RAYAT & BAHRA INSTITUTE OF PHARMACY

Rishab Mehta
1339557
B.Pharmacy
7th Semester
INDUSTRIAL TRAINING
 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
 Clobedem G cream
 Trioxaslen tablet
 Locan -150 tablet
 Dermofade cream
 Alerta D tablet
 Candirid powder
 Xecam 180 tablet
 Oramin SR tablet
 Bioglow Forte
 Azoly 250 Tablet
 Duties assigned:
PRODUCTION

 To go through the manufacturing of tablets.

 To observe and perform ‘in process quality control’ procedures for

tablet.

 To learn the procedure of manufacturing of Creams, ointment and

Lotions.

 To check the packaging and labelling procedure of creams,

powders, tablets and lotions.

 To observe the labelling requirement of raw material being under

test or being approved.

 To understand the procedure of coating of tablets

Quality Control Department
To observe the disintegration time of enteric coated tablet (Pancure 40) by
disintegration apparatus.

To record the disintegration time for uncoated tablet and dispersible
tablets.

To perform the dissolution test on Oramin SR tablet

To perform Assay of Paracetamol Tablet using UV spectrophotometer

To perform Moisture test for Xecam 180 Tablet using IR Apparatus

To quality control test for Bentonite to be used as raw material in

production.

To perform Assay of Ofloxacin 200 Tablet

To check Refractive Index of Propylene Glycol.

To check Friability of Tablet.

TABLET SECTION
Tablet Manufacturing
Process
 Equipments
• MASS MIXER: Mass mixer are special pharmaceutical
machinery used for thorough mixing of wet as well as dry
lump material, especially suited for tablet granulation.
• It is basically mixing an assembly wherein the mixing stirrer
is in horizontal position in the container and has a single
speed, simple rotation.
The stirrer
•• SIFTER: sifter isrotates around
used to sieve dry rawitself atinapowder
material low speed inside
form before the
it is fed to rapid
mixer.
bowlIt and
is suitable for separation
thereby of foreign
achieving objects from
intimate dry powder
mixing of drybefore
or drying.
wet
•  
materials
• SPECIAL of tablet granulation, powder.
FEATURES
Mass and
•• Portable mixer can mix the sticky material and also uniformly
compact.
and energy
• Lower intimately mix the materials which are difficult to mix.
consumption.
• Explosion proof.
• Flame proof
• Wide range of screen sizes 4-300 mesh.
 Dryer
•TRAY DRYER: It is an enclosed
insulated chamber in which trays
are placed on top of each other in
trolleys. A highly effective
recirculating air system is provided.
The heated air is recirculated with
fresh air in selected proportions for
optimum drying. A control panel to
control the temperature and other
parameters is fixed outside the
dryer.
• TABLET COMPRESSOR: It is a
mechanical device that compresses
powder into tablets of uniform size and
weight. To form a tablet the granulated
material must be metered into a cavity
formed by two punches and a die, and
then the punches must be pressed
together with great force to fuse the
material together.
 Coating & packaging:
Tablet coating machine is used for sugar and film
coating of tablets, pellets and granules etc.
• COATING PAN: the standard pan is elliptical in
shape. Hot air blower thermostat controlled, to
deliver required quantity of air at selected
temperature.
BLISTER PACKAGING MACHINE:
• these are used for packing tablets.
• The packing process starts with tablets being loaded into a
hopper and then into a feeder, which in turn can either be
linear feeder depending on the shape of the product and also
the material to be used.
• Heated rollers in the machine use different plastic films to form
blisters that are filled with tablets. It also uses aluminum foil to
form blisters. After tablets have been inserted in the formed
blisters, cavities are heat sealed using foil.
• Blister sealing machines are used to seal filled plastic blister to
a piece of coated carton board, by heat. The blister is kept in
the sealing die which has the same shape as that of the cavity.
The cavities are then filled and sealed by a foil using heat.
.
 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.

 Acc to IP:
Average weight of maximum percentage
tablets (mg) 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%
CREAMS and Ointments

Production of Pharmaceutical Creams and Ointments

Pharmaceutical preparations for treatment of conditions such as

rashes, skin irritation, stings, fungal infections etc. are normally supplied
in the form of a cream or ointment as this provides an effective means of
delivering the active ingredient directly to the required area.

Products can be either a water in oil (w/o) or oil in water (o/w)

emulsion, consisting of waxes, emollients and lubricants dispersed in an
oil phase, and a water phase containing emulsifying, stabilizing and
thickening agents, preservatives and in some cases, colorant.

Active ingredients are dispersed in either phase or added when the

emulsion has been formed and allowed to cool.
Manufacturing Process
Ingredients, formulation and product viscosity differ widely, however, a
typical manufacturing process breaks down into four individual
operations:
• Preparation of the oil phase. Flake/powder ingredients, sometimes
dry blended in advance, are dispersed into mineral oil or silicone oil.
Heating may be required to melt some ingredients.

• Hydration of aqueous phase ingredients. Emulsifiers, thickeners and

stabilizers are dispersed into water in a separate vessel. Heating may be
required to accelerate hydration.

• Forming the Emulsion. The two phases are blended under vigorous
agitation to form the emulsion.

• Dispersion of the Active Ingredient. The active ingredient often

makes up only a small proportion of the formulation; this must be
efficiently dispersed to maximize yield and product effectiveness.
 CREAM, OINTMENT
AND LOTION MANUFACTURING
EQUIPMENTS
 Quality control:
• pH meter
• Melting point apparatus
• Oven
• Electrical balance
• Friability apparatus
• Disintegration apparatus
• Dissolution apparatus
• Digital balance
• Electromagnetic stirrer
• Sonicator
• Water bath rectangular
• Heating mantle
• Muffle Furnace
• UV Spectrophotometer
• HPLC
• Dissolution apparatus:
• A paddle type dissolution apparatus is used to test the dissolution of
Gravid 200 - 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 Gravid - 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.
Dissolution apparatus
• 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.
• 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
Tablets 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

A look back…
A look back…
 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 50 oC,
lubrication, compression were observed.
• Manufacturing procedure of creams, ointments and lotions were
learned along with their packaging and labeling procedures.
• In process quality control methods: Weight variation, disintegration
time, friability, hardness were learned.
• Procedure for use of Disintegration apparatus, U.V. spectrophotometer,
and HPLC equipment were observed
• Sampling and testing of raw material were learned
• Overall the 40 day industrial training at Gary Pharmaceuticals,
Ludhiana. Help us to understand arious aspects of pharmaceutical
industry and give us appropriate exposure to the industrial applicability
of our field.