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Report On Industrial Visit

The document is a report on an industrial training conducted by a pharmacy student at AIMEX PHARMA in Tirupati, India. The key points are: 1. The student spent 1 month training in various departments including quality control, microbiology, production, and packaging. 2. Quality control tests raw materials and finished products to ensure safety and efficacy. Microbiology monitors the environment and ensures sterility. 3. The student observed operations in quality testing labs using instruments like HPLC, GC, and UV-Vis spectroscopy and learned GMP compliance practices.

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0% found this document useful (0 votes)
263 views25 pages

Report On Industrial Visit

The document is a report on an industrial training conducted by a pharmacy student at AIMEX PHARMA in Tirupati, India. The key points are: 1. The student spent 1 month training in various departments including quality control, microbiology, production, and packaging. 2. Quality control tests raw materials and finished products to ensure safety and efficacy. Microbiology monitors the environment and ensures sterility. 3. The student observed operations in quality testing labs using instruments like HPLC, GC, and UV-Vis spectroscopy and learned GMP compliance practices.

Uploaded by

Loki MrPerfect
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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REPORT ON

INDUSTRIAL TRAINING
Gokula krishna
college Of pharmacy
Name : Mailapuri Mohan Mouli
Roll.no : 19Z71R0042
Course : B. Pharmacy
Academic year : 2019-2023
Topic : Report on industrial visit
Guiding faculty : Mr. saikiran
Mr. suman
Date of visit : 10.8.2022
Duration : 1 month
Aim of industrial visit:
The purpose of industrial training is to
expose students to real work of environment
experience and at the same time, to gain the
knowledge through hands on observation and
job execution. From the industrial training,
The students will also develop skills in work
ethics, communication, management and others.
Name of the industry: AIMEX PHARMA,Tirupati
ABOUT AIMEX PHARMA COMPANY:

AIMEX PHARMA is a private company


and it is classified as non govt company and
is registered at registrar of companies
located in Tirupati, A.P.
INDUSTRIAL TRAINING:
DEPARTMENTS INVOLVED IN INDUSTRIAL:
1. Quality control department
2. Microbiology department
3. Quality assurance department
4. Production department Quality
5. Storage and ware house department
6. API division department
7. Documentation department
8. Packaging department
1.QUALITY CONTROL DEPARTMENT:
Quality control, or QC for short,
Is a process by which entities review the quality
of all factors involved in production. ISO 9000
defines quality control as “ A part of quality
management focused on fulfilling Quality
requirements”.
Quality policy:
1. To gain customers satisfaction through
manufacturing and providing high quality
pharmaceutical products.
2. To achieve sustained growth in market share
by developing satisfied customers. 3.To pursue
total quality management.

• In quality control department every step is


followed on the basis of SOP.
FLOW CHART OF QUALITY CONTROL:
Raw material inspection

Raw material

Receipt

Verification

Sampling

Under test

Quality control testing
• If qc test is passes it is approved
for manufacturing.
• If qc test is fail then it is return or
supplier/ destruction.
Pharma industries do the following test in
qc department:
1. breakage test
2.lekage test
3.watter attack test
4.visible test

Quality control instruments in pharma lab:
In the pharma industry number of
instruments are used to produce, Analyze,
And pack the drug product.
The quality control lab equipment list and
instruments used in the qc department
are: 1.HPLC
2. gas chromatography
3.Uv visible spectroscopy
4.infrared spectroscopy
5.karl Fischer
6.PH
7. potentiometer
8.polarimeter
9.TLC
10.refractometer
11.friabliator
12.weighing machines
13.vernier callipers

Fig..2. quality control department


These are the most common
instruments used in the quality control
department that helps to generate data related to
the drug product, on the basis of generated data
we could able to say pass or fail or not meeting the
acceptance criteria of the drug product.

HPLC: HPLC is a widely used, high accuracy,


high performance technique to analyze the
drug product. HPLC is used for detection of
percent drug products present in the
unknown samples.
This technique is a quantitative type of
technique where the present amount of
drugs can find out from drug products

Fig..3. HPLC

HPLC is a separation technique of the


components of mixture by using solid stationary
phase and liquid mobile phase.
GAS CHROMATOGRAPHY:
Gas chromatography is used to
carry the sample to be analyzed. Gc is a
separation technique is based on the
principle of adsorption of gases or vapours of
a liquid by an adsorbent.
• UV VISIBLE SPECTROSCOPY:
In UV visible spectroscopy can be analyzed
quantitative analysis as well as qualitative
analysis.
When a beam of monochromatic light is
passes through the homogenous absorbing
medium, the rate of decrease intensity of light
is directly proportional to the concentration and
path length of the cell.
• IR SPECTROSCOPY:

It is a technique used to determine the


functional group of compound. It is a qualitative
analysis. The infrared spectroscopy is vibrational
energy level changes when IR radiation passes
through the material.

KF:
It is a technique to identify the water content
of or moisture present in the drug product.
• PH:
The hydrogen ion present in the solution.

Fig ..4.PH
PH is to measure the electromotive force
generated by the system of two electrodes, an
indicator electrode whose potential depends on
the concentration of hydrogen ion
reference electrode with known potential.
• POTENTIOMETER:
It is a titrimetric method of
determination of percent drug availability. It is
a quantitative type of technique to know the
percent of drug availability.
Potential difference across any two
points of the wire is directly proportional to
the length of the wire.
• POLARIMETER:
It is used to detect the optically
active property of the drug product
Polarimeter measures the rotation polarized
light as it passes through on optically active fluid
• TLC:
It is also a well known technique or the
separation of solute from the solvents through
the migration process.it is a qualitative analysis.
• REFRACTOMETER:
It is a refraction technique to measure the
angle of rotation.
It is a refraction based on the speed of light
that passes in the different mediums.
2.MICROBIOLOGY DEPARTMENT:
The role of microbiology is to investigative
the growth and characteristics of microscopic
organisms such as bacteria, algae, fungi.
The role of the microbiology is to ensure the
quality of raw materials before they are
processed in the production area, monitor
the microbiological quality of environment
and water, validate the test methods.
 MEDIA PREPERATION & INSTRUMENT
ROOM:
Assemble all chemicals in work area
before beginning.
Accurately weight the media base
calculated powder by electronic
balance. Add the powder into flask.
Add distilled water to the flask, for
making the correct volume.
Heat & stir until all the ingredients go
into solution when the media boils, it is
ready for sterilisation.
For sterilization autoclave should be
used, flask top should be covered by
aluminium foil to prevent contamination.
 STERILISATION ROOM:
A sterile object contains no
viable microorganisms.
sterile conditions are require to maintain -
complete removal of microorganisms -kills
bacteria as well as their pores. Very strict
protocols to follow, mainly used in
industrials application.
ISOPROPYL ALCOHOL(70%) is most
commonly used disinfectant in
pharmaceutical industries. The important
thing is that only 70% solution of
isopropyl alcohol acts as a disinfectant
killing all surface microorganisms. It is
used to disinfect hands and equipment
surface in pharmaceuticals.
 INCUBATION ROOM:

 The incubator maintains optimal


temperature, humidity and other conditions
such as the co2 and oxygen content of the
atmosphere inside. It is a device and is used
to grow and maintain microbiological
cultures or cell cultures.
 INOCULATION ROOM:

Inoculation is the process of


introducing microorganism or suspension of
microorganism into a culture medium. It helps to
isolate the microbe.

• Lab equipment and instrument used in the


microbiology department:
1.Laminar air flow
2.Autoclave
3.Bod incubator
[ Biological oxygen
demand ] 4.hot air oven
1. laminar air flow :
It is an enclosed bench designed to
maintain a working area devoid of contaminants.
Laminar air flow can provide the best solution.
It is used for aseptic transfer of microbial culture.

Fig..6. laminar air flow


2. Autoclave:
An autoclave is a machine that uses steam
under pressure to kill harmful bacteria , viruses ,
Fungi, and spores on items that are placed
inside A pressure vessel.
3. BOD INCUBATOR:

Bod are used to maintain temperature for


test tissue culture growth, storage of bacterial
culture and incubation where high degree of
constant temperature accuracy is required
Fi..7.Incubator
Fig..8 BOD
incubator 4. Hot air oven:
Hot air ovens are electrical devices
which use dry heat to sterilize.
It is used to sterilize the product in a
particular period of time. Under specific
conditions like humidity, pressure and
other environmental factors.
Hot air ovens need to sterilize the
materials with in the limits of 160◦c, 150◦
for 60 minutes.
The materials sterilized in hot air oven are as
follows: glass wares - (syringe, test tube,
petri dishes, flask) surgical instrument.
3.packing department:
Packing is the technology of
enclosing or protecting products for
distribution, storage, sale, and use. It also
refers to the process of designing,
evaluating and producing packages.
Usually three types of packing take place
in Primary packing
Secondary packing
Tertiary packing
fig..9. types of packing

PRIMARY PACKING :
It is first layer of packing. It protects
and preserves the finished products. For
example : bottles, vials, blisters,
closures, ampoules, pre filled syringes.
Primary packing is in direct contact with
the product.
SECONDARY PACKING:
Secondary packing appears outside of
the primary packing. It gives extra
protection to the products. It do not
make direct contact with the product. Eg:
wrappers, labels, cartons, injection trays.
TERTIARY PACKING:
System is used for bulk handling
& shipping.
Eg: barrel, container, edge protectors.
• PHARMA INDUSTRIES* DO PACKING TESTS
WHICH INCLUDES THE FOLLONG TESTS:
1.Drop Test
2.Vibration Test
3.Shock Test
4.Inclined impact Test 5. Revolving Drum Test.
Pharma industries use the following
material for packing the products plastic,
glass, rubbers, metals.
• Art work: Pharmaceutical art work is a printing
matter which placed on pharmaceutical
products packing material as label,
carton, leaflet etc.,
DESIGN PART: Design part of art work designed as
per marketing requirement & is managements
deal.
PRINTING TEST MATTER: Printing test contains
compositions, dosage, manufacturing firms
address, batch no, mfg. date, MRP, pack size and
whatever required by drug & cosmetic act
including any
regulatory
rules like
precautions
schedule m
drugs etc..

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