ONE MONTH INDUSTRIAL TRIANING REPORT
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ACME LIFE SCIENCE BADDI, SOLAN HIMACHAL
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ONE MONTH INDUSTRIAL TRIANING REPORT
CONTENTS
S.NO. NAME OF SECTION PAGE NO.
1. FORNT COVER PAGE 01
2. ACKNOWLEDGEMENT 03
3.A QUALITY ASSURANCE UNIT 4-4
3.B QUALITY CONTROL: 5-8
3.C MICROBIOLOGY LAB 8-9
3.D PRODUCTION AREA 9-12
3.E PACKING SECTION 12-13
3.F TESTING OF PACKING 13-14
MATERIAL
ACKNOWLEDGEMENT
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I Vinay Sharma take this opportunity to thank ACME LIFESCIENCE. for
the successful completion of my training. I am obliged to Unit Head
……………..for providing me this opportunity to do a really resourceful
training in the company. I thank the HR department of the company for
providing me all the facilities to carry out the training as per schedule. Iam
also grateful to all the staff members of ACME LIFESCIENCE who gave
me a sound knowledge on the various functional aspects of the company.
My special thanks to Mr. Lucky thakur and team for giving me all
necessary guidance and assistance during my training period. I also render
my special thanks to all the members of the Q&A department for giving me
a good knowledge on the various aspects of Quality. Last but not the least I
thank ………………… , production department for recommending me to do my
training in this esteemed company.
Regards
Vinay Sharma
B.Pharmacy (Perusing)
L.R College of pharmacy Solan (H.P)
3.A QUALITY ASSURANCE UNIT:
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ONE MONTH INDUSTRIAL TRIANING REPORT
Prime responsibility of maintaining quality of product during production
relied on production department. Removal of responsibility from
manufacturing for producing a quality product could result in imperfect
composition, such as ingredient missing, sub potent or sub potent mixing of
material, mistakes in packing or filling, such as product contamination,
mislabeling or deficient package and lack of conformance to product
registration. Quality person must establish control or checkpoints to monitor
the quality of the product as it is processed and upon completion of
manufacture.
Q.A along with Q.C performs raw material and component testing and
include-in process, packing, labeling, and finished product testing as well as
batch auditing and stability monitoring.
Parameters of quality analysis:
a. Specificity.
b. Sensitivity.
c. Linearity.
d. Precision
e. Accuracy.
f. Ruggedness.
g. System suitability.
3.B QUALITY CONTROL: Quality control (Q.C) was concerned with
sampling, specification and testing. Product was tested for biological activity
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& purity by physical and chemical techniques. Stability and shelf life of
product the product was also studied.
The Following were followed for successful functioning of Q.C:
1. Availability of Good facilities, trained personnel and approved
procedure for sampling, inspection and testing starting material, packing
material, intermediate, bulk and finished products.
2. Samples for Q.C were taken in approved manner.
3. Validated methods were used for testing.
4. Sufficient reference samples of the starting material and product were
retained to permit future examination of the product.
TESTING IN QUALITY LAB:
Mainly three type of testing were done:-
1. Tests for raw material.
2. Tests for chemicals.
3. Tests for finished goods.
1. Tests to be performed in finished products were :
Description.
Moisture determination.
Sulphated ash.
Total ash analysis.
Loss on drying
Water soluble extractive
Alcohol soluble extractive.
Ether soluble extractive.
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Acid insoluble ash.
Sulphated ash.
Calcium content determination.
Phosphorous determination.
Disintegration time.
Hardness of bolus.
Thickness of bolus.
Average weight for bolus.
Filled weight in capsule.
Density.
pH.
Bulk density.
Sieve analysis.
Total dissolved solid.
Total undissolved solid.
Total solid
Total sugar determination.
Estimation of volatile content.
2. Tests to be performed for chemicals were :
Identification.
Solubility.
Assay.
Refractive index
Optical rotation.
Density.
Heavy metal.
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Saponification value of oils.
Acid value of oils.
Ester value.
Instruments commonly used in quality lab were .
a. Bulk density apparatus.
b. Soxhelet apparatus.
c. Volatile oil extraction apparatus.
d. Karl fisher instrument.
e. pH instrument.
f. Vernier caliper.
g. Centrifugation machine.
h. U.V cabinet.
i. Viscometer
j. Dessicator.
k. Grinder.
l. Water bath.
m. Hot plate.
n. Polarimeter.
o. Oven.
p. Muffle furnace.
q. Disintegration tester.
r. Conductivity meter.
s. IR moisture balance.
t. Melting point apparatus.
u. Leakage test apparatus.
3. B.P.R:
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B.P.R was the abbreviated form of Batch Production Record. It
was based on master batch formula and was issued by production
department. They were subdivided into manufacturing B.P.R and
production B.P.R
Batch Production Record (BPR)
MFG BPR PACKING BPR
MFG BPR:
1. Based on MBF (Master Batch Formula).
2. Step Wise Complete Processing Mentioned in MFG BPR.
3. BOM (Bill of Material) & Cleaning & Sanitization Forms are attached
with it.
Deviation form is attached if the need arise due to non compliance of the
proper procedure. The product was approved for packing only after quality
control check
Packing BPR:
1. BOM & Cleaning & Sanitization Forms were attached with it.
2. Packing Form for Different Products was also attached with it.
Deviation form may be attached if the need arises due to non compliance of
the proper procedure. However in the case of packing B.P.R was not
generated a Dummy B.P
3.C MICROBIOLOGY LAB
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INSTRUMENTS OF A MICROBIOLOGY LAB
1. AUTOCLAVE: It was basically used for sterilization of Medias and
other laboratory glassware. It worked on the principle of moist heat
sterilization which was achieved through steam under pressure. It
worked at a temperature of 121ºC at 15 lb for 15 minutes.
2. LAMINAR AIR FLOW: Any microbiological work was carried out
under the laminar air flow chamber. As it had HEPA (High Efficiency
Particulate Air) filter which filtered the air entering the chamber and it
also had a U.V source which killed the microbes.
3. INCUBATOR: It was basically used for growth of microbes at
specific temperatures.
4. B.O.D INCUBATOR: This also performed the same function as the
incubator. But it consisted of a compressor which helped in
temperature regulation.
5. HOT AIR OVEN: It was basically used for sterilization which works
on the basis of dry heat sterilization. It worked at a temperature of 160
o
c for 1 hour.
6. MICROSCOPE: This was basically used to observe the morphology
and motility of microbes.
3.D PRODUCTION AREA
TABLET / BOLUS SECTION:
EQUIPMENTS:
a. Mass mixer
b. F.B.D (Fluid bed drier)
c. Tray drier
d. Multi mill
e. Cad mill
f. Pin mill
g. Roller mill
h. Shifter
i. Ribbon blender
j. Nauta mixer
WORKING:
a) Cleaning:
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a. There should proper cleaning of the powder manufacturing area and
the entire machine.
b. There should be no dust on the windows and exhaust fan. Floor
should be clean.
c. There should be no material of previous batch.
d. Drains, dustbin should be properly cleaned and free from previous
batch material as well as other unwanted material.
b) Calibration: Weighing machine should be daily calibrated and record
should be maintained
c) Status tags: Status tags should be properly filled and should be clear
at every stage of powder manufacturing, mixing, drying, grinding,
sieving, blending etc.
d) Drying: Drying should be done with in proper temperature limit, over
heating should be avoided to retain the proper effect of product
e) Sieving :Material should be sieved as according to B.P.R.
f) Prepared material: Material ready for packing should be properly
tagged and kept in proper condition, should be free from dust,
moisture.
CAPSULE MFG SECTION:
Product produced here are in the form of CAPSULES.
EQUIPMENTS:
a. Planetary mixer
b. Capsule filling machine
c. Wieghing balance
WORKING:
a. Cleaning:
There should proper cleaning of the powder manufacturing area and the
entire machine.There should be no dust on the windows and exhaust
fan.Floor should be clean.There should be no material of previous
batch.Drains, dustbin should be properly cleaned and free from previous
batch material as well as other unwanted material.
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b. Calibration :
Weighing machine should be daily calibrated and record should be
maintained
C. Status tags :
Status tags should be properly filled and should be clear at every stage of
gel manufacturing.
3.E PACKING SECTION
CAPSULE PACKING:
CLEANING
I. Working area should be cleaned.
II. There should be no material of previous batch.
III. Everybody have cap on their head.
IV. Every worker should have gloves in their hand.
LEAKAGE CHECK
a) Ensure proper sealing of the capsules.
b) Ensure caps of tubes.
c) Ensure proper coding on capsules .
COADING OF CARTONS
I. Take quality approval before coding.
II. Ensure clarity of coding.
STRIP PACKING:
CLEANING
I. Working area should be cleaned.
II. Door of packing hall should be closed.
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III. There should be no material of previous batch.
IV. Everybody have cap on their head.
V. Every worker should have gloves in their hand.
LEAKAGE CHECK
I. Ensure proper sealing of the strips.
COADING OF STRIPS
I. Take quality approval before coding.
II. Ensure clarity of coding.
SEALING AND CUTTING:
I. Ensure proper coding on the cartons.
II. Ensure strips are being packed correctly or not
III. Ensure proper cutting.
IV. Ensure number of bolus in strips.
DUPLEX BOARD COADING:
I. Ensure proper correct number of strips.
II. Coding of duplex board should be outwards.
COADING OF C.B. BOXAES:-
I. Take quality approval before coding.
II. Ensure clarity of coding.
GUMMING AND TAPPING:-
I. Ensure proper gumming of the C.B.boxes
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II. Ensure proper alignment of tapping.
3.F TESTING OF PACKING MATERIAL
COMMON TESTS PERFORMED WERE:
1. DIMENTIONS: This test included the length, breadth and height of
the packing materials like:
Glass bottles / plastic bottles.
BOPP tapes.
Cartons/ CFB boxes/ corrugated trays.
ROPP caps/ plastic screw caps.
Aluminium foils/ labels/ laminates/ shrink films.
Tin container.
Polybags.
2. GRAMMAGE: It was the gram per square meter of the packing
materials like:
BOPP films/ paper tapes.
Cartons/ dispenser cartons/ shrink films/ PVC films.
Self adhesive labels (Labels + Release paper)
Grammage of release paper.
Grammage of adhesive.
Labels.
Corrugated trays.
Aluminium foils with hot seal lacquer.
Heat seal lacquer.
Total Grammage of Aluminium foil + Polybags.
3. THICKNESS: This test was done for packing materials like:
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Plastic bottles.
BOPP films.
ROPP caps.
Tin container.
Laminated tubes.
Shrink films.
4. Leakage test: This test was done for pouch and blisters by applying
pressure. This determined the leakage in the product. Leakage test was
also done for container, jerry canes.
5. Moisture balance: This test was done by use of IR MOISTURE
BALANCE. This test was mainly done for CB Boxes.
6. Bursting strength: This test was done to determine the pressure that
the packing material can withstand. This test was done for CB
boxes, cartons.
7. Puncture resistant tester: This test was done to determine the force
that the packing material can withstand to resist the puncture.
This test was also done mainly for cartons, CB boxes.
8. GSM (gram square meter): This test was done by cutting the piece
of packing material and then the weight and the area of the
sample was calculated, by specific formulas.
9. Brimful capacity: It was the volume of liquid that can be filled in the
container or the jerry canes.
10. Visual defects
11. Number of ply in corrugated boxes.
12. Art work of labels
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13. Text matter.
14. Scuff test: This test was done for labels by rubbing the label to check
the spread of its varnish.
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