Mehfuj Ahmad B.Pharm 3rd Year Pharmaceutical Industry Project Roseate Medicare, Solan, H.P.

1. INDUSTRIAL TRAINING REPORT
ON
ROSEATE MEDICARE
Submitted for Partial Fulfillment for the Degree of
BACHELOR OF PHARMACY
By
MEHFUJ AHAMAD
B.Pharm IIIrd year
(1523450028)
Under the supervision of
MS. KUMKUM SHARMA
Assistant Professor
DEPARTMENT OF PHARMACY
!
ALIGARH COLLEGE OF PHARMACY
(Aligarh- Mathura road, UP,202001)
Approved by AICTE; PCI and Affiliated to Dr. A.P.J. Abdul Kalam Technical
University, Lucknow, UP.
APRIL,2018

2. ALIGARH COLLEGE OF PHARMACY
!
!
!
DECLARATION
I hereby declare that this project work entitled “INDUSTRIAL
TRAINING REPORT” Submitted to A.K.T.U. , Lucknow, is a bonafide
and genuine work carried out by us under the guidance of MS.
KUMKUM SHARMA. I also declare that the material entitled in it is
original and the same has not previously formed the basis for the award
of any diploma, degree association ship or fellowship of other university
or institute.
!
MEHFUJ AHAMAD
(15234500028)
Date:
ii

3. ALIGARH COLLEGE OF PHARMACY
!
!
!
ENDORSEMENT BY THE GUIDE
This is certifying that the project entitled the study of “INDUSTRIAL
TRAINING REPORT” is a bonafide work done by MEHFUJ AHAMAD
in a partial fulfillment of the requirement of the degree of “Bachelor of
pharmacy” of A.K.T.U. Lucknow.
!
!
!
Signature
Ms. KUMKUM SHARMA
Assistant Professor
!
!
Date:
!
iii

4. ALIGARH COLLEGE OF PHARMACY
!
!
!
ENDORSEMENT BY THE PRINCIPAL
This is certify that the project entitled the study of “INDUSTRIAL
TRAINING REPORT” is a bonafide work done by MEHFUJ AHAMAD
in a partial fulfillment of the requirement of the degree of “Bachelor of
pharmacy” of A.K.T.U. Lucknow.
!
!
!
signature
Mr. RIJUVED GARG
Principal
!
!
Date :
!
!
iv

5. ACKNOWLEDGEMENT
First and foremost, I am very much grateful to GOD, without whose
blessings I would be unable to complete this project work. Then I thank
my parents for their constant support, encouragement and blessings.
The joyful satisfaction and euphoria that came along successful
completion of this would be incomplete unless we mention the people
who made it possible and whose constant guidance and encouragement
served as a beam of light and give me energy to enjoy and complete this
work.
Then I prevail my sense gratitude to MR. RIJUVED GARG, Aligarh
college of pharmacy. It gives me an immense pleasure to thank my guide
MS. KUMKUM SHARMA whose constant encouragement installed
enough confidence in me. This project would not have become reality
without his support and critical evaluation.
I am also thank full to Mr. Kalyan Pandey (Production Manager of
Roseate Medicare), Dr. Raghvendra, Ms. Neetu Singh, Ms. Shaista
Yousuf, Dr. R.K. Rajppoot,Mr. Kamal Uddin,Mr. Kuldeep Singh,Dr.
Amit Kumar,Ms. Atiya Akthar & Ms.Farah Khanam
I must place on record very special thanks to my friends, respected
seniors and loving juniors for their knowledgeable company, timely
help, moral support and co-operation and at last but not the least, I thank
to entire college staff for help in project work.
!
!
!
MEHFUJ AHAMAD
(1523450028)
!
v

6. CONTENTS
I. Certificate………………………..…………….…………………(i)
II. Declaration………………………….……………………………(ii)
III.Endorsement by guide…………………………………………..(iii)
IV.Endorsement by principal……………………………………….(iv)
V. Acknowledgement ………………………………………………(v)
VI.Table of contents………………………………………………..(vi)
S.No. Title Page No.
1 Introduction 1-2
2 Manufacturing Section 3-9
3 Packaging Section 10-12
4 Testing Section 13-16
5 GMP Requirements 17-20
6 SOPs 21-25
7 Batch Manufacturing Record (BMR) 26-33
8 Analysis Record 34
9 Conclusion 35
10 Reference 36
vi

7. 1) INTRODUCTION
Roseate Medicare is situated in the hills of
Himachal Pradesh, one of the fastest
growing pharmaceutical companies in the
state, is a ‘One Stop Shop for Oral
Therapeutics’ with a promise of quality
products and impeccable customer
service. We offer tie-up for third-party
manufacturing, franchisee marketing, loan
licensing, tender supply, export, and
development of new products through
reverse engineering.
!
The Unit has already been audited and approved by MNC’s like Alkem
Laboratories Ltd. and IND SWIFT, and Comed Chemicals Ltd., etc. It is equipped
with ultra-modern machinery (as per GMP norms laid down in Schedule M
(revised) of the Drugs and Cosmetics Act), in-house well-equipped laboratory
ensuring stringent quality checks at each level of production, and an absolute
pollution free environment.
!
The unit also boasts its position as the only company in the region to have installed
state of the art granulation machinery offering us a competitive advantage. Besides
GMP certification, the company is ISO 9001-2008 certified and is at par with
WHO certification. The company is in the process of receiving WHO certification.
!
Besides a state of the art manufacturing facility, we offer management by industry
professionals with long technical experience from all across the country.
!
VISION AND MISSION
!
Under the visionary leadership of Managing Partner Mr. Ajay Sood, an industry
expert and management specialist, the company aims to become the foremost
healthcare provider in the entire Northern region of India. Our company also
understands its responsibility towards the society and has undertaken several
projects under the leadership of Managing Partner Mrs. Rashim Dhar Sood. One
noteworthy accomplishment is its focus on empowering women through
employment. The company hence boasts a majority women employment and
employment of special people.
1

8. Roseate Medicare currently manufactures over 3500 brands for over 300 clients
across India. We see ourselves as a 'One Stop Shop.' We offer our clients a choice
of over 300 formulations in tablet, capsule, syrup, and dry powder dosage. We also
offer new molecules. Over the last decade, we have established our speciality
in Beta-Lactum, Cephalosporin, NeuroPsychiatry and Narcotic products.
!
PRODUCTS MANUFACTURED
1) Rosiron
2) Rofenac
3) Rosepep
4) Rosecal-D3
5) Roserab-L
6) Rosepod-CV
7) Roseplex
8) Rosemycin Fig 1:- Rofenac Fig 2:- Rosepod
9) Kymex
10) Dimet-G2
11) Rosecold
12) Roseclat-625
13) Cefscor-CV
14) Rosegesic-SP
15) Rosecold-EX
16) Yprox
17) Zenolid
18) Ceficon-CV
19) Merix Fig 3:- Rosepep Fig 4:- Roseclav
20) Relevit
!
!
!
!
!
!
!
!
!
!
!
!
2

9. 2) MANUFACTURING SECTION
!
Pharmaceutical manufacturing is the process of industrial scale synthesis of
pharmaceutical drug by pharmaceutical companies.The process can be broken
down 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 shock
encountered 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 long
period of time.
v. To formulate tablets that have elegant product identity which is free from any
tablet defects.
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
!
a. 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.
The equipments used in the process of Granulation are :-
i) Mass Mixer
3

10. ii) Tray Dryer
iii) FBD (Fluidized Bed Drier)
iv) Multi-mill
v) Roll Compactor
!
i) 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 the
mixing 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.
!
!
!
!
!
!
!
!
!
Fig 5:- Mass Mixer
ii) 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. For
the 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
4

11. wind passes over it to provide the latent heat of vaporization. This kind of dryers
provides proper control of humidity and temperature.
!
Fig 6:-Tray Dryer
iii) 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
5

12. 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.
Fig 7:- Fluidized Bed Dryer
iv) 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, processing
chamber with beater assembly, Motor, DOL stater, three speed pulley, screen and
study body.
Fig 8:- Multi-mill
6

13. v) 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). Roll
Compacters 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.
Fig 9:- Roll Compactor
b. 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.
!
!
!
7

14. Fig 10:- Blender
c. 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 improve
the production rates and now it is possible to produce more than 500,000 tablets
per hour. A tablet formation takes place by the combined pressing action of two
punches and a die.
!
!
!
!
!
!
!
!
!
Fig 11:- Single Rotary Compression Machine
!
8

15. 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:-
i) Filling
ii) Metering
iii) Compression
iv) Ejection
d. 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.
Fig 12:- Coating Machine
!
!
9

16. 3) PACKAGING SECTION
!
Packaging is defined as the collection of different components which surround the
pharmaceutical product from the time of production until its use.
!
Importance of packaging
!
• Protect against all adverse external influences that can alter the properties of the
product.
• Protect against biological contamination.
• Protect against physical damage.
• Carry the correct information and identification of the product.
• Tamper evident / Child resistance / Anti counterfeiting.
!
There are mostly three types of packaging are used and these are as follows :-
a.ALU-ALU Packing
b.Blister Packin
c.Strip Packing
!
a. ALU-ALU Packing
Ideal for products that need packaging between two sheets of aluminum foil, such
as candies, foodstuff, tablets and pills. The equipment is able to operate without
light, and therefore meets the requirement for sensitive products that are cannot
tolerate exposure to light.
!
• Can also be used for plastic to plastic sealing
• Ideal for aluminum to aluminum foil heat sealed packaging of products
• The machine automatically completes functions such as cutting margin scrap,
broken piece filtering, and material feeding. Batch number printing can be
automated, and even transverse impressing.
• It is fully programmable via a programmable logic controller (PLC).
• Cutting speed and travel range are fully adjustable
• Gives accurate feeding, full purpose, ease of operation, tight sealing, stable
performance
• Can enhance the presentation of the product item and extend its durability
• Ideal for pharmaceutical companies.
10

17. !
Fig 13:- ALU-ALU Packing Machine
b. Blister Packing
This machine is ideal for packaging pharmaceutical materials in blister packs that
use materials such as polyvinyl chloride, polystyrene and polypropylene.
• The vibration feeder and crisp remover can remove the powder and crisps
inside medicine effectively.
• Horizontal perforation.
• Auto-counting slitting waster-side cutting.
• Automatically prints batch number.
• The diameter of the heat pressing cam can be modify from 110 to 140mm.
!
!
Fig 14:- Blister Packing Machine
11

18. c. Strip Packing
A high-speed machine that is ideal for different products such as tablets or
capsules. Machines are robust and well constructed and generally provide high
quality by using accurate temperature control, and the ability to exert variable
pressure on the sealing rollers.
A strip packaging machine is ideal for coating heat sealable films such as polymer-
coated aluminum foil, and polymer-coated paper.
Important features of the machine are:
• Availability of Standard interchangeable parts
• Cutting arrangement are adjustable
• Quick and easy change of parts for application with different product types
• Precise knurling (sealing rollers)
• Smooth, silent operation
• Compact – minimal floor space
!
Fig 15:-Automatic Strip Packing Machine
!
12

19. 4) TESTING SECTION
Tablets should be subjected to a number of tests before they are deemed fit for
marketing and consumption.
The tests that are performed during manufacturing process are as follows:-
a. Shape and Size of Tablets
b. Weight Variation Test
c. Friability Test
d. Hardness Test
e. Disintegration Test
f. Dissolution Test
!
a. Shape and Size of Tablets
It can be dimensionally described monitoring and checked visually the tablet shape
is Round, Elongated, Triangular, Oval, etc
Tablet diameter and thickness can be measured by Vernier Calipers.
Tablet thickness should be controlled within a range of ± 5%.
b. Weight Variation Test
Weigh individually 20 units selected at random and calculate the average weight.
Not more than two of the individual weights deviates from the average weight by
more than the percentage given in the pharmacopeia and none deviates by more
than twice that percentage.
!
Table 1:- Weight Variation Limit according to IP, BP & USP
IP/BP Limit USP
80 mg or less ± 10% 130mg or less
More than 80mg or
Less than 250mg
± 7.5% 130mg to 324mg
250mg or more ± 5% More than
324mg
13

20. c. Friability Test
Friability testing is a method, which is employed to determine physical strength of
uncoated tablets upon exposure to mechanical shock and attrition.
In this test 20 tablets are used, the rotation is 25 RPM per minutes and is done for 4
minutes.
The tablets fall down from 6 inches height.The % weight loss should not be more
than 1%.
Percentage Friability = W1 – W2/W1 × 100
Where, W1 = weight of tablets before testing
W2 = weight of tablets after testing.
Fig 16:- Friability Test Apparatus
d. Hardness Test
Tablet hardness testing is a kind of laboratory technique, which is employed to test
breaking point of a tablet. For pharmaceutical units this process is an important
part of medicine production that ensures tablets must be hard enough to withstand
mechanical stress during various conditions such as storage and packaging,
transportation and handling by the consumer etc.
There are two types of Hardness Tester:-
i) Monsanto Hardness Tester
ii) Pfizer Hardness Tester
!
14

21. !
!
!
!
!
Fig 17:-Monsanto Hardness Tester Fig 18:- Pfizer Hardness Tester
!
e. Disintegration Test
Disintegration test is performed to find out that in how much time the tablet
disintegrate.Sieves size used in Disintegration test apparatus is 10 no. And up &
down rotation is 28-32 cycles per minutes at a height of 5-6 cm. The temperature
of liquid medium is 37°C .
Disintegration Time for tablets as per IP, BP and USP
!
Disintegration Time:-
i)Uncoated Tablet
NMT 15 min, in water with Disc 370C ± 20C
!
ii)Coated Tablet
NMT 30 min, In water with Disc for Film Coated Tab, and NMT 60 min Other
than Film coated tablet
!
iii)Enteric Coated Tab
Intact for 2 hr in 0.1 N HCl & disintegrate within 1 hr in Mixed 6.8 Phosphate
buffer.
According to USP 1 hr in Simulated gastric fluid, then in Simulated Intestinal
Fluid.
!
iv)Dispersible/Soluble
Within 3 min in water at 250C ± 10C
!
!
!
!
!
!
15

22. Fig 19:- Disintegration Test Apparatus
f. Dissolution Test
A dissolution test is a means of identifying and proving the availability of active
pharmaceutical ingredient (API) in their delivered form. A dissolution test reflect
the availability of active substance and allows the prediction of the time for
complete release of the material from the dosage form.
There are many kinds of dosage forms of course and all of them have a dissolution
rate. The dissolution time can range from seconds to hours or even days for
implants according to IP, BP & USP to the specified drugs.
!
!
!
!
!
!
!
!
!
!
!
Fig 20:- Tablet Dissolution Test Apparatus
!
!
16

23. 5) GMP REQUIREMENTS
Good Manufacturing Practice (GMP) is a system for ensuring that products are
consistently produced and controlled according to quality standards.
It is designed to minimize the risks involved in any pharmaceutical production that
cannot be eliminated through testing the final product.
A product that conforms to GMP guidelines is considered to be of high quality and
will pose no risk to consumers or the general public.
!
a. PRODUCTION
Principle
Production operations must follow clearly defined procedures; they must comply
with the principles of Good Manufacturing Practice in order to obtain products of
the requisite quality and be in accordance with the relevant manufacturing and
marketing authorizations.
General
1) Production should be performed and supervised by competent people.
2) All handling of materials and products, such as receipt and quarantine,
sampling, storage, labeling, dispensing, processing, packaging and distribution
should be done in accordance with written procedures or instructions and
should be recorded.
3) All incoming materials should be checked to ensure that the consignment
corresponds to the order. Containers should be cleaned where necessary and
labelled with the prescribed data.
4) Damage to containers and any other problem which might adversely affect the
quality
5) Incoming materials and finished products should be physically or
administratively quarantined immediately after receipt or processing, until they
have been released for use or distribution.
!
b. QUALITY CONTROL
Principle
Quality Control is concerned with sampling, specifications and testing as well as
the organization, documentation and release procedures which ensure that the
necessary and relevant tests are carried out, and that materials are not released for
17

24. use, nor products released for sale or supply, until their quality has been judged
satisfactory. Quality Control is not confined to laboratory operations, but must be
involved in all decisions which may concern the quality of the product. The
independence of Quality Control from Production is considered fundamental to the
satisfactory operation of Quality Control.
General
1) Each holder of a manufacturing authorization should have a Quality Control
Department. This department should be independent from other departments,
and under the authority of a person with appropriate qualifications and
experience, who has one or several control laboratories at his disposal.
2) The Quality Control Department as a whole will also have other duties, such as
to establish, validate and implement all quality control procedures.
3) Finished product assessment should embrace all relevant factors, including
production conditions, results of in-process testing, a review of manufacturing
(including packaging) documentation, compliance with Finished Product
Specification and examination of the final finished pack.
4) Quality Control personnel should have access to production areas for sampling
and investigation as appropriate
5) Control Laboratory premises and equipment should meet the general and
specific requirements for Quality Control areas.
6) The personnel, premises, and equipment in the laboratories should be
appropriate to the tasks imposed by the nature and the scale of the
manufacturing operations. The use of outside laboratories, in conformity with
the principles detailed under Contract Analysis, can be accepted for particular
reasons, but this should be stated in the Quality Control records.
!
c. PACKAGING INSTRUCTIONS
There should be formally authorized Packaging Instructions for each product for
pack size and type. These should normally include, or have a reference to, the
following:
1) Name of the product.
2) Description of its pharmaceutical form, and strength where applicable.
3) The pack size expressed in terms of the number, weight or volume of the
product in the final container.
18

25. 4) A complete list of all the packaging materials required for a standard batch size,
including quantities, sizes and types, with the code or reference number relating
to the specifications of each packaging material.
5) Where appropriate, an example or reproduction of the relevant printed
packaging materials, and specimens indicating where to apply batch number
references, and shelf-life of the product.
6) Special precautions to be observed, including a careful examination of the area
and equipment in order to ascertain the line clearance before operations begin.
7) A description of the packaging operation, including any significant subsidiary
operations, and equipment to be used.
8) Details of in-process controls with instructions for sampling and acceptance
limits.
!
d. STERILE PHARMACEUTICAL MANUFACTURING
Maintenance of sterile area is a critical task because of air, as well as the personnel
working in the sterile classified area, are the main source of the contamination.
Following are some good manufacturing practice points those shall help in the
maintenance of sterile area.
1) Precautions to minimize contamination should be taken during all processing
stages, including the stages of sterilization.
2) Preparations containing live microorganisms should not be made or containers
filled in areas used for the processing of other pharmaceutical products;
however, vaccines consisting of dead organisms or of bacterial extracts may be
dispensed into containers, after validated inactivation and validated cleaning
procedures, in the same premises as other sterile pharmaceutical products.
3) The validation of aseptic processing should include simulating the process
using a nutrient medium. The form of the nutrient medium used should
generally be equivalent to the dosage form of the product. The process-
simulation test should imitate as closely as possible the routine aseptic
manufacturing process and include all the critical subsequent manufacturing
steps.
4) Care should be taken to ensure that any validation does not compromise the
processes.
19

26. 5) Activities in clean areas, especially when aseptic operations are in progress,
should be kept to a minimum, and the movement of personnel should be
controlled and methodical, so as to avoid excessive shedding of particles and
organisms due to over-vigorous activity. The ambient temperature and
humidity should not be uncomfortably high because of the nature of the
garments worn.
6) The presence of containers and materials liable to generate fibers should be
minimized in clean areas and avoided completely when aseptic work is in
progress.
!
!
!
!
!
!
!
!
!
!
!
!
!
!
20

27. 6). SOPs (STANDARD OPERATING PROCEDURE)
A Standard Operating Procedure (SOP) is a set of written instructions that
document a routine or repetitive activity which is followed by employees in an
organization. The development and use of SOPs are an integral part of a successful
quality system. It provides information to perform a job properly, and consistently
in order to achieve pre-determined specification and quality end-result.
a. SOPs for Compression Machine
• SETTING PROCEDURE FOR ROUND PUNCHES
1) Examine machine for cleanliness including rinse water results, dust-extraction
unit and area. Check punches and dies cleanliness.
2) Rotate hand wheel and check that turret rotates freely.
3) Check that pressure wheels are free and pressure is released.
4) Check that sockets of upper / lower punches and dies are properly cleaned.
5) Fit dies using die rod. Ensure that die is fitted in turret, Tighten die holding
screws.
6) Fit lower punches using thin coat of Food Grade Oil on punch barrel. Ensure
that punches are ‘freely moving’ by pushing the punch tips through die and
allowing the punches to drop back freely on its own weight. Tighten lower
punches with plugs using anti turning strip.
7) Rotate hand wheel and check that all lower punches moves freely.
8) Fit upper punches.
9) Close lower punch guard covers and fit the feed frame and check the clearance
with turret.
10)Fix hopper in such way, so as to give 3-5 mm clearance from turret for free
flow of granules to the feed frame.
11)Rotate hand-wheel and check that machine is free.
12)Fit the acrylic guard. Check the condition of oil cups for any spillage of oil,
which may contaminate the product. Clean if necessary.
21

28. 13)Check tablet and granules containers, and polyethene bags, etc. for cleanliness.
14)Affix the Status label with Product Name, Batch Details to equipment, area and
get the clearance from Q.A.
15)Load granules in hopper, Rotate machine by hand to fill feed-frame and dies.
16)Apply pressure just to form tablet. Check weight of the tablet. Further increase
the pressure to produce required thickness of the tablet.
17)Put “ON” electric supply and press the green button of machine and check for
required Physical Appearance, Thickness, Hardness, Average Weight, Weight
Variation, disintegration time, friability and record in the BMR.
18)After setting all parameters, pharmacist should counter check the same.
• TABLET PARAMETER CHECKING
1) After the setting is complete. Put “ON” the mains. start the machine and check
for following parameters at specified frequency.
2) For Physical Appearance check the surface of all tablets obtained in one rotation
for the elegance and absence of defects such as sticking, picking and correctness
of embossing. Appearance to be checked after every two hours and after every
break.
3) Weight Variation of 20 tablets after every 15 min.
4) Individual weight of tablets (weight variation) initially & after every 2 hour of
one full rotation.
5) Thickness of tablets in one full rotation at the beginning of the batch and then
for not less than 3 tablets afterwards every half an hour.
6) Hardness for not less than 3 tablets every half an hour.
7) Friability for tablets at start and afterwards every two hours.
8) Disintegration time for 6 tablets at start and afterwards every two hours.
9) After the compression is complete. Put “OFF” the mains.
10)Affix “To be Cleaned” label. & fill the “Equipment Log Book”.
22

29. b. SOPs for Blister Packing Machine
• PROCEDURE: MACHINE STARTING
1) Production person shall ensure the cleanliness of the Blister Pack Machine, its
part & area and ‘CLEANED’ label on it.
2) Before starting the operation production person get the line clearance from Q.A
person by writing the status label with Product Name, Batch Det to equipment &
area as per BMR.
3) Compressed air supply – “ON”.
4) Cooling unit – “ON”.
5) Mains – “ON” then control unit “ON”, PLC screen show. Press the main (F4),
then select Manual / Auto mode.
6) Vacuum “ON”, then Contact Heaters “ON” and Set temperature.
7) Sealing Heaters – “ON”.
8) Set knob to starting speed.
9) Lubricates Punch unit and web transport plate.
10) On attaining operating temperature.
•Engage Blister Sealing Roller.
•Start Machine for fresh blister web.
•Stop machine and insert Al Foil for sealing. 10.4 Insert sealed web in punching
unit (Open position) and check web tension behind ratchet.
•Start machine and adjust Idler roller of Batch code printing unit to get even over-
printing.
•After satisfactory batch printing, engage tablet feeding unit and open gate for
filling tablets after 2 revolutions (approx.) of blister forming rolls record it in
format.
!
!
23

30. c. SOPs for Disintegration Test Apparatus
• Precautions:
1) Do not switch on the mains if water in the tank is not up to the mark.
2) While placing and removing the basket assembly do not apply excessive force.
3) Do not use abrasive materials to clean the instrument.
4) Do not bend the heater while cleaning the water bath.
• Operating instructions:
1) Ensure the cleanliness of area and the instrument.
2) Ensure that clean purified water is filled in the beakers till the desired level.
3) Switch ‘ON’ the Main supply & the instrument ‘On/Off’ switch on the rear side.
4) Switch ‘ON’ the heater by pressing ‘Temp’ key.
5) Press ‘Set’ & ’Temp.’ key to set the temperature to 37°C.
6) Press ‘Set’ & ‘Timer’ key to set the desired test time.
7) Place one tablet / capsules to be tested in each of the six cylinders of basket rack
assembly.
8) Place the disks if mentioned in the monograph.
9) Press ‘Start/Stop’ key once to start the test.
10)Watch the complete disintegration of the tablet / capsule and note down the
time.
11)Press ‘Start/Stop’ key to stop the test.
!
!
!
!
24

31. d. SOPs for Friability Test Apparatus
• PROCEDURE: Operation
1) Weigh the specified number of tablets for the test.
2) Remove the acrylic cover of the drum and place the tablets inside the drum.
3) Replace the cover and tighten with the help of plastic knob taking care not to
tighten the knob excessively as the drum and threading may get damaged.
4) Switch on the Main power supply; the display shall show "VEEGO
FRIABILITY TEST APPARATUS" for few seconds.
5) Then the display shall show “ENTER-START PROGRAM, INC-PROGRAM"
6) Then press the "START" key, display shall show both Set and Actual rotations.
7) When the actual rotations reach the Set rotations, the drum shall stop rotating
along with a beep sound.
8) Take out the tablets from the drum by removing the cover.
9) Weigh the tablets again and determine the loss in weight, calculate the
percentage.
• Procedure to Set Rotations:
1) Follow above procedure till step 5.
2) Then press "INC" switch.
3) Display shall show "SET ROTATIONS 0000", and the last digit shall be
blinking.
4) Press "INC" switch till the last digit reaches desired figure.
5) Then press the "ENTER" key.
6) The third digit shall start blinking.
7) Continue as per steps 4 and 5 till value is set for each digit.
8) The display shall return to “ENTER-START TEST, INC-PROGRAM”.
25

32. 7) BATCH MANUFACTURING RECORD (BMR)
Batch manufacturing record is a written document of the batch, prepared during
pharmaceutical manufacturing process. It contains actual data and step by step
process for manufacturing each batch.
This ensures that proper ingredients are added and each processing step is
completed according to the SOP and also ensures uniformity in finished product in
each batch.
A good batch manufacturing record format should include following parts:-
a.Batch records
Batch records include master production and control records (MPCR) and batch
production and control records (BPCR). MPCR includes name of the product,
name and codes of API, batch formula, batch or code no., identification of
equipment, line and location used, start and finishing date with processing and
packaging.
!
b. Bill of Material
Complete list of raw materials needed for manufacturing the finished product with
required quantity and weight.
!
c. General instruction for manufacturing
Clear instructions related to safety and health of operators, should be followed
during the manufacturing process.
!
d. Equipment cleaning record
Checklist for the cleaning of all equipments used in the manufacturing of the batch
with the previous product, batch and date of cleaning.
!
e. Yield
Yield of the batch should be calculated at the end of every stage to calculate the
process loss. Final yield should be calculated at the end of the manufacturing that
should not be less than 99.00%.
!
f. Abbreviations
List of the abbreviations used in the batch manufacturing records (BMR) should
be made to understand easily.
!
26

33. 27

34. 28

35. 29

36. 30

37. 31

38. 32

39. 33

40. 8) ANALYSIS RECORD
!
• ASSAY OF PARACETAMOL TABLETS
Paracetamol is a para-aminophenol derivative with analgesic and antipyretic
properties.It is widely used in several formulations and pharmaceutical
presentations that are intended to optimize the use of the medication by good
absorption and reduction of secondary effects.
The test formulation allows a more rapid dissolution of the active principal
ingredient (paracetamol), which is intended to lead to a more rapid absorption.
• Procedure:-
1) Weigh and powder 20 tablets.
2) Take a quantity of the powder equivalent to 0.15 g of paracetamol 20 tablets *
0.5g paracetamol wt 0.15 g paracetamol X
3) Place in a volumetric flask (200ml)
4) Add 50 ml 0.1 M NaOH(using a burette)
5) Dilute with 100 ml of water, shake for 15 minutes, and add sufficient water to
produce 200 ml. Mix, and filter
6) Dilute 10 ml of the filtrate to 100 ml with water (in a volumetric flask 100ml).
7) Add 10ml of the resulting solution to 10 ml of 0.1 M NaOH, dilute to 100 ml
with water (in a volumetric flask 100ml)
8) Measure the absorbance of the resulting solution at max = 257 nm taking 0.715
as the value of E1%
Blank:
Take 20 ml of 0.1 M NaOH and complete to 100 ml with water
Limit:
Content: 95-105% of the prescribed (labeled) amount.
!
34

41. 9) CONCLUSION
During Industrial training period, a lot of experience, knowledge and exposure that
I have handy . All disclosures were awaken myself in a boost of self- confidence to
face life more challenging now. Practical is a complement to the science or theory
learned. This is clearly the concept of science and charity, where they have learned
without practice will be lost and will not give anything.
!
During my industrial training, there are many changes from the point of learning
environments and discussion among colleagues. It can directly increase the
dedication and rational attitude toward myself.
!
However, there are still some weaknesses that can be improved in the future.
Therefore I conclude that the industrial training program has provided many
benefits to students even if there are minor flaws that are somewhat disfiguring
condition , so that this weakness can be rectified in the future.
!
I can conclude that this industry is through training I received a lot of exposure in
the Pharmacy world. I would like to thank all student for find their own experience
with having Industrial Training like this.
!
!
!
!
!
!
!
!
!
35

42. 10) REFERENCE
• Mehta R.M. ‘Pharmaceutics’ 2nd edition Vallabh Prakashan, Page no:-246-252
• Lachman, L., Lieberman, H. A., and Kanig, J. L. (1986 ), The Theory and
Practice of Industrial Pharmacy, 3rd ed. , Philadelphia: Lea & Febiger.
• Allen L. V and Ansel H. C. (2014). Ansel’s Pharmaceutical Dosage Forms and
Drug Delivery Systems. Philadelphia: Lipincott Williams and Wilkins.
• Dash, A. (2014). Solid Dosage Forms. In A. Dash, S. Singh and J. Tolman
(Eds), Pharmaceutics: Basic Principles and Application to Pharmacy. (pp.
161-180 ). USA: Elsevier Inc.
• Debjit, B., Duraivel, S., Rajalakshmi, A. and Sampath K. (2014). Tablet
manufacturing process and defects of tablets. Elixir Pharmacy
• Jones D. (2008). Fasttrack Pharmaceutics – Dosage Form and Design.
London: Pharmaceutical Press.
• Sakr, A. A and Alanazi, F. K (2012). Oral Solid Dosage Form. In L.A Felton
(Eds.), Remington Essentials of Pharmaceutics (pp. 581-610). London:
Pharmaceutical Press.
• Shayne C. G. (2008), Pharmaceutical Manufacturing Handbook Production and
Processes. New Jersey: John Wiley & Sons, Inc.
• 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
!
!
!
!
36