A COMPREHENSIVE REPORT
ON SUMMER INTERNSHIP AT
LIFE PHARMACEUTICALS
Abstract
Two weeks long summer internship at Life Pharmaceuticals, Kolkata was a nice first-hand
experience on different processes, equipments, instruments used in Production and Quality
Control units of a Pharmaceutical Industry. Situated at Uluberia, Howrah, Life Pharmaceuticals,
Kolkata is manufacturing tablets and parenteral products for last three decades or so with the
help of about 50 employees.
They have a patent product CHROMOSTAT®
Life Pharmaceuticals Pvt Ltd.’s Corporate Identification Number is (CIN)
U24232WB1964PTC026271 and its registration number is 26271. It’s registered address is 3/2B
ORIENT ROW KOLKATA WB 700017 IN .
Kuheli Dhang (18901915035)
[email protected] LIFE PHARMACEUTICALS
DIFFERENT UNITS IN THIS COMPANY
▪ Raw Material Storage House
▪ Water Plant
▪ Air Handling Unit
▪ Production Unit
o Tablet Production Unit
o Parenteral Production Unit
▪ Quality Control and Quality Assurance Unit
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Raw Materials Storage House
DIFFERENT SECTION IN THIS AREA
• Dedusting unit
• Raw Materials Passed Section
• Raw materials unpassed section
• Raw materials store room
• Vitamins and biological materials store room
• Raw materials rejection store room
• Dispensing room
• Raw materials, packed in cartoon, enter through the entry gate and dedusting of the
packaging materials are done.
• Samples are collected from raw materials and sent it to Quality Control (QC) department
for testing purpose.
• QC approved materials are kept in Raw Materials Passed Section and others are kept in
Raw Materials Unpassed Section.
• Finally, the raw materials (QC approved) are kept in raw materials store room.
• Vitamins and other biological materials are kept separately in an air-conditioned room,
namely Vitamins and Biological store room.
• Waste materials are kept in rejection room.
• Raw materials are weighed under LAF Hood kept in Dispensing room.
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AIR HANDLING UNIT (AHU) - air of the production area is regulated and circulated by HVAC
(heating ventilation air condition) system.
Components of AHU-
• Housing- made up of metal and contains all the other components.
• Fan- centrifugal fan is used to circulate the air to the various parts of the section in the
building. Types of fan are used: backward, forward, curved, inclined.
• Filter-HEPA filter is used. It is able to achieve efficiencies up to 99.97%, removing minute
particles and air born bacteria from the air.
• Humidifier-heating coil is used to control the humidity level of the air.
• Cooling coil- is used to cool and dehumidify the air.
• Mixing box- this is the place where the outside air and the return air are mixed to provide
the correct proportion of air to be distributed.
▪ Smoke test is done for validation of H-VAC.
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WATER PLANT
Demineralized Water and Water for Injection is mainly used for Production.
DEMINERALIZED WATER PRODUCTION
• Six different types of ion exchanger are used.
IRON CATIONIC ANIONIC CATIONIC
FILTER EXCHANGE EXCHANGE EXCHANGE
R R R
ANIONIC
MIXED EXCHANGER
EXCHANGER
Water comes out from the mixed ion exchanger and passes through the UV pump, here
conductivity of the water is checked by Online Conductivity meter and finally stored in
VAT (150 L/ 300 L).
WATER FOR INJECTION PRODUCTION
Equipment: 1) Boiler
2) Multi Column Distillation Still
Boiler: portable water is heated above 100°C to produce steam which is used in multi
column distillation still.
Multi-Column Distillation Still: capacity – 100 lit/ hr.
Pressure – 90 lb.
Description- It has two control device a) Feed water
b) Cooling water
Principle: Double Distillation.
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Working procedure:
1. Demineralized water is heated with steam i.e. produced by boiler at 124°C
2. Then it is condensed by Cooling Water control device.
3. 1 & 2 are repeated again i.e. double distillation is done.
4. Finally, water for injection is produced.
USES - 1) Ampule washing
2) Parenteral formulation
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PRODUCTION UNIT: Mainly Tablets and Parenterals are produced here.
TABLET PRODUCTION UNIT: Class D is maintained throughout this area.
Equipments:
• DRY GRANULATION EQUIPMENT
1) Roller Compactor (Gran-01)
Mesh size- 40; Capacity- 60Kg; Mfg. by- Hindustan
Construction-it contains
i. Feeding system- which conveys the powder to the
compaction area between the rolls.
ii. Compaction unit- it contains two counter rotating rolls,
powder is compacted to ribbon, between these two rolls.
iii. Size reduction unit-milling the ribbons to the desired
particle size.
Uses: size reduction and granulation.
2) Double Cone Blender (Precikot)
Capacity- 300 Kg;
Uses- Mixing of granules, dry powder, heavy and abrasive materials.
• WET GRANULATION EQUIPMENT
1) Rapid Mixer Granulator or RMG (Precikot)
Capacity- 30 KG
Working principle-formation of granules occurs by rising, whirling, tumbling
motion of material. During the addition of binder solution to the powder
impeller and chopper are operated at low speed after the formation of wet mass
impeller and chopper are operated at high speed to form the granules.
Uses-In rapid mixer granulator mixing, densification and agglomeration is
achieved using shear mixing (breaking inter-molecular forces) and compaction
forces exerted by impeller on the powder mass.
2) MASS MIXER
Capacity-50 KG
Used in mixing.
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• DRYER
1) FLUIDIZED BED DRYER
Capacity- 30 KG; Temperature used- 60°C
Power- 440 Volt
It consists of – air preparatory unit, product container, exhaust filter and blower,
control panel spray nozzle, solution deliver, distribution plate.
Uses- used to reduce the moisture of granules.
2) TRAY DRIER (KILBURN DRYING OVEN)
Mfg. by-McNeill & Barry limited;
Capacity -48 KG; motor H.P- 15 kilowatt, total AMPs-15.4.
Used in drying of granules.
• LUBRICATOR
1) Drum mixer
RPM: 40-45
Uses- mixing and lubrication.
• TABLET PUNCHING MACHINE (CADMACH)
Station -27, power supply-440 volt.
Uses- used in compression of granules
• BLISTER PACKAGING MACHINE- primary packaging of the tablet is done
by this machine.
Rapid pack 240
Forming temperature-155°C; sealing temperature- 213°C
• COATING MACHINE
1) Film coating machine (UNICOTA-36)
Capacity-60KG; Temperature maintained -220°C; rpm – 4-5; mesh size -100;
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Coating solution- INSTACOAT+ titanium di-oxide+ Isopropyl alcohol+
methylene chloride (for TRANXEMIC ACID).
Spraying of coating solution is done by spraying gun.
2) PANCOTA
Conventional coating machine, spraying of coating solution is done
manually.
• TABLET POLISING MACHINE
Uses- polishing of tablet.
In process quality control- hardness testing, disintegration test, weight variation
test, content uniformity test is done to check the quality of the tablet.
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PARENTERAL PRODUCTION UNIT
Different section of this unit –
• Ampule washing and drying room- here washing and drying of the ampule is done.
Ampule washing machine (OLO-60)
Ampules are washed with demineralized water two times and finally washed with water
for injection.
Ampule drying machine (DHS)
Dry heat sterilization of Ampules are done by heating at 240°-260°C for 70 min.
Sterilization of these ampules are done before filling and sealing.
• Solution preparation room – Class C is maintained throughout this room. Active
pharmaceutical ingredients are diluted with water for injection (within 24 hr. of production)
to prepare the solution. Sterilization of the solution is done with membrane filter (pore
size-.25 micron). Then a sample of the solution, sent to quality control unit for sterility
testing.
• Ampule filling and sealing room- Class B is maintained in ampule filling and sealing
room and under the LAF (laminar air flow) hood class A is maintained.
Ampule filling sealing machine- filling of the solution into ampule and sealing of the
ampule is done by this equipment.
• Changing room- sterilized apron, gloves, hair mask, and shoe cover should be wear before
entering into the production area.
• In-process quality control room-
• Ampules are kept against black and white background to check white and black particles
manually.
• After filling and sealing, samples are sent to QC unit for microbial testing that is
pyrogen test/ bacterial endotoxin test.
Reagent used in this test-
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C.S.F (E.coli) O55:B5 (in powder)
Strength- 33 mg/ vial; volume-50 ml
• LAL reagent water is used to dissolve it.
• Store at 2°C to 8°C.
LYSATE
Volume-1.8 ml; wave length- 0.125EU/ ml
• Store at 2°C to 8°C.
LAL REAGENT WATER
Store at 15 to 30°C
Volume-100 ml
Endotoxin content- <0.005 EU/ ml
• Ampule labeling – ampules are labeled manually.
• Secondary packaging – ampules are packed into small boxes than in a cartoon.
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QUALITY CONTROL AND QUALITY ASSURANCE UNIT
QUALITY CONTROL – a system of maintaining standards in manufactured products by
testing a sample of the product against specification (that mentioned in pharmacopeia).
Different apparatus used in QC
• INCUBATOR- It is used to grow and maintain the microbial culture. It maintains
optical temperature (35-37°C), humidity and other condition like carbon di oxide,
oxygen.
• BOD INCUBATOR: Bio- oxygen demand incubator is used to maintain temperature
(22°C) for storage or incubation of bacterial culture where high ° of constant
temperature accuracy is required.
• LAMINAR AIR FLOW CABINET- is a carefully enclosed bench designed to
prevent contamination of semiconductor wafers, biological samples or any particle
sensitive materials. Air is drawn through a HEPA filter and blown in a very smooth,
laminar flow towards the user. Due to the direction of air flow sample is protected.
Cabinet is made up of stainless steel (grade- 316L).
• STABILITY TEST CHAMBER (REMI)
Temperature and relative humidity is maintained.
• SPECTROPHPTOMETRY
Double beam spectrophotometer (ELICO)
Uses- quantitative measurement of the reflection or transmission properties of a material as a
function of wavelength.
• HPLC /High Performance Liquid Chromatography (SHIMADZU)
HPLC column – C (18)
250x 4.60 cm
Used to separate, identify and quantify each component in a mixture.
• DISINTREGATION TEST APPARATUS
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Mfg. by -Electro Meta Corporation
➢ Single pan
➢ Temperature maintained: 37±2°C
Used to measure disintegration time of a dosage form like tablet, capsules, and
suppositories etc.
• FRAIBILITY TEST APPARATUS
Mfg.by- Campbell Electronics
Used to determine the physical strength of tablet.
• MONSANTO HARDNESS TESTER
Used to determine hardness of the tablet.
• POLARIMETER
Mfg.by-TOSHNIWA INSTS. & ENGINEERING.CO
Used to measure the angle of rotation caused by polarized light.
• SIMPLE MICROSCOPE
Uses- for determination particle size, morphology and roughness of the raw materials, finished
product etc.
• REFRACTOMETER
Used to measure refractive index.
• MOISTURE BALANCE
Provide a primary method for accurate moisture measurement by using the loss on drying (LOD)
method.
Tablet granules are kept at 105 ° c for 15 min.
• ULTRASONIC CLEANER (SONICA)
Uses – degassing and cleaning
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• DIGITAL POTENTIOMETER
Range -200 mv-2000mv
Different electrodes are-
1. Reference electrode (Type RE-20); pH- 7
2. Glass electrode (Type GE 15)
3. Silver electrode (TYPE SE 70)
4. Platinum electrode (TYPE PE 60)
• DIGITAL COLONY COUNTER
It is designed for quick and accurate counting of bacterial and mould counting in petri dishes.
• ELECTRONIC DIGITAL BALANCE
Used for weighing substances to the milligram (0.000g)
• UV-DETECTOR
Range – (254 nm -366 nm)
Uses- Detection and identification of analytic sample by measuring of absorption of the sample.
• VACUUM GAUGE
Uses- used to check loss on drying of different biological materials like vitamin (to prevent
degradation by heating).
For vitamins 12-25 lb. pressure is applied.
• HOT AIR OVEN
Used in dry heat sterilization of
1. Glassware (like petri dishes, flasks, test tubes),
2. Materials that contain oil,
3. Metal instrument like scalpels, scissors and blades.
Temperature used- 160°C for 2 hrs.
• WATER BATH
Used for heating (some chemical reactions require elevated temperature).
• AUTOCLAVE
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It is used to sterilize equipment (glass wares) and supplies (liquid media, nonflammable
liquids) by subjecting them to high - pressure saturated steam at 121°C at 15 lbs. pressure
for 15 minutes.
• MUFFLE FURNACE
Used for converting the materials in absolute ash. This ash is used for performing the
analysis of different chemical properties of the materials that are being tested.
Temperature used-up to 1200°C.
• CRUCIBLE FURNACE
Use- used for heating above 800°C
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QUALITY ASSURANCE UNIT
➢ They prepare, approve and monitor the implementation of key documents like SOP
(standard operating procedure), BMR (Batch Manufacturing Record), BPR (Batch
Packaging Record), BP quality manual, validation master plan etc.
➢ They check the qualification of raw materials, vendors, testing methods, document
control, equipment calibration, data recording, and formulation of API batches.
➢ They ensure the specifications and test procedure for raw materials, packing
materials, in-process testing, APIs, stability testing etc.
➢ They approve an equipment calibration, qualification and maintenance schedules,
as well as qualification of HVAC, gas and power distribution system.
➢ They review and approve manufacturing records and QC testing data before any
intermediate, API or finished batch is released.
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