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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
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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 :
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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:
CHEMICAL LAB
Water bath
Friability apparatus
INSTRUMENTAL LAB
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Magnetic stirrer
Refrigerator
pH meter
titrator
Polarimeter apparatus
Autoclave
SPECTROSCOPY LAB
U V spectrometer
CHROMATOGRAPHY LAB
HPLC
MICROBILOGY LAB
Incubator
Hot air oven
CHEMICAL LAB
Frontline ultrasonic cleaner:
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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
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:
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
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.
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.
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testing which is conducted in dissolution apparatus must be able to provide
accurate and reproducible results.
USP Dissolution Apparatus 2 is the most widely used apparatus among these
four.
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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.
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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.
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
Principles
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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
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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.
Filter
Sample Holder
Detector
Wavelength selector
(2) Spectrophotometer
Source
Monochromator
Sample Holder
Detector
Amplifier
& Recorder
Colorimeter
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465,
Blue
Green
635
Red
Absorption value
can be used to
can be used to
determine the
concentration
Spectrophotometer
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
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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
(3) Detector
Photomultiplier Tubes
Application
Absorption measurement could be used to for
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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 Resolution is
due to Application of
area.
INSTRUMENT
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Column:
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.
1) Microporous Supports
Micropores ramify through the particles which are generally 5 10 nm
/ 20 40 nm in 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
Or alumina (Pellicular)
Partition
Ion Exchange
chromatography
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.
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
pressure
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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
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.
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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.
Equipments:
Centrifuge
Remi R24
Refrigerator
LG
Electronic balance
Klenzaids
Microscope
Olympus
Vortex
Spinix
Micropipette
Eppendroff
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Chapter-4
List of Machineries
Tablet & Powder Section
Mass Mixer
Shifter
Multi Mill
Octagonal Blender
Capsule Section
Cone Blender
Capsule Loader
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Syrup Section
Motorised Stirrer
Filling Machine
Sealing Machine
Inspection Table
Labeling Machine
Colloidal Machine
Filter Press
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
Pharmaceuticals
Chemicals
Food
Confectionery
Mineral
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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
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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.
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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.
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.
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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.
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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.
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
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of 100 tablets is taken mostly because there is a variation in tablet to
tablet weight.
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
Paracetamol is 4-hydroxyacetanilide.
Paracetamol Contains not less euan 99 percent and not more than 101 percent
of C8H9O2
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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
0.500 Kg
Magnesium Stearate
0.500 Kg
Talc
2.500 Kg
S.S.G
2.500 Kg
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
0.700 kg + 150 + 30 kg
Magnesium Stearate
0.700 kg
Talc
2.500 kg
S.S.G.
2.500 kg
80.00 kg
3.AMINOPHYLLINE
C6H24N10O4
Molecular Weight: 420.4
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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% ¬ 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
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
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.
pipette 1ml from above solution and make up the volume to 50ml by
adding methanol
RESULT:a=0.328 nm.
Hence Raw Material is Passed for the Production of Tablets.
7. METRONIDAZOLE
C6H9N3O3
Molecular Weight: 171.2
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:
Neutralise by HCLO4
Now titrate with Perchloric Acid i.e. 0.97766M HCLO4 (3-4 drops)
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Thickness
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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
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1000ml(with H2O)
Buffer : MeOH
95V :5V
973.9*50/500= 97.39mg
HPLC Condition :
Column : 300 cm
Flow
Lambda : 220nm
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Purge
Equilibriate
To detect the 2 unkown peaks, we will prepare the standard of any salt.
The sample was allowed to run,hence the peak created was compared
to test solution s peak.
CHAPTER-7
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NUTRACEUTICALS
PRODUCT PROFILE
Biovit Syrup
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Biovit Capsule
Quantity
Protein
0.41gm
1250 IU
Vitamin B1 HCl
0.75mg
Vitamin B6 HCl
0.5mg
Vitamin B12
3 mcg
Vitamin D3
200IU
2.5IU
Zinc Sulfate
22.2mg
Copper Sulfate
100mcg
Potassium Iodide
50mcg
L-Lysin HCl
5mg
Niacinamide
7.5mg
D-Panthenol
1.25mg
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.
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Beta Carotene
10mg
Lycopene
2000mcg
Selenium(as di-oxide)
150mcg
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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Standardization Inspection
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
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OFIN
NIP
NODDY
BIOVIT
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
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 :
Mix well
Leave for the rapid mixing in a manufacturing tank for half an hour.
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.
M.C.C.P Wax
Liquid PArrafin
Salicylic Acid
help of impeller.
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Then nozzle will fill the tubes with ointment with help of piston which is
present at the back of machine
Again press
The packed tube is passed to the tray from the filling machine
CHAPTER-10
INJECTABLES SECTION
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2.
3.
Freedom from physical contaminants viz. particulate matter, fibres etc.; and
4.
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.
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PRODUCTS :
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AMOXYCILLIN 250 300 mg
AMPICILLIN 250
INGENTA-DX (EYE/EAR)
GENTAMYCIN SULPHATE
Claim
{A}
Gentamycin Sulphate
W-fi
0.03%w/v
130L
7.31
{B}
Dexamethasone Sodium-
0.05%w/v
-Phosphate
Propylene Glycol
Mix {A}+ {B}
Adjust p[H]
7-8
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All above ingredients are added in a batch. The p[H] is adjusted upto 7-8.
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
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Injectables
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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.
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.
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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.
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
BRITISH PHARMACOPIA
WWW.WIKIPEDIA.COM
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WWWW.PHARMAENCYCLOPEDIA.COM
WWW.GOOGLE.COM
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