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Rayat & Bahra Institute of Pharmacy: By: Saurav Dadhwal B.Pharmacy 7 Sem

The document provides information about an industrial training completed at Gary Pharmaceuticals Pvt. Ltd. Gary Pharmaceuticals manufactures dermatological formulations and was established in 1990. The trainee observed production of tablets and capsules, performed quality control tests including disintegration testing and dissolution testing, and gained experience in the tablet and capsule sections including operating machinery like the tablet press and capsule filling machine. The training covered both production and quality control departments to provide exposure to pharmaceutical manufacturing processes and quality standards.

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0% found this document useful (0 votes)
67 views21 pages

Rayat & Bahra Institute of Pharmacy: By: Saurav Dadhwal B.Pharmacy 7 Sem

The document provides information about an industrial training completed at Gary Pharmaceuticals Pvt. Ltd. Gary Pharmaceuticals manufactures dermatological formulations and was established in 1990. The trainee observed production of tablets and capsules, performed quality control tests including disintegration testing and dissolution testing, and gained experience in the tablet and capsule sections including operating machinery like the tablet press and capsule filling machine. The training covered both production and quality control departments to provide exposure to pharmaceutical manufacturing processes and quality standards.

Uploaded by

nikhil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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RAYAT & BAHRA INSTITUTE OF PHARMACY

BY: SAURAV DADHWAL


B.PHARMACY
7th sem
INDUSTRIAL TRAINING

GARY PHARMACEUTICALS PVT.LTD.


COMPANY PROFILE:
GARY PHARMACEUTICALS Pvt. Ltd. was formed in 1990 essential, to
provide excellence in Dermatology pharmaceuticals formulations.

 The company was established by Mr. RAVI GREWAL who has over 20
years of rich experience in marketing of Skin Care Creams, Lotions, Soaps,
Suspensions and other Derma care products all over India. In 2004 Gary
Pharmaceuticals Pvt. Ltd. was formed to provide the pharmaceuticals
formulation manufactured at its own plant.

 A progressive and quality conscious organization is dedicated to


discovering, developing and delivering medicines for human health.

 A GMP- certified company following WHO- GMP standard to


manufacture quality range of tablets and ointments formulations.
INFRASTRUCTURE:
 Unit is highly spacious for manufacturing medical formulations.
 Unit is also fitted with temperature controller to maintain and
stabilize the temperature of the production unit as well as
medical propositions prepared.
 Manufacturing operations are carried out under the most
controlled of environments where quality is a prized ideal.
 With comprehensive systems and specialized departments for
various stages such as Production, Research & Development and
marketing, company ensure that quality is never compromised at
any stage of operations.
DEPARTMENTS:
Warehouse
Store
Production
Quality control.
Products manufactured :

 Benzo lotion
 Crotin cream
 Imec- M/H tablet
 Locan -150 tablet
 Moist cream
 Zepan D tablet
 Zeloc D capsule
 Selofer capsule
 Candirid powder
Duties assigned:
PRODUCTION
 To go through the manufacturing of tablets and capsules.
 To observe and perform ‘in process quality control’ procedures for
tablet.
 To record the quantity of PVC foils used in packaging of tablets and
capsules.

QUALITY CONTROL / MICROBIOLOGICAL DEPARTMENT:


 To observe the disintegration time of enteric coated tablet by
disintegration apparatus.
 To record the disintegration time for uncoated tablet.
 To perform the dissolution test on LOCAN- tablet
TABLET SECTION:
Equipments:
MASS MIXER: Mass mixer are special SIFTER: sifter is used to sieve dry
pharmaceutical machinery used for raw material in powder form before
thorough mixing of wet as well as dry it is fed to rapid mixer. It is suitable
lump material, especially suited for for separation of foreign objects
tablet granulation.
from dry powder before drying.
It is basically mixing an assembly
 
wherein the mixing stirrer is in
horizontal position in the container SPECIAL FEATURES
and has a single speed, simple rotation. Portable and compact.
The stirrer rotates around itself at a low
Lower energy consumption.
speed inside the bowl and thereby
Explosion proof.
achieving intimate mixing of dry or wet
materials of tablet granulation, powder. Flame proof
Mass mixer can mix the sticky material Wide range of screen sizes 4-300
and also uniformly and intimately mix mesh.
the materials which are difficult to mix.
Dryers:
TRAY DRYER: It is an enclosed VACUUM DRYER: It is used

insulated chamber in which mainly for drying of high grades,


trays are placed on top of each temperature and oxygen sensitive
products. It is highly suitable for
other in trolleys. A highly drying hygroscopic substances,
effective recirculating air which are dried to very low
system is provided. The residual moisture content level. It
heated air is recirculated with is commonly used batch dryer.
fresh air in selected They are box shaped and loaded
proportions for optimum and unloaded via a door. Inside are
drying. A control panel to several heating plates mounted
one above the other on which the
control the temperature and products are placed in trays.
other parameters is fixed Heating temperature is normally
outside the dryer. in the range between 8o0C to 110oC.
 MULTI MILL: It operates on the  TABLET COMPRESSOR: It is a

principle of variable force swing, mechanical device that


beaters having both knife and compresses powder into tablets
impact edges rotating within a of uniform size and weight. To
selected screen to get the form a tablet the granulated
required size reduction. material must be metered into a
 Special features
cavity formed by two punches
and a die, and then the punches
 Machine rated for continuous
must be pressed together with
operation. great force to fuse the material
 Higher output with process together.
uniformity.
Coating & packaging:
BLISTER PACKAGING MACHINE: these are used

Tablet coating machine is for packing tablets.


The packing process starts with tablets being loaded

used for sugar and film into a hopper and then into a feeder, which in turn
can either be linear feeder depending on the shape
coating of tablets, pellets of the product and also the material to be used.
Heated rollers in the machine use different plastic
and granules etc. films to form blisters that are filled with tablets. It
also uses aluminum foil to form blisters. After
COATING PAN: the tablets have been inserted in the formed blisters,
cavities are heat sealed using foil.
standard pan is elliptical  Blister sealing machines are used to seal filled
plastic blister to a piece of coated carton board, by
in shape. Hot air blower heat. The blister is kept in the sealing die which has
the same shape as that of the cavity. The cavities are
thermostat controlled, to then filled and sealed by a foil using heat.
BLISTER TRIMMING MACHINES: These are used
deliver required quantity for cutting, trimming the sealed blister or formed
blister packs in individual pieces or bunch.
of air at selected
temperature.
IN PROCESS QUALITY CONTROL
 WEIGHT VARIATION: Weight variation test is performed to check that the
manufactured tablets have n uniform weight. For a tablet to pass a test, the
average weight and percentage difference should lie in percentage limit.
 
 According to IP;
Average weight of tablets (mg) maximum percentage
difference

80 or less 10%
80 – 250 7.5%
More than 250 5%
 According to USP;

Average weight of tablets maximum percentage

Difference
130 or less 10%
130 – 324 7.5%
More than 324 5%
 Friability: Tablets must be able to withstand mechanical stresses
during their manufacturing, distribution and handling by the end
users. Friability is a measure of the resistance of the tablets to
shipping and abrasion drum. After tumbling, the integrity of the
tablets and the weight loss are evaluated. Friability should be less
than 1%
 Friability= final weight – initial weight/ initial weight X 100..
 This test is a method to determine physical strength of uncoated
tablets upon exposure to mechanical shock and attrition.
 DISINTEGERATION: An orally administered drug must disintegrate
to attain good absorption of its active substance. The first step
towards dissolution is usually the break- up of the tablets; a
process described as disintegration. It results in a time necessary to
disintegrate a group of tablets into small particles under standard
conditions. The disintegration test is a valuable tool in quality
control environments.
CAPSULE SECTION:
CAPSULE FILLING MACHINE:
HAND OPERATED: Following are the parts of capsule
filling machine:
• Bed with 200-300 holes
• Capsule loading shell
• Powder tray
• Pin plates having 200-300 pins corresponding to the no. of holes in the bed and capsule loading
tray.
• Lever
• Handle
 Working: a base contains holes or cavities for holding capsules. There is a plate over the base plate

which holds the capsules. There is a locking plate in the base which locks the weight of capsule so that
they may not move out. With the help of spreader the medicament to be filled is spreaded over base
plate. There are thimbles over the base plate and gives pressure to the powdered drug so that powder
remain a little below the top.
5000 capsules were filled per hour with 200 hole machine.
CLOTH POLISHING: the filled capsules are rubbed with a cloth. This is a hand operated
procedure.
Quality control:
 pH meter
 Melting point apparatus
 Oven
 Electrical balance
 Friability apparatus
 Disintegration apparatus
 Dissolution apparatus
 Analytical balance
 Electromagnetic stirrer
 Sonicator
 Water bath rectangular
 Heating mantle
 Dissolution apparatus: A paddle type dissolution apparatus is
used to test the dissolution of LOCAN- tablet. Description of
dissolution test in USP monograph specifies the test medium and
volume, which apparatus to be used, the speed (rpm) at which the
test is to be performed, the time limit of the test and the assay
procedure.

 Dissolution test for LOCAN- tablet: 900 ml water in 0.1N HCl is


selected as a medium. Time interval is set up at 45 minutes and
speed is adjusted at 50rpm. The tablets are placed in the medium
and temperature of the medium is set up at 27.20 C and water bath
is maintained at temperature 36.10C. After 45 minutes sample from
the vessel is taken and assay is performed to determine the
amount of drug in solution.
 DISINTEGRATION APPARATUS: This device uses 6 glass tubes
that are 3 inch long open at the top and held against a 10- mesh
screen at the bottom end. To test the disintegration time, one tablet
is placed in each tube and the basket is placed in o.1N HCl and
water solution, at 36-37oC. A standard motor driven device is used
to move the assembly containing the capsules up and down.
Perforated plastic disc are placed on top of the tablet to impart
abrasive action to the tablets.
  Tablets type Disintegration time
Uncoated tablet 15 minutes
Film coated tablet 30 minutes
Sugar coated tablet 1 hour
Enteric coated tablet 2 hours
CONCLUSION:
 Granulation process for tablets is learned. Manufacturing of tablets
involving the processes like:
 Sieving, mass mixing for 2 hours, and pasting i.e. aqueous and non
aqueous, granulation, drying at 50oC, lubrication, compression. In
process quality control methods:
 Weight variation, disintegration time, friability, hardness are
learned.
THANK YOU

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