INDUSTRIAL TRAINING REPORT

ON
RESCUE LABORATORIES

ARYA COLLEGE OF PHARMACY

KUKAS, JAIPUR

Supervised By: Submitted By

Dr. Ashok Kumar Sharma Vikram Choudhary
(Associate Professor) Enroll No.: 2019/0192
B. Pharma 7th semester

ARYA COLLEGE OF PHARMACY, KUKAS, JAIPUR

AFFILIATED TO
RAJASTHAN UNIVERSITY OF HEALTH SCIENCE, JAIPUR (RAJ.)
 TRAINING REPORT AT

RESCUE LABORATORIES
This training report submitted to the Arya College of Pharmacy,
Kukas, Jaipur, in the partial fulfillment of the requirement for the
award of Degree of Bachelor of Pharmacy.

Date: Submitted by :-
Vikram Choudhary
B.Pharma 7th sem.
(2019-2024)

ARYA COLLEGE OF PHARMACY, KUKAS, JAIPUR

AFFILIATED TO
RAJASTHAN UNIVERSITY OF HEALTH SCIENCE, JAIPUR (RAJ.)
 ARYA COLLEGE OF PHARMACY
KUKAS, JAIPUR
(Approved by PCI, AICTE, New Delhi and recognized by

Govt.of Rajasthan, affiliated to RUHS Jaipur)

CERTIFICATE
This is to certify that Mr. Vikram Choudhary
Enrollment No. 2019/0192 Student of B. Pharma
Final year has satisfactorily submitted Report on

“INDUSTRIAL TRAINING’’

Supervised By :-
Dr. Ashok Kumar Sharma PRINCIPAL
Associate Professor Dr. Vandana Sharma
Dept. of Pharmaceutical Arya college of Pharmacy
Arya college of pharmacy
 ACKNOWLEDGMENT
I great please and dedicated gratitude to those personalities who gave me
their valuable blessings, guidance & esteemed co-operation in
motivating me to complete my Industrial training.
I am heartly thankful to Dr. Arvind Aggarwal (president, Arya college
of Pharmacy) to give me their valuable time for awarding me guidance
and genuine interest in completing my training quite nicely.
I am also thankful to Dr. Ashok Kumar Sharma (Guide), to give me
valuable guidance. His valuable suggestions, comments and guidance
encourage me to learn more day by day, as well as providing necessary
information regarding the training report & also for his support in
completing the training report.
I am very thankful to Mr. Vinod Sharma (Director), and all the
employees of Rescue laboratories Ltd. Who permitted me for training
and give the complete information which helps me in completing my
training. I am also thankful to my friends. In the last I acknowledge the
affection courage and consistent motivation given to me by My
Teachers & My Family.
I would also convey my heartiest thanks to all my teachers for their
direct and indirect helping this venture.

Place:- Jaipur Vikram Choudhary

Date: B. Pharma, 7th semester
 CONTENT

 INTRODUCTION

 QUALITY POLICY AND OBJECTIVES

 REQUIREMENTS OF FACTORY PREMISES

 PRODUCTION

 PACKAGING SECTION

 QUALITY CONTROL

 QUALITY ASSURANCE

 MICROBILOGICAL LAB

 STORES

 SAFETY AND PRECATIONS

 MANUFACTURING RECORDS

 CONCLUSION
 TRAINING REPORT

1. INTRODUCTION

1.1 Information about the firm:-

 RESCUE LABORATORIES FN-01 Industrial area VKIA-14

Jaipur ( raj ).
 We are a full Manufacturer of Calcium Bones Animal Feed Supplement,
Feulidium Powder & Lactozyme Vet from Jaipur, Rajasthan, India.
 Due to the establishment of industrial area, water, electricity, raw
materials are easily available.

Name of the Company : RESCUE LABORATORIES

Constitution : Pvt Ltd.
Address : FN-01 Industrial area VKIA-
14 Jaipur (Rajasthan)
Location of the Unit:-

 Location plays very important role in establishments of the company. in

the beginning of the company many factors affect upon the location of the
company.
 Good infrastructure facilities have also attained the promoters to choose
this place for the establishment of the company facilitates like water.
Transport, electricity and availability of raw materials and large estate
help the company.
 Due to the establishment of industrial area, water, electricity, raw
materials are easily available.

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1.2 Product Licensed For Manufacture In RESCUE

LABORATORIES LIMITED

licensed to manufacture, store & distribute for sale of different formulations of

capsules, dry syrups, oral liquids (under schedule C& C(1) and other than C&
C(1) of the Indian Drugs & Cosmetics Acts & Rules, 1945) By the Drugs
Controller and Licensing Authority , ( India ).

2. QUALITY POLICY AND OBJECTIVES:-

RESCUE LABORATORIES LIMITED is a relentless

commitment to continuous improvement in product, process and system to
provide consistent quality products to meet our customer’s requirements
worldwide. The management is fully committed to quality and ensures all
resourced to accomplish this test.

2.1 Quality Objectives:-

 To focus on customers and successfully met their needs and requirements.
 To manufacturing effective health care products at competitive prices and
to improve the quality of life common message.
 To implement systems to ensure prevention of errors rather than detection
of errors.
 To ensure safety in all operations and to follow the systems in the areas of
operation.
 To ensures global competitiveness by striving to achieve current good
manufacturing practice.
 To continuously train people to build up their skills and expertise and thus
involved than to become committed to the quality process.
 To reduce wastage within the organizational and increase productivity.

2.2 Quality Management:-

Regarding quality management, the Q.A. manager have responsible to managing
the quality of product.Q.A. Manager appoint Q.C. in charge and Asstt. Chemist
who have the responsible for testing and in process control. Q.A. manager appoint
Mfg. Chemist and Asstt. Chemist who have responsible for manufacturing
quality. All the S.O.P. was prepared by Q.A. manager who was assign each work

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to responsible person. The quality management system can be renewed after

suggestion of any worker or staff.

 Each & every steps of manufacturing is documented and signed by

authorized person.

 Specification of material is documented.

 Method of manufacture and control is- documented.

 Every product has master formula record.

 S.D.P. bas been. Prepared to ensure the quality management system.

3. REQUIREMENTS OF FACTORY PREMISES:-

3.1 Location & surroundings-

 The factory shall be suited in a place, which shall not be adjacent to an open
sewage, drain, and public lavatory, or any factory, which produces a
disagreeable or obnoxious odors or fumes or large quantity of soot or smoke.
 The factory shall be located in a sanitary place, remote from filthy
surroundings.

3.2 Buildings:-

 The building used for the factory shall be constructed as to print of production
under hygienic conditions.
 The walls of the room in which manufacturing operations are carried out up to
the height of six feet from the floor, be smooth, water proof and must be
capable of being kept clean.
 The flooring shall be smoothing even and washable and shall be such as not to
permit retention or accumulation of dust.
.

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3.3 Water Supply:-

The water used in manufacture shall be pure and of drinkable quality free from
pathogenic microorganisms.

3.4 Disposal of Waste:-

Wastewater and other residues from the laboratory, which might be prejudicial to
the workers or to public health, shall be disposed of after suitable treatment to
render them harmless

3.5 Medical services:-

The manufacture shall provide:-
 Adequate facilities for First aid.
 Medical inspection of worker.
 Facilities for vaccine and inoculation against the entire or any other
epidemic group of disease.
 Adequate precautions for safeguarding the head of worker.

3.6 Health Clothing and Stationary Requirements of the staff:-

All workers shall free from contagious disease. Their clothing shall consist of a
white or colored Uniform suitable to the nature of work and the climate, and shall
be clean. Adequate facilities for personal cleanliness, such as clean towels, soap,
and hand-scrubbing brushes shall be provided separately for each sex

3.7 Production: -
The production department plans for scheduling of batches in consultation with
material department the schedule is sent to the quality assurance department. The
Q.A. department issues a batch manufacturing record (BMR) and a batch packing
record (BPR) to the production department. The records, includes bill of various
types of materials (BOMs) like raw materials, primary packing materials and
secondary (printed) packing materials.

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4. PRODUCTION

Manufacturing Product Lists are given below:

 Lactoenzyme Vet
 Feulidium Powder
 Attapulgite Powder
 Calcium Bones Animal Feed Supplements
 Cattle Feed Supplements
 Milk O Gold Chelated Mineral Mixture
 Cafal Gold Animal Feed

4.1 LACTOENZYME VET PRODUCTION

LACTOENZYME –
Lactase is an enzyme found in the mammalian small intestine that digests lactose, which is a
sugar found in milk.
Mammals use milk to feed their young, and in most mammals, the activity of lactase decreases
after the young is weaned and can consume other foods. Lactose tolerance (also called lactose
persistence), or being able to digest milk through adulthood, is a genetic mutation; the
“default” state in humans, like other mammals, is lactose intolerance after childhood.

FUNCTION OF LACTOENZYME -
Lactase’s function is to break down lactose into the two simple sugars it is made up of,
glucose and galactose. Breaking down lactose into its simple sugars makes it possible for it to
be absorbed via the small intestine and used by the body. If lactose is not broken down, it will
pass through thedigestive tract without being absorbed.

Infant mammals rely on nutrients from their mother’s milk to survive. During infancy, lactase
activity is high so that the body can obtain nutrients from this important food source.
However, after a young mammal is weaned off of milk, the activity of lactase declines.
Lactase is not needed since milk is not being consumed, and its production decreases. In
humans, lactase production decreases by around age four. The exception is found in some
humans that have lactose persistence and can produce lactose beyond early childhood.

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STRUCTURE OF LACTASE

The gene that produces lactase is located on chromosome 2 in humans. The initial polypeptide, or
chain of amino acids, that forms from this gene is called pre-pro-lactase. Pre-pro-lactase is a long
chain of 1,927 amino acids. Parts of the chain are then removed as the polypeptide is converted
into its mature form, lactase. Multiple chains are put together to form lactase, which is made up of
four of the same subunits. Each subunit has 1023 amino acid residues for a total of 4092 amino
acid residues. Lactase is a homotetramer molecule because it has four identical subunits.

This is an artist’s representation of lactase’s structure.

EQUIPMENT USED IN LACTOENZYME VET PREPARATION

CONTINOUS STIRRED TANK REACTOR

The continuous stirred-tank reactor (CSTR), also name a mixed flow reactor (MFR), vat-
or back mix reactor, or a continuous-flow stirred-tank reactor (CFSTR), is one types of
chemical reactor in environmental engineering and chemical engineering. A CSTR
usually refers to a class utilized to estimate the critical unit running variables when
employing a continuous agitated-tank reactor to have a specified output. The
mathematical model is valid for all fluids, same as liquids, gases, and slurries

A continuous stirred-tank reactor is typically used for homogeneous liquid-phase

reactions. For the laboratory applications, we may also use it for a gas-phase reaction for
temporary measurements, especially for a catalyzed reaction. The continuous stirred-tank

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reactor is accepted for a gas-liquid reaction when gas has a reaction with a liquid phase,
and the gas molecules transfer from the gas into the liquid phase. The gas is introduced
under the impeller, and the Gas-Liquid reaction will happen in a later section.

Because of slow reaction rates in a continuous stirred-tank reactor, the reactor volumes
usually are large. A CSTR-type reaction process is usually carried out in a series of
reactors to provide higher conversions, named cascades of CSTR.

Continuous stirred-tank reactors have the following characteristics:

1. Continuous flow passes through a CSTR, both output and input streams. But not
certainly at equal rates.
2. The mass of the system inside a CSTR is not necessarily steady.
3. The fluid is perfectly mixed inside a CSTR. Hence, its properties are consistent at any
time because of adequate stirring.
4. The flow in the system may not necessarily have a constant density. The density of the
inlet flow may vary among the process to reach the exit and have a different density
output stream.
5. The system may work at unsteady-state or steady-state.
6. We may provide some kinds of heat transfer equipment for temperature control.
There are several significant consequences of the model explained above, as presented
below:

 The fluid inside the continuous stirred-tank reactor is uniformly mixed, and
components of fluid are uniformly dispersed. As a result, all fluid particles have an
equal possibility of leaving the reactor with the output flow at any time.
 As an outcome of the above item, the output stream holds the properties same as the
fluid inside the reactor.
 Consequently, there is a step-change in any property of the system that changes within
the inlet to outlet.
 There are two extremes: first, fluid flowing directly from inlet to outlet in a short time
(t). Second: fluid being caught up in loops cycling many times by the stirring action in
a long time (t).
 For steady-state flow, the average residence time of fluid inside the tank is the ratio of
the total reactor volume to the volumetric steady-state flow rate of fluid at the outlet of
the reactor.
 For steady-state flow, space-time is the ratio of the total reactor volume to the steady-
state flow rate for the feed at inlet states.
 For steady-state multi-stage operation, every stage of a CSTR is stable (uniform
concentration, temperature, etc.), independent of time.

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Cross-sectional diagram of a CSTR. (Reference: Wikipedia.org)

Parts of a Continuous Stirred-Tank Reactor

CSTRs consist of a tank, regularly with a constant volume, and stirring equipment to mix reactants. Feed
and outlet pipes are present to enter reactants and discharge products. The figure below shows a cross-
section of a CSTR and the interior part of that.

Cross-section of a continuous stirred-tank reactor (Reference: umich.edu)

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We call the stirring blades agitators, and they are prepared in the tank to mix the reactants. Here some of
the various agitators are presented that are used inside CSTRs.

Different agitators in CSTRs (Reference: pharmaguides.in)

A CSTR can also operate as a loop reactor if a heated, pressurized fluid is introduced into the system to
help the stirring. It provides higher heat and mass transfer rates, including easy maintenance because of
not having agitators.

A cell culture reactor is presented below. An exact amount of cells are set on the fibrous-bed basket. A
rich nutrient medium is continuously supplied into the reactor, and outputs are harvested. As the cells
mature, they provide by-products, which are continually extracted from the reactor. The presented reactor
has a pitched-blade impeller to mix the reactants continuously.

4.2 POWDER PRODUCTION

POWDER-

 A pharmaceutical powder is solid dosage form which contains mixture of

finely divided drugs or chemicals in a dry form meant for internal or external use.

 It is a preparation in which drug is blended with other powdered substances

and used for internal or external purpose.

PROPERTIES OF POWDER

 can be administered easily to animals who cannot swallow tablets or

capsules

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 drug will have a rapid onset of action since disintegration is not required
 can be applied to many body cavities such as ears, nose, tooth socket,
throat
 drugs tend to most stable as a solid
 can be made into many different dosage formulations (capsules, tablets,
powders for reconstitution, dusting powders, bulk powders, powders for
inhalation, powder supplements etc.)

CLASSIFICATION OF POWDER

Powders are subdivided solids which are classified in the BP according to the size
of their constituent particles of range from 1.25 (µ m to 1.7 mm in diameter.
Another classification of powders is based on the manner of their dispensing.

1. Bulk powders for external use:

Dusting powders

Snuffs

Dental powder

Insufflations

2. Bulk powders for internal use

 Rhubarb powder
 Light magnesium carbonate
 Heavy magnesium carbonate
 Ginger powder
 Make a powder.

3. Simple and compound powders for internal use.

4. Effervescent granules

5. Cachets

POWDER FORMULATION
Powder blending

In the pharmaceutical industry, a wide range of excipients may be blended

together with the active pharmaceutical ingredient to create the final blend used to
manufacture the solid dosage form.
Milling

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During the drug manufacturing process, milling is often required in order to reduce the
average particle size in a drug powder. There are a number of reasons for this, including
increasing homogeneity and dosage uniformity, increasing bioavailability, and increasing the
solubility of the drug compound.

Granulation

In general, there are two types of granulation: wet granulation and dry granulation.
Granulation can be thought of as the opposite of milling; it is the process by which small
particles are bound together to form larger particles, called granules. Granulation is used for
several reasons. Granulation prevents the "demixing" of components in the mixture, by
creating a granule which contains all of the components in their required proportions,
improves flow characteristics of powders (because small particles do not flow well), and
improves compaction properties for tablet formation.

Hot melt extrusion

Hot melt extrusion is utilized in pharmaceutical solid oral dose processing to enable delivery
of drugs with poor solubility and bioavailability. Hot melt extrusion has been shown to
molecularly disperse poorly soluble drugs in a polymer carrier increasing dissolution rates and
bioavailability.
POWDER FEEDING IN CONTINOUS MANUFACTURING
In continuous manufacturing, input raw materials and energy are fed into the system at a
constant rate, and at the same time, a constant extraction of output products is achieved. The
process performance is heavily dependent on stability of the material flowrate. For powder-
based continuous processes, it is critical to feed powders consistently and accurately into
subsequent unit operations of the process line, as feeding is typically the first unit operation.
Feeders have been designed to achieve performance reliability, feed rate accuracy, and
minimal disturbances. Accurate and consistent delivery of materials by well-designed feeders
ensures overall process stability. Loss-in-weight (LIW) feeders are selected for
pharmaceutical manufacturing. Loss-in-weight (LIW) feeders control material dispensing by
weight at a precise rate, and are often selected to minimize the flowrate variability that is
caused by change of fill level and material bulk density. Importantly, feeding performance is
strongly dependent on powder flow properties
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4.2 METHODS

5. PACKAGING SECTION:-

In every pharmaceutical industry, it is vital that the package selected adequately

preserves that integrity of the product. The section of acerbate therefore being
with a determination of the product’s physical and chemical characteristics, its
protective needs and its marketing requirements. The materials selected must have
the following characteristics:

 They must protect the preparation from environmental conditions.

 must not be reactive with the product.
 They must not import to product tastes or odors. They must be nontoxic.
 They must be FDA approved.
 They must meet applicable tamper resistance requirements.
 They must be adaptable to commonly employed high speed, packaging
equipment.

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5.1 GLASS CONTAINER

Type I - Borosilicate Glass

Type II- Treated soda lime Glass

Type III- regular soda lime glass

Type NP- General purpose Soda lime Glass.

5.2 CLOUSER:-

The closures is commonly made of metal of plastics, the metal is usually tinplate
or aluminum, and in plastic both thermoplastics and thermo setting materials are
used metal caps are usually coated in the inside with an animal or laeqer for
resistance against corrosion.

Designs of closures :-

 Threaded screw cap

 Lug cap

 Roll-on closures

 Non-reusable Roll-on closures

5.3 RUBBER STOPPER

Rubber is used in the pharmaceuticals industry or makes stoppers, cap linear and
bulbs for dropper assemblies. The rubber stopper is used primarily for multiple-
dose vials and disposable syringes:

 Natural Rubber

 Neoprence Rubber

 Batyl Rubber

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5.4 PACKAGING METHOD

The company has different packaging method according to dosage forms and its
marketing.

 Film wrappers

 Bubble pack

 Strip seals and bands

 Foil, paper or plastic pouches

 Bottle seals

 Tape seals

 Breakable caps

 Sealed tubes

 Sealed cartons.

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6. QUALITY CONTROL

6.1 Gas chromatography mass spectrometer (GC MS –QP 2010)

Fig. 2 Gas chromatography mass spectrometer

Principle
The GC works on the principle that a mixture will separate into individual
substances when heated. The heated gases are carried through a column with an
inert gas (such as helium). As the separated substances emerge from the column
opening, they flow into the MS.

Instrumentation
The GC-MS is composed of two major building blocks: the gas chromatograph
and the mass spectrometer. The gas chromatograph utilizes a capillary column
whose properties regarding molecule separation depend on the column's
dimensions (length, diameter, film thickness) as well as the phase properties (e.g.
5% phenyl polysiloxane).These two components, used together, allow a much
finer degree of substance identification than either unit used separately.

6.2 U-V spectrometer [lambda 365]

Fig. 3 U-V spectrometer

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UV spectroscopy is type of absorption spectroscopy in which light of ultra-violet region

(200-400 nm) is absorbed by the molecule which results in the excitation of the electrons
from the ground state to higher energy state.

Principle
The Basic Principle of UV Spectroscopy:

The GC-MS is composed of two major building blocks: the gas chromatograph
and the mass spectrometer. The gas chromatograph utilizes a capillary column
whose properties regarding molecule separation depend on the column's
dimensions (length, diameter, film thickness) as well as the phase properties (e.g.
5% phenyl polysiloxane).

This law is expressed through this equation:

A = log (I0/I) = ECI

Instrumentation
Instrumentaion of uv- spectroscopy consist mainly :
 Light source
 Monochromators
 Sample and reference cell
 Detector
 Amplifier
 Recording device

Applications of UV Spectroscopy

1. Detection of Impurities
2. Structure elucidation of organic compounds
3. UV absorption spectroscopy can be used for the quantitative determination
of compounds that absorb UV radiation.
4. UV absorption spectroscopy can characterize those types of compounds
which absorbs UV radiation thus used in qualitative determination of
compounds. Identification is done by comparing the absorption spectrum
with the spectra of known compounds.

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5. This technique is used to detect the presence or absence of functional

group in the compound. Absence of a band at particular wavelength
regarded as an evidence for absence of particular group.
6. Kinetics of reaction can also be studied using UV spectroscopy. The UV
radiation is passed through the reaction cell and the absorbance changes
can be observed.

6.3 Karl Fischer Titrator

Fig. 4 Karl Fischer Titrator

Karl Fischer titration is a widely used analytical method for quantifying water
content in a variety of products. The fundamental principle behind it is based on
the Bunsen Reaction between iodine and sulfur dioxide in an aqueous medium.

Principle
The GC-MS is composed of two major building blocks: the gas chromatograph and the
mass spectrometer. The gas chromatograph utilizes a capillary column whose properties
regarding molecule separation depend on the column's dimensions (length, diameter, film
thickness) as well as the phase properties (e.g. 5% phenyl polysiloxane).

Karl Fischer Titration Procedure

The Karl Fischer titration experiment can be performed in two different methods.
They are:

 The GC-MS is composed of two major building blocks: the gas

chromatograph and the mass spectrometer. The gas chromatograph utilizes
a capillary column whose properties regarding molecule separation depend

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on the column's dimensions (length, diameter, film thickness) as well as

the phase properties (e.g. 5% phenyl polysiloxane).

 Coulometric determination – The endpoint is detected in this experiment

electrochemically. Iodine required for KF reaction is obtained by anodic
oxidation of iodide from solution.

6.4 5 TLC scanner 3

Fig. 6 TLC scanner 3

Principle

The TLC Scanner 4 is a scanning densitometer. It measures the reflection of

separated compounds in absorption and/or fluorescence mode. Controlled
by visionCATS software the TLC Scanner 4 enables quantitative evaluation of the
generated densitometric data. The spectral range of light from 190 to 900 nm is
available for selecting single or multiple wavelengths for scanning densitometry.
Detection can thus be fine-tuned to match the spectral properties of the analyte to
its optimized specificity and sensitivity of the detection.

6.5 Head Space Auto sampler

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Fig. 9 Head Space Autosampler

Headspace Autosampler for Routine, Simplified Analysis featuring the high
quality and value you have come to know from Shimadzu Products.

The HS-10 is a static headspace autosampler equipped with advanced features

such as a mixing function and the ability to heat-ahead sample vials waiting for
analysis. This instrument is the perfect high value platform for routine
analysissuch as residual solvents in pharmaceutical samples and trace VOCs in
wastewater.

Principle
The basic principle underlying all instrumentation for headspace-gas
chromatography is that an aliquot of the analyte from the vapor phase above a
liquid or solid sample in a sealed vial or container must be reproducibly and
effectively transferred to the inlet of a gas chromatograph.

Working
An autosampler is merely an automated injection valve with a mechanism to
hold multiple samples and to load these samples into the sample loop as dictated
by the system controller.

6.6 Atomic Absorption Spectrophotometer

Atomic absorption spectroscopy (AAS) and atomic emission spectroscopy (AES)
is a spectroanalytical procedure for the quantitative determination of chemical
elements using the absorption of optical radiation (light) by free atoms in the
gaseous state. Atomic absorption spectroscopy is based on absorption of light by
free metallic ions.

Fig. 10 Atomic Absorption Spectrophotometer

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Principle
The technique makes use of the atomic absorption spectrum of a sample in order
to assess the concentration of specific analytes within it. It requires standards with
known analyte content to establish the relation between the measured absorbance
and the analyte concentration and relies therefore on the Beer-Lambert law.

Instrumentation
In order to analyze a sample for its atomic constituents, it has to be atomized. The
atomizers most commonly used nowadays are flames and electrothermal (graphite
tube) atomizers. The atoms should then be irradiated by optical radiation, and the
radiation source could be an element-specific line radiation source or a continuum
radiation source. The radiation then passes through a monochromator in order to
separate the element-specific radiation from any other radiation emitted by the
radiation source, which is finally measured by a detector.

6.10. Melting point Apparatus

A melting-point apparatus is a scientific instrument used to determine the melting

point of a substance. Some types of melting-point apparatuses include the Thiele
tube, Fisher-Johns apparatus, Gallenkamp (Electronic) melting-point apparatus
and automatic melting-point apparatus.

Fig. 11 Melting point Apparatus

Principle
A melting point apparatus is a machine that helps chemists determine the identity
of the compound based on what temperature it turns from a solid to a liquid. Most
elements and compounds have a specific temperature at which it melts. Small
amounts of whatever is tested is inserted into small, thin tubes and inserted into
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the machine. A magnification tool is attached to the machine to closely observe
the material in the tubes. The machine can then heat the tube and material at a
predetermined temperature. The heat can be adjusted to find the temperature that
the material just starts to melt, which is the melting point for that material.

Instrumentation

While the outward designs of apparatuses can vary greatly, most apparatuses use
a sample loaded into a sealed capillary (melting-point capillary), which is then
placed in the apparatus. The sample is then heated, either by a heating block or an
oil bath, or as the temperature increases, the sample is observed to determine
when the phase change from solid to liquid occurs. The operator of the apparatus
records the temperature range starting with the initial phase-change temperature
and ending with the completed phase-change temperature. The temperature range
that is determined can then be averaged to gain the melting point of the sample
being examined.

Measurement of melting point:

The temperature of the sample is measured with a digital thermometer. The

sample is heated slowly as the temperature approaches the MP, while the sample
is carefully observed. The temperature at which the first drop of liquid is observed
is recorded as the beginning of the melting point range.

6.11. High Performance Liquid Chromatography

Fig. 12 HPLC

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Principle
All chromatographic separations, including HPLC operate under the same basic
principle; separation of a sample into its constituent parts because of the
difference in the relative affinities of different molecules for the mobile phase and
the stationary phase used in the separation.

Instrumentation

Applications of HPLC
The information that can be obtained by HPLC includes resolution,
identification and quantification of a compound. It also aids in chemical
separation and purification. The other applications of HPLC include :

Pharmaceutical Applications
1. To control drug stability.
2. Tablet dissolution study of pharmaceutical dosages form.
3. Pharmaceutical quality control.

Applications in Forensics
1. Quantification of drugs in biological samples.
2. Identification of steroids in blood, urine etc.
3. Forensic analysis of textile dyes.
4. Determination of cocaine and other drugs of abuse in blood, urine etc.

Food and Flavour

1. Measurement of Quality of soft drinks and water.
2. Sugar analysis in fruit juices.
3. Analysis of polycyclic compounds in vegetables.
4. Preservative analysis.

Applications in Clinical Tests

1. Urine analysis, antibiotics analysis in blood.
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2. Analysis of bilirubin, biliverdin in hepatic disorders.
3. Detection of endogenous Neuropeptides in extracellular fluid of brain etc.

7. QUALITY ASSURANCE

 There is a real and significant difference between finished product compendia

standard and the quality assurance of manufacturing process.
 The FDA-CGMP regulation emphasize environmental factors to minimize
cross contamination of product and errors in labeling and packaging, and
integrity of production and quality control records; however they do little to
minimize with in batch and batch-to-batch variation in the output of
production.

 Thee fore it is an important function of the in process quality assurance

program to ensure that finished dosage form have uniform purity and quality
with in a batch and between batches.
 This is accomplished by identifying critical steps in the manufacturing process
and controlling them within-defined limits.

8. MICROBIOLOGICAL LAB

A microbiology lab is a place to grow and study tiny organisms, called microbes.
Microbes can include bacteria and viruses. Microbiology labs need equipment to
help properly grow and culture these organisms.

8.1 LAMINAR FLOW

Fig. 14 Laminar Flow

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A laminar flow cabinet or tissue culture hood is a carefully enclosed bench designed to
prevent contamination of semiconductor wafers, biological samples, or any particle
sensitive materials. Air is drawn through a HEPA filter and blown in a very smooth,
laminar flow towards the user. Due to the direction of air flow, the sample is protected
from the user but the user is not protected from the sample. The cabinet is usually made of
stainless steel with no gaps or joints wherespores might collect.

Uses
Laminar Flow Cabinets are suitable for a variety of applications and especially
where an individual clean air environment is required for smaller items, e.g.
particle sensitive electronic devices.

Types of Laminar Flow Cabinets

Laminar Flow Cabinets can be produced as both horizontal and vertical cabinets.
There are many different types of cabinets with a variety of airflow patterns for
different purposes.

 Vertical Laminar Flow Cabinets

 Horizontal Laminar Flow Cabinets
 Laminar Flow Cabinets and Hoods
 Laminar Flow Benches and Booths

8.2 CULTURE MEDIA

A growth medium or culture medium is a solid, liquid or semi-solid designed to
support the growth of microorganisms or cells, or small plants like the moss
Physcomitrella patens. Different types of media are used for growing different
types of cells.

 The two major types of growth media are those used for cell culture,
which use specific cell types derived from plants or animals, and
microbiological culture, which are used for growing microorganisms, such
as bacteria or fungi. The most common growth media for microorganisms
are nutrient broths and agar plates; specialized media are sometimes
required for microorganism and cell culture growth.

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Fig. 15 Petridish Showing Microbial Growth

Culture media

Culture media contain all the elements that most bacteria need for growth and are
not selective, so they are used for the general cultivation and maintenance of
bacteria kept in laboratory culture collections.

Physcomitrella patens plants growing axenically on agar plates (Petri dish, 9 cm

diameter)

An undefined medium (also known as a basal or complex medium) contains:

 a carbon source such as Glucose

 water
 various salts
 a source of amino acids and nitrogen (e.g., beef, yeast extract)
 This is an undefined medium because the amino-acid source contains a
variety of compounds with the exact composition being unknown.

A defined medium (also known as chemically defined medium or synthetic

medium) is a medium in which

 all the chemicals used are known

 no yeast, animal, or plant tissue is present

Some examples of nutrient media include:

 Plate count agar

 Nutrient agar
 Trypticase soy agar

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Fig. 16 Microbial growth in the presence of Nutrient Agar

8.3 HEPA FILTER

HEPA is an acronym that stands for High Efficiency Particulate Air, so a HEPA
filter is a High Efficiency Particulate Air filter. Filters, whether for an air purifier
or other implementation, come with many benefits and claims.

HEPA stands for high-efficiency particulate air. A HEPA filter is a type of

mechanical air filter; it works by forcing air through a fine mesh that traps
harmful particles such as pollen, pet dander, dust mites, and tobacco smoke.

How do HEPA filters work?

To put it simply, HEPA filters trap air contaminants in a complex web of fibers.
Depending on the size of the particle, this can happen in four different ways:
Inertial Impaction, Diffusion, Interception, or Sieving

Fig. 17 Working of HepaFilter

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TYPES OF HEPA FILTER :

What are HEPA filters made of?

The HEPA filters are made of borosilicate glass fibers or plastic fibers (e.g.,
polypropylene) bound together with up to 5% acrylic binder (the same compound
that binds latex paint to a house).

9. STORES:-

The store department of rescue laboraties is divided into two departments-one for
the bulk store and other for the excisable goods.

The function of the store department must be:

• To efficiently requisition material and store and to see that the stock of
no item is allowed either to fall below the prescribed minimum level or to
go above the fixed maximum quantity

• To carefully examine all goods and material on receipt and to arrange for
a systematic and efficient storing of the same

• To see the accurate and promote distribution of all items to the factory
department as required under issue requisition notes.
• To maintain efficient quantity records of movements of stocks and to
account for all goods that have come in to their charge

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• To prevent any theft wastage or deterioration of stock

Goods Received Notes or Sheets:-

• All material and stores received from day to day will be recorded by the
storekeeper on goods received sheets are numbered serially and are
prepared in triplicate.

• He will retain one copy and pass on the other two copies two the buying
office after certifying these as to goods having being duly received.

• The latter after comparing the items in these notes with their relative
invoices will fill in the dates and numbers of the copies which will be
handed over to the stores accountant.

• The copy remaining with the buying office will enable it to compare how
the deliveries are made to him.

10. SAFETY AND PRECAUTION:-

10.1 Health and Safety Precaution:-

10.1.1 Fire:-

 In every section fire extinguisher should be at right place and available 24

hours firefighting equipment should check properly time-to-time.
 We should trained our workers to operate the fire fighting equipment in
the emergency and give some other tips to fight the fire situation
 Don’t touch the electric wiring and switchboard during fire situation and
off all the electrical equipment.

10.1.2 Explosion:-

 There should be separate space or the warehouse required for corrosive

and highly inflammable materials and chemicals.
 Don’t allow any unauthorized person to enter in indicated areas
 The electric board and monitoring panel of equipment should not covered
by any unwanted material and packing material and finished goods.

10.1.3 Chemicals:-

 All chemicals should store in proper chambers and leakage and mixing
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should be avoided.
 The all chemicals should be proper labeled and during processing label
checked by supervising authorities.
 The chemicals always kept in locked chambers

10.1.4 Cleanliness:-

 Accumulation of dirt will be removed deadly by sweeping or by any other

effective method from the floors and benches or workrooms and from
staircases and passage and disposable off in suitable number.
 The floor of every workroom should be cleaned at least once a week by
washing, using disinfectant where necessary or by some other effective
method.

10.1.5 Disposal of wastes and effluents:-

 The effective and suitable arrangement must be made in every factory for the
treatment of wastes and effluents due to manufacturing process carried on
there in so as to sender them innocuous and easily disposable.

10.1.6 Ventilation and temperature:-

 Adequate ventilation by circulation of fresh air. Such a temperature as will

secure to the workers there in reasonable conditions of comfort and prevent
injury to health.
 Walls and roofs must be made of such materials and so designed that such
temperature shall not be exceeded and kept as low as practicable.

10.1.7 Dust and Fumes:-

 In every factory if manufacturing process gives off any dust or fume or other
impurity which is likely to be injurious or effective to the workers, or any dust
in substantives
 Qualities; effective measures must be taken to prevent this inhalation and
accumulation in any workroom.

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11. MANUFACTURING RECORDS:-

Proper maintenance of records is essential for the manufacture of drugs. If there is

a complaint about the quality of drug from the market, it is through these records
the manufacturer can investigate the matter and find out the cause of the
complaint.

11.1 List of records to be maintained:

 General
 Medical examination of workers
 Receipt and expenditure of raw materials
 Labels, cartons and printed packing materials issue.
 Specifications of input materials containers, packing material, etc.
 Receipt and issuance of finished product
 Reference sample records
 Records for distribution of finished products
 Records of complaints and adverse reactions
 Recall of drugs from market records
 Production
 Master formula records
 Batch manufacturing records
 Standard operating procedure (SOP) on cleaning premises
 SOP on cleaning of plant and machinery
 Purified water preparations records.
 Reprocessing and recovery records.
 Quality control
 Analysis of raw materials records.

 Analysis of finished product records

 Analysis of recalled drugs.
 Requisition of reagents and chemical records

11.2 Medical examination of workers

 Name
 Father’s Name
 Address
 Age/Date of Birth
 Height
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 Weight
 Mark of Identification
 General Examination
 Eyes (Vision)
 Ears (Hearing)
 Chest
 Investigation: Blood reports
 Receipt and expenditure of raw materials
 Receiving number
 Date of receipt
 Purchase order number
 Name of supplier
 Invoice/ Challan number
 Name of raw material
 Name of manufacturer
 Quality received
 Previous stock
 Total Stock
 Number of containers and weight
 Date of sending for analysis
 Control reference number
 Result of analysis
 Date of issue for production
 Quality issued
 Name preparation & B. No. for which issued
 Requisition slip number

11.3 Signature of In-Charge

Signature of incharge is necessary for maintaining the manufacturing records.

Incharge check the quality of product and if any complaint arises in market than
he is responsible for it.

11.4 Label/Cartons/Printed packing materials records:

 Stock issue
 Name of the item
 Date of receipt
 Name of the printer

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 Quantity received
 Quantity issued
 Quantity used
 Quantity rejected
 Quantity returned
 Name of product
 Batch number
 Signature

11.5 Distribution records:

 Name and strength of the product

 Date
 Transfer Note No. and Date
 Quantity received
 Batch number
 Quantity issued
 Invoice number and date
 Name and address of the distributor and his Reg/License No.

11.6 Master formula records

 Name of the product

 Strength of product
 Composition formula on the label/carton for one dosage unit
 Composition formula for different batches size
 Complete list of raw material used whether they appear in finished product or
not, along
 with quantity required and overages added, if any.
 Specification of raw materials
 Complete list of packing materials
 List of equipments and machinery used
 Details of various process involved including packing procedures
 In process controls during processing and packing statement of theoretical
weight/measure
 at various stage of processing
 Complete processing procedure, Instructions and precautions to be followed
during
 packing
 Finished product specifications
 Expiry date
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 Instruction for storage

11.7 Batch productions records

 S.No.
 Master Formula Reference No.
 Name of the Product
 Batch No.
 Batch Size
 Size of commencement of manufacturer
 Date of completion of manufacture
 Weight and measure of raw material used in manufacturing process including
initial of person who weighted/measured each material and who counter
checked the weight or measure
 Control reference No.
 Amount of recovered product residue of reprocessed materials used, it any.
 Records of cleaning of equipments used

 Records of various processes involved including in-process controls carried

out statement of actual yields at different stages.
 Description of containers closured their specifications and control references
no.
 Actual quantities of packing materials

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CONCLUSION

The four weeks (200 hours) industrial training proved to be a golden

opportunity for us in letting us understand various operations involved in
Pharmaceutical industry.

During our training period we came very close to all the aspects and
analysis which we are carried out in the industry at the same time we learn
how to follow the rules & regulation as per CGMP and GLP & according
to WHO & ISO 9001 think that the company soon achieve a very good &
reputed position on the country level.

On the exposure to the industrial staff we found that the company staff is
really hard working sincere & very co- operative in nature. On the whole,
the company members work like family members and support each other.
We are thankful and wish the best for the welfare and letter achievement
along with every worker of this company.

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