PROJECT REPORT

ON TRAINING
AT
ARBRO PHARMACEUTICALS PVT. LTD.
Submitted to
Hindu College of Pharmacy, Sonipat

Submitted By
RISHI VERMA (52-B-21)
MADHUR KUMAR (33-B-21)
VIVEK KHATRI (68-B-21)
YUGANSH JAIN (69-B-21)

B. PHARMACY 7th SEMESTER

 INTRODUCTION

ARBRO PHARMACEUTICALS PRIVATE LIMITED, a tested & trusted name in Indian

pharmaceutical industry having more than 35 years of experience in manufacturing and
exporting of pharmaceutical formulations, trading of raw materials and Research &
Development for pharmaceutical Industry
Dedicated to providing the best quality products in pharmaceutical, biotechnology & healthcare
Industry, Arbro is at paramount & has a strong presence in exports, generic formulations,
ethical range of products, institutional & government supplies as well as recognized as
Government approved R & D facility by Department of Science and Technology, Government
of India.
Established in 1985 by the chairman of the group Mr. Vijay Kumar Arora with the long term
objective and high corporate values.
Manufacturing facilities at Arbro Pharmaceuticals are in accordance with WHO GMP
standards. Arbro Pharmaceutical Ltd. is accredited with WHO GMP and ISO 9001:2008
certification.
 PURPOSE OF TRAINING
As Bachelor of Pharmacy students, we recently completed a valuable training program at
Arbro Pharmaceuticals. This immersive experience was designed to bridge the gap between
theoretical knowledge and practical application within the pharmaceutical industry.
Our primary objective was to gain firsthand exposure to real-world operations, observing and
learning the intricacies of laboratory procedures, equipment handling, and overall workflow
within a pharmaceutical setting. We sought to understand the practical application of the
concepts learned in our coursework and to develop a deeper appreciation for the complexities
and precision required in pharmaceutical manufacturing and quality control. This training
provided a unique opportunity to witness how theoretical principles translate into tangible
processes within a professional laboratory environment.
• Pharmaceutical Industry: "This training at Arbro Pharmaceuticals provided invaluable
insight into the various stages of drug development, manufacturing, and quality
control within a real-world pharmaceutical setting. This experience directly aligns
with my career aspirations of working in the pharmaceutical industry, specifically in
areas like [mention specific areas like quality assurance, research and development, or
production]."
• Research and Development: "Observing the research and development processes at
Arbro, particularly [mention specific techniques or technologies you observed],
solidified my interest in pursuing a career in pharmaceutical research. This hands-on
exposure has given me a clearer understanding of the challenges and rewards involved
in developing new drugs and therapies."
• Quality Control and Assurance: "The rigorous quality control procedures I witnessed
at Arbro Pharmaceuticals emphasized the critical role of quality assurance in ensuring
patient safety and drug efficacy. This experience has strengthened my desire to
specialize in quality control within the pharmaceutical industry, where I can
contribute to maintaining the highest standards of pharmaceutical products.
• Practical Skills: "The training at Arbro allowed me to develop essential practical
skills, such as operating lab equipment, following SOPs, data analysis, etc., which are
highly transferable to various roles within the pharmaceutical field.
• Industry Knowledge: "Gaining insights into the regulatory landscape, industry
standards, and ethical considerations within the pharmaceutical industry has provided
me with a competitive edge as I enter the job market.
• Professionalism: "Working in a professional environment at Arbro has enhanced my
communication, teamwork, and problem-solving skills, all of which are crucial for
success in any pharmaceutical career.
Our month-long training at arbro pharmaceuticals provided a comprehensive overview of
various key departments within the pharmaceutical industry. The program was structured to
give us in depth experience in four distinct areas, with each week dedicated to a specific
department.
There were four departments:
1. Analytical department
2. Instrumental department
3. Manufacturing/Production unit
4. Microbiology department
Spending a week in each department afforded us the opportunity to observe and participate in
the daily operations, gaining a practical understanding of processes and technology involved.
 ANALYTICAL DEPARTMENT
Analytical department consisted of various sub areas i.e., separate areas for testing of drug
and cosmetics, food products, raw materials, Water and packaging Lab.
In analytical department materials from all over the market are sent for testing to check
whether they contain the right amount of ingredients or not as mentioned on the labelling of
the product.
Various tablets and capsules are also tested for their dissolution and disintegration time and
their packaging is also subjected to leak test.
I)Testing for drugs and cosmetics:
While we were in that area we did test on various drugs. For eg:
1.IROSTEP-XT:
It was tested for its iron content.
PROCEDURE:
i. 1st dilution:Take sample/test and add 15ml HCl. Heat the mixture for 10-15 mins.
Make volume with H20 and filter the sample.
ii. 2nd dilution:5ml from previous sample is taken and dissolved in 50ml water.
iii. If black coloured, charcoal is added.
iv. 3rd dilution:
STANDARD TEST BLANK
-5ml std soln -5ml test soln -Citric acid (2ml)
-Citric acid (2ml) -Citric acid (2ml) -Thioglycolic acid (0.2ml)
-Thioglycolic acid (0.2ml) -Thioglycolic acid (0.2ml) -Ammonia (5ml)
-Ammonia (5ml) -Ammonia (5ml)

+ make the volume upto 25ml with water

v. The standard solution, test solution and blank solution are subjected to UV
Spectrophotometry.
OBSERVATION:
COLOUR Absorbance
STANDARD SOLUTION Pink 0.2719
TEST SOLUTION Pink 0.4431
BLANK SOLUTION No colour

2.Diethylcarmabazine Citrate Tablets IP 100mg:

These tablets were tested for their hardness, friability and dissolution. During hardness testing
12 tablets are taken from each sample
For friability of tablets, approx. 6.5gm of tablets are taken and put in friability test apparatus
for 4 mins. In 1min the apparatus completes about 25 rotations, therefore in 4 mins it will
complete 100 rotations. For tablet to pass the friability test the reading should be less than 1.
Friability=W1-W2
X 100
W1

Where W1= initial weight

W2= weight after 4 mins in friability apparatus
For dissolution testing apparatus consist of:
• A cylindrical vessel with a hemispherical bottom
• A motor with a speed regulator capable of maintaining the speed of rotation of the
serialized paddle
The buffer which is filled in the cylindrical vessel is made by phosphate buffer (47.6g) +
NaOH (6.3g) + make the volume upto 7L.

II) Testing for food products:

In this department, various products are such as nutraceuticals, dietary supplements, all types
of meat and other ingredients used in daily use such as besan, wheat, dal, etc.
The products are tested mainly for fats, Sugar, proteins and dietary fibres.
Various procedures used for testing these are:
FIG: Protein distillation
Fig: Dietary fibres

INSTRUMENTAL DEPARTMENT
In instrumental department there were different areas for different instrument i.e.,
1. Gas chromatography
2. HPLC
3. HPTLC
4. ICP

I)GAS CHROMATOGRAPHY:
PRICIPLE: The equilibrium for gas chromatography is partitioning, and the components of the
sample will partition (i.e. distribute) between the two phases: the stationary phase and the mobile
phase.

Compounds that have a greater affinity for the stationary phase spend more time in the
column and thus elute later and have a longer retention time (Rt) than samples that have a
higher affinity for the mobile phase.
Affinity for the stationary phase is driven mainly by intermolecular interactions and the
polarity of the stationary phase can be chosen to maximize interactions and thus the
separation.
PARTS OF GAS CHROMATOGRAPHY:
1. Carrier gas in a high-pressure cylinder with attendant pressure regulators and flow
meters
2. Sample injection system
3. The separation column
4. Liquid phases
5. Supports
6. Detector
7. Recorder
II)HPTLC:
• HPTLC apparatus consists of three parts:
1.Injector
2.Visualizer
3.Scanner
• Steps involved in HPTLC:
1.Definition
2.sample application
3.pre-chromatographic derivatization
4.development
5.post chromatographic derivatization
6.Detection
7.Documentation

Figure: INJECTOR

Figure: Visualizer

Figure: Scanner
III)HPLC (HIGH PERFORMANCE LIQUID CHROMATOGRAPHY)
HPLC is an analytical technique used for the separation of components of an organic mixture
of compounds when such compounds are nonvolatile, thermally unstable, and have relatively
high molecular weights.
A liquid carrier stream termed as the mobile phase serves to carry the injected sample through
the separation column and to the detector. In the separation column, the individual
components are separated based on physicochemical interactions, and the elution order is
based on such interactions. The separated components are detected by the detector based on
the absorption of light or changes in refractive index, electrochemical/conductivity changes,
or simply the size distribution of eluting molecules.
Major parts of machine include:
1. Pumps
2. Detectors
3. Injectors
Liquid Phase
The liquid phase is pumped at a constant rate to the column packed with the stationary phase.
Before entering the column, the analysis sample is injected into the carrier stream.
On reaching the column, the sample components are selectively retained based on
physicochemical interactions between the analyte molecules and the stationary phase.
Mobile Phase
The mobile phase serves to transport the sample to the system. Essential criteria of the mobile
phase are inertness to the sample components. Pure solvents or buffer combinations are
commonly used. The mobile phase should be free of particulate impurities and degassed
before use.
Mobile Phase Reservoirs
These are inert containers for mobile phase storage and transport. Generally, transparent glass
bottles are used to facilitate visual inspection of mobile phase level inside the container.
Stainless steel particulate filters are provided inside for the removal of particulate impurities
in the mobile phase if any.
Pumps
Variations in flow rates of the mobile phase affect the elution time of sample components and
result in errors. Pumps provide a constant flow of the mobile phase to the column under
constant pressure.
Injectors
Injectors are used to provide constant volume injection of the sample into the mobile phase
stream. Inertness and reproducibility of injection are necessary to maintain a high level of
accuracy.
Column
A column is a stainless-steel tube packed with a stationary phase. It is a vital component and
should be maintained properly as per supplier instructions for getting reproducibility and
separation efficiency run after run.
Column Oven
Variation of temperature during the analytical run can result in changes in the retention time
of the separated eluting components. A column oven maintains a constant column
temperature using air circulation. This ensures a constant flow rate of the mobile phase
through the column.
Detector
A detector gives a specific response for the components separated by the column and also
provides the required sensitivity. It has to be independent of any changes in mobile phase
composition. The majority of the applications require UV-VIS detection, though detectors
based on other detection techniques are also popular these days.
Data Acquisition & Control
Modern HPLC systems are computer-based and software controls operational parameters
such as mobile phase composition, temperature, flow rate, injection volume and sequence,
and also acquisition and treatment of output.

IV)ICP-MS (Inductively Coupled Plasma Mass Spectroscopy):

ICP-MS is an elemental analysis technique, meaning it is used to measure elements, rather
than the molecules and compounds that are measured by LC/MS and GC/MS.
Main components of a triple quadrupole ICP-MS instrument:
1. The sample introduction
ICP-MS is usually used to measure liquid samples. The sample solution is pumped into a
nebulizer, where the liquid is converted into a fine spray or aerosol mist using a jet of argon
gas. The aerosol mist passes through a spray chamber, where the larger droplets are removed.
The fine droplets are carried by the argon gas flow to the ICP plasma torch.

2.The ICP (plasma) ion source:

The term “plasma”, which refers to a substantially ionized gas. The plasma is formed from
argon gas flowing in a quartz tube. The argon gas is ionized by a radio frequency generator.
The sample aerosol is carried through the center of the plasma. The plasma of an ICP-MS
plays a critical role in decomposing the sample matrix, dissociating potential interferences,
and ionizing the analyte atoms. Indeed, the overall performance of an ICP-MS is highly
dependent on the plasma torch design and operating conditions.

3. The vacuum interface

The plasma ion source and the quadrupole mass spectrometer are separated by a vacuum
interface, which transfers ions from the plasma (at atmospheric pressure) to the mass
spectrometer (in a vacuum chamber). The interface consists of a series of cooled metal plates
or “cones” with small holes in them to allow the ions to pass through. An ICP-MS interface
includes a sampling cone (left) and skimmer cone (right).
4. Ion focusing and separation
After the ions pass through the interface cones, they are focused into a narrow beam using an
ion “lens”. The lens is composed of several metal plates with adjustable voltages applied to
them. A plate with a positive voltage repels the positively charged ions while a plate with a
negative voltage attracts the ions. A combination of lens plates with different voltages is used
to steer and focus the ions.
5. The mass spectrometer (MS)
Most ICP-MS instruments use a quadrupole (or “quad”) mass spectrometer to filter ions by
mass, or, more accurately, by mass to charge ratio (m/z).
6. The electron multiplier detector
The EM uses a high voltage electrode (or dynode) positioned so that ions that emerge from
the quadrupole strike the dynode. Each ion that strikes the first dynode releases one or more
electrons from the dynode surface. These electrons strike the second dynode, releasing further
electrons to strike the third dynode and so on down the detector. By the final dynode, the
cascade of electrons has built up to a high enough level that it can be recorded as a pulse or
“count” by the EM electronics.
 MICROBIOLOGY DEPARTMENT
Next we went to microbiology department, where they showed us various
SOP’s which stated how to enter and exit a microbiology lab, how to make a
culture media and lastly regarding environmental monitoring.
There we performed finger dabbing.
Method of finger dab:
1. Prepare SCDA medium as per SOP for preparation of culture media.
2. Aseptically pour approximately 15-20 ml of sterile molten cooled (45°C)
SCDA agar into sterile 90 mm Petri plates.
3. Allow solidifying the plates at the room, after solidification label all the
plates with the name of media, preparation batch No. and date of preparation.
4. Invert and incubate the plates at 30 to 35°C for 24 hrs. After incubation
checks the plates for any contamination if there is contamination discard the
plates as per the latest SOP for Destruction of Microbial waste by Autoclaving.
5. After pre-incubation, label all the plates with the date of sampling, Personnel
name and Shift with the help of marker pen and wrap with aluminum foil and
then keep in clean SS container
6. Transfer the container to the sterile area through pass box and personnel must
be entered through Air locks as per latest SOP for Entry and gowning procedure
for the sterile area.
7. Collect the materials from pass box and disinfect the container with sterile
70% IPA solution.
8. Call operator or personnel to be monitored, open the plate and tell personnel
to place his/her right-hand fingers with gloves gently on the surface of SCDA
plate. Use a fresh plate for left-hand finger and fallow the same procedure.
9. Immediately, disinfect the fingers with sterile 70% IPA solution and observe
his/her finger carefully for the absence of media.
10. Close the plate and fallow the same procedure for all personnel.
11. Prepare a positive control plate by streaking any pure culture of E. coli /
Salmonella abony/ Staph. aureus/Ps. aeruginosa or wild culture, on the surface
of SCDA plate. For negative control, incubate the plate as it is without
streaking.
12. Invert and incubate all the plates at 20 – 25°C for 72 hrs and 30 to 35°C for
48 hours.
13. After incubation, count the number of CFU formed on the plates with the
help of colony counter. Operate the colony counter as per SOP and record the
results per 5 finger.
 PRODUCTION/MANUFACTURING UNIT
In our last week we went to manufacturing unit. There were basically following departments
.i.e.,
Storage, syrup manufacturing, tablet manufacturing.
I)STORAGE:
Storage was in the basement where the raw material is received, stored, dispensed to various
other departments.
Incoming materials undergo a rigorous quality control process upon arrival. Initially, they are
held in a designated quarantine area and labeled with a yellow "Under Testing" tag. This
allows for thorough evaluation. Once testing is complete and the material meets our stringent
quality standards, it receives a green label, signifying its release for use in production and
materials who fail the quality tests are labelled with a red label and are unfit for use.
Our storage system is organized alphabetically for efficient retrieval, with a separate,
specialized area dedicated to temperature-sensitive (thermolabile) materials.
To maintain the highest standards of purity and prevent contamination, all dispensing occurs
under a reverse laminar air flow. Meticulous records are kept, detailing the quantity of
material received, the amount dispensed, the time of dispensing, and the remaining balance.
This comprehensive tracking ensures complete transparency and accountability.

II)TABLET MANUFACTURING:
Steps involved in processing of tablets:
1. Preparation of granules for drying
2. Drying
3. Mixing
4. Compression of granules into tablets
 5. Coating of tablets
6. Evaluation of tablets

Rapid mixing graulator

Fluidised bed dryer

Octagonal mixer

Compressing machine

Tablet coating
III) SYRUP MANUFACTURING:
Basic steps involved in production of syrup:

Stirrer- for mixing all solid components

Sugar melting vessel- in this the sugary base for the syrup is made using
steam

Syrup manufacturing vessel- the sugary base is mixed with the solid
components in this vessel

Storage vessel-After the syrup is produced it is transferred into

storage vessel

Transfer pump (filter press)- it is used to transfer the syrup from

storage vessel to packaging area

Further it is transferred to filling area to be filled in the containers

The container filled with syrup is sent for capping and after capping the bottle
is washed again and it is labelled and packed

STIRRER
 Bottle washing machine

Filling machine