S.S.

AGRAWAL INSTITUTE OF ENGINEERING& TECHNOLOGY, NAVSARI

B.E. 7th SEM SUMMER INTERNSHIP REPORT

“To Study About Manufacturing Process at
Indasi Lifescience Private Limited”

Submitted to
Institute Code: (123)
S.S. Agarwal Institute of Engineering &
Technology

Under the Guidance of

Assistant Professor: - Snehal. K. Patel

In partial Fulfillment of the requirement of the summer

Internship

Gujarat Technological University

Ahmadabad

Prepared by:
Chauhan Ravi Rajendra
(201230105503)

B.E. (Semester-VII)

June-July 2022

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 S.S. AGRAWAL INSTITUTE OF ENGINEERING& TECHNOLOGY, NAVSARI

CERTIFICATE

This is to certify that the “Indasi Lifescience Private Limited” submitted by Chauhan Ravi
Rajendra Enrollment. No: 201230105503 of S.S. Agarwal Institute of Engineering &
Technology (Institute Code) is work done by his / her and submitted during 2022–2023
academic year, in partial fulfillment of the requirements for the award of the degree of
BACHELOR OF ENGINEERING in CHEMICAL ENGINEERING, at (“Indasi Lifescience
Private Limited”) during from 20/06/2022 to 09/07/2022.

Guide
Name:
Sign:

Department Internship Coordinator Head of the Department

Prof. Snehal K. Patel
(Assistant Professor)

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 S.S. AGRAWAL INSTITUTE OF ENGINEERING& TECHNOLOGY, NAVSARI

Student’s Declaration

I hereby declare that the Internship “to Study About Manufacturing Process in “Indasi
Lifescience Private Limited” Organization is a result of my own work and my indebtedness
to other work publications, references, if any, have been duly acknowledged. If I am found
guilty of copying from any other report or published information and showing as my original
work, or extending plagiarism limit, I understand that I shall be liable and punishable by the
university, which may include ‘Fail’ in examination or any other punishment that university
may decide.

Chauhan Ravi
(201230105503)

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S.S. AGRAWAL INSTITUTE OF ENGINEERING& TECHNOLOGY, NAVSARI

Certificate of Internship

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 S.S. AGRAWAL INSTITUTE OF ENGINEERING& TECHNOLOGY, NAVSARI

TABLE OF CONTENT

Table of Contents
ACKNOWLEDGEMENT ………………………………………………….

ABSTRACT …………………………………………………………………

CHAPTER 1. INTRODUCTION TO THE INDUSTRY ………………...

1.1 INTRODUCTION …………………………………………………..
1.2 MANUFACTURING CAPABILITIES …………………………….
1.3 RESEARCH & DEVELOPMENT ………………………………….

CHAPTER 2. PRODUCTION AREA ……………………………………..

CHAPTER 3. PHARMA AREA …………………………………………...

CHAPTER 4. PRODUCTION DEPARTMENT ………………………….

4.1 AMPOULE AND VIAL MANUFACTURING …………………….

CHAPTER 5. ENGINEERING SECTION ……………………………......

5.1 AHU ………………………………………………………………...
5.2 BOILER ……………………………………………………………..
5.3 WFI ………………………………………………………………….
5.4 ETP ………………………………………………………………….
5.5 NDS …………………………………………………………………

CHAPTER 6. STORAGE …………………………………………………..

CHAPTER 7. SAFETY ……………………………………………………..

CONCLUSION ……………………………………………………………...

Prof Devarshi P. Tadvi Prof. Hitesh N. Parihar

(Internship Coordinator) (I/C HOD Of Chemical Engineering Department)

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 S.S. AGRAWAL INSTITUTE OF ENGINEERING& TECHNOLOGY, NAVSARI

ACKNOWLEDGEMENT

Every project big or small is successful largely due to the effort of a number of wonderful
people who have always given their valuable advice or lent a helping hand. I sincerely
appreciate the inspiration, support and guidance of all those people who have been
instrumental in making this project a success.

I, Ravi Chauhan, student of S.S. Agarwal Institute of Engineering & Technology, am

extremely grateful to “Indasi Lifescience Private Limited” for the confidence best owed in
me and entrusting my project.

At this juncture I feel deeply honored in expressing my sincere thanks to Director, Mr. Vikas
Singh form a king the resources available at the right time and providing valuable insights
leading to the successful completion of my project.

I express my gratitude to the entire Team, who guided and encouraged me all through the
summer in tern ship and imparted in-depth knowledge of the program.

I am very grateful to the Director Mr. Vikas Singh for providing me this opportunity to
work in this prestigious organization.

I am extremely thankful to my internal guide Mr. Snehal Patel for giving me his valuable time
and guidance during my Internship Program.

Last but not the least, I place a deep sense of gratitude to my fellow trainees who gave me
insights into the work in go fall the departments in the plant and therefore helped me better
understand the ways of the company.

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 S.S. AGRAWAL INSTITUTE OF ENGINEERING& TECHNOLOGY, NAVSARI

ABSTRACT

An engineer is always focused toward challenges of bringing ideas and concept in life. Our
college has given us a chance to do summer internship so that we can study and understand
corporate world of chemical engineering. That’s why for industrial summer internship I
choose “Indasi Lifescience Pvt. Ltd”. located at Daman, Gujarat. Here on during internship
I just understand working of different machinery and did observation. In pharmaceutical
company chemical engineering related work is done and I learned very much about
manufacturing of medicines and I learn engineering work on the AHU, Chiller, Boiler, WTP
etc., without these machines there will be no production have done and I study on this
Process in Indasi Lifescience Pvt. Ltd.

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 INTRODUCTION

 “Indasi Lifescience Pvt. Ltd”.

Established in 2012 as a small-volume parental unit, Indasi Lifescience PVT LTD has ever since
grown from strength to strength. We have set out on our quest to empower lives through pathbreaking
solutions in the medical realm. With core competencies in the area of medicine and consumer
healthcare, we, as a WHO-GMP certified organization, aspire to become global leaders by
strategically catering to every medical need across the globe.

 FACILITIES

 MANUFACTURING CAPABILITIES:

 We’re a WHO-GMP certified company carrying out our corporate and manufacturing practices at
Daman, India. These practices include automatic injectable dry powder filling, automatic ampoule
filling and sealing, and automatic liquid vial filling


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  Indasi’s sister concern company with WHO-GMP certificate by the name Arihantanam Lifecare
PVT LTD with an API facility of bulk drug and sterile powder, based in Sarigam, Gujarat,
delivering products to the domestic and export markets.
 A sister concern of Indasi Lifescience - Arihantanam Lifecare PVT LTD, also a WHO-GMP
certified company, deals in sterile powder, bulk drugs, and API facilities. With its manufacturing
base in Sarigam, Gujarat, Arihantanam Lifecare efficiently delivers its products to the domestic and
export markets. Yesh Enterprise, another subsidiary of Indasi Lifescience PVT LTD based in
Sarigam, Gujarat, makes sure the existing technology in fine chemical manufacturing is optimized
time and after and new technologies are implemented when required.

facility is equipped with world class machines capable of manufacturing a wide range of formulations
viz. Injections, Tablets, Capsules, Suspensions, Dry Syrups, etc. Indasi Lifescience facility is equipped
with serialization and tamper-evident packaging for EU and US markets.

 QUALITY POLICY

 Our long-term binding policy leaves no room for us to compromise on our values and moral standards.

 We commit ourselves to only those products that meet international WHO-GMP standards.

 Customer satisfaction is our utmost priority as we continuously strive to achieve it by supplying

products meeting quality parameters and within the stipulated delivery time.

 We understand and anticipate our customer’s perspectives and provide them with all the technical data
in a time-bound manner.

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 We continuously review our various operations to make them more efficient and relevant with
changing international scenario and environmentally friendly.
 We comply with all the relevant statuary and regulatory requirements.
 We provide training to our employees as a part of our corporate program to inculcate them with recent
innovations and advancements in the industry around the world.
 We strongly adhere to implementing Quality Management Systems and are committed to making
continual improvements to the same.

 RESEARCH& DEVELOPMENT

A full-fledged R & D Centre, located at Turbhe, Mumbai is manned by a team of skilled and
experienced scientists to develop innovative formulations. The R & D Center has been approved
by the Ministry of Science & Technology, Government of India.

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Product list

• Injections

• Tablets

• Capsules

• Liquid syrups

• Sprays

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 Export

 GLOBAL BUSINESS

Indasi Lifescience high quality products are accepted in more than 85 countries covering US,
EU, Canada, Australia, Middle East, Central & South American countries, Africa, Asian &
CIS countries

“Indasi Lifescience Vision”

We strive to achieve unprecedented goals by implementing cutting-edge technologies in

medical science. There’s a room for every innovative and visionary idea as we believe in
raising the bar with every accolade we achieve. Our deeply-rooted values keep us firm with
our ethical and moral standards.

“Indasi Lifescience Mission”

• To protect and improve human health worldwide by providing superior and innovative
products for the prevention and treatment of disease

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Pharma Area:
- In this area paper work, Inspection and other work is carried out. This area
has various rooms: -

1) Quality Assurance

2) Quality Check

3) Light Inspection

4) Ampoule Area

5) Vail Area

6) Coating Area

7) Filling Area

8) Incubator Area

9) Injection Area

10) Granulation Area

11) Cleaning Area

12) Raw Material receiving area

13) Storage

14) Production Area

15) Packaging Area

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Chapter: -2 Production Department:

14
 Process Validation:

 AMPOULES

The primary packaging material for injectable is the ampoules.

FIG.2.1

 Ampoules maybe clear or amber, manufactured with type glass, type C form (acc. To ISO 9187-2).
 Ampoules glass must comply with European Pharmacopoeia requirements for type I glass
containers and, if they are manufactured with amber glass, it should also comply with light
transmittance
 Ampoules Washing:

FIG.2.2

 Ampoules washing is performed in a rotary washer machine. This machines CPPs are:
 Water Temperature- This parameter can influence the efficiency of the washing;

 Water Pressure-this parameter will influence the correct and efficient washing of the ampoules.

 Washer Velocity-this parameter can influence the efficiency of the washing as well as the efficient
processing, as if the washer is too fast, more ampoules can break on the process.

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 VIAL WASHING- A vial (also known as a phial or flacon) is a small glass or plastic vessel or
bottle, often used to store medication as liquids, powders or capsules. They can also be used as
scientific sample vessels; for instance, in auto sampler devices in analytical chromatography. Vial-like
glass containers date back to classical antiquity modern vials are often made of plastics such as
polypropylene. There are different types of vials such as a single dose vial and multi-dose vials often
used for medications. The single dose vial is only used once whereas a multi-dose vial can be used
more than once. The CDC sets specific guidelines on multi-dose vials.

FIG.2.3

Washed by series of water at high pressure and the pressure should be maintained throughout the
Process.

 Pressure less= improper washing.

 Pressure more – breakage.
 Compressed air is used for drying the washed vials and are moved towards the tunnel.

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 Ampoules and vials Depyrogenation:

FIG.2.4

 After washing, the ampoules are continuously conveyed to the tunnel, sterilized, depyrogenated and
then cooled before being transferred to the filling and sealing station. The key parameters are:
 1)Conveyor belt velocity- this parameter can influence the stability of the ampoules in the
tunnel and also the time that they spend in the tunnel, affecting the exposure to the sterilization
temperature.
 2)Chamber temperature the temperature should be high Enough so that the ampoules are
efficiently sterilized and Depyrogenated and the value of FH is sufficiently high to Assure the
accomplishment of the process.

 Filling:

FIG.2.5

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 After cooling, the ampoules are directed to the filling and sealing line. The Filling process can
be influenced by:
 1)Solution flow-the solution should flow properly in Order to be filled in the ampoules.
Filling needles depend on product flow.
 2)Volume to fill- The correctness of the volume will Influence the intended use on the dosage
form, as it Can influence the dosage uniformity

 Sealing:

FIG.2.6

 The sealing process can be influenced by:

 Flame Temperature- the flame will melt the glass and seal the ampoule. If the flame
temperature is not adequate, the sealing may be compromised.
 Ampoules Height- it is determined by the height of the flame and will influence the ease of
opening.
 Sterilization:
Ampoules are now placed in trays and, depending on the product, maybe sterilized in
the autoclave by hot steam. This step assures the use of the finished product.
 Time-This parameter determines the time that the product remains under the 121°C
temperature. Together with the temperature it will influence the Flow of the sterilization
process. According to European Pharmacopoeia (EP) the process should take at least 15
minutes.
 Temperature-This parameter is the key to the sterilization process, as high temperatures
assure the absence of microorganisms. According to EP it should be at least 121°C, unless the
process is demonstrated to possess the same lethality rate.

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 Visual Inspection:

FIG.2.7

 Visual inspection is performed in an automated machine. The machine contains alight-

transmission double-check system for detecting particles in ampoules.
1. Static Division system
2. Divides photo-detection system into individual parts, detection is done from base of ampoule.
3. Container is spin at specified speed.
4. Liquid forms a vortex imparts movement insoluble part
5. Vial stops. Vortex collapses image is projected with variation in transmitted light is detected.
 This machine inspects the following defects: particles, volume and cosmetic defects in the head
of the ampoule. The inspection process can be influenced by:
 Rotation Speed– this parameter is defined so that it can optimize the particles to suspend.
 Brake Position-this parameter affects meniscus recovery and the timing between the end of
spin and the Inspection.
 Light Intensity- this parameter defines the intensity of the light that will illuminate the solution.
 Sensitivity–this parameter defines the threshold of particle detection, differentiating the signal
from the noise.

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 Integrity Inspection:
 Integrity inspection is performed in an automated machine by High Voltage Leak Detection
(HVLD).

 High voltage is applied to the container.

 If crack is present, then current will flow through and detected by the detector.

 Difference in the conductivity is measured.

 Labelling:

FIG.2.8

 Labelling is performed in an automated machine that imprints the batch number and expiry
date on the label, as well as possesses a sensor that detects the ring code colour and label
presence.
 The parameters that can influence the labelling process are:
 Label-The correctness of the label placement is essential to the identification of the product,
influencing its quality.
 Ring quality & quantity- The correctness of the ring color code is essential to the
identification of the product to be labelled, as the colour code is exclusive to one product.
 Barcode-Thecorrectnessofthebarcodeisessentialtothecorrectnessofthelabelthatwillidentifythe
product.

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  Batch & Expiry date printing - The correctness of the printing will allow the correct
traceability of the batch.
 Packaging:
 Packaging is performed in an automated machine that forms the blister tray, presses the
ampoules in the blister tray and places the trays in the carton box with the leaflet.

The parameters that can influence the labelling Process are:

 Leaflet– The correctness of the leaflet (detected by bar code sensor) and its placement is
essential to the completeness of the packaging.
 Carton Box- The correctnessofthecartonbox(detectedbybarcodesensor)anditscorrectformation
is essential to the correctness of the packaging.
 Batch & Expiry date printing-The correctness of the printing will allow the correct
traceability of the batch.

 Processes must be validated in pharmaceutical manufacturing are:

 Cleaning

 Sanitization

 Depyrogenation

 Sterilization

 Sterile filling

 Purification

 Filling, capping, sealing

 Lyophilization

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 ENGINEERING SECTION

 AHU (AIR HANDLING UNIT):

An air handler, or air handling unit (often abbreviated to AHU), is a device used to regulate
and circulate air as part of a heating, ventilating, and air-conditioning (HVAC) system. An air
handler is usually a large metal box containing a blower, heating or cooling elements, filter racks
or chambers, sound attenuators, and dampers. Air handlers usually connect to a ductwork
ventilation system that distributes the conditioned air through the building and return sit to the
AHU. Sometimes AHUs discharge (supply) and admit(return) air directly to and from the space
served without ductwork

FIG3.1

An air handling unit; air flow is from the right to left in this case. Some AHU components shown
are
1 – Supply duct
2 – Fan compartment
3 –Vibration isolator ('flex joint')
4 –Heating and/or cooling coil
5 – Filter compartment
6 – Mixed (recirculated + outside) air duct

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 A rooftop packaged unit or RTU FIG.3.2

Small air handlers, for local use, are called terminal units, and may only include an air filter,
coil, and blower; these simple terminal units are called blower coils or fan coil units. A larger air
handler that conditions 100% outside air, and no recirculated air, is known as a makeup air unit
(MAU) or fresh air handling unit (FAHU). An air handler designed for outdoor use, typically
on roofs, is known as a packaged unit (PU), heating and cooling unit (HCU), or rooftop unit
(RTU).

 Schematic air flow diagram:

The air handler is normally constructed around a framing system with metal infill panels as
required to suit the configuration of the components. In its simplest form the frame may be made
from metal channels or sections, with single skin metal infill panels. The metalwork is normally
galvanized for long term protection. For outdoor units some form of weatherproof lid and
additional sealing around joints is provided.

FIG3.3
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Larger air handlers will be manufactured from a square section steel framing system with double
skinned and insulated in fill panels. Such constructions reduce heat loss or heat gain from the air
handler, as well as providing acoustic attenuation. Larger air handlers maybe several meters long
and are manufactured in a sectional manner and therefore, for strength and rigidity, steel section
base rails are provided under the unit.
Where supply and extract air is required in equal proportions for a balanced ventilation system, it
is common for the supply and extract air handlers to be joined together, either in aside-by-side or
a stacked configuration.

 Air handling unit types

There are two main types of air handling unit

 Blow-through.

 Draw-through.

Blow through: The blow-through AHU has a fan which blows the air through the mixing box,
cooling coil and filters before it goes to the ducting network.

Draw through: The draw-through AHU can be vertical or horizontal. It has a fan which pulls the
air through the mixing box, cooling coil and filters before it goes to the ducting network.

You can also get different sizes of AHU. Terminal units are small, simple units, also called fan
coil units or blower units. These units may only include a coil, blower and air filter. A makeup air
unit (MAU) is a larger AHU that does not recirculate the air and conditions 100% outside air.
This unit is also known as a fresh air handling unit (FAHU).

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BOILER:

A boiler is an enclosed vessel that provides a means for combustion and transfers heat to water
until it becomes hot water or steam. The hot water or steam under pressure is then usable for
transferring the heat to a process.

FIG3.4

Water is useful and cheap medium for transferring heat to a process. When water is boiled into
steam its volume increases about 1,600 times, producing a force that is almost as explosive as
gunpowder. This causes the boiler to be extremely dangerous equipment and should be treated
carefully.

Liquid when heated up to the gaseous state this process is called evaporation.

The heating surface is any part of the boiler; hot gases of combustion are on one side and water
on the other. Any part of the boiler metal that actually contributes to making steam is heating
surface. The amount of heating surface of a boiler is expressed in square meters. The larger the
heating surface a boiler has, the more efficient it becomes.

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  Application of boiler:

The boiler has a diverse application in the following industries:

 Food processing industries
 Chemical industries
 Refineries and distilleries
 Thermal power plants
 Sugar plants
 Textile industries
 Health care industries
 Paper industries
 Pharmaceutical industries
 FMCG (Fast Moving Consumer Goods)

 Types of Boilers:
When we think about boilers, there are two types that typically come to mind; fire tube, or
scotch marine, and water tube boilers. These types of boilers can be classified as hot water,
steam, high pressure, and low pressure.

 Fire-tube boiler
A fire-tube boiler is a type of boiler in which hot gases pass from a fire through one or more
tubes running through a sealed container of water. The heat of the gases is transferred through
the walls of the tubes by thermal conduction, heating the water and ultimately creating steam

26
The fire-tube boiler developed as the third of the four major historical types of boilers:
low-pressure tank or "haystack" boilers, flued boilers with one or two large flues, fire-
tube boilers with many small tubes, and high-pressure water-tube boilers. Their
advantage over flued boilers with a single large flue is that the many small tubes offer far
greater heating surface area for the same overall boiler volume. The general construction
is as a tank of water penetrated by tubes that carry the hot flue gases from the fire. The
tank is usually cylindrical for the most part—being the strongest practical shape for a
pressurized container—and this cylindrical tank may be either horizontal or vertical.

FIG3.5
This type of boiler was used on virtually all steam locomotives in the horizontal
"locomotive" form. This has a cylindrical barrel containing the fire tubes, but also has an
extension at one end to house the "firebox". This firebox has an open base to provide a
large grate area and often extends beyond the cylindrical barrel to form a rectangular or
tapered enclosure. The horizontal fire-tube boiler is also typical of marine applications,
using the Scotch boiler; thus, these boilers are commonly referred to as "scotch-marine"
or "marine" type boilers Vertical boilers have also been built of the multiple fire-tube
type, although these are comparatively rare; most vertical boilers were either flued, or
with cross water-tubes.

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.

 Components & Mountings Placed on the fire tube boiler:

Mountings are those which are used for the functioning of the boiler and these play a critical role
in the proper design of the Firetube boiler

 Safety valve
 Feed check valve (a kind of non-return valve)
 Water level indicator
 Pressure gauge
 Steam stop valve

 Pressure Gauge:

FIG3.6

The pressure gauge is mounted on the top of the shell. It indicates the amount of pressure
observed inside the boiler. It is a dial-type instrument that indicates pressure in different units
such as kg/cm2 or K.pa or PSI. Nowadays digital type instruments are also used where it senses
the pressure by some transducers and sends the signal to the display unit.

28
  Water Level Indicator:

FIG3.7

During the operation of the boiler, the operator must know the level of water. If not knowing the
boiler cannot withstand the pressure and may lead to an explosion. So, a water level indicator is
mounted to the shell of the water tube boiler

 Safety Valve:

FIG3.8

Water at higher pressures has a lot of energy so, safety precautions should be taken to prevent any loss.
For this purpose, we install a safety valve to the boiler. Whenever the pressure is above the prescribed
limit I.e. withstand capability then safety valve will be opened. At-least two safety valves are to be
provided.

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  Steam Stop Valve:

FIG3.9

A stop valve is provided to operate the steam control according to the requirement, the wet steam
in the shell is sent to the superheated to reheat. The reheated steam is resent to the shell in this
situation, the steam stop valve is operated to meet the requirements.

 Feed Check Valve:

It is used for the entry of feed water into the boiler and also used as a non-return valve to prevent the feed
water from returning.

FIG3.10

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 Accessories are provided to increase the efficiency of the boiler. They are

 Superheated
 Economizer
 Air pre-heater

Without mountings, boilers cannot operate but without accessories, boilers can operate. The
efficiency will be low without accessories.

• Observations: - In the industry which I had done internship has a 3 ton capacity gas fired
steam boiler of “Industrial Boiler ltd” is used, it can produce 3 tph steam. The diagram of
boiler is as shown below:

FIG 3.11
1) It can produce3TPH steam.

2) It takes 1tonwaterandproduce ±1-ton steam.

3) The water which enters in the boiler has been filter by multigrid filtrations process.

4) Water hardness should not be more than 5ppm,it is done by the

softener.
5) Water level inside is checked by the mobrey.

6) LPG gas is used in this boiler.

7) For ignition spark plug is used.

31
 8) UV light sensor is used to check if the ignition is proper.

9) Gas pressure is 5kg

10)Pressure inside the boiler is 2kg

11)Steam pressure is at 7kg/cm² for cut off and restarts at 6kg/cm².

12)GIDC water is used.

13)Blower is used for air supply.

 Boiler Maintenance:
The boiler operator is responsible for operating and maintaining the boiler in a safe and efficient
manner through the use of sound engineering practices and manufacturer’s specified maintenance
procedures. Most boiler accidents are caused by operator error and poor maintenance. The Chief
Engineer of a boiler plant holds the responsibility for directing boiler operations, procedures and
maintenance. The information used by the Chief Engineer comes from manufacturer’s
recommendations.
Log sheets: are a paper record of boiler operation and maintenance, and should be used in all
boiler rooms to help ensure safe operation. A log sheet will specify the task to be performed, such
as blowing down the low water cut-out (LWCO), and the operator can then mark the sheet to show
that this operation was completed. General Boiler Operations include:
Start-up: Cold iron start up and new plant start up. Most furnace explosions occur during start up
and when switching fuels, so always follow the manufacturer’s guidelines.

Operation & General Maintenance:

– requires proper training, equipment familiarity and routine maintenance procedures

Shutdown:
Whether for a short time or long time, different procedures exist. If the boiler is to be placed out of
service for an extended period of time, proper lay-up procedures are required and must be followed.

32
Water Purified system:

FIG 3.12

 Operating principle:
• Feed water (D.M.) enters the system and flows through two Pre-Heaters where heat is
transferred between the feed water on the tube side. Then feed water enters the evaporator at a
higher, more efficient temperature. The heated feed water flows into the lower part of
separator trough the tube side of the evaporator, and the level is controlled by two level
indicator switches.
• At the same time, supply steam enters the shell side of the evaporator. Heat energy from
steam is transferred to the feed water through the evaporator tubes. The Steam is thus coming
out through separator in centrifugal form separating any impurities.

33
 The principle of operation of ETP is Physio-Chemical treatment followed by Polishing
Treatments like –Sand Filtration, Activated Charcoal treatment (Adsorption), Ozonation
(Chemical Oxidation), Ultra Filtration (UF), Reverse Osmosis (RO) and evaporation (If
required).

Purified water systems may be used for a variety of purposes in pharmaceutical manufacturing.
For non-parenteral products it may be used in product formulation and final washing of process
29 equipment and containers. In the manufacture of parenteral products, it may be used in the
initial washing of containers and to feed WFI systems.
To produce Purified Water, it’s necessary to remove organic substances, high and medium
molecular weight ions and bacteria/pyrogens to a level that meet the Eur.Ph, USP or JP
requirements.
Purified Water is obtained by further purification of RO or Pre-Treated Water through Ion
Exchange Deionization/Demineralization (DI), Electro Deionization (EDI/CEDI) and UV light
treatment depending on the grade required.

Honey man Water has built a market leading reputation on designing Purified Water systems that
work for you, irrespective of the desired grade, capacity or application. Our water systems are
design to ensure:

 Capacity varying from 100 to 20,000 mph (liters per hour)

 Compliance with cGMP, Eur.Ph, USP and JP regulatory requirements or site-specific requirements
 Sanitary in-line instrumentation to monitor product critical parameters such as conductivity,
temperature, Ozone in water, TOC and Ph.
Depending on the required grade, our typical Purified Water generation systems may consist of:

 Sodium hypochlorite dosing station for water disinfection and oxidation of organic substances,
reducing the bacterial charge (not typically in UK and Ireland)

 Sodium met bisulphite dosing station for neutralization and chlorine (not typically in UK and
Ireland)

 Double filtration system to eliminate solid substances in inlet water

34
  Water Injection System:

FIG3.13

Water for Injection System (WFI) can be created through distillation and through further
purification by Reversed Osmosis. The more common method is through distillation, which is an
intrinsically safe method. If a distiller would fail or produce insufficient heat, there is no
evaporation and no WFI generation. Whilst the use of RO and polishers can generate WFI, it is a
cold process and not intrinsically safe as seal ruptures or membrane failures are not easily
detectable without the use of additional equipment such as inline micro or endotoxin monitors.

 Single Effect Distillation Units

Our single effect distillation units can produce both pure steam and WFI, depending on
operational requirements and is a perfect solution for applications with limited demand or budget
constraints. The Single Effect Stills are available with an electrical heat source or steam as the
primary heat source.

In the single effect still the heated deaerated feed water is used to create saturated steam. Droplet
entrainment is controlled through the use of centrifugal and gravity separation methods.

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 All parts in contact with process fluid and steam in the single effect stills are constructed from
AISI 316L stainless steel and are designed in accordance with P.E.D. pressure regulations. All
pipes are orbit ally welded, where possible and fully traceable.

 Multiple Effect Distillation Units

Our Multiple Effect Stills are designed and manufactured according to cGMP to produce Water for
Injection (WFI). Each unit contains a number of boiling columns (or effects) with the first column
producing pure steam, which is condensed and re-distilled in the following columns decreasing
operational costs.

Double Tube Sheet (DTS) exchangers provide swift and effective heating for evaporation and
cooling for condensation processes. Condensation is achieved by means of the thin-falling film
technology.

The process is repeated in each column: the higher the quantity of columns, the lower overall the
consumption of the equipment. The quantity of columns therefore does not influence the quality
nor the output of the equipment.
A special labyrinth-separator installed at the top of each column separates the steam generated by
the evaporation process from entrained substance in the steam itself. The result is a pure, “dry”,
pyrogenic-free steam, condensed in compendia Water for Injection.

The first column of the Still may be used to produce alternatively or even at same time, also Clean
Steam. Pressure vessels are designed according to PED regulation and the equipment features:
 Double tube sheet heat exchangers
 Certified AISI 316L stainless steel mirror-polished and passivated product contact surfaces
 AISI 304 frame, jackets and control board
 PTFE gaskets
 Pneumatic valves with Teflon membranes and AISI 316
 Capacities range: from 50 to 15,000 lph with three to eight columns.

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 Effluent Treatment Plants:
We Design, Manufacture, Supply, Erection and Commissioning Effluent Treatment Plant (ETP)
on Turnkey basis for various types and natures of wastewaters, effluents which combines
advanced physio-chemical treatment processes with tertiary polishing system for the removal of
organic, inorganic, oil and grease, heavy metals & suspended solids.

Our methodology - We analyze the effluent samples for different effluent parameters as per
nature and compositions, carry out the treatability studies by using different methods checking
techno-commercial Feasibility and then designed treatment schemes, processes accordingly to
suit the purpose and need.

FIG.3.14

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 Our ETP systems are very compact, tailor made designs, portable required very less foot-print to
accommodate, energy efficient. The up-gradation, modification in the existing ETP system is
possible to achieve desired limiting standard laid down by the Pollution Control Board (PCB)

The Principle
The principle of operation of ETP is Physio-Chemical treatment followed by Polishing
Treatments like –Sand Filtration, Activated Charcoal treatment (Adsorption), Ozonation
(Chemical Oxidation), Ultra Filtration (UF), Reverse Osmosis (RO) and evaporation (If
required).

Nitrogen Distribution System

 Nitrogen Generation in the Pharmaceutical Industry:

Like with the food packaging and the chemical industries, the pharmaceutical industry relies
heavily on nitrogen in its various applications. In fact, pharmaceutical companies require are liable
source of high purity nitrogen and can benefit by generating their own nitrogen in-house to reduce
cost while controlling quality and boosting efficiency. Let’s learn more about why nitrogen is such
a key element (pun intended) for this industry

FIG3.15

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 Why is Nitrogen Used in the Pharmaceutical Industry?

 One of the biggest advantages of nitrogen is that it is a dry, inert gas; this means that it
doesn’t react with other elements. This makes N2 extremely useful as a replacement for a
hazardous or otherwise undesirable atmospheric gas, most notably oxygen. Nitrogen
reduces the presence of oxygen that may provide the catalyst for combustion or
negatively affect product quality. It also controls the level of oxygen in a workspace, lab
or throughout an entire facility.

 Nitrogen is also readily available for use! In fact, the atmosphere is composed of 78%
nitrogen and 21% oxygen, with the remaining percentage being divided among a few
other trace gases. Finally, nitrogen can help maintain sterility and cleanliness of
pharmaceutical products.

 How the Pharmaceutical Industry Uses Nitrogen Gas?

Examples of nitrogen gas used in pharmaceutical manufacturing processes include:
 Blanketing. Nitrogen blanketing reduces the presence of oxygen by replacing it with nitrogen.
This prevents rapid oxidation, corrosion, and rust; suppresses fire; helps prevent 34 combustion;
and otherwise ensures that that high purity pharmaceutical ingredients remain pure during
manufacturing.
 Nitrogen Purging. This is a widely used technique that removes oxygen from packaging
before sealing to help preserve and protect the product during transport, as well as protects again
airborne contamination. Examples of items frequently packaged with nitrogen gas include blister
packaged pharmaceutical products, test kits for physician offices, blood supplies, specimen
containers, and sterile medical devices.

 Product Transfer. In pharmaceutical manufacturing, nitrogen is frequently used to move a

reaction mixture from one vessel to another. Using a safe, inert gas to transfer liquid or powder
pharmaceutical materials is crucial as they can be hazardous if improperly handled. Many
pharmaceutical ingredients can be damaged or even explode if allowed to contact oxygen or
water vapor.

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 Nitrogen Generators for the Pharmaceutical Industry:
Shifting to on-site nitrogen generation of nitrogen gas can help pharmaceutical facilities achieve
significant cost savings—from 40 to 80 percent, depending on current liquid nitrogen market
prices. Generating nitrogen on-site enhances production flexibility by ensuring that a company
has the nitrogen they need, at the purity level they need and when they need it. Generating your
own N2 also frees up space otherwise needed to store nitrogen bottles (both full and empty) and
can lower a company’s carbon footprint. It is very simple to financially compare generating
your own nitrogen vs. purchasing liquid or high-pressure vessels filled with N2

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STORAGE:

FIG4.1

Industrial Pallet Storage Rack in Indasi Lifescience is an ideal choice for section and assembled
type of goods. The use of industry-grade steel is the reason that ensures a high bearing capacity of
the rack. Their assembling and disassembling are a no task and can be managed easily with little
efforts

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Safety:

Fig5.1

The term “Industrial safety” is a set of safety protocols, policies and regulations to protect the
workers, workplace, work equipment and environment from hazards. It acts as a corrective
measure that is reviewed and approved by safety experts periodically to ensure a safe workplace
and sustainable business operations

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  Pharmaceutical Manufacturing Safety Consideration:

When working in any type of laboratory, following basic laboratory safety is a necessity. The
Occupational Safety and Health Administration (OSHA) provide detailed guidelines on
laboratory safety. For laboratory workers, these guideline should be second nature. A few of the
guidelines include:

 Quickly clean up all spills

 Maintain a tidy work area
 Frequently wash hands
 Wear a laboratory coat
 Never smoke inside the laboratory
 Label containers correctly
 Wear eye protection and other personal protective equipment (PPE)
 Do not wear clothing that exposes the skin (e.g. shorts and T-shirts)
 Do not eat in the laboratory
 Regularly check that glassware is not cracked and that all equipment is safe to use
 Keep entry ways clear
These safety standards apply to any laboratory and can be altered to adhere to pharmaceutical
work specifically. Follow these practices as well as basic manufacturing practices like
maintaining and using the proper equipment. Besides basic laboratory safety and manufacturing
safety measures, there are many more safety standards for pharmaceutical manufacturing sites.
Here are a few other suggested pharmaceutical manufacturing safety considerations.

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Conclusion

In the end I am glad to tell you that training in “Indasi Lifescience Pvt. Ltd.” was an excellent
and fabulous experience. During the training I actually learned about the Pharmaceutical
Company and above it working the theoretical knowledge is worth for getting a degree, and it is
accessible in the book. We can only imagine about the thing we read, but practical life is always
different and excellent one. We could acquire a lot of information regarding the latest
instruments and their working procedures. Similarly, from practical point of view a
pharmaceutical company is very difficult. During the training session I tried to my level best to
gain practical knowledge as much as I can. I improved my basic classified doubts and also
understood the importance of maintaining of quality of products at Pharmaceutical Company. I
was successfully able to complete my short venture of training. Lastly, I hope that my training
report fulfill the intended requirements.

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Reference:

Book reference:

 Boiler Operator's Guide, 5th Edition

Ray Wolfforth, Anthony L. Kohan, Publication Date &Copyright:2021 McGraw Hill

 Air Handling Unit Selection with AHP Method in Turkey

M.BenanYazicioglu1, Oguz Borat2, Osman Yazicioglu

 Website reference:

Reference from moravek for safety-considerations

Reference from airtecnics for air handling unit

Reference from Wikipedia for Chiller

Reference from mvsengg for nitrogen system

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