Industrial Training Report

B. Pharm. VIII Semester

(2023-2024)

October, 2022

Adesh University, Bathinda

Supervised by: Submitted by:

Dr. Diksha Jindal Rahul Kumar

Department: Department of Pharmaceutical Chemistry Roll No. 214020003

Place of Training:
Oniosome Healthcare Private Limited

Adesh Institute of Pharmacy & Biomedical Sciences

(A constituent College of Adesh University, Bathinda)
 Industrial Training Report

Submitted
In partial fulfillment of the requirements for the degree of
Bachelor of Pharmacy

October, 2022

Adesh University, Bathinda

Supervised by: Submitted by:

Dr. Diksha Jindal Rahul Kumar

Department of Pharmaceutical Chemistry Roll No: 214020003

Place of Training:
Oniosome Healthcare Private Limited

Adesh Institute of Pharmacy & Biomedical Sciences

(A constituent College of Adesh University, Bathinda)
 Adesh Institute of Pharmacy &Biomedical Sciences
(A constituent College of Adesh University, Bathinda)

NH-7, Barnala Road, Bathinda – 151101 Punjab (India)

Ph: 0164-5055087, 5055096 Fax: 0164-5055255, 2742902, E-mail : [email protected] , Website : www.adeshuniversity.ac.in

Date: ____________

CERTIFICATE

This is to certify that Mr. Rahul Kumar S/o Sh. Shyam Lal of B. Pharm. VIII Sem. (2023-2024) has undergone a
150 hours practical training spread from 15th Sep. 2022 to 15th Oct. 2022 at Oniosome Healthcare Private Limited,
Mohali, Punjab

This on the job training report submitted by him/her in partial fulfillment of the requirement of the academic
regulations for the award of Degree of Bachelor of Pharmacy is a bonafide work of his/her own, carried out by him
at allotted training centre.

Supervisor: Dr. Diksha Jindal

Department: Department of Pharmaceutical Chemistry

Date: ____________

Approved by Training coordinator:

________________ __________________
Prof. Dr. Ashutosh Upadhayay Dr. Keshav Jindal
Principal, AIPBS Associate Professor, AIPBS

Date: ____________ Date: ____________

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B. Pharm. VIII Sem. (2023-2024) Industrial Training Report

Acknowledgement
I consider it a great honor to have the opportunity to undergo the industrial training work in Oniosome HealthCare
Pvt. Ltd.

The project is a great achievement in my carrier and it is my privilege to acknowledge all those in completing this
project report.

Firstly and foremost, I wish to express my sincere thanks and gratitude to my esteemed Mentor “Mr. Survesh
Kumar” who has contributed so much for successful completion of my Industrial Training by his thoughtful
reviews and valuable guidance.
I am also thankful to my parents for their love, prayers, caring and sacrifices for educating and preparing me for my
future.

Finally, I would like to thank all the people who directly or indirectly co-operated with me.

Date:
(Name of Student)

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B. Pharm. VIII Sem. (2023-2024) Industrial Training Report

TABLE OF CONTENTS

Chapter Title Page No.

No.
Certificate i
Acknowledgement ii
1. Introduction 1-3
2. Area specificity of industry 4-5
3. Studied analysis apparatus in 6-34
industry
4. Learning outcome 35-38
5. Contact details of organization 39-40

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B. Pharm. VIII Sem. (2023-2024) Industrial Training Report

LIST OF FIGURES

Figure Title Page No.

No.
1. Soxhlet Apparatus 7
2. Maceration Apparatus 9
3. Reflux Assembly 11
4. Ultrasonic Sonicator Bath 12
5. Rotavapor 14
6. Diffusion Cell Apparatus 16
7. Cooling Centrifugation 17
8. High Performance Liquid 18
Chromatography (HPLC)
9. Column Chromatography 21
10. Paper Chromatography 23
11. UV Spectrophotometer 25
12. Fourier Transform Infrared 27
Spectroscopy (FTIR)
13. Dissolution Apparatus 28
14. Spray Dryer 30
15 Freeze Dryer (Lyophilizer) 32
16. Particle Analyser 33
17. Gel 36
18. Glycerosomes 37
19. Patches 38

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Chapter-1
Introduction

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1.1 General information about the company:

1.1.1 Brief history: Oniosome Healthcare was established by a group of pharmaceutical scientists in the year
2010, at Mohali. Oniosome is registered under the Indian companies act and has been recognized as Department of
Scientific and Industrial Research (DSIR) Central Body in Govt. Company is registered in Chandigarh (Chandigarh)
Registrar Office. Oniosome Healthcare Private Limited registered address is HOUSE NO. 5568 SECTOR 38 WEST
CHANDIGARH CH 160014 IN.

1.1.2 Objectives: Oniosome Healthcare Private Limited was established in the year 2010 by a group of
scientists with the aim to be most preferred Contract Research and Services Organization delivering the
best end-to-end solutions to global Pharma & Biotech industry catering niche segment comprising of
nano formulations, lyophilized oncolog y Products, Vaccines

1.1.3 Products: Services provided by the company is following:

 Research & Development Services
 Pharmaceutical Process development & Scale Up
 Biological Process development & Scale Up
 Analytical Testing Services development & Scale Up
 Regulatory & Intellectual Property Rights Support services

1.1.4 Organization: The management of the company is as following:

 Dr. Sarvesh Malviya Jain (CEO)
 Mrs. Namita Malvia (Co-CEO)
 Miss Anupam Jain (Worker)
 Mr. Prince Goyal (Worker)
 Mr. Ankush Goyal(Worker)
 Mr. Deepak Goyal (Worker)

1.1.5 Location: Plot No. F-103, Ground Floor, Phase 7 SAS,Nagar, Mohali-160055, Punjab, India

1.1.6 Turnover and sales: Company‟s annual turnover is Rs. 1-2 crore and sales data is not available

1.1.7 Workforce: Oniosome Healthcare Private Limited (Non-Government Company)

1.1.8 Infrastructural investment: Data not available.

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1.1.6 Layout of industry

WASHING HUMIDITY MICROBIOLOGY

WASHROOM
AREA CHAMBER LAB

WORKING
WEIGHING STORAGE &
CONTROL
AREA LAYOUT OF
SAMPLE ROOM
ONIOSOME
HEALTHCARE
Pvt. Ltd.
(MOHALI)
SPRAY
DRYER IPOC LAB

ARD LAB
OFFICE

F & D LAB

SAMPLE
ENTRANCE CONFERENCE CODING &
ROOM REPORTING
SECTION

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Chapter-2
Area specificity of industry

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2.1 Research & Development Services: Oniosome has a team of experienced scientists specializing in
formulation development, analytical development and conducting stability studies. The dedicated research team of
company is committed to developing a range of formulations and products as per customer specifications and for
positively impacting health and well-being.
2.2 Pharmaceutical Process development & Scale Up: The primary focus of company is in the domain of
pharmaceutical research is product based on NDDS (Novel Drug Delivery System) to overcome the shortcoming of
the pharmaceutical products based on conventional formulation approaches.
2.3 Biological Process development & Scale Up: We can provide process optimization, scale-up and tech
transfer of mammalian-based processes to produce monoclonal antibodies, glycoproteins, complex fusion proteins
and other recombinant proteins.
2.4 Analytical Testing Services development & Scale Up: The Company can provide analytical support,
contract formulation development and consultation services to pharmaceutical, chemical and biotechnology
companies.
2.5 Regulatory & Intellectual Property Rights Support services: In the company there was some quite
specialist in the field of IP services including patents, trademarks and copyrights. Company can also provide
assistance in every step of registration, prosecution and maintenance for Patents, Trade Marks and copyrights.

In the company some instruments can used for analysis or testing which are as following:
 Soxhlet Apparatus
 Maceration Apparatus
 Reflux Assembly
 Ultrasonic Sonicator Bath
 Rotavapor
 Diffusion Cell Apparatus
 Cooling Centrifugation
 High Perforated Liquid Chromatography (HPLC)
 Column Chromatography
 Paper Chromatography
 UV Spectrophotometer
 Fourier Transform Infrared Spectroscopy (FTIR)
 Dissolution Apparatus
 Spray Drier
 Freeze Drier (Lyophilizer)
 Particle Analyser

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Chapter-3
Studied analysis apparatus in industry

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3.1 Instrumentation: In the Oniosome Industry there was following instrumentation:

3.1.1 Soxhlet Apparatus
Principle: It is based on extraction.
 A Soxhlet Apparatus is lab equipment designed for processing certain kind of solids.
 These devices allow for continuous treatment of a sample with a solvent over a period of hours or days to
extract compounds of interest.
 Typically, a Soxhlet extraction is only required where the desired compound has a limited solubility in a
solvent, and the impurity is insoluble in that solvent.

Parts: A Soxhlet extraction has three main parts

 Percolator (boiler and reflux) which circulate the solvent.
 Thimble (made of thick filter paper) which retains the solid to be extracted.
 Siphon mechanism which periodically empties the thimble.

Fig. 1 Soxhlet Apparatus

Procedure:
 Normally a solid material containing some desired compound to be extracted is placed inside the thimble
which is made from thick filter paper which is loaded to the main chamber of Soxhlet extractor. The
Soxhlet extractor is placed into a flask containing the extraction solvent.
 The solvent is beated to reflux. The solvent vapor travels up a distillation arm. The condenser ensures that
any solvent vapors cools, and drips back down the chamber housing the solid material.
 The chamber containing the solid material slowly filled with warm solvent. When the Soxhlet chamber is
almost full, the chamber is automatically emptied by a siphon side arm, with the solvent running
background to the distillation flask.
 After extraction the solvent is removed, typically by means of rotary evaporator, yielding the extracted
compound. The non-soluble portion of the extracted solid remains in the thimble, and is usually discarded.
 This cycle may be allowed to repeat many times, over hours or days. During each cycle non-volatile
solvents dissolve in the solvent, and desired compound is concentrated in the distillation flask.

Advantages:
 It is able to extract solute from insoluble impurities.
 It is often used as a benchmark when developing new extraction method.

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Disadvantages:
 Lengthy process (>24hrs)
 Require large vol. of solvent
 Time Consuming.

Applications:
It is the most useful apparatus for solid-liquid extraction in various fields such as:
 Pharmaceutics
 Environment
 Food stuffs

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3.1.2 Maceration Apparatus

Principle: It is based on extraction.
In this process solid ingredients are placed in a stoppered container with the whole of the solvent and allowed to
stand for a period at least 3 days (3-7 days) with frequent agitation, until soluble matter is dissolved. The mixture is
then strained (through sieves / nets), the mare pressed and the combined liquid clarified (cleaned by filtration) or by
decantation, after standing.

Types: Various types of maceration process

 Simple Maceration: A process for tincture made from organized drug e.g. roots, stem, leaves etc.
 Maceration with adjustment: A process for tincture made from unorganized drugs such as oleo resins
and gum resins.
 Double maceration or Triple maceration: Process for concentrated preparations which includes both
“Double maceration” and “Triple maceration”.

Fig. 2 Maceration Apparatus

General Procedure:
 Plant material (crushed or small or moderately coarse powder)
 Placed in a closed vessel.
 Whole of the selected solvent (Menstruum) added.
 Allowed to stand for seven days shaking occasionally.
 Liquid strained off.
 Solid residue (mark) pressed (Recover as much as occluded solution).
 Strained and expressed liquids mixed.
 Clarified by subsidence or filtration.
 Evaporation and concentration.

Advantages:
 Improve juice fermentability.
 Helps to view cells in their entirely, which is not possible while sections are used.
 Helps to study the nature of cell wall thickening including pores.

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Disadvantages:
 A large quantity of inert material (ballast) that has no therapeutic value is extracted.
 This method is slow.
 Raw material is fully exhausted.

Applications:
 This technique is used for the extraction of essential oils and active compounds from plant materials.
 Maceration was a popular and homemade technique for the preparation of tonic for the long time.

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3.1.3 Reflux Assembly

Principle: It is based on heating the chemical reaction for a specific amount of time, while continuously cooling
the vapour produced back into liquid form, using a condenser.
A reflux condenser, also called a vent condenser or knockback condenser, is a vertical tube-side condenser in which
the vapor flows upward. These units are typically used when relatively small amounts of light components are to be
separated from a vapor mixture.

Fig. 3 Reflux Assembly

Advantages:
 The use of reflux condensers prevents evaporation of the solvent of a reaction mixture even when it is
heated for long periods of time.
 A reflux apparatus allows for facile heating of a solution, but without the loss of solvent that would be
result in an open vessel.

Disadvantages:
 One of the most common problems that occur during refluxing is bumping (superheating), and this tends to
happen when you don‟t stir your solution.
 Increasing reflux ratio would act in reverse i.e. it would have a disadvantage of increase in duty of
condenser and reboiler as load increases.

Applications:
 Reflux condensers are used to cool the vapors that heated fluids emit and change their physical state back
to liquid by means of a straight, spiraled or coiled circulation cooling method.
 It is used in industrial and laboratory distillations.
 It is also used in chemistry to supply energy to reactions over a long period of time.

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3.1.4 Ultrasonic Bath Sonicator

Principle: Sonicator works through high-frequency sound waves transmitted through liquid to scrub clean the
surface of immersel parts.
Ultrasonic baths are a cleaning method that uses ultrasound and a liquid to clean objects. Because it is reliable, it is
often used for the final cleaning of components and tools. Ultrasonic baths use Cavitation bubbles induced by high-
frequency pressure (sound) waves to agitate a liquid.

Fig. 4 Ultrasonic Bath Sonicator

General Procedure:
 In your ultrasonic bath, ultrasonic sound (sonics) can be used for cleaning materials and parts, and for
dissolving, homogenizing and degassing liquids. This is how it works:
 As the sound waves from the transducer radiate through the solution in the tank, they cause alternating high
and low pressures in the solution.
 During the low pressure stage, millions of microscopic bubbles form and grow. This process is called
cavitation, meaning “formation of cavities”.
 During the high pressure stage, the bubbles collapse, or “implode” releasing enormous amounts of energy.
 For ultrasonic cleaning applications, these implosions act like an army of tiny scrub brushes. They work in
all directions, attacking every surface and invading all recesses and openings.
 This same energy can be used for other applications, such as liquid dissolving, homogenizations, and
degassing.

Advantages:
 It requires less time to clean the components.
 It is more efficient compare to other methods in removing contaminants.
 The number of rejected parts is reduced and hence cost of materials will be less.
 Solvent expenses have been reduced to greater extent.

Disadvantages:
 The efficiency of transducer affects both cleaning time as well as efficacy achieved during cleaning cycle.
Hence it is advisable to purchase reputed brand ultrasonic cleaner.
 Other factors such as heat, power, frequency, detergent type and time influence overall cleaning process.
 It is made of electronic parts, which has susceptibility of damage due to excess temperatures. Hence
optimum temperature levels are being maintained as recommended by ultrasonic cleaner manufacturer.
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Applications:
 Cleaning the glass ware, lab instruments.
 Dissolve and disperse samples.
 It is used to disperse nano-sized particles into liquids, such as water, oil, solvents or resins.

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3.1.5 Rotavapor
Principle: It is based on evaporation of solvent.
A rotary evaporator (rotovap) is a device used in chemical laboratories for the efficient and gentle removal
of solvents from samples by evaporation. Rotary evaporators are also used in molecular cooking for the preparation
of distillates and extracts.

Fig. 5 Rota Evaporator (Rotavapor)

General Procedure:
 Turn on water bath and set to relevant temperature.
 Ensure water following into water condenser.
 Connect round bottom flask to rotavap. Remember to use clip to ensure flask doesn‟t slip off!
 Turn on vacuum pump, then immediately close tap to put the system under reduced pressure.
 Turn on rotation.
 Briefly wait to see bumping occurs before lowering round bottom flask into water bath.
 Monitor round bottom flask until solvent is removed.
 Once complete, raise round bottom flask out of water bath and stop the rotation.
 Turn off the vacuum pump and immediately but carefully open the tap to release the system from reduced
pressure.
 The round bottom flask should now be available to remove from the rotavap.

Advantages:
 All rotary evaporators have a built-in lifting motor, which can automatically raise the flask to a position
above the heating pot when the power is turned off.
 Due to the centripetal force and frictional force between the liquid sample and the evaporation bottle, the
liquid sample forms a liquid film on the inner surface of the evaporation bottle, and the heated area is large.
In this way, rotary evaporator can guarantee a high evaporation efficiency.
 The feeding system of a rotary evaporator is continuous feeding, which improves the working efficiency of
the evaporation system.

Disadvantages:
 Some samples will boil during the heating process, such as heated ethanol and water.

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 In the rotary evaporator equipment, the glassware needs to be cleaned very often, because rotary evaporator
needs a totally clean container to guarantee the purity of materials. If there is any impurity in the glassware,
the extracted materials will be not pure.

Applications:
 Evaporators are also ideal for very low temperature applications in the food and pharmaceutical industries.
 These include the production of plasma, coffee extracts, fruit juices, bulk drugs, glycerin, sweet water and
yeast extract.

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3.1.6 Diffusion Cell Apparatus

Principle: It is based on measurement of in-vitro drug release from creams, ointments and gel.
Diffusion cell apparatus is used to measure in vitro release of drugs from creams, ointments, oils, and gels. Conduct
Science's diffusion cell apparatus offers six and seven-stage stirring. It comes with a digital RPM indicator and
speed controller, a water level indicator, and a digital temperature controller.

Fig. 6 Diffusion Cell Apparatus

Advantages:
 few handling of tissues
 no continuous sample collecting
 low amount of drug required for analysis.

Disadvantages:
 Franz diffusion cell still has some limitations such as the requirement of a relatively large solution volume
and a large skin area.
 During sampling, gas is often generated between the donor and receptor and interferes with the transdermal
diffusion.

Applications:
 Franz diffusion cells are normally used with excised human or animal skin. However, when biological skin
is not readily available, synthetic membranes are employed.
 Diffusion cell apparatus is used for in vitro release testing (IVRT), pre-formulation characterization of
semi-solid dosage forms, evaluation of permeation of drugs through biofilms, and biomimetic artificial
membrane permeability assay.

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3.1.7 Cooling Centrifugation

Principle: It is based on the principle of sedimentation.
Centrifugation is the process of separating two or more liquids in a mixture by rotation in a container so that the
lighter density liquid rises to the top. It is occasionally necessary to centrifuge samples in refrigerated
conditions to ensure sample integrity.
Most of the work in a refrigerated centrifuge is done at 4 °C. Most centrifuges will claim a lower temperature
range of –20 °C, but not all.
Refrigerated Centrifuge is a high speed centrifuge for medium capacity needs.

Fig. 7 Cooling Centrifuge

Advantages:
 Low weight, easy to design and manufacture.
 Suitable for continuous compressed air supply, such as cooling unit.
 The oil free in nature.
 They have fewer rubbing parts
 Relatively energy efficient.

Disadvantages:
 Unsuitable for very high compression, limited pressure.
 They are sensitive to change in gas composition.

Applications:
 Centrifugation is used to collect cells, to precipitate DNA, to purify virus particles, and to distinguish subtle
differences in the conformation of molecules.
 The refrigerated centrifuge is a vital tool in various scientific and industrial fields, offering precise
temperature cooling during centrifugation process.

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3.1.8 High Performance Liquid Chromatography (HPLC)

Principle: It is based on separation of compounds from mixturers.
HPLC is an abbreviation for High Performance Liquid Chromatography. "Chromatography" is a technique for
separation. The solvent used to separate components in a liquid sample for HPLC analysis is called the mobile
phase. The mobile phase is delivered to a separation column, otherwise known as the stationary phase, and then to
the detector at a stable flow rate controlled by the solvent delivery pump. A certain amount of sample is
injected into the column and the compounds contained in the sample are separated. The compounds separated in the
column are detected by a detector downstream of the column and each compound is identified and quantified.

Fig. 8 HPLC

Parts of HPLC:
 Solvent Reservoir
A glass reservoir holds the mobile stage ingredient. In HPLC, the flexible stage, or dissolvable, is often a
mixture of polar and non-polar liquid segments where specific fixations change depending on the specimen
arrangement.

 Pump
The pump system was developed as a result of the development of HPLC. The pump is located in the upper
stream of the liquid chromatographic column and pumps eluent into the system from the solvent reservoir.

 Injector:
Next to the pump, there is an injector. The easiest way is to use a syringe to insert the sample into the
eluent flow. Sampling loops are the most extensively utilised injection mechanism.

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 Column
The separation takes place within the column. Instead of glass columns, contemporary columns are
frequently manufactured in stainless steel housing. In comparison to calcium carbonate, silica or polymer
gels are commonly utilised as packing materials

 Detector
The separation of analytes takes place inside the column, and the separation is seen using a detector. When
no analyte is present, the eluent has a constant composition. While the presence of analyte alters the
eluent‟s composition. These differences are measured by the detector. This disparity is measured using an
electrical signal. Different kinds of detectors are available.

 Data Collection
Signals from the indicator might be collected via outline recorders or electronic integrators with varying
degrees of multi-sided fidelity and the ability to analyse, store, and reprocess chromatographic data. The
PC coordinates the identifier‟s reaction with each component and records it in a chromatograph that is
simple to read and understand.

General Procedure:
 Read the SDS for all materials.
 Prepare the analyte solution in a fume hood.
 Make sure the solvent reservoirs are filled before using the instrument.
 Make sure that you are using the correct mobile phase. (If you are changing the mobile phase, completely wash
all lines and columns before use.)
 Ensure that the pump lines have been purged of air bubbles and check the system for leaks before beginning
the analysis.
 Turn on the HPLC and equilibrate the mobile phase solution.
 Make sure that the pressure is behaving normally and is well below the maximum pressure for the HPLC
system.
 Constantly monitor the solvent levels in the solvent mobile phase bottles, never let them run dry.
 Click the „injection‟ icon button (or the equivalent on your instrument). Inject the background into the
instrument.
 Once the background has stabilized, then inject your sample into the instrument.
 The HPLC column should be washed for at least 30 minutes after each run to ensure that it is properly cleaned.
The procedure for washing the column and inject will vary depending on the instrument and on the sample that
is being analyzed.
 Turn off the HPLC.
 Dispose of all waste in the appropriate hazardous waste containers.

Advantages:
 Provides data management, security features, and reporting and instrument validation.
 Powerful and adaptable.
 Increases productivity by managing all the areas of analysis - from sample to instrument, and from
separation to reporting results.

Disadvantages:
 HPLC can be a costly strategy, it required countless costly organics, needs a force supply and ordinary
support is required.
 Limitations of HPTLC include short separation bed (62 mm effective length), limited number of samples
per plate.

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Applications:
 The applications of HPLC extend from analyzing small molecules to peptides, to larger complex
compounds like proteins, antibodies, and more.
 HPLC is the main tool for separation and analysis of amino acids, carbohydrates, proteins, lipids and
steroidal hormones.
 Product purity and quality control of industrial products and fine chemicals
 Separation and purification of biopolymers such as enzymes or nucleic acids

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3.1.9 Column Chromatography

Principle: It is based on the principle of adsorption, in which mixture of components dissolved on the mobile
phase is introduced in to the column and the components move depending on their relative affinities.
Column Chromatography is used to isolate active ingredients. It is very helpful in separating compound mixtures. It
is used to determine drug estimation from drug formulations. It is used to remove impurities. Used to isolate
metabolites from biological fluids.
Mobile phase: This phase is made up of solvents
Stationary phase: It is a solid material which should have good adsorption properties.

Types of Column Chromatography:

 Adsorption column chromatography: Adsorption chromatography is a technique of separation, in
which the components of the mixture are adsorbed on the surface of the adsorbent.
 Partition column chromatography: The stationary phase, as well as mobile phase, are liquid
in partition chromatography.
 Gel column chromatography: In this method of chromatography, the separation takes place through a
column packed with gel. The stationary phase is a solvent held in the gap of a solvent.
 Ion exchange column chromatography:A chromatography technique in which the stationary phase is
always ion exchange resin.

Fig. 9 Column Chromatography

General Procedure:
1. Preparation of the column
 Mostly the column is comprised of a glass tube with an appropriate stationary phase
 The bottom end of the column is packed with a glass wool/cotton wool or an asbestos pad after which the
stationary phase is packed.
 After packing the column, a paper disc is placed on the top to avoid the disturbance of the stationary phase
during the introduction of the sample or mobile phase.
 The disturbance in the stationary phase (adsorbent layer) leads to the irregular bands of separation.
 The column should be properly washed and completely dried before in-use.
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2. Introduction of the sample:

 The sample (a mixture of components) is dissolved in the minimum amount of the mobile phase.
 At one instant, the sample is introduced into the column and on the top portion of the column, it is absorbed.
 Through the elution process, the individual sample can be isolated from this zone.

3. Elution technique:
 Through this technique, the individual components are separated completely from the column.
 The process of elution can be carried out by employing two techniques:

(a) Isocratic elution technique: Throughout the procedure, a solvent of the same polarity or same solvent
composition is utilized.
Example: Use of chloroform alone
(b) Gradient elution technique: Throughout the separation procedure, solvents of gradually increased polarity
or increased elution strength are utilized.
Example: Benzene → Chloroform → Ethyl acetate → Chloroform

4. Detection of Components
 In case the mixture separated in a column chromatography procedure are colored compounds, then monitoring
the separation progress is simple.
 In case the compounds undergoing separation are colorless, then small fractions of the eluent are sequentially
collected in tubes that are labeled. Thorugh TLC, the composition of each fraction is determined.

Advantages:
 All different kinds of complex mixtures can be separated by column chromatography.
 The mobile phase has a wide range.
 There is no limit for quantity as any amount of mixture can be separated by this technique

Disadvantages:
 It is a time-consuming process for the separation of compounds.
 It is expensive as higher quantities of solvents are required.
 It has a low separation power.

Applications:
 Column Chromatography is used to isolate active ingredients.
 It is very helpful in separating compound mixtures
 Estimation of drugs in formulation‟
 Isolation of active constituents

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3.2 Paper Chromatography

Principle: It is based on the principle of paper chromatography is partition.
Chromatography technique that uses paper sheets or strips as the adsorbent being the stationary phase through which
a solution is made to pass is called paper chromatography. It is an inexpensive method of separating dissolved
chemical substances by their different migration rates across the sheets of paper. It is a powerful analytical tool that
uses very small quantities of material.

Types of paper chromatography:

Ascending Paper Chromatography: The techniques goes with its name as the solvent moves in an upward
direction.
Descending Paper Chromatography: The movement of the flow of solvent due to gravitational pull and
capillary action is downwards, hence the name descending paper chromatography.

Fig. 10 Paper Chromatography

General Procedure:
Step 1: Prepare the Stationary Phase
Cut a piece of filter paper to the desired size. The size of the paper depends on the amount of the mixture to be
separated. The paper should be long enough to hang over the edge of the container holding the solvent.

Step 2: Spotting the Sample

Using a capillary tube or micropipette, spot the mixture onto the filter paper. The spot should be small and
concentrated. The spot should be allowed to dry completely before proceeding.

Step 3: Preparing the Mobile Phase

Prepare the mobile phase by pouring a small amount of the solvent into a container. The level of the solvent should
be below the spot on the filter paper.

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Step 4: Placing the Paper in the Container

Place the filter paper in the container with the solvent. The paper should be held in place so that it does not move.

Step 5: Developing the Chromatogram

Allow the solvent to move up the paper by capillary action. The solvent will carry the different components of the
mixture along with it. Once the solvent has reached the top of the paper, remove the paper from the container and
allow it to dry completely.

Step 6: Analysing the Chromatogram

The chromatogram can be analysed visually or using other methods such as UV or fluorescence spectroscopy. The
different components of the mixture will appear as spots on the paper. The distance travelled by each component can
be measured and used to identify the component.

Advantages:
 It requires fever quantitative material.
 Separation of compounds in a short time.
 Analysis requires a low amount of sample.
 Compare to other chromatography methods paper chromatography is a cheap technique.

Disadvantages:
 Volatile substances cannot be separated using paper chromatography techniques.
 Paper chromatography cannot be compatible with large amounts of sample.
 Quantitative analysis is not useful in paper chromatography.

Applications:
 To check the purity of pharmaceuticals.
 To inspect cosmetics.
 To detect the adulterants.
 To detect the contaminants in drinks and foods.

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3.2.1 UV Spectrophotometer
Principle: It is based on the principle is that each compound absorb an transmits light cover a certain range of
wavelength.
Ultraviolet-visible (UV-Vis) spectroscopy is a widely used technique in many areas of science ranging
from bacterial culturing, drug identification and nucleic acid purity checks and quantitation, to quality control in the
industry and chemical research
UV spectroscopy is a type of absorption spectroscopy in which light of the UV region (200–400 nm) is absorbed by
the molecule. Absorption of the UV radiations results in the excitation of the electrons from the ground state to a
higher energy state.

Fig. 11 UV Spectrophotometer

Advantages:
 The advantage of an Ultraviolet - Visible Light Spectrophotometer (UV-Vis spectrophotometer) is its quick
analysis ability and easy to use.
 Quick analysis ability and easy to use.
 Due the advantage of fast and easy analysis ability, an UV-Vis spectrophotometer is also widely used in the
researches.

Disadvantages:
 The main disadvantage of UV-Vis spectroscopy is that it can only be used to analyze substances that absorb
light in the ultraviolet or visible region of the electromagnetic spectrum.
 The machine is susceptible to contamination.
 It cannot be used to measure solid or gaseous samples.

Applications:
 UV visible spectroscopy technique is applied as a quantitative technique in various market segments such
as food and beverages, pharmaceutical, chemical, water testing, and biotech industry
 UV Spectroscopy uses ultraviolet light to determine the absorbency of a substance. In simple terms, the
technique maps the interaction between light and matter and measures. As matter absorbs light it undergoes
either excitation or de-excitation, which generates what is known as a spectrum.
 Used for quantitative and qualitative analysis of those compounds which absorbs uv radiation.

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 There are still some fields where UV-Vis spectroscopy is widely used like Quality control, Cosmetic
industry, Pharmaceutical research, Optical components, Food and agriculture, Life sciences, Traditional
chemistry.

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3.2.2 Fourier Transform Infrared Spectroscopy (FTIR)

Principle: It is act on the principle that when infrared (IR) radition passes through a sample, some of the radiation
is absorbed. The radiation passes through the sample is recorded.
FTIR stands for “Fourier transform infrared” and it is the most common form of infrared spectroscopy. All infrared
spectroscopies act on the principle that when infrared (IR) radiation passes through a sample, some of the radiation
is absorbed. The radiation that passes through the sample is recorded.

Fig. 12 FTIR Spectroscopy

Advantages:
 With FTIR, spectrum can be obtained very quickly and saves time.
 Gases, solids as well as liquid can be analysed with FTIR.
 By using FTIR no external calibration is required and gives accurate results.
 FTIR is non-destructive technique.

Disadvantages:
 FTIR instrument have only single beam while dispersive instrument generally have a double beam.
 Limited surface sensitivity (typical limit of detection is a film thickness of 100 nm)
 Limited to identifying functional groups.
 Difficulty in identifying complex samples.

Applications:
 FTIR spectroscopy is used to quickly and definitively identify compounds such as compounded plastics,
blends, fillers, paints, rubbers, coatings.
 FTIR can be used in natural products research to identify and characterize the compounds found in
microorganisms, plants, fungi and animals.
 It can also be used to understand biomaterials to optimize their properties for different applications.
 It helps in verifying the composition of drugs, ensuring batch consistency and detecting impurities.

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3.2.3 Dissolution Apparatus

Principle: It is based on the principle to provide information on the in-invitro release of drugs in order to predict
their in-vivo behavior.
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate
the performance of the product. Currently there are 7 different types of dissolution apparatus defined in Usp (United
State Pharmacopoeia) - basket, paddle, reciprocating cylinder, flow-through cell, paddle over disc, rotating cylinder
and reciprocating disc.

Fig. 13 Dissolution Apparatus

Advantages:
 The major advantage of dissolution testing is that the rate of release and the extent of absorption of a drug
is determined by the dissolution of the dosage form.
 The dissolution test apparatus is simple to use, requiring no specialist to handle.
 It is well standardized and sufficiently flexible to allow perform testing for a broad range of oral solid
dosage forms.

Disadvantages:
 The major disadvantage of the dissolution process is that the amount of media required to be maintained at
each interval time, which feels the analyst uncomfortable.
 The results depend on other instruments, the sample of dissolution needs to be analyzed in UV/VIS
spectrophotometer or high-performance liquid chromatography (HPLC).
 Dissolution requires large amounts of media and takes longer to prepare and adjust the pH of the buffer.

Applications:
 Dissolution apparatus are used throughout the product development life cycle, from Product release to
stability testing and study of the product data from product to product. Then after passing or approval from

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the Quality control and Quality assurance, drugs are sent to markets.
 It is primarily carried out to assess product stability, monitor formulation changes over time.
 Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet,
capsule, ointment, etc.

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3.2.4 Spray Dryer

Principle: It atomizes the lipid into small droplets, providing the large surface for mass and heat transfer. Using
hot air the drops are sprayed so that they dried into solid particles.
Spray drying is a method of forming a dry powder from a liquid or slurry by rapidly drying with a hot gas. This is
the preferred method of drying of many thermally-sensitive materials such as foods and pharmaceuticals

Fig. 14 Spray Dryer

Advantages:
 Short residence times and suitability for both heat-sensitive and heat-resistant foods are other advantages.
 The technology is suitable for a variety of feed materials.
 Superior product quality
 Preservation of active ingredients
 Versatility
 Reduction of contaminants

Disadvantages:
 Spray drying only works for feeds that can be atomized.
 Often, dilutions and solvents can overcome atomization problems, but not always
 High energy consumption
 High capital cost
 High tempratures

Applications:
 Spray drying is a highly cost-effective method of obtaining powder from heat-sensitive liquids such as milk
and whey while retaining valuable nutrients, aromas, and flavours.
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 Spray drying preserves the potency and efficacy of active components, making it a suitable method for
manufacturing high-quality pharmaceuticals and biopharmaceuticals.
 Drying of organic and inorganic products
 In pharmaceuticals, spray drying disperses active ingredients evenly into a polymer matrix, producing
amorphous solid dispensation.

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3.2.5 Freeze Dryer (Lyophilizer)

Principle: It is based on the principle of sublimation. Freeze dryers work by freezing the material, then reducing
the pressure and adding heat to allow the frozen water in the material to change directly to the vapor.
Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed
under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase.

Fig. 15 Freeze Dryer

Advantages:
 Freeze-drying retains nutritional value better than other drying methods.
 The process also preserves the actual color and shape of the original raw material.
 Enhancing the stability of a dry powder as well as the product stability in dry state.

Disadvantages:
 High cost of equipment.
 It takes longer time.
 Requires higher energy consumption.
 Production cost

Applications:
 Primary applications of freeze drying include biological (e.g., bacteria and yeasts), biomedical (e.g.,
surgical transplants), food processing (e.g., coffee) and preservation.
 In the pharmaceutical industry, freeze drying is used for preserving and storing high value products such as
vaccines, antibiotics, biologicals, hormones, active ingredients and reactives.
 It is also used for collagens, APIs and electrolytes.

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3.2.5 Particle Analyzer

Principle: It works on the principle that when a beam of light (a laser) is scattered by a group of particles, the angle
of light scattering is inversely propotional to particle size (i.e. the smaller the particle size, the larger the angle of
light scattering).
Particle analyzers are used to determine the size and distribution of particles making up a material. Particle size
analyzers are used in numerous fields for research and development, manufacturing and for quality control and
product testing.

Fig. 16 Particle Analyser

Advantages:
 Easy to operate.
 Fast test speed.
 Wide test range.
 Good repeatability and accuracy on-line measurement and dry measurement.
 Simple to use
 Wide measurement range

Disadvantages:
 High equipment cost.
 Low resolution.
 Low representation
 Not apply to wide size distribution of samples

Applications:
 Particle characterization analyzers have found uses in quality control, process material evaluation, research
and development for dozens of applications.
 Particle size is a crucial parameter in the pharmaceutical industry, because it influences surface area and
porosity, hence, has an impact on bioavailability, effectiveness and shelf life of a drug.
 Particle size analyzers are used to measure small size of particles, such as powders used to make foods and
pharmaceutical preparations to nano materials.

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 Particle size is important as it plays a key role in the amount of chemical reaction required when the
product is being used.

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Chapter-4
Learning Outcome

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4.1 Learning Outcome:

Industrial training is very much essential for Pharmacy Students. It is also a great opportunity to acquire practical
knowledge. During our training period, in the industry I acquired lots of experiences in Pharmaceutical Production
and Production management. This will help me to clarify my theory knowledge. I hope and pray that it will help me
much in my future profession.
During our training period, we had seen the various instruments an apparatus in the industry. The highly
sophisticated instruments that work precisely must be operated with intense care for opmim use. We could acquire a
lot of information regarding the latest instruments and their working procedures. It was taught to us that, CGMP
guidelines are to be strictly followed in the industries in each and every section and the similar guideline was seen
followed in ONIONSOME HEALTHCARE PVT.LIMITED INDUSTRIAL AREA, SECTOR-73 PHASE-8B
SECTOR-7, S.A.S NAGAR MOHALI, PUNJAB. It helped us to acquire knowledge on punctually ,regularity and
working environments in industries.
The friendly working environment in ONIONSOME HEALTHCARE PVT.LIMITED. Will remain in our mind in
near future. Hence, we can say that our goal of attending the industrial tour is fulfilled. We acknowledge the great
help “ONIONSOME HEALTHCARE PVT.LIMITED”.
During our traning period we can prepare some preparations which are as following:

4.1.2 METHOD OF PREPARATION OF GEL:

GEL: Pharmaceutical gels are semisolid preparations which may contain suspension of molecules dispersed in a
suitable vehicle using a gelling agent.
Requirements: sample (drug), Carbopol, Volumetric flask, culture tube, Glass
rod, NaOH Solution, water, petri dish.
Procedure:
 Take sample from the culture tube in the volumetric flask.
 Dilute it and make up the volume up to mark with water.
 Transfer it into culture tube.
 Add 2% carbopol to it.
 Keep it aside for 24 hrs. So that it can swell.
 On the next day, add conc.NaOH to it to form gel & mix it well.
 Gel will be formed.
 Repeat this procedure by taking 1% carbopol & 3% carbopol.
 Check that gel of best quality in which conc. of carbopol is formed.

Fig. 17 Gel

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4.1.2 METHOD OF PREPARATION OF GLYCEROSOMES

Glycerosomes: Glycerosomes are bilayer vesicles used for dermal and transdermal drug delivery. These vesicles
differ from conventional liposomes in bilayer fluidity, formed by the addition of phospholipids and varying
concentrations of glycerol.
Requirements: Phospholipid -300 mg (0.300 g), Cholesterol- 20 mg (0.020g), Glycerol-3%
Procedure:
 Weigh 0.300g Phospholipid &0.020g cholesterol by weighing machine.
 Add 10ml chloroform in round bottom flask, add both weighed cholesterol and phospholipid to it &
sonicate it.
 Keep in Rotaevaporator at 400C & evaporate it.
 Keep it aside for 1 hr.
 Prepare3% glycerol solution .(take 0.3ml glycerol by using micropipette & add it into A grade 10 ml
volumetric flask and make up the volume with water.
 Then add glycerol solution to dried mixture of Round bottom flask.
 Sonicate it.
 Glycerosomes will be formed.

Fig. 18 Glycerosomes in rota evaporator

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4.1.3 METHOD OF PREPARATION OF PATCHES

Patches: The mouth dissolving patches are the patches that attach to your skin and contains medication. The drug
from the patch is absorbed into your body over a period of time. If you'd rather not have a pill or an injection, a
patch may be a more comfortable option for taking some medications.
Requirements: HPMC (Hydroxy propyl methyl cellulose) E50 400mg (0.400g), HPMC E15 400mg (0.400g),
Paracetamol-50mg (0.050 mg), Propylene glycol-2.2ml, Citric acid 20mg (0.020g), bead,
Procedure1:
 Weigh 400mg HPMC E15 & dissolve it into 20ml water by
 Continue stirring at 200 rpm on Digital Magnetic Stirrer.
 Keep it on the stirrer for at least 3hrs. until it gets dissolved completely.
 Then, add 50mg paracetamol, 2.2ml propylene glycol, 20mg citric acid to it while keeping on stirrer.
 Keep it in the desiccator for 24 hrs. at 580C.
 Ultimately, cut the patches into 1×1cm2

Fig. 19 Mouth Dissolving Patches of PCM

Procedure 2:
 Weigh 400 mg HPMC E50 & dissolve it into 20ml water by
 Continue stirring at 200 rpm on Digital Magnetic Stirrer.
 Keep it on the stirrer for at least 3hrs. Until it gets dissolved completely.
 Then, add 50 mg paracetamol, 2.2ml propylene glycol, 20mg citric acid to it while keeping on stirrer.
 Keep it in the desiccator for 24 hrs. At 580C.
 Ultimately, cut the patches into 1×1cm2.

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Chapter-5
Contact details of organization

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5.1 The Contact details of the company are:

Address of the company: F-237, Phase VIII-B, Industrial Area, S.A.S Nagar, Mohali- 160071 (Punjab) INDIA

General Enquiries
 Company Email: [email protected]
 CEO Emial: [email protected]
[email protected]
 Phone No: +91172460 8443
 Mobile No: +9197818 59505

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