Training Report | Sky biotech Life Sciences Pvt.Ltd.

ACKNOWLEDGEMENT

I consider it great privilege and honour to have had the opportunity to

undergo the INDUSTRIAL TRANING work in SKY BIOTECH LIFE
SCIENCES PVT. LTD. was great chance for learning and professional. I
consider myself as very lucky individual as I provided as an opportunity to
be a part of it. I am also grateful for having a chance to meet so many
wonderful people and professionals who led me through this internship period.

I convey my heartiest thanks to Mr. Dhawal Ghandi and Dr. Shivaji

R. Aher (Director-Technical). And also Production manager , QA & QC
Manager, Maintenance Manager etc. for their most valuable suggestion,
constant encouragement ,and affectionate guidance during the period.

I express my deepest thanks to Dr. Sohan Chitalange, Principle of Dr.

D.Y. Patil, IPSR, Pimpri . for giving necessary advice and guidance and
arranged all facilities to make learning easier.

I express my deepest sense of gratitude to Mr. Ritesh Bhole and Mr.

Devendra Visokar .

I perceive as this opportunity as a big milestone in my career development.

I will strive to use gained skill and knowledge in the best possible way, I will
continue to work on their improvement, in order to attain desires career
objectives. Hope to continue cooperation with all of you in the future.

Sincerely,

Kaveri Aher.

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 Training Report | Sky biotech Life Sciences Pvt.Ltd.

PREFACE

Pharmacy is the Art and Science of preparing and dispensing drug. It

is the health profession that links health sciences with chemical sciences and
aims to ensure the safe and effective use of pharmaceutical drugs. So it is fully
technical profession where practical knowledge is much more important along
with theoretical knowledge.

According to curriculum of a four year integrated degree course of

BACHELOR OF PHARMACY each student has to undergo practical training
for a periods of one month in various pharmaceutical industries in India. I
was directed to undergo my industrial training at SKY BIOTECH LIFE
SCIENCES PVT. LTD.,AURANGABAD and this report contains a brief
description of the above pharmaceutical industry which was observed
during the training program.

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INFORMATION ABOUT INDUSTRY

Address : Gut No. 5, Georai Tanda, Paithan Road

,Aurangabad,
Maharashtra 431001
Closed : Opens 9am -6pm, Friday closed.
Contact Name : Dr. Shivaji R. Aher.
Mobile No. : 9767886654
Email Us : aher.sr@gmail.com

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INDEX

Sr CONTENT Page no.

No.
1. Production Section 5 to 11
- General Instruction and Precaution
- Granulation
- Compression
- Coating
- Packaging and labeling
- Encapsulation

2. Quality Control and Quality assurance. 12 to 14

3. Microbiology section. 15 to 16
4. Engineering section. 17
5. Raw Material and Finished Good Section. 18
6. Summary 19

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PRODUCTION SECTION

GENERAL INSTRUCTIONS AND PRECAUSIONS

 Ensure area and equipment cleanliness before starting the manufacturing

operations.
 Check and ensure that all manufacturing equipment and other required
accessories are clean ready for use.
 Wear gloves and nose mask during all manufacturing process.
 Counter check the weights of all ingredients before using in the batch
 Get line clearance from QA for manufacturing.
 Air handling unit (AHU) system should be kept ON throughout the
manufacturing process.
 Temperature should be kept between 25ºC ±2ºC and relative humidity
should be kept between 50±10%.
 Ensure that only QC approval purified water is being used for
manufacturing purpose
 Always transfer solution to the manufacturing vessels through 20 meshes.
 During the preparation of this product, no other product processing
should be done in the same area.
 Whenever sifting through SS mesh is involved; check the mesh integrity
before and after use.
 All critical aspects during manufacturing like temperature, duration of
mixing, weight, etc. must be checked and recorded by the supervisor.
 Supervisor to ensure completion of all in-process records during various
stages of manufacturing operations till completion of the batch.
 Release from QA should be taken from all in-process tests mentioned in
batch manufacturing record
 No over writing is allowed in batch manufacturing record. If initial data is
wrong entered, cancel the data by single stroke arrow and put initials.
Record reasons for change as foot-note on the same page.
 All the details whatever is necessary should be recorded in batch
manufacturing record (BMR).

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 Send a test request form to QC after manufacturing is completed

 Check all polyethylene bags before and after material loading for black
particles and sealing. Check calibration of respective equipment/machine
before use.

Tablet component and Additives

Active Ingredients:

Aceclofenac,olmesartan, montelukast, loperamide, paracetamol,

chlozoxazole, seratiopeptidase, sesquihydrate AF, domperidone,
pantoprazole, ranitidne, amiodorone, fexofenadine, amikacin,
dexamethasone, ciprofloxacin, fluconazole, vitamin B 3 granule etc.

Non-active Ingredients :

 Diluents: starch, lactose, mannitol, sorbitol

 Binders: acacia, gelatin, Tragacanth, Calcium lactate trihydrate granular
N.F, Starch paste, polyvinyl pyrollidone, sodium alginate
 Lubricant: Stearic acid, Magnesium stearate, Calcium stearate and Talk
 Disintegrates: Starches and most common disintegrants
 Colous: D&C and FD&C Dyes and lacquers

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GRANULATION

Departments

 Line A : for tablets preparation

 Line B : for tablets preparation
 Line C : for tablets preparation

There are three methods of preparing Tablets. These are:

 Wet granulation
 Dry granulation (also called slugging)
 Direct compression

Each of these methods has its advantages and disadvantages. The first two
step of milling and mixing of the formulation are identical, but thereafter the
processes differ, Each individual operations of the process is known as unit
operation.

Step in different methods of manufacture WET

GRANULATION

 Mixing of drugs and excipients

 Mixing of milled powder
 Preperation of Binder solution
 Mixing of binder solution with powder mixture to form wet mass
 Coarse Screening of wet mass using 6-12 mesh
 Drying moist granules
 Screening dry granules with lubricant and disintegrants
 Mixing screened granules with lubricant and disintegrants

Tablet compression DRY GRANULATION

 Milling of drugs and excipients

 Mixing of milled powders
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 Compression into large, hard tablets called slugs

 Screening of slugs
 Mixing with lubricants and disintegrating agents

Tablet compression DIRECT COMPRESSION

 Milling of drugs and excipients

 Mixing of ingredients
 Tablet compression

Equipments

 Rapid Mixing Granulator (RMG)

 Steam Kettle
 Fluid Bed Dryer (FBD)
 Vibro Sifter with Loader
 Tippler and Co-Mill
 Rimek Communiting Mill
 Conta Blender
 Compressor

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COMPRESSION:

This step involves consistent flow of an adequately lubricated, uniform

blend, into dies where the granules are being compressed into tablets.
Compression is to be carried out as per batch manufacturing record. Collect
the samples at various stages i.e. at start up, high RPM, low RPM, low weight
at target speed, high weight at target speed, initial, middle and end of
compression and carry out the testing of content uniformity and physical
parameters such as hardness, thickness, friability etc.In compression stage
three batches i.e. Batch No I, II and III shall be considered for validation.
Compression results of all the batches are well within the acceptance criteria
results of the compression at different speed, low weight at target speed, high
weight at target speed, initial, middle and end of the compression.

Compressor
For increase production, rotary machine offers a great advantage. A
head carrying a number of sets of punches and dies revolves continuously
while tablet granulation runs from the hopper,through a feed frame and into
the dies placed in a large, steel plate revolving under it. This method
promotes a uniform fill of the die and therefore an accurate weight for the
tablet. Compression takes place as the upper and lower punches passes
between a pair of rollers. This action produce a squeezing effect on the
material in the die cavity from the top and bottom and so gives a chance for
the entrapped air to escape. The lower punch lifts up and ejects tablet. The
punches and dies can be removed for inspection, cleaning and inserting
different sets to produce a great variety of shapes and sizes.

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COATING

Types of coating include:

 Sugar coating
 Film coating
 Modified coating

EQUIPMENT:
 GANSONS

PACKAGING AND LABELLING

Packing is the technology of enclosing or protecting product for

distribution, storage, sale, and use. Packaging is also refers to the process of
designing, evaluating, and producing packages. Packaging can be described
as a coordinated system of preparing goods for transport, warehousing,
logistics, sale, and end use. It is sometimes convenient to categorize
packages by layer or functions.

 Primary Packaging
 Secondary Packaging
 Tertiary Packaging

TYPES OF PACKAGING :
 Blister Packing
 Strip Packin
 Bulk Packing

PACKING MACHINERIES ;

 Accumulating and collating machine

 Blister packs, skin packs and vacuum packing machines
 Converting machine
 Filling machine
 Coding, printing, marking, stamping and imprinting machine
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 Package filling and closing machine

 Packing sealing machine

Label dispenser: Domino printer

Weighing machine: check weigher
Wrapping machine
Carton machine Other specialty machinery: Slitters, perforating, laser
cutters, parts attachment, etc.

ENCAPSULATION

Encapsulation is the process of manufacture of capsules. Capsules are

solid dosage forms in which the drug substance is enclosed in either hard or
soft, soluble form of gelatin.

TYPES OF CAPSULES:
 Hard gelatin capsule
 Soft gelatin capsule

Filling of hard gelatin capsules:

a) Removal of caps
b) Filling of the bodies,
c) Replacement of caps, and
d) Ejection of filled capsules

Capsules equipment seen

 Medicament preparation vessel
 Gelatin preparation vessel
 Colloidal mill
 Water storage tank
 Gelatin holding tank
 Encapsulation machine
 Tumbler dryer
 SS trolley
 Auto sorting machine
 Weighing balance
 Bottle filling/ capsule sealing machine

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QUALITY CONTROL AND QUALITY ASSUARANCE SECTION

Quality control is the part of GMP concerned with sampling,

specification and testing and with organization; documentation and release
procedures which ensure that necessary and relevant tests are carried out and
that materials are not released for sale or supply, until their quality has been
judged satisfactory.

Quality Control (QC) laboratory ensures that the products are pure, safe
and effective and are released only after thorough analysis as per stringent
specifications, methods and procedures developed according to international
guidelines viz. EU cGMP, MHRA, WHO, TGA, etc. One of the most
important elements in QC laboratory programme is the quality and assurance
of the standard, which are used. The standard can be broadly defined into
two categories

 Reference standard or primary standard

 Working standard or secondary standard

The working standard are those obtained from reliable source and whose
purity and strength have been optimized through test, generally compared
with the reference standard. The quality control section performs different
control measure and test
procedure to verify the product and material quality.

The tests are performed by the QC personnel and the results are matched
with a reference standard. Quality control is an essential operation of the
pharmaceutical industry.

Drugs must be marketed as safe and therapeutically active formulations

whose performance is consistent and predictable. New and better medicinal
agents are being produced at an accelerated rate. At the same time more
exacting and sophisticated analytical methods are being developed for their
evaluation
Different types of test are performed for different material.

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The types of test performed for each material are as follows-

1.Testing Purified water

2.Assay of different tablet
3. Disintegration Test
4. Dissolution Test
5. In Process Quality Control
6.HPLC
High Pressure Liquid Chromatography
7.Testing Uniformity of Weight of Tablets

EVALUATION

 SIZE AND SHAPE: - Thickness: ±5% of standard value control to

facilitate packaging. shaped tablet requires slotted punches because of the
non-uniformity force during compression
 ORGANOLEPTIC PROPERTY: -Color of product must be uniform.
Non uniformity of color on the tablet is called Mottling.

Instrument used to measure color uniformity and quantitative measurement

includes

 Reflectance spectrophotometer
 Micro reflectance photometer
 Tristimulus Collimating

HARDNESS AND FRIABILITY:-

Both for tablet strength testing. Force required to break a tablet in a
diametric compression test is called hardness, also called tablet crushing
strength. Friability is the resistance shown by the tablet during packing and
transshipment.

Friability tester:

Roche friabilator
Revolution at 25 rpm for 4 minutes (100 rev.)
Dropping from 6 inches
%Friability = (Initial weight- Final weight)/ Initial weight × 100

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WEIGHT VARIATION:-
20 tablets are weighted Meet USP test: Not more than 2 tablets are outside of
limit if no tablet differ more than 2 times the percentage limit. IP % USP Less
than 85mg ±10% Weighing 130mg or less 85mg-250mg ±7.5% Weighing
130-324mg Greater than 250mg ±5% Weighing 324mg or more

DISINTEGRATION
 6 test tube and 3 inch long
 10 mesh screen
 1L beaker of water (0.1N HCL) simulated gastric fluid or simulated
intestinal fluid
 Temperature 37±2ºC
 Up and Down from 5-6 cm
 Frequency 28-32 cycle/mi Tablet should remain 2.5cm below the surface
of liquid on their upward movement and same for downward movement.
The potency of tablet is expressed in mg ,g, µg. Official range is not less
than 95%. Majority of tablets has their disintegration time of 30 min.

Instruments and Devices seen in QA/QC

1. Hot Air Oven.
2. Dissolution Test Apparatus.
3. Vacuum Oven.
4. Bulk Density Apparatus.
5. Membrane Filter.
6. Conductivity meter
7. Halogen moisture balance
8. Gas chromatograph
9. Melting point detector
10.Viscometer
11.Muffle Furnace.
12.Centrifuge.
13.Magnetic Stirrer.
14.Ultrasonic Bath.
15.UV Cabinet.
16.Bursting Strength Test Apparatus.
17.UV-VIS Spectrophotometer. (Ultra Violet Visible)
18.FT-IR Spectrophotometer.(Fourier Transform Infrared).
19.Karl Fisher Titration.
20.HPLC system
21.Polarimeter
22.Digital pH meter

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MICROBIOLOGY SECTION

The Guide to the Inspection of Pharmaceutical Quality Control

Laboratories provided very limited guidance on the matter of inspection of
microbiological laboratories. While that guide addresses many of the issues
associated with the chemical aspect of laboratory analysis of
pharmaceuticals, this document will serve as a guide to the inspection of
the microbiology analytical process. As with any laboratory inspection, it is
recommended that an analyst (microbiologist) who is familiar with the tests
being inspected participate in these inspections.

Following processes are carried out in microbiology laboratory:

Sterility Testing
Antimicrobial Efficacy Testing (AET)
Microbial Limits Testing
Bioburden Determination
Endotoxin (LAL) Testing
Environmental Monitoring and Identification
Water Analysis
 Sterilization technique

PROCESS VALIDATION:

“Process Validation is establishing documented evidence which

provides a high degree of assurance that a specific process will
consistently produce a product meeting its pre-determined specifications
and quality characteristics.”

Types of process validation:

1) Prospective validation
2) Retrospective validation
3) Concurrent validation
4) Revalidation

Instruments and Devices seen in Microbiology Laboratory

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Analytical balance
Incubator
Refrigerator
Biosafety cabinet / Laminar Air Flow
Magnetic stirrer
Deef freezer
Light microscope
PH meter
Autoclave
Hot air oven

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ENGINEERING SECTION

 Electricity unit
 Water treatment system
 Water softening unit
 Chilling/ steam unit
 Air Handling Unit (AHU)
 Effluent Treatment Plant ELECTRICITY UNIT: Generation of electricity
in cadila is from three sub-station red, yellow and blue (RYB)
 Light arrester: -
 A lightning arrester is a device used on electrical power systems and
 systems to protect the insulation and conductors of the system from the
damaging effects of lightning. The typical lightning arrester has a high
voltage terminal and a ground terminal.
 Transformer:-
 Step-down unit, this transformer converts high-voltage, low-current
power into low-voltage, high-current power. The larger-gauge wire used
in the secondary
 winding is necessary due to the increase in current. The primary winding,
which doesn’t have to conduct as much current, may be made of smaller-
gauge wire. Cadila has two step-down transformers, one which convert
voltage from 66kv to 11kv and the other one which convert the voltage
from 11kv to 440 volt for the industrial use.
 Vacuum Circuit Breaker
 Water softening: - Water softening
 is the removal of calcium, magnesium, and certain other metal cat ionsin
hard water. The resulting soft water is more compatible with soap and
extends the lifetime of plumbing. Water softening is usually achieved
using lime softening or ion-exchange resins.
 Chilling/Steam unit
 Chiller
 Boiler
 Oil Separation
 Flow Equalization
 Sedimentation
 Neutralization

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 Activated Sludge

RAW MATERIAL AND FINISHED GOOD SECTION

Different class of material are received from vender and stored at

stored area.
Materials are stored according to their characteristic property, att
particular envirnoment and at different condition.

FINISHED PRODUCT

Finished product stored separetaly from raw material and they are
labelled as green for dispensing and exporting.

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CONCLUSION

In dustrial training is very much essential for Pharmacy

Student. It is a great opportunuity to acquire practical knowledge.
During my trainin g period I acquired lots of knowledge and
experience in all department .This will help to clearify all my thery
knowledge.
During my training period , we had seen various instruments
and apparatus in the industry. The highly sophisticated instrument
that work precisely must be operated with intense care for optimum
use.
We could acquire a lot of information regarding the
instruments and their working procedure.

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