Fyp Biotech

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com
ACKNOWLEDGEMENT
Happiness lies in pursuit as much as in reaching the goal & today I stand with the
kernel of my endeavor, while pursuing it, many a known & unknown hands pushed
me towards, learned souls put me on the right path & enlightened me with their
knowledge & experience. No words could adequately express my feelings. I shall ever
remain thankful indebted to them all.
Indeed the words at my command are just not sufficient to express my sincere thanks
& deep sense of gratitude to MR. AMIT GARG & MR. NITIN GARG
(DIRECTOR).
I take the privilege of thanking Mr. CHANDRA MANI SINGH for his critical
editing and inspiring words to do always something a new. I gratefully acknowledge
the help rendered by Mr. MAHESH CHANDRA in terms of technical guidance, &
for his valuable suggestion in formulating the technical program.
The present endeavor of mine, would have never been completed without financial
facilities from SOUL HEALTCARE(INDIA) PVT. LTD. I am highly obliged to the
director of SOUL for providing facilities.
My whole hearted thanks to my colleagues for their assistance at each & every step
and nice memorable company during course of training.
It is impossible to forget good friends; for their continuous rejuvenating, inspiring
letters & best wishes which came across thousands of miles.
Words would not suffice for the constant encouragement, love, & affection of my
parents & brother. I would not have completed this training without their relentless
hard work, sacrifice & everlasting blessings.
I am thankful to the Dr. R.K. Tiwari (HOD - AIB) who provided me the opportunity
to do the industrial training, I am also thankful to my mentor Dr. Vineet Awasthi who
has been a supporting guide throughout my training.
Finally, let me not fail to express my tributes to those experimental birds, animals &
microorganisms, who were sacrificed for the great course of science.
Sakshi Bansal
Amity University
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SOUL HEALTHCARE (I) PVT. LTD.
SOUL HEALTHCARE (I) PVT. LTD.

professionally managed Pvt. Limited ISO certified company backed by
the expertise of the Pharma group with a good to serve the suffering
mankind through their quality products & try to provide relief to the
suffering on the humanity basis.
The foundation of company was laid down in year 1999 at Muzzafarnagar and soon
transferred at Kashipur uttarakhand.
The company soon got a reputed position in the market by increasing
their product popularities.
QUALITY POLICY OF COMPANY

The Company is committed to Total Quality Management.
The raw and packaging materials are procured either from approved
vendors or reliable resources. These are received at the stores with all the
necessary documents, which are properly scrutinized.
The Material received is first stored in the Quarantine area and label
indicating "QUARANTINE"is affixed on all the containers of the lot
received.
The Material received is immediately recorded into the stock records.
Sampling is done by the Quality Control Department in accordance with
the SOPs for drawing samples for various materials.
Samples are tested by the Quality Control Department to confirm
compliance to the prescribed specifications. The materials approved by
the Quality Control Department are labeled "APPROVED" by the Quality
Control Department.
The materials rejected by the Quality Control Department are labeled "
REJECTED " by the Quality Control Department and such rejected
materials are transferred to the REJECTED MATERIALS AREA.
Rejected materials are promptly returned to the supplier or are destroyed
(Destruction in presence of Q.A. Person).
The labels of "APPROVED " and "REJECTED"are controlled by Quality
Control Department
Approved materials are dispensed to production in first in first out (FIFO)
basis. Active ingredients are dispensed in a separate dispensing booth.
Production is carried out under supervision of FDA approved technical
staff, as per the prescribed SOPs and procedures.
There are prescribed provisions for in-process checks by the quality
control and production department. The particulars of in-process checks
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carried out and the results thereof are entered in Batch Manufacturing
Records (BMR).
The bulk is tested for compliance with the prescribed specifications,
before these are filled in the primary container.
The finished products are tested as per the specifications.
All equipment in the manufacturing area are regularly cleaned,
maintained and validated.
The Company has a well-equipped quality control laboratory. The
instruments in the quality control laboratory are calibrated at regular
intervals as per the SOPs.
Proper records are maintained for all calibrations.
Self-inspections are carried out regularly by the internal audit team.
There is well- defined procedure for handling product complaints.
The quality assurance department (Q.A.) scrutinizes each BMR. Products
are released for dispatch only after Q. A. Approval.
COMPANY MANAGEMENT :
Mr. Amit Garg,(Director of the Company)- having experience in the

analysis and manufacturing of drugs. He is managing his own company.
Mr. Nitin Garg:-Managing the Company.

Mr. ChandraMani Singh - is having experience in
the analysis, manufacturing, & managing the company.
Mr. Mahesh Chandra - B.Sc. & is having about 10 years of

experience in Quality Control. he has experience of working in the
Testing Lab,formulation-testing laboratories. he is approved in
Chemical & microbiology. he is Q.C. Executive of the plant.
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Table of Content
S. No.
1
2
3
4
5
6
7
8
9
10
11
Chapter
Introduction
Quality Control
Instruments
Machinery Section
Tablet Section
Capsule Section
Nutraceuticals
Syrup & Suspension
Ointment Section
Injectables
Quality Assurance &
Page no.
6
8
9-30
31-39
40-59
60-62
63-65
66-68
69-71
72-78
79-80
12
13
14
Documentation
Figures
Learning & Conclusion
Bibliography
81-83
84-86
87
CHAPTER-1
INTRODUCTION
WHEN BUSINESS IS GOOD IT PAYS TO ADVERTISE
WHEN BUSINESS IS BAD YOU ARE GOT TO ADVERTISE
- Henri Pioneer
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Drugs and pharmaceutical industry plays a vital role in the economic
development of a nation. It is one of the largest and most advanced sectors in the
world, acting as a source for various drugs, medicines and their intermediates as well
as other pharmaceutical formulations. India has come a long way in this field, from a
country importing more than 95% of its requirement of drugs and pharmaceuticals;
India now is exporting it even to developed countries. Being the intense knowledge
driven industry, it offers innumerable business opportunities for the investors/
corporate the world over. The Pharmaceutical industry in India is the world third
largest in terms of volume and stands 14th in terms of value. It is one of the major
contributors to health care not only in India but whole world. The industry is almost
exclusively concerned with the provision of prescription and over the counter drugs to
meet human needs, but veterinary drugs also represent a significant market segment.
The Indian Pharmaceutical Industry today is in the front rank of Indian science based
industries with wide ranging capabilities in the complex field of drug manufacture and
technology. It ranks very high in the third world, in terms of technology, quality and
range of medicines manufactured. From simple headache pills to sophisticated
antibiotics and complex cardiac compounds, almost every type of medicine is now
made indigenously. International companies associated with this sector have
stimulated, assisted and spearheaded this dynamic development in the past 53 years
and helped to put India on the pharmaceutical map of the world. Indian
pharmaceutical industry is now the third largest in the world in terms of volume. Its
rank is 14th in terms of value. The recent developments in the technology and R & D
work in this field have led to the increased growth rate of industries and have
established Indian Pharmaceutical industries in the international market.
The training basically deals with properties, uses & applications, Quality
control and assurance, manufacturing processes with flow diagrams of various
sections such as tablets, capsules, syrups, injectables, A.H.U. & water plant.
This report covers an intensive study on manufacturing, production,
formulation and quality control of drugs and pharmaceuticals with technology
involved in it.
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CHAPTER -2
QUALITY CONTROL:
Quality control can be defined as day to day control of quality within the company.
They are responsible for the acceptance or rejection of incoming raw material,
packing components and finished products, for the myriad of in process tests and
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inspections, to assure that system are been controlled and monitored for the approval
and rejections of complete dosage.
Quality Control Result From:1. Team Work
2. Analytical testing of raw materials
3. Analytical testing of packing materials
4. Analytical testing of finished products
5. Sampling under hygienic conditions
6. Monitoring of Temperature in Q.C
Area Limit
1. Chemical Laboratory 25 5C
2. Instrument Room 25 5C
3. Microbiology Laboratory 25 3C
4. Packing Storage Room 25 5C
5. Chemical Storage Room 25 5C
6. Control Sample Room 25 5C
The quality control function in an organization normally consist of at least three
primary units Analytical control
Microbial control
Packaging control
CHAPTER-3
INSTRUNMENTS
Various Labs
CHEMICAL LAB
INSTRUMENTAL LAB
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SPECTROSCOPY LAB
CHROMATOGRAPHY LAB
MICROBIOLOGY LAB
OBJECTIVE
Aim:
The Main aim of this Analytical lab training is to get experienced with practical
environment of analytical lab.
THE MAIN OBJECTIVES OF THE PROPOSED WORK ARE:
To get expose to the analytical instruments.
To learn the various analytical techniques in brief.
To learn the manner of handling, and minor precautions to be taken during

analysis.
To take the opportunity to get idea about advanced analytical instrumentation.
CHEMICAL LAB
Frontline ultrasonic cleaner
Water bath
Heater (ceramic plate)
Friability apparatus
INSTRUMENTAL LAB
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Magnetic stirrer
Refrigerator
pH meter
Digital disintegration test apparatus
Digital dissolution test apparatus
titrator
Polarimeter apparatus
Karl fischer titration
Autoclave
SPECTROSCOPY LAB
U V spectrometer
CHROMATOGRAPHY LAB
HPLC
MICROBILOGY LAB
Incubator
Hot air oven
CHEMICAL LAB
Frontline ultrasonic cleaner:
An ultrasonic cleaner is a cleaning device that uses ultrasound (usually from

20400 kHz) and an appropriate cleaning solvent
An ultrasonic cleaner is a cleaning device that uses ultrasound (usually from

20400 kHz) and an appropriate cleaning solvent (sometimes ordinary tap
water) to clean delicate items. The ultrasound can be used with just water, but
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use of a solvent appropriate for the item to be cleaned and the soiling enhances
the effect. Cleaning normally lasts between three and six minutes
Ultrasonic cleaning uses high frequency sound waves to agitate in a liquid.

Cavitation bubbles induced by the agitation act on contaminants adhering to
substrates like metals, plastics, glass, rubber, and ceramics.
Heater (ceramic plate):
Hot Plate with Ceramic Top is appropriate for laboratory heating and sample
drying. The Hot Plate has a pure ceramic material top that endow with both
impact strength and chemical resistance. The Hot Plate has reflective white
colour that increases the visibility and the body which is constructed of rugged
aluminium for stability and durability. The Hot Plate with Ceramic Top is
equipped with variable heat control that provides up to 375 W of even heat.
Friability apparatus
The crushing test strength test may not be the best measures of potential tablet
behavior during handling and packaging. The resistance to surface abrasion
may be a more relevant parameter, as exemplified by those tests that measure
the weight loss on subjecting the tablets to a standardized agitation procedure.
The most popular version is the Roche Friabilator , in which approximately 6
g (w1) of dedusted tablets are subjected to 100 free falls of 6 inches in a
rotating drum and are then reweighted (w). The friability, f, is given by;
F=100(1-W1/W)
INSTRUMENTAL LAB
Magnetic stirrer:
A magnetic stirrer or magnetic mixer is a laboratory device that employs a

rotating magnetic field to cause a stir bar (also called "flea") immersed in a
liquid to spin very quickly, thus stirring it. The rotating field may be created
either by a rotating magnet.
They are preferred over gear-driven motorized stirrers because they are
quieter, more efficient, and have no moving external parts to break or wear out
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(other than the simple bar magnet itself). Due to its small size, a stirring bar is
more easily cleaned and sterilized than other stirring devices. They do not
require lubricants which could contaminate the reaction vessel and the
product.
On the other hand, the limited size of the bar means that magnetic stirrers can
only be used for relatively small (under 4 liters) experiments. They also have
difficulty dealing with viscous liquids or thick suspensions.
pH Meter:
A pH meter is a small device that is used to tests water for its level of acidity
versus base or alkalinity. In pharmaceutical industry, the pH meters are
designed to cater the requirements of analytical labs. The instrument is used to
test the level of concentration of acids, alkalines and other unwanted particcles
in medicinal fluids and liquids.
Application of pH Meter
Pharmaceutical
Agriculture
Wine
Soil testing
Food products such as butter and yogurt
Melting point apparatus:
It is used for the determination of the melting point of the solidsubstances.

Here mostly unknown sample are determine
Digital disintegration test apparatus
Time not more than 15 min. A generally accepted maxim is that for a drug to
be readily available to the body, it must be in solution. For most tablets, the
first important step toward solution is break down of tablets into smaller
particles or granules, a process known as disintegration. The time that it takes
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a tablets to disintegrate is measured in a device described in the usp Wagner
to which the reader is referred for a more detailed study.
Research has established that one should not automatically expect a

correlation between disintegration and dissolution. However, since the
dissolution of a drug burg the fragmented tablet appears to control partially or
completely the appearance of the drug in the blood, disintegration is still used
as a guide to the formulator in the preparation of an optimum tablet formula
and as an in-process control test to ensure lot-to-lot uniformity.
The USP device to test disintegration uses 6 glass tubes that are 3 inches long,
open at the top, and held against a 10-mesh screen at the bottom end of the
basket rack assembly to test for disintegration time, one tablet is placed in
each tube, and the basket rack is positioned in a 1-l breaker of water,
simulated gastric fluid, or simulated intestinal fluid, at 37`C. hence the time is
measured after the tablet is disintegrated completely in a medium.
Digital dissolution test apparatus
In the pharmaceutical industry, drug dissolution testing is routinely used to

provide critical in vitro drug release information for both quality control
purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms
such as tablets, and drug development, i.e., to predict in vivo drug release
profiles.
In vitro drug dissolution data generated from dissolution testing experiments

can be related to in vivo pharmacokinetic data by means of in vitro-in vivo
correlations (IVIVC). A well-established predictive IVIVC model can be very
helpful for drug formulation design and post-approval manufacturing changes.
The main objective of developing and evaluating an IVIVC is to establish the

dissolution test as a surrogate for human bioequivalence studies, as stated by
the Food and Drug Administration (FDA). Analytical data from drug
dissolution testing are sufficient in many cases to establish safety and efficacy
of a drug product without in vivo tests, following minor formulation and
manufacturing changes (Qureshi and Shabnam, 2001). Thus, the dissolution
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testing which is conducted in dissolution apparatus must be able to provide
accurate and reproducible results.
Several dissolution apparatuses exist. In United States Pharmacopeia (USP)

General Dissolution, there are four dissolution apparatuses standardized and
specified. They are:
USP Dissolution Apparatus 1 - Basket (37C)
USP Dissolution Apparatus 2 - Paddle (37C)
USP Dissolution Apparatus 3 - Reciprocating Cylinder (37C)
USP Dissolution Apparatus 4 - Flow-Through Cell (37C)
USP Dissolution Apparatus 2 is the most widely used apparatus among these
four.

Water Determination
The Water Determination Test (Karl Fischer Method) is designed to determine
water content in substances, utilizing the quantitative reaction of water with iodine
and sulfur dioxide in the presence of a lower alcohol such as methanol and an organic
base such as pyridine, as shown in the following formulae:
H2O+I2+SO2 + 3 C5H5N 2(C5H5N+H)I- + C5H5NSO3
C5H5NSO3 + CH3OH (C5H5N+H)OSO2OCH3.
There are two determination methods different in iodine-providing principle: the
volumetric titration method and the coulometric titration method.
In the volumetric titration method, iodine required for reaction with water is
previously dissolved in water determination TS, and water content is determined by
measuring the amount of iodine consumed as a result of reaction with water in a
sample.
In the coulometric titration method, first, iodine is produced by electrolysis of the
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reagent containing iodide ion, and then, the water content in a sample is determined
by measuring the quantity of electricity which is required for the electrolysis (i.e., for
the production of iodine), based on the quantitative reaction of the generated iodine
with water.
Method Volumetric titration

Apparatus Generally, the apparatus consists of an automatic burette, a backtitration flask, a stirrer, and an equipment for amperometric titration at constant
voltage or potentiometric titration at constant current.
Because water determination TS is extremely hygroscopic, the titration
apparatus should be protected from atmospheric moisture. Silica gel or calcium
chloride for water determination is usually used for moisture protection.
Procedure As a rule, the titration of the sample with water determination
should be performed at the same temperature as that at the standardization of the
TS, while protecting from moisture.
The apparatus is equipped with a variable resistor in the circuit, and the resistor
is adjusted to apply a definite voltage (mV) between a pair of platinum electrodes
immersed in the solution to be titrated. The change in current (A) is measured
during the dropping of water determination TS (Amperometric titration at constant
voltage). As titration continues , the abrupt change in current in the circuit occurrs,
but returns to the original state within several seconds. At the end of a titration, the
change in current persists for a certain time (usually, longer than 30 seconds). The
end point of titration is determined at this electric state. Direct titration Unless
otherwise specified, proceed as directed below.
Take 25ml of methanol for water determination in a dried titration flask, and
titrate with water determination TS to the end point. Unless otherwise specified,
weigh accurately a quantity of the sample containing 10 to 50 mg of water, transfer it
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quickly into the titration flask, and dissolve by stirring. Titrate the solution with
water determination TS to the end point under vigorous stirring.
When the sample is insoluble in the solvent, powder the sample quickly, weigh a
suitable amount of the sample accurately, and transfer it quickly into the titration
vessel, stir the mixture for 30 minutes while protecting it from moisture. Perform a
titration under vigorous stirring.
When the sample interferes with the Karl Fisher reaction, water in the sample
can be removed by heating and under a stream of nitrogen gas, and introduced into
the titration vessel by using a water-evaporation device.
water(H2O)= Volume(ml) of water determination consumed * f(mg/ml) * 100%

wt of sample(mg)
Autoclave
An autoclave is an instrument used to sterilize equipment and supplies by
subjecting them to high pressure saturated steam at 121 C for around 1520
minutes depending on the size of the load and the contents. Autoclaves are
widely used in microbiology, medicine, tattooing, body piercing, veterinary
science, mycology, dentistry, chiropody and prosthetics fabrication. They vary
in size and function depending on the media to be sterilized.
Machines in this category largely operate under the same principles as
conventional autoclaves in that they are able to neutralize potentially
infectious agents by utilizing pressurized steam and superheated water. A new
generation of waste converters is capable of achieving the same effect without
a pressure vessel to sterilize culture media, rubber material, gowns, dressing,
gloves, etc. It is particularly useful for materials which cannot withstand the
higher temperature of a hot air oven. For all-glass syringes, sterilizing in a hot
air oven is a better method.
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SPECTROSCOPY LAB
Spectroscopy Definition:
It is a branch of science which deals with the interaction of EMR with matter.
It is the measurement and interpretation of the EMR absorbed (or) emitted
when molecules or atoms or ions of a sample exited from one energy state to
another state.
U V spectrometer
Most widely used spectrophotometric technique.
Based on absorption of UV Visible light by molecules
Principles
Based on the absorption of light
Absorption of light by a substance in solution follows Beer Lamberts Law
Beer Lamberts Law
Combination of two laws dealing with absorption of light in relation to

1) Concentration of the absorber
2) Pathlength/Thickness of the layer (absolute amt. of the absorber)
Provided an absorbing substance that is partially transparent
Transmit a portion of incident light

T = Transmittance of the substance will be the ratio of the intensities of
transmitted incident light
T = I / Io
I = Intensity of the transmitted radiation

Io = Intensity of the incident radiation
Intensity = no. of photons interacting in unit time

T = 100%; totally transparent substance
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T = 0%; totally opaque substance
Beer Lamberts Law is applicable for intermediate values of transmittance & can be
defined as follows
Absorbance A or Extinction coefficient E can be expressed as the logarithm of the
reciprocal of transmittance. i.e.
A = E = log(1 / T) = log Io / I
It also states, Absorbance is proportional to both the concentration & the thickness or
pathlength of the solution.
A = cl
= Molar absorption / extinction coefficient at wavelength
C = concentration (mol-1 or mol dem-3) of absorbing solution
L = path length (cem, M.10-2) through the solution
UV Visible spectroscopy is used to determine the absorption spectra of

substance
Absorption spectra is a unique characteristics of substance
UV Visible spectra can be used to identify substance
To establish absorption spectrum for a given substance:
Transmittency or optical density of a particular concentration of the substance is

measured at different wavelengths.
Since the absorption spectrum of substance is characteristic for it can

serve to identify the substance.
Increase substance concentration
Increase in absorbance at every wavelength

Absorption of compound at max is chosen during quantitative experiment.
Instrumentation for UV Visible Spectrophotometry
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Instrument used to study the absorption or emission of electromagnetic radiation are
(1) Colorimeter: Applies wavelength in visible range
(2) Spectrometer / Spectrophotometer: Applies wavelength both is visible &
UV range.
Essential Components Include

(1) Colorimeter
Source
Filter
Sample Holder
Detector
Amplifier & Recorder
Wavelength selector
(2) Spectrophotometer
Source
Monochromator
Sample Holder
Detector
Amplifier
& Recorder
Colorimeter
Based on the principle of absorption of light thus follows Beer Lamberts

Law.
Biomolecules; do not absorb light in visible region in their original form

Chemically modified to produce colored product which absorb visible light
Can be studied with colorimeter
Most of the incoming light is absorbed by the solution, wavelength

corresponds to the color of the solution will be transmitted.
E.g. Blue color solution
Absorbs all wavelength
Transmit wavelength that correspond to blue color.
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Light Source: Light Emitting Diode (LED)

In colorimeter consisting of wavelengths
450,
465,
Blue
Green
635
Red
Absorption value
can be used to
can be used to
determine the abs of blue sol.
determine the
concentration
Spectrophotometer
Used both for qualification & quality measurement of biomolecules
Measure absorbance of UV & Visible light
Instrumentation
Consist of
(1) Light source
(2) Monochromator
(3) Transparent sample holder called cuvette
(4) Light detector
(5) Meter / Recorder to measure the output of the detector
Operation Of Instrument
Single Beam
Measurement of absorbance of light of a single wavelength first
By the solvent alone & then
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By an experimental solution
Absorbance of the solvent alone called Reference is subtracted from the experimental
one.
Double Beam
Measurement of absorbance of lights of a range of wavelength by
Sample & reference simultaneously
Absorbance of reference is subtracted from the sample electronically at each

wavelength.
(1) Source of light
Hydrogen / deuterium lamp for: UV
Tungsten filament lamp: Visible
cover 200 400 &

400 700 mm
(2) Cuvettes / Sample Holder
Silica cuvettes suitable for UV
Borosilicate glass cuvettes for visible range
(3) Detector
Photomultiplier Tubes
Operation depends on the photosensitive property
Application
Absorption measurement could be used to for
Quantitative analysis (determine conc. of substances)
Qualitative analysis (identify certain classes of compounds)
The performances of dissolution apparatuses are highly dependent on hydrodynamics

due to the nature of dissolution testing. The designs of the dissolution apparatuses and
the ways of operating dissolution apparatuses have huge impacts on the
hydrodynamics, thus the performances. Hydrodynamic studies in dissolution
apparatuses were carried out by researchers over the past few years with both
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experimental methods and numerical modeling such as Computational Fluid
Dynamics (CFD). The main target was USP Dissolution Apparatus 2. The reason is
that many researchers suspect that USP Dissolution Apparatus 2 provides inconsistent
and sometimes faulty data. The hydrodynamic studies of USP Dissolution Apparatus 2
mentioned above clearly showed that it does have intrinsic hydrodynamic issues
which could result in problems. In 2005, Professor Piero Armenante from New Jersey
Institute of Technology (NJIT) and Professor Fernando Muzzio from Rutgers
University submitted a technical report to the FDA. In this technical report, the
intrinsic hydrodynamic issues with USP Dissolution Apparatus 2 based on the
research findings of Armenante's group and Muzzio's group were discussed.
More recently, hydrodynamic studies were conducted in USP Dissolution Apparatus
4.
Polarimeter apparatus
A polarimeter is a scientific instrument used to measure the angle of rotation caused
by passing polarized light through an optically active substance.
Some chemical substances are optically active, and polarized (unidirectional) light
will rotate either to the left (counter-clockwise) or right (clockwise) when passed
through these substances. The amount by which the light is rotated is known as the
angle of rotation.
INSTRUMENTATION:
Light source : Na vapor lamp
Prisms : 2 prisms are used (Nichol Prism & Calcite Prism with quartz windows).
Length of tube : 1 decimeter = 10cm
Detector : PDA detector
Wavelength : 365nm, 405nm, 436nm, 589nm, 633nm
Temperature : 20 to 25 c
The polarimeter consists of 2 openings, sample is injected through one hole and care
should be taken while injecting the sample so that no air bubbles are formed. The
other opening is meant for checking the temperature.
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TROUBLE SHOOTS:
air bubbles, temperature limits
PROCEDURE
:Steps for sample preparation:
1.0.5 g of sample is taken in 100ml volumetric flask 2.To this add 60 to 70 ml of 50%
methanol (v/v).3.Keep the flask in sonicator (for proper mixing).4.Then measure the
absorbance at 589nm at temp 20.
FORMULA:
SOR= Average angle of rotation*100/Length of the tube*Wt of the sample*(100- %
of Water content)
APPLICATIONS:
This equipment is used for measurement of SOR (specific optical rotation).
It is also used to analyze the compound whether it is levorotatory or dextrorotatory
HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

(HPLC)
Separation & identification of amino acids, lipids, carbohydrates, nuclic acid,

proteins, pigments, steroids & pharmaceuticals
Resolution & speed of analysis exceed the classical method
High Resolution is
High Speed elution is
Due to usage of Stationary
due to Application of
phase with very Small

particle size & large surface
high pressure to the

solvent flow.
area.
All chromatographic modes are possible in HPLC
INSTRUMENT
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Column:
Stainless steel withstand high pressure (5.5 * 107 pa)

1) Generally used: straight, 15 50 cm long
1 4 mm diameter
2) Besides, smaller, microbore or open tubular columns are also used.
Microbore Columns
25 cm long
1 2 mm internal diameter
3) Preparative Column
Have a diameter of 25 mm
4) Precision bored column with an internal mirror finish
Porous plugs of stainless steel / Teflon used at the end of the HPLC column.
Matrix & Stationary Phases

3 types of rigid solid supports / packing matrix
1) Microporous Supports
Micropores ramify through the particles which are generally 5 10 nm
/ 20 40 nm in diameter.
2) Pellicular (superficially porus) Supports

Porus particles are coated onto an inert solid cone (e.g. glass beads of
40 nm diameter.
3) Bonded Phase
The stationary phase is chemically bonded on to an inert support (e.g.
silica)
HPLC columns are packed with different packing materials enabling adsorption,
partition, exclusion or ion exchange chromatography
Types of stationary phase used for different class through HPLC
Type of Ch.
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Adsorption
Small glass bead core coated with silica
Or alumina (Pellicular)
Partition
Solid support coated with liquid

stationary phase as in GLC ( Pellicular or
Microporun)
Ion Exchange
Hard gels / Vesins are covalently linked
chromatography
to exchanges (bonded phase)
Column Packing
Rigid solid / hard gel should be packed as densely as possible, but without
fracturing the particle.
Packed with high pressure slurring technique packing is done under pressure.
Mobile Phase & Pump

1) Single Solvent / or 2 or more solvents premixed in fixed proportion
Applied to the column with single pump for Isocratic
Separation / Elution.
2) Two Solvents in predetermined proportion
Applied to the column with separate pumps for Gradient
Separation / Elution
Properties of Mobile Phase

1) Pure
2) Non reactive
3) Detector compatible
Pumps
(1) Output at least 5 * 107 Pa
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(2) No pulse (ideally) = no variation in pressure
(3) Flow capacity at least 10 cm3/min
Upto 100 cm3/min
(4) 1 pump (Isocratic Separation)
(5) 2 pumps (Gradiant Separation)
Sample Preparation
Involves
Desalting, Ion removal, Metal Removal, Removal Of Detergent, Particulate
Removal.
Application of Sample
(1) Injecting the sample directly to the column / onto a small plug of inert
material above the column packing
While system is under
or, under the atmospheric pressure, called
pressure
Stop Flow Injection
(2) Use of loop injector
Injection is done under pressure
Loop injector consists of Metal loop of fixed small volume

Filled with the sample
The eluent from the pump is channeled through the loop
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The outlet of the loop directly leads to the column
The sample is thus flushed onto the column
Animation: www.restek.com/info_sixport.asp
Detectors:
Ideal detector should give linear & rapid response over a wide range of concentration
specially at low concentration of analyte.
Types of detectors:
Refractive Index Detector
Monitor diff. in refractive indices between column effluent & mobile phase
Variable Wavelength Detector

Based on UV Visible Spectroscopy
Scanning Wavelength Detector
Record complete adsorption spectra of each analytic
MICROBIOLOGY LAB
Incubator
An incubator is a device used to grow and maintain of course microbiological
cultures or cell cultures. The incubator maintains optimal temperature,
humidity and other conditions such as the carbon dioxide (CO2) and oxygen
content of the atmosphere inside. Incubators are essential for a lot of
experimental work in cell biology, microbiology and molecular biology.
Hot air oven

Hot air ovens are electrical devices used in sterilization. The oven uses dry
heat to sterilize articles. Generally, they can be operated from 50 to 300 C
(122 to 572 F) . There is a thermostat controlling the temperature. These are
digitally controlled to maintain the temperature. Their double walled
insulation keeps the heat in and conserves energy, the inner layer being a poor
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conductor and outer layer being metallic. There is also an air filled space in
between to aid insulation. An air circulating fan helps in uniform distribution
of the heat. These are fitted with the adjustable wire mesh plated trays or
aluminium trays and may have an on/off rocker switch, as well as indicators
and controls for temperature and holding time. The capacities of these ovens
vary. Power supply needs vary from country to country, depending on the
voltage and frequency (hertz) used. Temperature sensitive tapes or other
devices like those using bacterial spores can be used to work as controls, to
test for the efficacy of the device in every cycle.
They do not require water and there is not much pressure build up within the
oven, unlike an autoclave, making them safer to work with. This also makes
them more suitable to be used in a laboratory environment. They are much
smaller than autoclaves but can still be as effective. They can be more rapid
than an autoclave and higher temperatures can be reached compared to other
means. The incubator should be resistant to corrosion (e.g., stainless steel,
although anodized aluminum is acceptable for a dry incubator) and easily
cleaned. A double chamber, or two incubators stacked, one above the other,
independently regulated, is preferable to one large incubator because it can
accommodate more cultures with better temperature control, and if one half
fails or needs to be cleaned, the other can still be used,avoiding the formation
of cold spots. These incubators also hold their temperature longer in the event
of a heater failure or cut in power.
In microbiology lab we test the microbial condition of the tablet.
First of all we prepare four SCDM flask (Soyabean Casein Digest Medium).
In the first flask we put 10g of the sample and then incubate it for one week.
Then we prepare the petriplate one for bacteria detection and other for fungus
detection.
One for bacteria is prepared with scdagar (Soyabean Cholraphenicol Agar).
The one bacteria is incubated at 32.5o for 5 days whereas one for fungus is
incubated for 7 days at 22.5o. The second test tube is combined with 4th and
then used for selective media. The third test tube is used for identifying
repovport vassilidis salmonella enterecus and its MIT is done.
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Basically there are three types of test performed
(1) MLT (Microbial Unit Test)
Sample total viable count
Identify by pour plate method
(2) Water Analysis
Water analysis of point 7 and 13 is done which are the starting and distribution
point of water. Then samples are collected by total viable count by membrane
filtration. The membrane is used of 0.45 micron. Buffer sodium chloride
phosphate is used as diluents for filtration.
(3) Environment Monitoring

Settle method directly expose 1 hr. air sample is also used which sucks air
from that particular environment
Glasswares and plasticwares:

All glasswares were properly washed, dried, wrapped and sterilized at 160oC
for 1 hr in hot air oven before use, as and when needed. Presterilized
plasticwares were used, made from Axygen or Hi-media.
Equipments:
Centrifuge
Remi R24
Refrigerator
LG
Electronic balance
KERN EMB 200-2
Laminar airflow cabinet
Klenzaids
Microscope
Olympus
Vortex
Spinix
Micropipette
Eppendroff
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Chapter-4
List of Machineries
Tablet & Powder Section
Mass Mixer
Shifter
Fluid bed dryer
Multi Mill
Octagonal Blender
Tablet Compression Machine
Film Coating Pan
Blister Packing Machine
Strip Packing Machine
Capsule Section
Cone Blender
Capsule Loader
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Capsule Filling Machine with Change Parts, Capsule Polishing
Syrup Section
Motorised Stirrer
Filling Machine
Sealing Machine
Inspection Table
Labeling Machine
Colloidal Machine
Filter Press
MACHINERY USED IN TABLET MAKING:

Mechanical shifter:
The Mechanical Shifter is suitable for the separation of granules. Powders and other
similar products for the pharmaceutical, chemical, dairy, food, paints, ceramic, rubber,
abrasives, plastic, printing ink, petroleum, cosmetics etc. industries.
The main hopper is directly coupled to the vibratory motor and is subjected to high
amplitude vibrations in all three axis, due to which better sieving takes place. The
hopper is provided with a radial outlet and specially designed 'C' clamps with gaskets
to prevent leakage of the powder. It is provided with uniquely designed springs to the
periphery to amplify the vibrations for better sieving and at the same time to prevent
the vibrations from being transferred to the floor
Multimill:
Multi Mill is a self-contained portable unit that is widely used for milling,
homogenizing, dispersing, shredding and breaking down of agglomerates into small
size particles. These machines find varied application in different industries such as
pharmaceuticals, chemicals, cosmetics, ceramics, colors, dyestuff, food products etc.
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Made from high quality stainless steel, our Multi Mill machines are rated for
continuous operation in Pharmaceutical, Cosmetic, Chemical and Food Processing
industry for higher output and process uniformity.
Mass mixer:
Mass mixer is a specially designed pharmaceutical machinery, that is used to blend
both wet as well as mass-mixer dry material. The main purpose of mass mixing
machinery in the pharmaceutical industry is to do thorough mixing of wet as well as
dry or lump material and highly suitable for tablet granulation process. It is also
considered one of the best blending equipment and that is why it is used widely in
various industries. Mass Mixers are perfect for mixing of pharmaceutical chemicals,
powders, confectioneries, food etc.
Special features
Mass mixers are available in standard and GMP model.
Models are usually available as per the mixing capacity.
Available width leaf type for ribbon type stirrer blade.
There is a specific range of mass mixers to suit working volume.
Application of Mass Mixers
Pharmaceuticals
Chemicals
Food
Confectionery
Mineral
Paint & Chemical Industries
Fluid Bed Dryer:
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The fluidization technique is efficient for the drying of granular solids,because each
particle is completely surrounded by the drying gas. In addition, the intense mixing
between the solids and gas results in uniform conditions of temperature, composition
and particle size distribution throught the bed.
Fluid Bed Dryer Application
The granules is produced by screw extraded granulator, swaying granulator or high
speed mixing granulator.
Pharmaceutical, foodstuff, feed, chemical industries and so on fields.
Large granules, small blocks and adhesive material.
The material that volumes might vary different during drying process.
Features
The structure of fluidization bed is round so as to avoid dead corner;
Inside the hopper there is a stir in order to avoid agglomeration of raw material
and forming canal of flow;
The granule is discharged through the method of turning over. In this way it is
very convenient. The discharging system can be designed as request too;
Principle
Purified and heated air is immited from the bottom by fan and passed through the
screen plate of hopper. In the work chamber, the state of fluidization is formed
through stirring and negative pressure. The moisture is evaporated and removed
rapidly and the raw material is dried quickly.
Octagonal blender:
The octagonal blender is an efficient and versatile blending machine for mixing and
lubrication process of dry granules homogeneously. Two third of the volume of the
cone blender is filled to ensure proper mixing.
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the octagonal blender or pharmaceutical octagonal blender gives best result for
granules due to very slow speed and octagon shape of container. It can be used for
pharmaceutical, food, chemical and cosmetic products etc.
in octagonal blender the granules comes from all sides due to the octagonal shape of
the product container, hence requirement of rpm is less. The pharmaceutical octagonal
blender is suitable mainly for crystalline & granular type material. This type of
material gets sufficient continuous movement due to their shape if container have only
slow movement and will results in good quality of blending / lubrication of granules.
SPECIAL FEATURES :
> Suitable for dry mixing of products in granule form.
> Easy for loading and unloading of material.
> Easy for cleaning.
> All contact parts are made out of SS 304 / SS 316 or SS 316 L quality material, as
per customer requirement.
> The octagonal shape & slow speed of rotating gives sufficient continuous
movement to the granules, result in good quality.
> Simple design requires minimum maintenance.
> General structure & safety guards made out of mild steel & coloured in Standard
Model and made out of SS 304 & polished to the matt finish in GMP Model.
> Maximum care has been taken to ensure safe operation of the unit.
> Manual rotating facility with hand wheel for inching.
> Bigger size batch at low power consumption.
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Coating pan:
Coating pans are used to form an aqueous or organic film around any kind of pellets
and tablets or micro granules. These pans are also widely used to sugar-coat tablets. A
coating pan is an essential requiremet in pharmaceutical applications. Different
coating techniques are applied in pharmaceutical industry.
Pellets/Tablets are continuously fed into a coating drum at a controlled rate. A high
volume of process air heats the tablets at the time of entering and moving in the drum.
Coating solution is applied through a series of spray guns as the product moves down
the length of the coating drum. The tablets are homogeneously mixed for a uniform
coating/weight gain. Shallow bed depth of the pan allows the tablet/pellets to pass
through the spraying zone and finally discharged from the exhaust end of the coating
drum and transported through a conveyor belt for collection, storage, inspection and
packaging. These machines ensure consistent exterior coating.
Salient features of Coating Pan are as follows:
Usually, temperature can be controlled with the help of temperature controller.
Compact hot air blower with inlet air damping arrangement, is generally there in
different coating pans.
Mounting facility is available for easy change from coating pan to polishing pan.
Coating pans do not require any foundation and are able to install on pre leveled floor.
Flameproof type of construction is optional.
Application of Coating Pan:
Pharmaceutical
Vitamins
Food
Candy
Tablet Blister packaging machine:

Blister packs are commonly used as unit-dose packaging for pharmaceutical tablets,
capsules or lozenges. Blister packs can provide barrier protection for shelf life
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requirements, and a degree of tamper resistance. blister packs are mainly used for
packing physician samples of drug products in the pharmacy. Blisters are the main
packaging type since pharmacy dispensing and re-packaging are not common. A
series of blister cavities is sometimes called a blister card or blister strip as well as
blister pack. The difference between strip and blister is that strip doesn't have thermoformed or cold-pressed cavitied. The cavity is formed around the piece of product at a
time when it's dropped to the sealing area between sealing moulds. The main
advantages of unit-dose blister packs over other methods of packing pharmaceutical
products are the assurance of product/packaging integrity (including shelflife) of each
individual dose and the possibility to create a compliance pack or calendar pack by
printing the days of the week above each dose. Blister packs also hinder the use of
OTC drugs in the manufacture of illegal drugs.[specify]
Blister packs are created by means of a form-fill-seal process at the pharmaceutical
company or designated contract packer. A form-fill-seal process means that the blister
pack is created from rolls of flat sheet or film, filled with the pharmaceutical product
and closed (sealed) on the same equipment. Such equipment is called a blisterline.
There are two types of blister machine's design: rotary and flat-plate.
Tablet strip packaging machine:

Automatic high speed packing machine with a capacity up to 2500 tablets per
minutes. In strip packing machine wide range of products can be packed
automatically / semi automatically. To operate the machine is very simple. The
product is fed through hopper and feeding device flows to the heat sealing roller
cavities, the desired laminated foil from the two rollers is drawn on the sealing rollers
which packs and seals the products continuously. The sealed strip passes through the
vertical and horizontal cutters to get desired strip sizes.
Application: Strip packing machine is extensively used to pack tablets, capsules,

caplets, coated tablets, soft gelatin capsules. The same is also used to pack supari,
tobacco, refills, battery cells, mats, bearings, oil seals, steel balls, chewing gum, tofees
etc.
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Machines Used In Capsule Making:

Cone Blender
The Double Cone Blender is an efficient and versatile machine for mixing dry powder
and granules homogeneously. All the contact parts made out of stainless steel of
required grade by customer. Two third of the volume of the Cone Blender is filled to
ensure proper mixing. It can be used for Pharmaceutical, Food, Chemical and
Cosmetic products etc.
Capsule Polishing Machine

Capsule polishing machine is basically used to polish and clean the dust that covers
the surface of capsules or tablets. Also referred to as capsule polisher or capsule/tablet
polishing machine, capsule polishing machine is counted as the integral part of the
treatment process of any capsule, tablet and other medicines. The machine is
considered quite effective to get rid off dust and powder from the capsules and
polishing them via a means of a soft nylon rotary brush, fixed in the machine. After
coating process employs different pharmaceutical coating techniques, the tables,
capsules are taken into the next stage thats polishing. The primary goal of a
pharmaceutical polishing machine is to enhance the extent of finish and fulfill the
requirements of the health standard of the pharmaceutical trade.
Capsule Loader
The capsule loader is suitable for loading of empty capsules into the loading trays of
the capsule filling machine. It can load 300 capsules at a time. Capsule the loader has
a capacity of 120 trays / hr. It comes in same combinations as the capsule filling
machine.
Machines Used In Syrup Making
Sugar Syrup Manufacturing Plant
Sugar Syrup Manufacturing Plants are used in the pharmaceutical industry for the
production of Oral Liquids with high quality and with minimum man interface to
result in cleanliness of liquid. The plant is specially designed vessels, pipes, pipe
fittings and other accessories. It includes Sugar Melting Vessel (With bottom entry
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stirrer), Manufacturing Vessel (With bottom entry homogenizer), Zero Hold-Up Filter
Press, Storage Vessel (With bottom entry stirrer), Control Panel, Piping for Transfer of
Liquids, Transfer Pumps and Working Platform.
Filter Press
Filter Press consist of Stainless Steel Shell & Top cover using bolts to give pressure
tight enclosure. The filter cartridge assembly inside the shell consists of several
horizontally arranged disc type filter plates with perforated supporting screens, filter
media & interlocking cups. The entire assembly complete with pump & piping
connection is mounted on a suitable S.S. Trolley.
Operation:
The Cartridge assembly consists of plates, perforated screens, spacers and fitter
media. Interlocking spacers internally form single pipeline. The unfiltered liquid is
centrally fed under pressure from bottom inlet. The liquids spreads out equally on
each plate fitted with filter media. Solids remain on filter media and clear. Filtrate
flows through precisely made holes on sides of plates and collects in the shell, which
then come out through the outlet. In this process, solids are evenly distributed on each
plate. The cake is then cleaned from the filter material and used again for filtration
process
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CHAPTER-5
TABLET SECTION
PRODUCTION DEPARTMENT OF TABLET :
Especially tablets and liquid preparation are manufactured in SOUL HEALTHCARE.
TABLETS : According to Indian Pharmacopia tablets are solid & biconvex discs,
prepared by containing a drug or a mixture of drugs with or without diluents.
In Soul Healthcare. Various type of tablets are manufactured like :
Sugar coated tab.
Film coated tab.
Enteric coated tab.
For these productions they required specific types of:
1. DILUENTS
2. BINDER ADHESIVE
3. DISINTEGRANS
4. LUBRICANTS
5. GLIDANTS & FLOW PROMOTERS
6. COLOURS, DYE & SWEETENERS
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Discussion
Diluents:
Diluents are fillers designed to make up the required bulk of tablet when the
drug dosage is inadequate to produce the bulk. The dose of some drugs is
sufficiently high that no fillers is required (e.g. aspirin and certain antibiotics).
A classic case of a chemical incompatibility that went unrecognized for
several years was the interaction of certain amine drugs with the commonly
used diluent lactose, in the presence of metal stearate lubricant (such as
magnesium stearate).
Lactose is the first diluent because it is still the most widely used diluent in
tablet formulation. Lactose is an excipient that has no reaction with most
drugs, whether it is used in the hydrous or anhydrous form. Anhydrous lactose
has the advantage over lactose in that it does not undergo the Maillard reaction
which can lead to browning and discoloration with certain drugs, as noted
previously. The anhydrous form, however, picks up moisture when exposed to
elevated humidity. Such tablets may have to be carefully packaged to prevent
moisture. When a wet granulation process is employed, the hydrous form of
lactose should generally be used.
Spray-dried lactose is one of several diluents now available for direct
compression following mixing with the active ingredient, and possible, a
disintegrant and a lubricant.
The material loses some of its direct compressional characherstics.
Spray-dried lactose is especially prone to darkening in the presence of excess
moisture, amines and other compounds.
Starch, which may come from corn, wheat or potatoes, is occasionally used as
a tablet diluent.
Dextrose is also used as a tablet diluent. Under the name Cerelose and comes
in two forms, as a hydrate, and in anhydrous form for when low moisture
contents are required. Dextrose is sometimes combined in formulation to
replace some of the spray-dried lactose which may reduce the tendency of the
resulting tablets to darken.
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Mannitol is perhaps the most expensive sugar used as a tablet diluent, it is
widely used in chewable tablets. It is relatively nonhygroscopic and can be
used in vitamin formulation.
Binder and Adhesive:

These materials are added either dry or in liquid form during wet granulation
to form granules or to promote cohesive compacts for directly compressed
tables. Acacia and tragacanth are natural gums. These materials are much more
effective when they are added as solutions in the preparation of granulations
than when they are added dry to a direct compression formula.
Gelatin is natural protein and is sometimes used in combination with acacia.it
is easier to prepare in solution form, and forms tablets equally as hard as
acacia or tragancanth. Starch paste has historically been one of the most
common granulating agents. It is prepared by dispersing starch into water,
which is then heated for some prescribed time. During the heating, the starch
(which would indicate virtually complete conversion to glucose) and produces
cohesive tablets that readily disintegrate when properly formulated.
Modified natural polymers , such as the alginates and cellulose derivatives
(methylcellulose, hydroxypropyl methylcellulose, and hydroxypropyl
cellulose), are common binders and adhesives. Used dry for compression they
have some binder capabilities, while their aqueous solutions have adhesive
properties. Hydroxypropyl cellulose may also be used as an alcohol.
Disintegrants:
A disintegrant is added to most tablet formulations to facilitate a breakup or
disintegration of the tablet when it contacts water in the gastrointestinal tract.
Disintegrants may function by drawing water into the tablet, swelling, and
causing the tablet to burst apart. Starch USP and various starch derivatives are
the most common disintegrating agents. They also have the lowest cost. Starch
is typically used in a concentration range of 5 to 20% of the tablet weight.
Such modified starches are Primogel and Explotab, which are low substituted
carboxylmethyl starches, are used in lower concentrations (1 to 8%, with 4%
usually reported as optimum). Various pregelatinized starches are also
employed as disintegrants, usually in a 5% concentration.
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Clays such as Veegum HV and bentonite have been used as dinintegrants of
about a 10% level. Such use of these materials is limited unless the tablets are
colored, since the clays produce an off-white appearance.
Lubricants, Antiadherents, and Glidants:

A material that is primarily described as an antiadherent is typically also a
lubricant, with some glidant properties as well. Lubricants are intended to
reduce the friction during tablet ejection between the walls of the tablet and
the walls of the die cavity in which the tablet was formed. Antiadherents have
the purpose of reducing sticking or adhesion of any of the tablet granulation or
powder to the faces of the punches or to the die wall. Glidants are intended to
promote flow of the tablet granulation or powder materials by reducing
friction between the particles.
The most widely used lubricants have been stearic acid and various stearic
acid salts and derivatives. Calcium and magnesium stearate are the most
common salts employed. Talc is probably the second most commonly used
tablet lubricant, historically. The higher-molecular-weight polyethylene
glycols and certain polymeric surfactants have been used as water-soluble
lubricants. Since lubrication is basically a coating process, the tiner the
particle size of the lubricant, the more effective the lubricant action is likely to
be.
Colors, Flavors and Sweeteners:

The use of colors and dyes in tablet making has served three purposes over the
years: disguising of oft-color drugs, product identification, and production of a
more elegant product. Two forms of color have typically been used in tablet
preparation. These are the FD&C and D&C dyes. In any colored tablet, the
formulation should be checked for resistance to color changes on exposure to
light.
Flavors are usually limited to chewable tablets or other tablets intended to
dissolve in the mouth.
The use of sweeteners is primarily limited to chewable tablets to exclude or
limit the use of sugar in the tablets. Until recently, saccharin was the only
artificial sweetener available. Its major disadvantages are that it has a bitter
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aftertaste and has been reported to be carcinogenic. A new artificial sweetener
that is expected to largely replace saccharin is aspartame.
Types and Classes of Tablets:

Enteric Coated Tablets
The enteric coated tablet is the most common example of delayed-action tablet
product. All enteric coated tablets (which remain intact in the stomach but
quickly release in the upper intestine) are a type of delayed-action tablet. In a
human drug application, a product may be designed to pass through the
stomach intact and then release gradually for several hours or longer in the
intestines.
The compendial specifications for an enteric coated tablet are that all of the six
tablets placed in separate tubes of the USP disintegration apparatus (using
discs) remain intact after 30 min of exposure in simulated gastric fluid at 37oC
2oC and then disintegrate within the time specified for that products
monograph, plus 30 min. prior to gastric exposure, the tablets are immersed in
water at room temperature 5 minutes.
Enteric coatings are employed for a number of therapeutic, safety, and medical
reasons. Some drugs are irritating when directly exposed to the gastric mucosa
including aspirin. While for most people the occasional aspirin tablet may not
cause irritation, those on daily dose of aspirin, such as arthritics, may find
gastric upset a major problem. Enteric coating is one method of reducing of
eliminating irritation from such drugs. There are other drugs that if released in
the stomach may produce nausea and vomiting. The low pH of the stomach
destroys other drugs (for example, erythromycin), and hence enteric coating
may be necessary to bring the drug through that environment to the more
neutral intestinal contents.
Sugar and Chocolate Coated Tablets
The primary historical role was to produce an elegant, glossy, easy-to-swallow
tablet dosage form. Also, they permit separation of incompatible ingredients
between coating and core, and this fact has been widely utilized in preparing
many multivitamin and multivitamin mineral combinations. The process as
originally developed was time-consuming and required skilled coating artisans
to be conducted properly. Earlier sugar coatings typically doubled tablet
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weight. Today, water-soluble polymers are often incorporated in the sugar
solution, automated-spray coating equipment is employed. The result is that
the coatings are more elastic and mechanically stable, and the process may be
completed in a day or less.
Film Coated Tablets
Film coated tablets offer a number of advantages over sugar coated tablets.
These advantages include better mechanical strength of the coating based on
the elasticity and flexibility of the polymer coating. The avoidance of sugar,
which is contraindicated in the diets of a significant segment of the population,
and the employment of a process that may be continuous, or that readily lends
itself to automation. The primary disadvantage of film coating compared with
sugar coating is that it is difficult to produce film coated tablets that match
the physical appearance and elegance of the sugar coated product. Film
coated tablets, which are basically tasteless, also offer the advantage over
sugar coated product. Film coated tablets, which are basically tasteless,
also offer the advantage over sugar coated tablets of being less likely to be
mistaken for candy.
Chewable Tablets
Chewable tablets are intended to be chewed in the mouth prior to swallowing
and are not intended to be swallowed intact. The purpose of chewable tablet is
to provide a unit dosage form of medication which can be easily administered
to infants and children or to the elderly, who may have difficulty swallowing a
tablet intact. The most common chewable tablet on the market is the chewable
aspirin tablet intended for use in children. Many antacid tablet products are of
chewable type. The chewable tablet offers two major advantages. First, the
dose of most antacids is large, so that the typical antacid is related to its
particle size. If the tablet is chewed prior to swallowing, better acid
neutralization may be possible from a given antacid dose.
Quality Control
After coating, the tablets should be inspected and tested for appearance and
performance. Inspection should include checks for color, size, appearance, and
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any physical defects in the coating, which could affect the performance or
stability of the product.
The in vitro performance of the coated product is evaluated by disintegration
and dissolution testing. Dissolution testing measures the amount of active drug
in solution over time.
Additional testing of coated tablets may also include tests for mechanical
strength and for resistance to chipping and cracking during handling. Methods
and devices for these tests are similar to those used for uncoated tablets.
Stability Testing
Stability testing is conducted to determine the effect of time and storage
conditions on the physical and chemical stability program should be designed
to determine the shelf life or expiry dating of the coated product under
normal storage conditions in its intended package. Tablets products should
have at least a two year expiration date.
The testing program may also be designed to test the products stability at
elevated or accelerated storage conditions. This type of program may help to
establish acceptable storage conditions for the product in relation to
temperature, humid, and light exposure, or it may help to study the rate of
degradation of the active ingredient under various conditions. On aging, or
under various conditions of storage, a particular variation may reach in
physical instability of the film, color changes, or chemical degradation of the
active ingredient.
Film Defects
Sticking And Picking
Overwetting or excessive film tackiness causes tablets to stick to each other or
to the coating pan. On drying, at the point of contact, a piece of the film may
remain adhered to the pan or to another tablet giving a picked appearance to
the tablet. Reduction in the liquid application rate or increases in the drying air
temperature and air volume usually solve this problem.
Hazing/Dull Film
This is sometimes called bloom. It can occur when too high a processing
temperature is used for a particular formulation. Tablets are exposed to high
humidity conditions.
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Color Variation
Improper mixing, uneven spray pattern and inefficient coating may result in
color variation.
Steps Involved in Manufacturing of a Tablet:Granulation

First step in granulation is shifting that is sieving. The raw material for
a particular medicine is taken and then shifted in a shifter with the
seive size of desired size as in 24R, 64R. after all the ingredients are
shifted then they are transferred into the RMG(Rapid Mixer
Granulator) in which API (Active Pharmeceutical Ingredient) and
ExiPient are mixed together to form a dry mix. API is the drug that is
needed to cure a particular disease. For dry mixing in the RMG only
the impeller is kept on and runned at slow rate. This is done for
uniform mixing. Then wet mixing is performed separately from the
ingredients such as water and mixed in the stirrer. During wet mixing
the chopper is also made on for avoiding clump formation. first the
chopper speed is slow till the binder is added but when water is added
the chopper speed becomes fast and the water is added which is mostly
equal to the amount of binder added.
On the screen there are two parameters which tells us the agitator
current and chopper current which gives the information whether
granules are formed or not. The value of these are measured due to the
amount of weight that is there on the impeller and chopper.
Sizing
Then sizing is done in a quadro mill along with a different sieve sizes.
When the sieve size is selected it depends on the size of the granules
required. In sizeing we get two type of particles
fines
granules
We require the granules hence we take the granules and fines are
shifted till they become granules then the process is stopped.
Blending
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The granules are then transferred to bin blender where blending takes
place. Blending is a process in which we add lubricant to the granules
for proper for movement in compression machine. The granules we get
before the blend are called intra granular and the products added at the
blend are called extra granular. The extra granular products are of two
types
Pre lubricants
Lubricants
The lubricants are added before that is when the granules are filled in
bin then they are added. After their mixing upto a particular time
lubricants are added. The extra granular products are shifted before
being added to bin. Once the blending is over it is ready for
compression
.
Dry mixing:
Dry mixing is done for products sensitive to water. For dry mixing
usually the machine used in compactor which convert the shifted
ingredients into biscuit form. The compactor machine is called
chizonator. The biscuit formed are the milled that is converted to the
granules then shifting takes place in which fines are discarded and
granules are taken. Then blending is performed and granules are ready
for compression.
Compression:
It is a process of converting the granules in the tablet form. The
machine is selected based on the size of the tablet to be manufactured.
In this machine there are two punches available one upper punch and
other lower punch. Between these two is the dye which contain the
actual size of the tablet. The pressure that is being applied on the
punches decide the width of the tablet and the pressure is applied on
the machine accordingly. The upper punch contain the name and the
lower punch may be plane or have some symbol. The granules are fed
in the machine with the help of vaccum. There are two rotating wheels
in which the dyes are kept. Every medicine has different type of dyes
based on the shape of the medicine. The granules enter from where it is
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filled in the dye and the powder is first weighed according to the
weight of the tablet then filled in the dye. The pressure is applied by
the first wheel which makes the tablet loose and then second wheel
also compresses this loose tablet and turn it into a compact structure.
When the tablet is formed it pass through the D-duster which removes
the dust other than that are compressed with the help of air. Then the
tablets passed through the metal detector which detects that whether
any metal is present in the tablet or not. If the metal is present then the
tablet is rejected. In the machine the amount of powder is weighed and
compressed. If the powder is more or less than the required then the
tablet is rejected.The tablets are ready for coating. Some tablets do not
need coating are packed directly.
Coating:
Coating is the procedure of giving a uniform coating of a substance on
the tablet for giving colour is protecting it from light, moisture,
oxidation, identification.
The critical parameters for coating are
PAN-RPM: the speed of the pan at which it moves.
SPRAY-RPM: the speed at which the spray is being done.
INLET-FLOW: the amount of air which is coming in the pan. It

should be not too high because if it is high then the spary will not reach
to the tablet and dry before.
DISTANCE OF GUN TO TABLET SHOULD BE BETWEEN 14-20
cm:
Blower is present above the machine that takes the fresh air and heater
makes the air hot which enters in through inlet pipes. Coating solution
is made up of water and opadry. The solution is prepared with the help
of stir. A pump is attached to the drum which takes the solution into the
machine. This drum is kept on weighing machine which tells the
amount of liquid that is being transferred to the tablets. Along with the
spraying there is another process for drying. The rest of the air is
moved out through the outlet wall. Spray is done by fan and the
process is atomization. The weight of the tablets is checked in between
so as to be assured that desired weight is achieved or not. An average
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of 100 tablets is taken mostly because there is a variation in tablet to
tablet weight.
PRODUCT PROFILE OF TABLETS
FOLIC ACID
B-COMPLEX
CETRIZINE 10 mg
DICLOFENAC SODIUM 50 mg
DOMPERIDONE 10 mg
NIMESULIDE 100 mg
PARACETAMOL TAB.
RANITIDINE 150, 300 mg
IBUPROFEN
METRONIDAZOLE 20, 400 mg
DIPHENYHYDRAZINE
OFLOXACIN
EVALUATION OF SOME TABLETS:
1.Paracetamol
Acetaminophen
C8H9NO2
Molecular Weight: 151.2
Paracetamol is 4-hydroxyacetanilide.
Paracetamol Contains not less euan 99 percent and not more than 101 percent
of C8H9O2
CATEGORY:-Analgesic; Antipyret2.DOSE; 500mg to 1 g every 4 to 6 hours,

up to 4g daily, in divided doses.
Description:- White crystals or a white, Crystalline powder.
SOLUBILITY:- Sprangily soluble in H2O, freely soluble in Alcohol, very
slightly soluble in methylene Chloride
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Loss on drying:- Max 0.5percent determined on 1.000 g by drying in an oven
at 105`c , 1M NAOH and dilute with 98 ml of Distilled water. Mix well for 5
minutes.
Formulation of Drug: NILID PLUS
ITEM
QUANTITY
Paracetamol
91.700 Kg
Starch
20.000 Kg
M.C.C.P
5.000 Kg
Gelatin
0.500 Kg
Sod. Benzoate + M.P. + P.P
0.500 Kg
Magnesium Stearate
0.500 Kg
Talc
2.500 Kg
S.S.G
2.500 Kg
Batch is prepared for Manufacturing of Tablets.

Assay:- Weigh Raw Material of Paracetamol i.e. 180 mg, add 2.5 ml of
NAOH by pipette. Mix well in sonicator for 5 minutes, dilute with 98 ml of
water. Mix and filter. Take 1 ml of the sample solution to another flask, add
1ml of 1M NaOH & dilute with 98ml 0f Distilled Water. Mix well for 5
minutes.
Observation:
Measure the Absorbance of the resulting solution at the maximum at about 257nm
lambda= 0.638
RESULT:- Hence the specified absorbance in IP is=0.650
Hence the result is passed.
the tested a = 0.638
the result is passed.
Note:- Slight variation May occur, it depends on different u v spectrophotometer.
2. Nimesulide
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Action Lose/Category;- Cyclo-oxygenase inhibitor, analgesic, antiiinflammatory.
DESCRIPTION:- Yellowish, Crystalline Powder.
SOLUBILITY:- Practically insoluble in water, freely soluble in acetone,
slightly soluble in anhydrous ethanol.
Melting Point:- about 149`c
Formulation of Drug:- SONICE PLUS
ITEM
QUANTITY
Paracetamol
53.330 kg
Nimesulide
40.000 kg
Starch
25.000 kg
D.C.P. + M.C.C.P
4.00 + 3.00 kg
Gelatin
0.700 kg
Sodium Benzoate + M.P. + P.P
0.700 kg + 150 + 30 kg
Magnesium Stearate
0.700 kg
Talc
2.500 kg
S.S.G.
2.500 kg
Color S.S. Yellow
80.00 kg
Absorbance;- Maximum 0.50 at 450nm.

Assay:- Weigh Raw Material Acetone (100 ml ) - Phenopthalein indi (3-4
drops) -0.1 M NAOH (for neutralisation) - Pink color develops. Add Raw
Material Colour changes Neutralisation by- 0.1 NAOH Colour-pink.
Calculation (Raw):6.354 * 30.83 * 0.1026 * 100/0.1*203. = 98.65%
(Finished):- 2.75 * 30.83 * 0.1026 * 452.88/0.1 * 423 = 91.35
3.AMINOPHYLLINE
C6H24N10O4
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Aminophylline is a stable mixture or combination of theophylline and
ethylenediamine. It may be anhydrous or may not contain more than 2
molecules of water of hydration.
AminoPhylline contains the equivalent of not less than 84.0% &not more than
87.4% of theophylline c7 H8 N4O2
Category:- Bronchodilator.
Dose:-Orally, 100 to 300 mg. by slow intravenous injection, 250 to 500 mg,
Description:- A white or slightly yellowish granules or powder, odour ,
slightly ammonical. On expousre to air it gradually loses ethylenediamine and
absorbs carbon-di-Oxide with liberation of free theophylline even in the
absence of light ,it gradually decomposed on exposure to as humid
environment , the degradation being faster at higher temperatures.
Assay:- Weigh accurately about 200.5mg, add 90 ml of H20 & warm the
mixture on water loath unull complete solution is effected. Cool, add 10 ml of
0,1 M silver Nitrate and 1,0 ml of bromothymol solution litrate with 0.1 M
Sodium hydroxide until a blue colour is obtained, means after Raw Material is
added the colour changes to turbid pink and after Neutralioes to blue.
1 ml of 0.1 M NaoH is equivalent to 0.01802g of c7h8n4o2.
Storage:-Store proteeted from moisture.
Calculation:- 1.25*0.09708 * 100 * 18.0L/ 0.1* 200 = 98.76%
AMINOPHYLLINE TABLETS
Tablets contain theophylline, C7H8N4O2 Equivalent to not less than 80.6% &
not more than 90.8% of the stated amount of aminophylline.
Usual strength = 100 mg.
Identification:Take a Quantity of the powered tablets containing about 100mg
powder in cylindrical flask. Add 0.1 M NaoH Solution make up
to 100 ml volume.
pipette out 1 ml of sample and again make up the vol to 100 ml
by adding 0.1M NaoH.
Observe in U.V. spectrophotometer.
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Take Reference solution also made from raw material
CALCULATIONS:- Standard at 270 nm
a=0.611
Test at 270 nm
= 0.508 nm
0.508*100*100*98.58/0.611*100*100*290.6*100 = 81.45%
Dissolution Test:Medium: 900ml of water
Speed & Time: 50 rpm, 45'
withdraw a suitable volume of the medium and filter. Measure the
absorbance of the filtered solution which is taken 10 ml,
suitably dilute it with water if necessary, at the maximum at
about 269 nm.
For making Test:
900 ml in Dissolutor
Speed= 50 rpm, 45
Weight=111.0 mg in 100 ml Volumetric Flask, take 1 ml
sample, make upto 100 ml. by adding D.W.
observe in U.V. Spectrophotometer:at =269
Test
=0.508
Reference=0.640
Calculations:0.508*111.2*900*1*100*98.58/8.640*100*100*100*10 = 77.84%
Not less than 70% of the stated amount 0f C7H8N4O2
HENCE PASSED.
4. IBUPROFEN-600mg.
(Quick Pain Relief)
C13H1802
Molecular Weight:- 206.3
Category:- Anti-inflammatory, Analgesic
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Dose:-600mg daily, after food.
Description:- A white or almost white crystalline powder, the assays and tests
are carried out at temperature between 20 C & 30 C
Formulation of Drug: Ibuprofen
Item
Quantity
Ibuprofen
40.000 Kg
Starch
06.000 Kg
P.V.P
00.300 Kg
Sod. Benzoate
00.300 Kg
Aerosil
00.300 Kg
Talc
1.500 Kg
S.S.G
1.500 Kg
Batch is prepared for the Manufacturing of Tablets.

Assay:- Weigh accurately the raw material i.e.0.2314mg, dissolve in 100 ml.
of ethanol(95%) & titrate with 0.1M sodium Hydroxide using 0.2ml(5-6
drops) of phenolphthalein solution as indicator.
Carry out a blank titration. i.e.
add raw material in a beaker having NaOH & indicator,
the above solution will become colorless, again carry out the
titration, The pink colour retains.
Calculations:volume*molarity*factor*100/weight of raw*molarity of
solution
=%
11*0.1026*20.63*100/231.4*0.1 = 100.61%
Result:- 1ml of 0.1M NaOH is equivalent to 0.02063g 0f C13H18O2
Tests:Optical Rotation:- +0.05 to -0.05, determined in a 2.5% w/v solution in
methanol.
5. FOLIC ACID
C19H19N706
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Molecular weight: 441.4
Folic Acid contains not less than 95.0% and not more than 102.0% of
C19H19N7O6. Calculated on the anhydrous basis.
Category:- In the treatment of anaemia assosciated with folic acid
deficiency, 5 to 20mg daily.
In the prophylaxis of anaemia of preganancy, 200 to 500mg
daily.
Description:- A yellow to yellowish orange, crystalline powder, odourless.
Formulation of Drug: Folic Acid
Item
Quantity
Folic Acid
1.00Kg
Starch
13.00Kg
Q.C.P
08.00Kg
Gelatin
0.100Kg
Sod. benzoate
0.100Kg
Mag. Stearate
0.100Kg
Talc
0.500Kg
Batch is made for the production of Tablets.

Assay:
Take raw material of folic acid in a cylindrical flask.
add 10ml 0.1M NaOH by pipette + 90ml D.W
Keep the volumetric flask in sonicator.
In another flask, pipette 10 ml 0.1M NaOH.
Add 1ml solution of prepared folic acid.
Add 89ml of D.W. and mix well in sonicator.
take solution for absorbance in U.V. Spectrophotometery.
Readings:
Standard- at 283 nm
a= 0.515
Test- at 283 nm
a=0.485 nm
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Calculations:
0.485*100*100*1*100*98.96/0.515*100*100*101.3*1 = 91.99%
Disintegration Time:- 4 minutes.
6. PREDNISOLONE
C21H28O5
Molecular Weight:- 360.4mg
Predinisolone consist of not more than 96.05%.
Category:- Adrenocortical Steroid
Dose:- upto 30mg daily.
Description:- A white or almost white, crystalline powder, hygroscopic.
Assay:- Weigh accurately about 0.0264g and dissolve in sufficient amount to
produce 50ml.
Firstly add 25ml methanol and sonicate,then again add 25 ml to this

solution and again sonicate.
pipette 1ml from above solution and make up the volume to 50ml by
adding methanol
Mix well in Sonicator.
observe the absorbance of the solution taking specific absorbance at

240 nm.
RESULT:a=0.328 nm.
Hence Raw Material is Passed for the Production of Tablets.
7. METRONIDAZOLE
C6H9N3O3
Metronidazole contain not less than 99.00% & not more than 101.0% of
C6H9N3O3. Calculate on the Dried Basis.
Category: Antiamoebic
For trichomoniasis, 200mg thrice daily for 7 days.
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For amoebiasis, 400mg thrice daily for 5 to 10 days.
1gm for children & 400mg daily for infants. Initial dose, by intravenous infusion
15mg/kg of body weight, subsequent doses, 7.5mg/kg of body weight upto a
maximum of 1gm every 6 hours, for 7 days or longer.
Formulation of Drug: Metronidazole
ITEM
QUANTITY (Kg)
Metronidazole
100.00
Starch
006.0
D.C.P.
003.0
Gelatin
1.500
Sod. Benzoate
0.600
Mag. Stearate
0.600
Talc
2.00
S.S.G.
2.00
Assay:
weigh accurately about 0.2303g dissolve in 80ml glacial acetic acid.
Neutralise by HCLO4
Put drops of a-Naptholbenzin, 2-3 drops.
Solution appear green in color.
Now titrate with Perchloric Acid i.e. 0.97766M HCLO4 (3-4 drops)
Result:1ml of 0.1M Perchloric Acid is equivalent to 0.01712g of

metronidazole.
Storage:protect from light and moisture.
Tablets are evaluated for their chemical characteristics like potency,
content uniformity & purity & physical characteristics like :
Weight & weight variation. ( 20 Tab. )
Limit : 10% - 130 mg
7.5% - > 130 mg.
5% - > 325 mg.
Hardness Pfizer & Monsanto tester
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Thickness
TABLET MANUFACTURING FLOW CHART
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CHAPTER-6
CAPSULE PRODUCTION
Capsules re solid dosage form usually containing one dose of drug
endlosed within a small, water soluble shell of a suitable form of gelatin.
A. Hard gelatin capsules of different sizes like : , 0, 1, 2, 3, 4, 5.
Processing of hard gelatin capsules :
Formulation of hard gelatin capsules.
Diluents
Protective sorbents
PRODUCT PROFILE OF CAPSULES :

MAGRON CAPSULES
AMOXYCILLIN 250 & 500 mg.
AMPICILLIN 250 & 500 mg.
CEPHALAXIN 250 & 500 mg.
DOXYCLINE 100 mg.
TETRACYCLINE 250 & 500 mg.
FURASHON CAPSULES
B. EVALUATION OF MAGRON CAPSULES :

Magron contains iron.
Assay : for finished capsule
Take the powder from capsule, weigh average weight of 20 tablets. Take about 400mg
powder. Pour 1ml H2SO4 in a cylindrical flask with help of pipette.keep it on hot
plate for 10 minutes,heat till color changes from brown to green/yellow. Let cool the
solution.
Now do titration by Potassium Permanganate. Slowly color changes to yellow.then
pipette out 15ml HCl in the above solution and add 2gm Potassium Iodide. Keep the
above solution in magnetic stirrer and simultaneously carry out the titration by 0.1M
Na2S2O3.
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RESULT : 1 ml of 0.1M sodium thiosulfate is equivalent to 0.005585g of Fe.
STORAGE : store protected from light & moisture.
Evaluation of Capsules is done to detect :

Weight variation
Content uniformity
Disintegration test
Dissolution test
Manufacturing of capsules is done by Hand Capsule filling
machine.
Evaluation Of Amoxycillin Trihydrate + Potassium clavulanate Tablet(as per
IP) by HPLC
Claim :
Amoxycillin = 500mg
Potassium Clavulanate= 125mg
Assay Preparation :Mobile Phase : NaH2PO4
(Buffer prep.) :
7.8gm ->
1000ml(with H2O)
P[H]-> 4.4(with H3PO4/NaOH)
Buffer : MeOH
95V :5V
Standard Preparation : 50mg Amoxycillin + 12.5mg Pot. Clav. In 100ml H2O.

Sample Preparation :
50mg amoxycillin -> 100ml H20
Sample wt. =Avg wt* req wt/ claim
973.9*50/500= 97.39mg
HPLC Condition :
Column : 300 cm
Flow
Lambda : 220nm
Injection Volume : 20ul
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Purge
Equilibriate
Wash HPLC by Acetonitrile.
Then put pumps pipe in mobile phase.
Inject alternately the test solution & the reference solution.
Set the HPLC at 220 nm.
Flow Rate= 2ml
Run for 60 minutes.
2 peaks will be observed(amoxy+clav.)
To detect the 2 unkown peaks, we will prepare the standard of any salt.
We made amoxycillin sample and loaded in HPLC.
The sample was allowed to run,hence the peak created was compared
to test solution s peak.
Thus, by comparing the two peaks with amoxycillins we get the

information of the result discussed in spectrum.
CHAPTER-7
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NUTRACEUTICALS
Nutraceutical, a portmanteau of the words nutrition and pharmaceutical, is a food

or food product that reportedly provides health and medical benefits, including the
prevention and treatment of disease. Health Canada defines the term as "a product
isolated or purified from foods that is generally sold in medicinal forms not usually
associated with food. A nutraceutical is demonstrated to have a physiological benefit
or provide protection against chronic disease." Such products may range from isolated
nutrients, dietary supplements and specific diets to genetically engineered foods,
herbal products, and processed foods such as cereals, soups, and beverages. With
recent developments in cellular-level nutraceutical agents, researchers, and medical
practitioners are developing templates for integrating and assessing information from
clinical studies on complementary and alternative therapies into responsible medical
practice. a product isolated or purified from foods, and generally sold in medicinal
forms not usually associated with food and demonstrated to have a physiological
benefit or provide protection against chronic disease. Examples are beta-carotene and
lycopene.
The use of nutraceuticals, as an attempt to accomplish desirable therapeutic outcomes
with reduced side effects, as compared with other therapeutic agents has met with
great monetary success.[citation needed] The preference for the discovery and
production of nutraceuticals over pharmaceuticals is well seen in pharmaceutical and
biotech companies.
PRODUCT PROFILE
Biovit Syrup
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Biovit Capsule
Formulation of Biovit Syrup :
Each 5ml contains :(Approximate)

Item
Quantity
Protein
0.41gm
Vitamin A(as palmitate)
1250 IU
Vitamin B1 HCl
0.75mg
Vitamin B6 HCl
0.5mg
Vitamin B12
3 mcg
Vitamin D3
200IU
Vitamin E(As acetate)
2.5IU
Zinc Sulfate
22.2mg
Copper Sulfate
100mcg
Potassium Iodide
50mcg
L-Lysin HCl
5mg
Niacinamide
7.5mg
D-Panthenol
1.25mg
Riboflavin Sodium Phosphate
0.75
All ingredients were mixed in a batch according to GMP & GLP. The batch of Sugar
Syrup was produced first then it was mixed with the desired ingredients, in a
manufacturing Vessel. Then it was allowed for filteration in a filter press. The
impurities retained and a clear solution was obtained. Finally the solution was stored
in a storage tank.the stored syrup was then allowed for filling in bottles, sealing of
lids, Inspection of the filled syrup if it contains any impurities. The inspection was
carried on a inspection table in the presensce of white and black light. Finally the
syrup bottles which were passed go for packing and Dispatching.
Formulation of Biovit Capsule:

Each Hard Gelatin Capsule contains : (Approximate)
Item
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Beta Carotene
10mg
Lycopene
2000mcg
Selenium(as di-oxide)
150mcg
Vitamin A(As Acetate)
5000IU
Vitamin E Acetate
15 IU
Zinc Sulfate
7.5mg
Copper Sulfate
1mg
Manganese Sulfate
1.5 mg
Thus the batch was prepared for the manufacturing of capsules. Hard gelatin
was purchased from outside vendors. The capsule bulk was passed to quality
control department for test. When the bulk is passed the capsule is ready for
final production. The capules were polished in a polishing machine. Capsules
were packed and finally dispatched.
CHAPTER-8
SYRUP & SUSPENSION
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Syrups are sweet, viscous, concentrated acquous solution of sucrose or

other sugars.
Suspension :
A pharmaceutical suspension is a biphasic system
composed of finely divided insoluble solid material suspended in a
liquid medium.
Washing area 16 bottle capacity (10ml-200ml)

washing D. M. water
Filling - 4 bottles capacity at a time

Belt conveyer
Sealing - single reading machine
Standardization Inspection
Visual dark / Light background
PRODUCT LIST OF SYRUP & SUSPENSION:

ANTITUSSIVE COGH EXPECTORANT
Dextromethorphane Hydrobromide & Phenyl propanolamine
Hydrochloride
COUGH SYRUP
Ambroxol HCL, Salbutamol syrup
ANTICOLD SUSPENSION
Cetrizine di HCL, Paracetamol suspension
ANTI DIARHEAL
Norfloxacin & Metronidazole suspension
CALCIUM SYRUP
Calcium syrup, Vita B12 & D3, L- Lysine
ANTIOXIDANTS & B Complex

ANTIFUNGAL SUSPENSION
Nystatin susp.
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HAEMANITIC WITH ENZYME SYRUP

Protein syrup with L-Lysine Mono HCL, Ferric Amm.
Citrate, Niacinamide, Papain, Zinc chloride, Mg Chloride
OFIN
NIP
NODDY
BIOVIT
Formulation of some Syrups:

NIP
Mefenamic Acid
C5H15NO2
It contains not less than 99% & not more than 99% calculated on dried basis.
Category :
Anti-inflammatory, analgesics
Description :
A white to greyish-white microcrystalline powder, odourless.
ASSAY :
Weigh accurately about 0.5gm and dissolve in 100ml of warm
ethanol(95%) previously neutralised to phenol red solution and titrate
with 0.1M NaOH using pheno red solution as indicator.
Result : 1ml of 0.1M NaOH is equivalent to 0.02413g of C15H15NO2.
Storage : Protect from light and moisture.
OFIN
Ofloxacin
C18H20FN3O4
Ofloxacin contains not more than 98.5% calculated on the dried basis.
Category : Antibacterial
Dose: 200 to 400mg daily.
Description: A pale yellow or bright yellow, Crystalline powder.
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Assay: Weigh accurately about 0.3g and dissolve in100ml of anhydrous glacial acetic
acid. Titrate with 0.1M Perchloric acid.
Result: 1ml of 0.1M perchloric acid is equivalent to0.03614g of C18H20FN3O4.
Storage: store protected from light and Moisture.
CHAPTER-9
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OINTMENT SECTION
Ointment is a semi solid preparation. Topical administration is
employed to deliever a drug at or immediately beneath the point of
application. Although occasionally enough drugs is absorbed in the
systemic circulation to cause systemic effects. A large no. of topical
medicaments are applied to skin , although topical drugs are also
applied to eye, nose, throat, ear etc.
MACHINES :
OINTMENT / CREAM MANUFACTURING TANK
WAX MELTING TANK JACKET
WATER PHASE CUM MANUFACTURING TANK
STORAGE TANK
TUBE FILLING CRIMPING & COATING MACHINE,
WATER CIRCULATION TANK
PRODUCT LIST :
1.ANTISEPTIC LOTION
2. NITROFLURAZINE CREAM
3. CETRIMIDE CREAM
4. AMR GEL
5. SILVERCIDE CREAM
6. POVIDONE OINTMENT
9. POVIFAR LOTION
10. DOLORON-GEL
11. CLOBEST CREAM
FORMULATION OF SOME PRODUCTS :
1. Povifar Lotion
Item
Quantity
Povidone-Iodine
11kg
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Glycerin
3L
Water
195L
Sodium hydrogen ortho-
400gm
-phosphate dihydrate(buffer)
Citric Acid
230gm
It is used by doctors for quick heal and wound cuts. Applied on patients prior to
injections for proper cleaning.
Batch :
Firstly, preheat the D.W. in a manufacturing tank.
Add glycerin and mix well with the help of impeller.
Buffer and Citric Acid added to maintain the p[H].
Mix well
Add Povidone-Iodine and mix well.
Leave for the rapid mixing in a manufacturing tank for half an hour.
Add shining agent /surfectant to the solution.
Leave the solution for cooling.
The bulk is passed for quality control,when the test is O.K., the filling of the
lotion is carried out then packing and finally dispatching.
2. Clobest (15 Kg)

Skin Cream
Antifungal, for Black Spots.
Composition :
M.C.C.P Wax
Liquid PArrafin
Salicylic Acid
Mix all the above ingredients in manufacturing tank with the
Heat at temp. 80C
help of impeller.
Let it cool for 25-30 minutes.
Add Clobetasol Propionate.
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FILLING OF OINTMENT IN TUBES
Switch ON the plug.
Then Switch ON Inch Button
Fix empty tubes on holder
Then nozzle will fill the tubes with ointment with help of piston which is
present at the back of machine
Then the tube will be pressed by pressing knob
Folding of the tube foil
Again pressing for better sealing
Again second fold
Again press
The packed tube is passed to the tray from the filling machine
The finished product is sent to the Q.C. for the test
If approved then dispatched after packing
CHAPTER-10
INJECTABLES SECTION
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AMPOULES / VIALS (INJECTABLES)

Injectables are sterile preparations intended for administration by
injection, infusion or implantatation into the body.
Its proper prcessing is strictly carried out into the sterile are which is
maintained by :
A . FUMIGATION Kmno4 + HCHO ( FORMALINE)

B . LAMINAR AIR FLOW
C . AIR HANDLING UNIT
It maintains the temperature of the particular area.
It contains the filters at its supply and return points.
Supply consist of = 3 & 5 filters
Return Consist of = 10 (2)
Supply consist of aluminium filter plates and cooling coils.
It filters the area by trapping the impurities.
From supply HEPA filters (3) To sterile area
The A.C. helps in cooling the air.
D . D.M WATER PLANT

Inlet waterRaw water motorMultimedia filterCartiage filterhi press
motorR.O. PlantpH maintainedCations (pH 4.5)Anions (pH 8.5)Mix
BedCartiage FilterU.V. LightsMulti ColumnDrug Injection Area
E . PROPER CLEANING SCHEDULE BY VARIOUS CHEMICALS

F . HUMIDITY MONITOR
It minimises the humidity of the room
It consist of inlet which have moisture in form of humidity which get

dried by silica gel drum
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Each processing were carried by well skilled persons in sterile section.

So only trained persons are allowed & another are prohibited in this
section.
Before entering into this section we have sterilized Our self
completely. in this section ampoules & vials of various drug were
manufactured.
Glass ampoules are special thin walled tubular glass containers to hold vaccines,
serums and other medicated solutions, solvents etc. These may be obtained as either
plain or the constricted type. The constricted style is preferred because of the greater
satisfaction obtained by a physician when the solution is withdrawn by a syringe. The
ampoule is broken at the point of constriction on the neck. This prevents the loss of
solution, permits the use of a short needle and also the removal of all the solution.
Ampoules are manufactured from special thin walled glass tubes. Coloured ampoules
especially the amber ones, are manufactured from amber coloured glass tubes. Several
sizes and shapes of ampoules are required for different uses and trades.
CHARACTERISTICS OF INJECTABLES
Injectables must possess the following characteristics:
1.
Freedom from living microbes;
2.
Freedom from microbial products viz. toxins, pyrogens etc;
3.
Freedom from physical contaminants viz. particulate matter, fibres etc.; and
4.
Matching synthetic qualities with respect to body fluids.
USES AND APPLICATION

Water for injection is generally used as the vehicle for aqueous injections.
MANUFACTURING PROCESS
Water for injection is prepared by a simple process called multiple stage evaporation.
The raw water is first treated with Kmno4 solution in order to remove the odor and
microorganism present in the water. Next comes the main step of the process
distillation in 3 repeated times.
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Distillation is a method of separation of substances which differ appreciably in their
vapour pressures. There are various types of distillation methods using different
equipments in the pharmaceutical industry. Fractional distillation is highly effective in
the point of view of purity of the separated liquid. The raw water is heated in the
reboiler to get vapourised. This vapour is condensed in a condenser and transfered to
the reboiler of the next distillation unit. This repeated distillation makes highly pure
water.
If saline water for injection is to be made required quantity of pure Nacl is added prior
to filling and sealing in ampoules. Sodium chloride injection water contains 0.9%
weight per volume of sodium chloride.
FILLING OF AMPOULES
As supplied by the manufacturer, ampoules for liquids are usually sealed to exclude
dust, having previously been washed and dried. For use, the ampoule is filled above
the neck and the sealed end broken off, care being taken to prevent glass spicules
from falling inside. The length of neck remaining should be sufficient to provide
adequate leverage when the completed ampoule is opened. Preliminary sterilization is
not essential if the contents are to be subjected to a final heating process after sealing,
but if the contents are thermolabile, the empty ampoules must be sterilized before
filling them.
In order that the ampoules may be dry, it is best to sterilize them in a hot air oven, but
if they are to be used for aqueous liquids, they can be sterilized by autoclaving
provided that they are well drained. For small batches, filling is usually carried out
under a screen using a syringe, while for slightly larger batches a burette fitted with a
hypodermic needle covered by a hood can be used. The necks may then conveniently
be sealed with a twin jet burner. On a large scale, of course, automatic filling, sealing,
labelling, machines are employed.
PROCESS FLOW CHART
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FLOWCHART OF MANUFACTURING OF STERILE
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PRODUCTS :
PRODUCT PROFILE OF STERILE PRODUCTS :

AMIKACIN 100, 250, 500 mg.
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AMOXYCILLIN 250 300 mg
AMPICILLIN 250
INGENTA-DX (EYE/EAR)
GENTAMYCIN SULPHATE
Formulation OF STERILE PRODUCTS :

Ingenta-DX (150L)
EYE/EAR DROP.
Composition
Claim
{A}
Gentamycin Sulphate
W-fi
0.03%w/v
130L
Disodium Hydrogen Phosphate

EDTA
p[H]
7.31
{B}
Dexamethasone Sodium-
0.05%w/v
-Phosphate
Propylene Glycol
Mix {A}+ {B}
Adjust p[H]
7-8
Make up the volume upto Batch Size.

NOTE :-Whole procedure to be done in a Sterile Area.
Dexa-Best (30L)
Wet Injection
Methyl Parabeen
Propyl Parabeen
Added in W-Fi
Sodium Metabisulphate
Sodium Citrate(Buffer)
E.D.T.A
Dexamethasone Sodium Phosphate
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All above ingredients are added in a batch. The p[H] is adjusted upto 7-8.
NOTE :- all the above procedures are to be done in Sterile Area.
CHAPTER-11
QUALITY ASSURANCE & DOCUMENTATION
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Quality Assurance creates the technical specifications regarded by the
Web community At large as Web standards. In ordered for access to all it is very
important that the quality of implementation be given as much attention as
standards development. There has always been and implementation of
quality assurance specification in both commercial and non-commercial
products.
The Quality Assurance (QA) Activity at quality assurance has a dual
focus to solidify and extended current quality practices, and to educateby
sharing out understanding of coordination, funding and tracking of the
quality of the products and services related to quality assurance
technologies. The mission of the QA team is to improve the quality assurance
specification implementation in the field. In
order to achieve that end, the QA activity :
Works on the quality of the species themselves (exa: to make sure
they have a comformance section, a primer, clear text that is
unmbigious for developers, good layoit, consistency between
specifications, and in particulars, that they are coordinated with the
TAG).
Promotes the development of good validations, test tools &
harmness for we & end users.
Thinks ahead in terms of what additional steps could be taken to
achieve QA goals more efficiently, including certification,
education, & communication.
DOCUMENTATION
It is a systematic & scientific process of collecting &recontrolling
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variable data that is enable to satisfaction
AIMS of documentation are
To define the specification for all mantainance
To define methods of manufacture & control
To ensure that the personnel authorized to release a batch for scale
average it have all the information that is necessary to take the
decision.
To provide information during investigation if a batch is suspected
to have defect
In India underschedule U & schedule M to the drugs and cosmetics
Rules that record are manes and path-own they are failing.
1. Batch reconciliation record
2. Environmental control record
3. Raw material requiring sheet
4. Recovery addition sheet
5. Manufacturing instrumentation
6. Bottle filling & washing record
7. Leak test record
8. Finished goods release record
9. Personnel records
10.SOP records.
11.Packaging material record
12.Packaging record
FIGURES
HPLC
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Inspection Table
Polarimeter
Ultrasonic Cleanersonicator
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UV Spectroscopy
Water Filtration Plant
Friability Test Apparatus
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Injectables
LEARNINGS & CONCLUSION

Purpose of Training:
The purpose of visit is to get a firsthand information about the operative system,
machines, proceduresadopted by the industries in practice and to gain some work
experience. Industrial visits provide vitalinformation about the organization, its
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performances and various functioning process of the organization.It also enables to
understand the internal working environment. As organizational behaviour is a part of
the management, it is necessary for a manager to understand and get accustomed to
the atmosphere of the organization.
What I have learn:

INSTRUMENTS DISCUSSION:
Chromatographically instruments like HPLC, U.V Spectrometery are playing major
role in pharma industry, which are majorly used in the qualitative and quantitative
analysis, the spectroscopic instruments are also more advanced and sophisticated.
R&D
The products from warehouse are taken in small quantities and are sent for analysis at
R&DThen they are analysed and if they reach the standards they are sent to
manufacturing department if notthey are sent to rejection block at warehouse.This is
department where method of synthesis of sample is done according to the requirement
of customer. The details of drug is sent to production department for further synthesis
MANUFACTURING
It is a place where the successfully analyzed samples are subjected to
manufacturing.This can be done by various types of reactors based on the nature of
the sample taken.
RAW MATERIAL STORE

Required dose of the raw material is purchased by the company and received by the
raw materialstores.These raw materials are stored under suitable conditions depending
upon their requirements.Approved& rejected materials are placed in different places
with different colour indications.
QUALITY CONTROL DEPARTMENT:

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This department is heart of the production department. After receiving the raw
material the material ischecked by the QC members for the impurities and for the
standards. If the results are negative the product is rejected.
After attending the training classes, I was filled with enormous

knowledge of analytical instruments. It proved to be very helpful
for completing and continuing an operation in pharma industry
and in R&D laboratory. As a SOUL HEALTHCAREs
participant I got the chance of becoming an instrumentally
skilled person, I utilised great opportunity very well.
CONCLUSION
The Three months industrial training proved to be a golden opportunity
for me in letting me understand various operations involved in
pharmaceutical industry.
During my training period I came very close to all the
aspects and analysis which we were carried out in the industry and at the same time
we learn how to follow the rules & regulation as per GMP and GLP & according to
WHO & ISO 9001, the company will
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soon achieve a very good & reputed position on the country level.
On the exposure to the industrial staff, i found that the
company staff is really hard working sincere & very co- operative in
nature.
On the whole, the company members works like family
members and support each other. I am thankful and wish the best
for the welfare and better achievement along with every worker of this Company.
BIBILOGRAPHY
INDIAN PHARMACOPIA
UNITED STATES PHARMACOPIA
BRITISH PHARMACOPIA
STANDARD OPERATING PROTOCOLS OF SOUL

HEALTHCARE.
WWW.WIKIPEDIA.COM
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www.final-yearproject.com
WWWW.PHARMAENCYCLOPEDIA.COM
WWW.GOOGLE.COM
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SOUL HEALTHCARE (I) PVT. LTD.

SOUL HEALTHCARE (I) PVT. LTD.

QUALITY POLICY OF COMPANY

Mr. Amit Garg,(Director of the Company)- having experience in the

Mr. Nitin Garg:-Managing the Company.

Mr. Mahesh Chandra - B.Sc. & is having about 10 years of

To get expose to the analytical instruments.

To learn the various analytical techniques in brief.

To learn the manner of handling, and minor precautions to be taken during

To take the opportunity to get idea about advanced analytical instrumentation.

Frontline ultrasonic cleaner

Heater (ceramic plate)

Digital disintegration test apparatus

Digital dissolution test apparatus

Karl fischer titration

An ultrasonic cleaner is a cleaning device that uses ultrasound (usually from

An ultrasonic cleaner is a cleaning device that uses ultrasound (usually from

Ultrasonic cleaning uses high frequency sound waves to agitate in a liquid.

Heater (ceramic plate):

A magnetic stirrer or magnetic mixer is a laboratory device that employs a

Food products such as butter and yogurt

Melting point apparatus:

It is used for the determination of the melting point of the solidsubstances.

Digital disintegration test apparatus

Research has established that one should not automatically expect a

Digital dissolution test apparatus

In the pharmaceutical industry, drug dissolution testing is routinely used to

In vitro drug dissolution data generated from dissolution testing experiments

The main objective of developing and evaluating an IVIVC is to establish the

Several dissolution apparatuses exist. In United States Pharmacopeia (USP)

USP Dissolution Apparatus 1 - Basket (37C)

USP Dissolution Apparatus 2 - Paddle (37C)

USP Dissolution Apparatus 3 - Reciprocating Cylinder (37C)

USP Dissolution Apparatus 4 - Flow-Through Cell (37C)

Karl fischer titration

Method Volumetric titration

water(H2O)= Volume(ml) of water determination consumed * f(mg/ml) * 100%

Most widely used spectrophotometric technique.

Based on absorption of UV Visible light by molecules

Based on the absorption of light

Absorption of light by a substance in solution follows Beer Lamberts Law

Beer Lamberts Law

Combination of two laws dealing with absorption of light in relation to

Provided an absorbing substance that is partially transparent

Transmit a portion of incident light

I = Intensity of the transmitted radiation

Intensity = no. of photons interacting in unit time

UV Visible spectroscopy is used to determine the absorption spectra of

To establish absorption spectrum for a given substance:

Transmittency or optical density of a particular concentration of the substance is

Since the absorption spectrum of substance is characteristic for it can

Increase substance concentration

Increase in absorbance at every wavelength

Essential Components Include

Amplifier & Recorder

Based on the principle of absorption of light thus follows Beer Lamberts

Biomolecules; do not absorb light in visible region in their original form

Most of the incoming light is absorbed by the solution, wavelength

Absorbs all wavelength

Transmit wavelength that correspond to blue color.

Light Source: Light Emitting Diode (LED)

determine the abs of blue sol.

Used both for qualification & quality measurement of biomolecules