical section:
Responsibilities: -
➢ Complete analysis of all RM/ process & F.G. sample as per prescribed standard.
➢ To send report to production, store, Q C office.
➢ To carry out stability testing etc.
➢ Instrument maintenance and calibration.

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VALIDATED ANALYSIS
SUCCESSFUL ANALYSIS
3. Quality control microbiology section:
Responsibilities: -
➢Microbiological analysis of RM/process/FG/sample.
➢To send report to production, store, QC office.
➢Quality control packaging material test.
➢To carry out stability testing.
4. Quality control office:
Responsibilities: -
➢To make certificate of analysis of R.M. &finished products.
➢To maintain & keep records of analysis & certificate of analysis.
4.4. Working Of Quality Control: -
VALIDATED ANALYTICAL INSTRUMENT
VALIDATED SAMPLING SYSTEM
ANALYTICAL VALIDATED METHOD

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4.5. List of quality control instruments:
S.NO NAME MAKE / MANUFACTURER
1 Tablet disintegration machine Campbell electronics
2 Water bath six-hole thermostatic control J S G W
3 pH meter ECIL
4 Magnetic stirrer Reml
5 Friability test apparatus I. Equipment Cors
6 Vacuum pump Tempo
7 Oven SEW
8 B.O.D. JRSC
9 HPLC WATERS (INDIA)
10 Six stage dissolution rate test apparatus Tab machines
11 Melting point apparatus IEC& JSGW
12 Laminar flow Klenzald
13 Flame photometer Systronic
14 Digital balance ATCO
15 Spectrophotometer UV-1601(with CVT) Shaimadzu
4.6. Introduction:
This the section essential for the quantitative & qualitative evolution of the raw material
provided by supplier, mixture material during processing & finished product evaluation
supplied by chief manufacturing chemist. Here also sample of finished batches are
regularly checked for their validation. It consists of 3 sections-
1. Chemical section.
2. Instrumental section.
3. Micro-biological section.

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4.6.A. Chemical section:
In this section evaluation of drug, elemental analysis, mineral analysis,
extraction, ignition, loss on dying, melting point recording processing are carried out
by following instruments: -
a) Test tubes, Boiling tubes, Pipette, Funnel, Beaker, Burette, Separating funnel:
▪ These are made up of borosilicate glass.
▪ Pipettes are available from 1.50 ml.
▪ Ammonia distillation test apparatus, boiling point apparatus are also available.
▪ Separating funnels are from 250-500 ml.
(A) Burette. (B) Pipette (C) Separating funnel
b) Magnetic stirrer: -
Use to dissolve the sample; they have also temperature control along with stirrer speed set
up.
Magnetic stirrer

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c) Kipp’s apparatus:-
Used ferrous sulphide with sulphuric acid to prepare hydrogen sulphide used for
elemental analysis.
Kipp’s apparatus
d) Elemental water bath: -
For gradual heating from 30-100 C.

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e) Melting point detector: -
Reads up to 500 C and is automatic electric heater melting is observed through a lenses.
Melting point detector
f) Muffle Furness: -
Consist of a steel body in which ¾ ft. thickness is coated by silica brick and glass wool
may heat up to 1000
C. it can have coarse and fine temperature set up along with temperature increase rate
controller.
Muffle Furness
g) Vacuum oven.
▪ It is also a cubic steel container like simple oven but have a well lockable air
tight- though with a glass window in it.
▪ It is attached with pressure gauze that reads 0-760 mmHg Vacuum.
▪ There are two outlets one of which is attached to the Vacuum pump and other is
open both are associated with locks.

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▪ Whenever Vacuum is to be created door is closely followed by locking the open
outlet. Vacuum outlet is opened and suction motor is start when Vacuum is created
up to desired value Vacuum lock is also close and Vacuum remains maintained up
to the need.
▪ Before opening the door lock of open, outlet is open to suck the air in the oven.
▪ It is used to determine the loss on drying of the drugs.
▪ Example- vitamin- B2- 5- Phosphates.
Vacuum Oven
h) Reagent used in analysis – acid, base.
▪ Acids. e.g. - Sulphuric acid, HCl, Nitric acid etc.
▪ Bases. e.g. - NaOH, KOH etc.
▪ Others e.g. – Distilled water, alcohol, Chloroform, Acetone, carbon tetrachloride,
Benzene Pyridine etc.
▪ Salts e.g. – Ammonium chloride, Na EDTA, Sodium acetate, calcium chloride etc.
▪ Gases. e.g. – Hydrogen Sulphide
4.6.B. Instrumental section: -
In this section quantitative analysis of drugs, drug release extent specific rotation
moisture content determination, TLC spot study, colony counting, bone of inhabitation
determination etc. processes are carried out with following instrument-
a) Electronic Balance
For the weight variation testing of solid dosage form we randomly collect 10-20 tablets and
weighting it and determine average weight of each tablet. It should not be less than 90% of
the required weight and not more than 110%.

24
Electrical Balance
▪ Weighing range is 1-100 mg.
▪ Tolerance limit +0.01 mg.
▪ It is used to weighing accurately the drug in small amount.
Testing Uniformity of Weight of Tablets
1) Product: Citicoline tablets.
Batch no. : DL-16893 Mfg. Date: 03/22 Exp. Date: 09/23
Data Obtained:
a) Weight of 20 tablets = 12.8867 g
b) Average weight (One Tablet) =
12.8867
20
= 0.6443 g
= 0.6443 x 1000 mg
= 644.3 mg
Serial Number Weight(G)
Weight – Paper Weight (G)
(Paper Weight = 0.1112 G)
1 0.7623 0.6511
2 0.7526 0.6414
3 0.7589 0.6477
4 0.7406 0.6294
5 0.753 0.6418
6 0.7407 0.6295
7 0.753 0.6418
8 0.7558 0.6446

25
9 0.7567 0.6455
10 0.7523 0.6411
11 0.7567 0.6455
12 0.7553 0.6441
13 0.7581 0.6469
14 0.7493 0.6381
15 0.746 0.6348
16 0.7559 0.6447
17 0.7408 0.6296
18 0.7503 0.6391
19 0.7687 0.6575
20 0.7576 0.6464
Calculations:
According to I.P.specification:
1) Average weight = 645 mg + 10mg
2) For maximum & minimum variation:
Tablet weight Variation specified
➢ Below80 mg +10 %
➢ 80—250 mg +7.5%
➢ Above 250 mg + 5 %
Result:
1) Average weight = 644.3 mg (Passed).
2) Minimum weight = 0.6294g(Sl. No. 4)
= 629.4 mg
So, minimum variation = (644.3-629.4) x 100/644.3
= -2.31% (Within Limit, Passed).
3) Maximum weight = 0.6575g (Sl. No. 19)
= 657.5 mg
So, maximum variation = (657.5-644.3)x 100/644.3
= +2.05% (Within Limit, Passed).

26
b) Friability tester:
This test is done for the knowing the amount of tablet is loss during the transportation
by the friction with the packing or during the manufacturing process.
The friability for tablet is not more or less than 10% of the actual weight.
Friability tester
c) Hardness tester:
▪ Hardness is the main factor which effects the disintegration & dissolution time.
▪ For the hardness testing generally hardness tester is used.
▪
Model CTHT
capacity 20 Kgs.
Max. Tablet Dia. 25 mm
Net weight (Approx.) 1 Kg.
Gross weight (Approx.) 2.2 Kgs.
Machine Dimensions 410 (L) x 680 (B)
Case Dimension 30.5 (L) x 25.5 (B) x 7.5 (H)

27
Tablet hardness tester: Pfizer type
d) UV-Spectrophotometer:
Infrared spectroscopy is one of the most powerful techniques of chemical identification. The infrared
region of the electromagnetic spectrum may be divided into three main sections: -
a) Newer infrared
b) Middle infrared
c) Far infrared
The main region of interest for analytical purposes is from 2.5 to 25 um i.e., 4000 to 400cm-1 lr
spectra originate from the different modes of variation and rotation of a molecules at wave length
bellow 25 um the radiation has sufficient energy to caves changes in the variation energy level of the
molecules and these are accompanied by change rotational energy level.
Spectrophotometer

28
e) Digital pH meter:
❖ It is a device that consists of a glass electrode with very sensitive glass membrane that
changes the potential rapidly with variation in H+ ion concentration in the dipping
solution.
❖ This change in the potential recorded by recorder and is transformed in the form of pH.
❖ The instrument is calibrated at pH=4 (Potassium hydrogen phthalate buffer), pH=7
(Citro phosphate buffer), pH-9.2 (Borax buffer). It has a tolerance limit of +0.05 (pH)
Digital pH Meter
f) Dissolution test apparatus:
❖ Drugs released from the capsules are sometimes suspension in dissolution media
is estimated with this instrument.
❖ At least 70% of the drugs should be released in 45 min.
❖ Example- Amoxicillin (water medium), Piroxicam (Dissolution media of pH- 6.5
Phosphate Buffer).
Dissolution Test Apparatus

29
g) Disintegration apparatus:
❖ For the drugs like sionate capsule (B-complex), Amiclox (Ampicilline &
Cloxacillin), cephalic (folic acid & ferrous sulphate), follifer (Ferrous fumerate
& folic acid, vitamin – B12) etc.
❖ Dissolution test are not specified in standard book hence disintegration test is carried
out.
❖ Water is used only as dissolution media.
❖ To pass this test sample must dissolved within 15 min. without leaving any clot in the
tube.
Disintegration Apparatus
h) Polarimeter:
❖ It is used for determine the purity, concentration and qualitative evaluation of
drugs by determining the specific rotation of the drug.
❖ The drugs evaluated by this instrument are Chlorpheniramine, Ampicilline, and
Amoxicillin etc.
Polarimeter

30
i) High Pressure Liquid Chromatography:
High Performance Liquid Chromatography
Apparatus: - A liquid chromatography consists of a reservoir containing the mobile
phase a pump of force the mobile phase throws the system at high pressure and injector
to introduce the sample into the mobile phase, chromatography column, detector, a data
collection device.
Pumping system: - HPLC pumping system deliver major amount of mobile phase from
the solvent reservoirs to the column through the high-pressure tubing and fitting.
Injector: - After dissolution in mobile phase is other suitable solution compounds to be
chromatographer are injected into the mobile phase either manually by syringe.
Columns: - For the most pharmaceuticals analysis separation is achieved by the partition
of compounds in the test solution between the mobile phase and stationary phase.
Detectors: - HPLC method requires the use of detectors such as consist of a flow through
sale mounted at the end of the column.
Data collection device: - Modern data station received and store dector output and print
variables.
j) Karl –Fisher Titrator:
❖ It is completely automatic Titrator in which in closed beaker (supplied with
dehumidified Nitrogen).
❖ There is an automatic burette associated in which Karl- fisher reagent is filled by
pumping.
❖ After filling the sample, reagent is allow to drain when reagent is in excess
indicator displays it and when sample is excess indicator displays it at the end point

31
another indicator displays the completion and burette is automatically closed.
❖ Moisture content is calculated in sample.
❖ Karl- fisher reagent is use like - Dexamethasone Phosphate, Ciprofloxacin,
Cephalexin, Cloxacillin, and Ampicilline.
Karl –fisher
k) UV-Light box:
❖ It is close box with door and a UV protective glass window fitted with an UV lamp &
Visual lamp.
❖ In this TLC chromatogram are observed in visual light range, upper UV range and
lower UV range while switching corresponding buttons respectively.
UV Light Box

32
4.6.C. Micro-biological section:
a) Fumigation: -
▪ This is a process to maintain asepsis in Lab.
▪ 500 ml of HCHO is mixed with 170 gm Potassium per magnate and is heated to
vaporize.
▪ During fumigation either of both solutions is heated in room after closing it
completely for over a night.
▪ So that intimation of vapors may occur with every corner and instrument.
▪ Excess of HCHO is removed by soaking in Ammonia solution.
▪ After fumigation wipening of instruments and wall in carried out with 70%
Isopropyl alcohol, this maintains asepsis for a long time.
b) Auto-clave: -
▪ Autoclave is the apparatus used to sterilize with pressurized steam,
▪ The autoclave is an essential unit of every microbiology laboratory,
▪ An autoclave is usually operated at a pressure of 15 lb in2, at which temperature of pure
steam is 121’C.
▪ The length of time depends on the material which is sterilized.
Auto Clave
c) Laminar flow bench –
▪ It is device in which a septic handling, transferring, filling etc. processes are carried
out.
▪ Consist of a HEPA Filter (Pole size 0.2µm) through which microbial free air is
blown that prevents the contamination of the area from microbes.
▪ Before processing UV-light is set on area is allowed to sterilized than UV-light
is set of windows are open (HEPA-filters remain on) and working is started.

33
▪ Whenever working is stop UV-light again set on to maintain the area sterile.
▪ It is used mostly for aseptic transfer of culture media to the Petridishes and test
tube and also in micro manipulation processes.
Laminar flow bench
d) Hot air oven –
Hot air oven
▪ Hot air ovens are electrical devices used in sterilization.
▪ The oven uses dry heat to sterilize.
▪ They can be operated from 50 to 300 °C (122 to 572 °F).
▪ There is a thermostat controlling the temperature.
▪ The standard settings for a hot air oven are:
➢ 1.5 to 2 hours at 160 °C (320 °F)
➢ 6 to 12 minutes at 190 °C (374 °F)

34
e) B.O.D. Indicator: -
▪ Used to provide suitable climatic condition like Temperature, Oxygen etc. to the
growing microbes in culture mediums in fully controlled way.
▪ Used to incubate the culture for complete growth of microbes to develop colonies
(about 10 days) it is available in 50 liter & 200 liter capacity.
BOD Incubator
f) Hot Plate with Thermostat: -
▪ It is used to dry and settle the Medias and Petridishes are to store the culture mediums
in microbial free environment below 100º C for small times.
Hot Plate with Thermostat

35
g) Compound microscope: -
▪ Maximum magnification is up to 1000 times and is used for microbial manipulations.
Compound Microscope
h) Membrane filter: -
Membrane Filter
▪ It is cellulose acetate / phthalate etc. derived circular pad of 100-150 µm thickness,
45 mm diameter & 0.45 mm pore size.
▪ Fitted in a steel holder supported by a steel strainer and used to check the microbial
contamination in fluids.
▪ Ophthalmic water is passed through filter under Vacuum and the filter disc is divided
in 4 parts aseptically in Laminar Flow Bench. Two of which are transferred to fluid
Thioglycolate media and rests are transferred to casein digest media. (For aerobic
and non-aerobic Bacteria) and are incubated in B.O.D. for 7 days.
▪ Any kind of microbial growth shows microbial contamination of the fluid.

36
i) Microbial colony counter: -
▪ Plate counting machine consist of a base plate printed with squares over which
magnifying lenses is present a touch counter electronic pen is used to count the colony
that get displayed on the screen.
▪ It is used for counting microbial colonies, Solid Agar Culture Media incubated for the
validation sterile area water containers of ophthalmic section filter membranes &
autoclaves.
Microbial Colony Counter
j) Zone Of Inhibition Reader: -
▪ Consist of a Petridis holder that moves over a plate form below a reflector assembly.
▪ Whenever diameter of Z.O.I is to be measured the Petridis is placed in the holder
and a prism is kept on the Z.O.I. in disc.
▪ Assembly is moved below the reflector in such a way that adjustment makes the
Z.O.I. visible from the front.
▪ The reading on the meter shows the Z.O.I. in mm.
▪ Used to check the efficacy of antibiotics.
Digital Antibiotic Zone Reader

37
5. PACKEGING SECTION
Packaging is the science, art and technology of enclosing or protecting products for
distribution, storage, sale, and use. Packaging also refers to the process of design,
evaluation, and production of packages. Package labeling or labeling is any written,
electronic, or graphic communications on the packaging or on a separate but associated
label.
5.1. Types of packaging:
There are two types of packaging-
1. Primary packaging.
2. Secondary packaging.
5.1.1. Primary Packaging: -
It is the packing which is in contact with medicament (capsule or tablet).
a) Blister packaging:-
• In this PVC and Al Foil is used for packaging.
• Sometimes Al foil is used wholly for packaging-
➢ Thickness of Al foil = 0.025mm ± 10%.
➢ Thickness of PVC = 0.25 mm ±10%.
• The blister package is formed by heat- softening a sheet of thermoplastic resin
and vacuum drawing the softened sheet of plastic into a contoured mold.
• Blister packaging machine consist of-
➢ Feeder (vibrator).
➢ A guide track.
➢ A forming dies.
➢ Forming heater.
➢ Sealing heater.
➢ Cutter.
➢ Printing registration controller.
➢
TEMPRATURE:-
▪ Forming heater = 140º-170º C.
▪ Sealing heater = 170º-200º C.
b) Strip packaging:-
The strip package is form by feeding to webs of a heat sealable flexible film through
either a heated crimping roller or a heated reciprocating platen. In this the product is drop
into the pocket formed prior to forming the final set of seals.

38
Machine:-
• It consist of –
➢ Hopper.
➢ Disc.
➢ Channel (chute).
➢ Two rollers (for Al foil).
➢ Cutter (center cutter).
➢ Conveyer belt.
➢ Thermostat.
➢ Selector.
• When primary (strip & blister) packaging is done. The strips & blisters are
subject for secondary packaging.
Strip Packaging
5.1.2. Secondary Packaging:-
It is the packaging which is in contact with the primary packaging. It involved –
• Cartoons (printed).
• Corrugated boxes (CB).
• White board box.
• Corrugated boxes consist of 3 ply or 5 ply or 7 ply as per requirement.
• When secondary packaging is complete a BOPP tape (Bio Oriented Poly
Propylene Tape) is use for sticking.

39
5.2. The Purposes of Packaging and Package Labels
Packaging and package labeling have several objectives:
❖ Physical protection - The objects enclosed in the package may require protection from,
among other things, shock, vibration, compression, temperature, etc.
❖ Barrier protection - A barrier from oxygen, water vapor, dust, etc., is often required.
Permeation is a critical factor in design. Some packages contain desiccants or Oxygen
absorbers to help extend shelf life. Modified atmospheres or controlled atmospheres are
also maintained in some food packages. Keeping the contents clean, fresh, and safe for the
intended shelf life is a primary function.
❖ Containment or agglomeration - Small objects are typically grouped together in
one package for reasons of efficiency. For example, a single box of 1000 pencils requires
less physical handling than 1000 single pencils. Liquids, powders, and granules need
containment.
❖ Information transmission - Packages and labels communicate how to use, transport,
recycle, or dispose of the package or product. With pharmaceuticals, food, medical, and
chemical products, some types of information are required by governments.
❖ Marketing - The packaging and labels can be used by marketers to encourage potential
buyers to purchase the product. Package design has been an important and constantly
evolving phenomenon for several decades. Marketing communications and graphic design
are applied to the surface of the package and (in many cases) the point of sale display.
❖ Convenience - Packages can have features which add convenience in distribution,
handling, stacking, display, sale, opening, reclosing, use, and reuse.
❖ Portion control - Single serving or single dosage packaging has a precise amount of
contents to control usage. Bulk commodities (such as salt) can be divided into packages
that are a more suitable size for individual households. It is also aids the control of
inventory: selling sealed one-liter-bottles of milk, rather than having people bring their own
bottles to fill themselves.

40
5.3. Packaging machines
A choice of packaging machinery includes, technical capabilities, labor requirements,
worker safety, maintainability, serviceability, reliability, ability to integrate into the
packaging line, capital cost, flexibility (change-over, materials, etc.), energy usage, quality
of outgoing packages, qualifications (for food, pharmaceuticals, etc.), throughput,
efficiency, productivity,
High speed conveyor with bar code scanner for sorting transport packages.
Label printer applicator applying a label to adjacent panels of a corrugated box

41
6. 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 and apparatus 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. But the same was seen not to be satisfactory in
the Dhanuka Pharmaceuticals Limited. The workers were seen dealing the active
medicaments with bare hands. The quality control section was also of substandard.
Due to lots of vacancy of chemists, they did not do the basic tests of the solid dosage
forms like assays, disintegration test, dissolution tests etc. They are doing the same
only on the paper documents, not in practice. Hence it can be said that, the authorities
are not paying much importance on the quality of the products.
❖ Apart from all that, the training was very interesting with lots of things to be learned.
It helped us to acquire knowledge on punctuality, regularity and working
environments in industries. The friendly working environment in Dhanuka
pharmaceuticals will remain in our mind in near future. Hence, we can say that our
goal of attending the industrial tour is fulfilled. We acknowledge the great help of
Dhanuka Phramaceuticals Limited.

42
7. REFERENCE
a) Mehta R.M. ‘Pharmaceutics’ 2nd edition Vallabh Prakashan, Page no:-246-252
b) Lachman, L., Lieberman, H. A., and Kanig, J. L. (1986 ), The Theory and Practice of
Industrial Pharmacy, 3rd ed. , Philadelphia: Lea & Febiger.
c) Allen L. V and Ansel H. C. (2014). Ansel’s Pharmaceutical Dosage Forms and Drug
Delivery Systems. Philadelphia: Lipincott Williams and Wilkins.
d) Dash, A. (2014). Solid Dosage Forms. In A. Dash, S. Singh and J. Tolman (Eds),
Pharmaceutics: Basic Principles and Application to Pharmacy. (Page no. 161-180 ).
USA: Elsevier Inc.
e) Debjit, B., Duraivel, S., Rajalakshmi, A. and Sampath K. (2014). Tablet
manufacturing process and defects of tablets. Elixir Pharmacy
f) Jones D. (2008). Fasttrack Pharmaceutics – Dosage Form and Design. London:
Pharmaceutical Press.
g) Sakr, A. A and Alanazi, F. K (2012). Oral Solid Dosage Form. In L.A Felton (Eds.),
Remington Essentials of Pharmaceutics (Page no. 581-610). London: Pharmaceutical
Press.
h) Shayne C. G. (2008), Pharmaceutical Manufacturing Handbook Production and
Processes. New Jersey: John Wiley & Sons, Inc.
i) Lachman, L., Lieberman, H. A., and Kanig, J. L. (1986 ), The Theory and Practice of
Industrial Pharmacy, 3rd ed. , Philadelphia: Lea & Febiger Page no:-1-74
j) www.ich.org
k) www.fda.gov

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