This document summarizes Arush's one month industrial training at Pharma Force Lab, a leading manufacturer of finished pharmaceutical dosage forms in India. The summary describes:
1) Pharma Force Lab manufactures oral solid dosage forms like tablets and capsules through processes like wet granulation, dry granulation, and direct compression.
2) Tablet production involves steps of mixing, granulating, drying, milling, blending, compression, coating, and packaging. Common tablet coating methods are sugar coating, film coating, and enteric coating.
3) Tablets are packaged via methods such as blister packing and strip packing to provide protection and convenient dosing.
1. INDUSTRIAL REPORT
Submitted for the partial fulfillment of the award of degree
of
BACHELOR IN PHARMACY
2016-2017
By
Arush
(13-PSHIP-02)
Date of Training: 23.06.2016 to 23.07.2016
Himachal Institute of Pharmacy
Paonta Sahib, Distt. Sirmour-173025 (H.P)
2.
3. ACKNOWLEDGEMENT
I consider it a great privilege & honour to have had the opportunity to undergo the industrial
training work in PHARMA FORCE LAB. Hence, I would like to offer my heartiest thanks to
Mr. V.K. MITTAL , (GM, PFL) .
I consider it my to convey me deep sense of gratitude and pay respectful regards towards Dr.
Y.S Chaudhary (Principal) for valuable guidance, consistence encouragement and pleasant
discussion throughout.
I am greatly indebted to Dr. Ujjwal Nautiyal, Dr. Ramandeep Singh, for enabling us to have
the chance of industrial training.
I am thankful to all teaching and non teaching staff members of Himachal Institute of Pharmacy,
Paonta Sahib (H.P).
I convey my heartiest thanks to Mr. Manoj Tyagi (Production Manager), Mr. Anuj (Asst.
Production Manager), Mr. Sukhjinder singh (Manager, QC), Mr. Dheeraj (Asst. Manager,
QC) for their most valuable suggestions, constant encouragement, and affectionate guidance
during the period of this training.
I owe deep gratitude to the chemist Mr. Prabhat Tiwari for their support and guide to carry out
the tasks assigned to us while we are in the training. At last, I am greatly thankful to all my
seniors and colleagues in PFL for extending their constant cooperation which went a long way
towards the completion of this Training and Report.
ARUSH
ROLL NO. BP 301402
B.PHARMACY 4th YEAR
4. PREFACE
Pharmacy is a profession which is concerned with the art and science of preparing suitable and
convenient material for distribution and use in the treatment and prevention of disease, so it is a
fully technical profession where practical knowledge is much more important along with
theoretical knowledge.
According to curriculum of a four year integrated degree course of BACHELOR OF
PHARMACY each student has to undergo practical training for a periods of one month in
various pharmaceutical industries in India .As it is to be done during the summer vacation of 4th
year B. Pharmacy.
I was directed to undergo the 4th year training at “PHARMA FORCE LAB.” and this report
contains a brief description of the above pharmaceutical industry which was observed during the
training program.
5. PHARMA FORCE LAB
INTRODUCTION
Pharma Force Lab Is one of the leading manufacturer of Finishes Pharmaceutical dosage forms.
The company journey in the pharmaceuticals began way back in 2006. Since then it has been
saga of growth. Pharma Force Lab has established its presence in the domestic front by
manufacturing a variety of dosage forms in many therapeutic segments.
The state-of-the-art manufacturing facilities stand testimony to the company’s commitment
towards providing the medical community with a range of top quality finished dosage forms.
Manufacturing Activities
Pharmaceuticals Oral Dosage Formulations are manufactured at Pharma Force Lab. The products
manufactured at the site comprise of Generics and Proprietary medicines. This site is licensed to
manufacture Oral Dosage Forms (Tablet and Capsules)
Types Of Product Manufactured
Pharma Force Lab Is licensed to manufacture, Oral Solid Dosage forms (Tablet & Capsules).
Formulations manufactured are for “HUMAN USE” only.
6. PRODUCTION SECTION
(TABLET & CAPUSULES)
TABLET
SECTION
GRANULATION
DIRECT
COMPRESSION
WET
GRANULATION
DRY
GRANULATION
(SLUGGING)
DRYING &
SIFTING OF
GRANULES
LUBRICATION
COMPRESSION COATING
SUGAR
COATING
FILMCOATING
MODIFIED
RELEASE
COATING
BLISTER/ALU-
ALU PACKING
TESTING OF
FINISHED
PRODUCT
CAPSULE
SECTION
POWDER BLENDING
FILLINGOF
POWDER IN EMPTY
H.G. CAPSULES
POLISHINGOG
CAPSULES
BLISTER/ALU-ALU
PACKING
7. TABLET SECTION
Tablet Components and Additives
A.Active Ingredients: ornidazole IP, Folic acid, pantoprazole sodium, tranexemic acid,
azithromycin, cefixime, metformin, vitamin B6, glimepiride, atorvastatin, voglibose, lactic acid
bacillus etc.
B.Non-active Ingredients: six major excipient categories
a. Diluents: lactose, starch, mannitol, Sorbitol
b. Binders: Acacia, Gelatin, Tragacanth, starch.
c. Lubricants: stearic acid, magnesium stearate, calcium stearate. and talc
d. Disintegrants: Starches are the most common disintegrating agents
e. Colors: D&C and FD&C dyes and lakes, and
f. Flavors and Sweeteners: mannitol, lactose, sucrose, saccharin and dextrose.
Unit Operations
There are three methods of preparing tablet granulations. Such as:
(a) Wet granulation,
(b) Dry granulation (also called "slugging"), and
(c) Direct compression.
Each of these methods has its advantages and disadvantages. The first two steps of milling and
mixing of the ingredients of the formulation are identical, but thereafter the processes differ ,
Each individual operation of the process is known as a unit operation. Steps in Different Methods
of Tablet Manufacture (Unit Operations)
WET GRANULATION
1. Milling of drugs and excipients.
2. Mixing of milled powders.
3. Preparation of binder solution.
4. Mixing binder solution with powder mixture to form wet mass.
5. Coarse screening of wet mass using 6- to 12- mesh.
8. 6. Drying moist granules.
7. Screening dry granules with lubricant and disintegrants.
8. Mixing screened granules with lubricant and disintegrants.
9. Tablet compression.
FLOW CHART OF WET GRANULATION PROCESS
DRY GRANULATION
1. Milling of drugs and excipients.
2. Mixing of milled powders .
3. Compression into large, hard tablets called slugs.
4. Screening of slugs.
5. Mixing with lubricant and disintegrating agent.
6. Tablet compression.
RAW MATERIAL
WEIGHING
SCREENING WET MASSING
SIEVING/MILLING
DRYING SCREENING
MIXING
COMPRESSION
9. FLOW CHART OF DRY GRANULATION PROCESS
DIRECT COMPRESSION
1. Milling of drugs and excipients.
2. Mixing of ingredients.
3. Tablet compression.
RAW
MATERIAL
WEIGHING
SCREENING MIXING
SLUGGING
MILLING SCREENING
MIXING
COMPRESSION
10. FLOW CHART OFDIRECT COMPRESSION
EQUIPMENTS
1. SIFTER
An instrument used to sieve the ingredients of a tablet with a replaceable mess ware. In this
technique, particles of power mass are placed on a screen made of uniform aperture. The sifter is
attached with a vibrator that helps in sieving the materials through the meshwork. The
mechanism of action is to loosen the packing of the particle in contact with screen surface,
permitting entrapped sub sieve particles to the screen surface.
2. Planetary Mixer
For wet granulation a planetary mixer is used. Solutions of the binding agent are added to the
mixed powders with stirring. The powder mass is wetted with the binding solution until the mass
has the consistency of damp snow. The planetary mixer can mix a material of 100kg. The beater
of the planetary mixer revolves 2-4times for each revolution of the head, providing double
mixing action.
RAW
MATERIAL
WEIGHING
SCREENINGMIXING
COMPRESSION
11. 3. Mass Mixer
This is also mixing equipment used to mix dry as well is wet ingredients. The mixer has blades
that are alternately arranged and is allows uniform mixing. The mass mixer is emptied by
inverting it and scrapping off its ingredients. The planetary mixer can mix a material of 100kg.
4. Multi-mill
This is a hammer mill that uses a high speed rotor to which a number of swinging hammers are
fixed. The unit is enclosed with chamber containing a grid or removable screen through which
the material can pass. The material is fed from the top and ground by impact of hammers or
against the plates around the periphery of the casing. The materials are enough pass through the
screen that forms the lower portion of the chamber. The fragments are swept downward against
the screen where they undergo additional hammering action until they are reduced to a size small
enough to pass through the openings and out. Oversize particles are hurled upwards into the
chamber where they also undergo further blows by the revolving hammers.
5. Fluidized bed dryer
In a fluidized bed dryer, the fluidized air stream is introduced by a fan or blower mounted at the
top of the apparatus. The air is heated to the required temperature in an air heater and flows
upwards through the wet materials, which remains in a drying chamber fitted with a wire mesh
supported at the bottom. By this process, the material is suspended and agitated in a warm air
stream while the granulation is maintained in motion.
6. Tray dryer
It consists of a chamber, containing horizontal arrangements of trays on which granules are
dried. The drying process is accomplished by a gust of hot air driven by or blower through an
electric heater and heat exchange. In this method, the wet materials are placed over paper sheets
and finally placed over the trays and the drying operation is carried out. These dryers are mainly
useful for materials that contain alcoholic solutions and where slow drying for better granule
characteristic is necessary.
7. Compressor
For increased production, Rotary machines offer a great advantage. A head carrying a number of
sets of punches and dies revolves continuously while the tablet granulation runs from the hopper,
through a feed frame and into the dies placed in a large, steel plate revolving under it. This
method promotes a uniform fill of the die and therefore an accurate weight for the tablet.
Compression takes place as the upper and the lower punches passes between a pair of rollers.
This action produce a slow squeezing effect on the material in the die cavity from the top and
12. bottom and so gives a chance for the entrapped air to escape. The punches and dies can be
removed for inspection, cleaning and inserting different sets to produce a great variety of shapes
and sizes.
TABLET PRESSES
The basic unit of any tablet press is a set of tooling consisting of two punches and a die which is
called a station. The die determines the diameter or shape of the tablet; the punches, upper and
lower, come together in the die that contains the tablet formulation to form a tablet. There are
two types of presses: single-punch and rotary punch. The single-punch press has a single station
of one die and two punches, and is capable of producing from 40 to 120 tablets per minute
depending on the size of the tablet. It is largely used in the early stages of tablet formulation
development. The rotary press has a multiplicity of stations arranged on a rotating table in which
the dies are fed the formulation producing tablets at production rates of' from a few to many
thousands per minute. There are numerous models of presses manufactured by a number of
companies, ranging in size, speed, and capacity.
Tablet presses consist of
1) Hoppers, usually one or two, for storing and feeding the formulation to be pressed
2) Feed frame(s) for distributing the formulation to the dies
3) Dies for controlling the size and shape of the tablet
4) Punches for compacting the formulation into tablets
5) Cams (on rotary presses) that act as tracks to guide the moving punches All other parts of the
press are designed to control the operation of the above parts.
13. COATING
Tablet coatings perform one or more of the following functions. They may: mask the taste of
unpalatable drugs, protect the drug from deterioration due to light, oxygen or moisture, separate
incompatible ingredients, control the release of medicament in the gastrointestinal tract, and
provide an elegant or distinctive finish to the tablet.
The materials used for coating may largely comprise sucrose (sugar coating), water-soluble film-
forming polymers (film coating) or substances which are soluble in the intestinal secretions but
not in those of the stomach (enteric coating). These types of coating can all be applied by the pan
or fluid-bed processes; the compression coating technique is suitable for sugar and enteric
coatings, but not for film coating.
TYPES OF COATING
1). SUGAR COATING
2). FILM COATING
3). MODIFIED RELEASE COATING
1). SUGAR COATING: This traditional coating imparts a smooth, rounded, elegant
appearance to the tablet. Stephenson and Smith (1951) have given a detailed discussion on the
composition of sugar coatings.
The sugarcoating process involves building up layers of coating material on the tablet cores as
they are tumbled in a revolving pan by repetitively applying a coating solution or suspension
and drying off the solvent. Before sugarcoating, the core is coated with a sealing coat of shellac,
PVP*-stabilized types of shellac, or other polymeric materials, such as cellulose acetate phthalate
and polyvinyl acetate phthalate. The next stage is to build up a subcoat that will provide a good
bridge between the main coating and the sealed core, as well as round off any sharp corners. This
14. step is followed by smoothing or grossing. The finishing stage is accomplished by again
applying one or two layers of clear syrup. The tablets are then left for several hours before being
transferred to the polishing pan. The polish is a dilute wax solution (e.g., carnauba or beeswax in
petroleum spirit) applied sparingly until a high luster is produced.
2). FILM COATING: Film coating has increased in popularity for various reasons. The film
process is simpler and, therefore, easier to automate. It is also faster than sugarcoating, since
weight gains of only 2 to 6% are involved, as opposed to more than 50% with sugarcoating. Two
major groups of film coating materials may be distinguished:
(a) those that are nonenteric and, for the most part, cellulose derivatives, and
(b) those that can provide an enteric effect and are commonly esters of phthalic acid. Films may
contain a plasticizer that prevents the film from becoming brittle with consequent risk of
chipping. Until recently, alcohols, esters, chlorinated hydrocarbons, and ketones have been
among the most frequently used types of solvents. However, because of increasing regulatory
pressures against undesirable solvents, there has been a pronounced trend toward aqueous film
coating.
3). Modified-Release Coatings: A coating may be applied to a tablet to modify the release
pattern of the active ingredient. Two general categories, enteric coating and controlled-release
coating, are distinguished. The former are insoluble in the low pH environment of the stomach
but dissolve readily in the small intestine with its elevated pH. They are used to minimize
irritation of the gastric mucosa by certain drugs and to protect others that are degraded by gastric
juices.
PACKAGING AND LABELLING OF TABLETS
Packaging and Labeling of tablets are done in Packaging and Labeling area. In this area
concurrently three actions i.e. visual checking for contaminant or deformity, Labeling and
Packing are taking place. This room is fitted with air-conditioners and a temperature of about
27◦C is maintained. This area has a inspection table where deformity and contamination are
checked against black and white background. The minimum luminosity required in the
inspection zone is 500lacs. The inspection table is fitted with stainless steel conveyors. The
equipment is attached with a motor of 1 H.P. and a reduction gear box with adjustable pulley.
TYPES OF PACKAGING
1). BLISTER PACKING
2). STRIP PACKING
1). BLISTER PACKAING: This is useful for packaging of unit dose of pharmaceuticals. This
packing mode has been used extensively for several good reasons. It is a packaging configuration
capable of providing excellent environmental protection, coupled with an aesthetically pleasing
15. and efficacious appearance. It also provides user functionally in terms of convenience, child
resistance and now temperature resistance.
Blister packing consists of two principals components:-
1). A formed base web creating the cavity inside which the product fit.
2). The lidding foil for dispensing the product out of the pack.
2). Strip packing: The blister package is formed by heat softening a sheet of thermoplastic resin
and vacuum drawing the softened sheets of plastic into a contoured mould. After coming, the
sheet is released from the mould and proceeds to the filling station of the packaging machine.
The semi-rigid blister previously formed, is filled with the product and lidded with a heat
sealable backing material. The backing material can be either a push through or peelable type.
For a push through type of blister, the backing material is usually heat seal coated aluminum foil.
16. The packaging of the final product is done in paper cartons, manually, and is finally sealed using
an automatic sealer. The machine can seal cartons.
CAPSULE SECTION
POWDER BLENDING
In Pharmaceutical Industries, in the making of capsules blending of powder plays a important
role. Different drugs in the powder form are mixed with another according to standard. Powder
blending is necessary in the manufacturing of capsule because with the help of blending different
powder drugs are mixed with one another in a proper way.
FILLING OF POWDER IN CAPSULE SHELL
Filling of powder is generally done by the different machines. The equipments used for filling of
powder in capsule shell are devided into two type. such as:
1). Hand Operated Capsule Filling Machine.
2). Automatic Capsule Filling Machine.
1).HAND OPERATED CAPSULE FILLING MACHINE
17. The machine is designed for filling a wide variety of formulation sutaible for all classes of
pharmaceutical industry. The machine is simple to operate with no variation. The machine is
fully made out of stainless steel 304 quality except harden and lubricant parts.
FEATURES
1). Low investment.
2). Benefit ration simple to operate can be handled by UN skilled labor.
3). All the loading plates are made of s.s.304 quality.
4). Easily dismantle and reassembled even by unskilled labor.
Output
8000 Capsule per/hour from 300 holes machine.
4500 Capsule per/hour from 200 holes machine.
2000 Capsule per/hour from 100 holes machine.
WORKING
It consist of a bed having 200-300 hole, a loading tray having 200-300 holes, a power tray, a pin
plate having 200-300 pins, a sealing plate having a rubber top, a lever, a cam handle. The empty
capsules are filled in the loading tray and it is placed over the bed. The cam handle is operated to
separate the capsule caps form their bodies. The power tray is placed in a proper position and
filled with an accurate quantity of power with scraper . The excess of the powder is collected on
the platform of the powder tray. The pin plate is lowered and the filled powder is pressed by
moving the pin downwards. After pressing the pin plate is raised and the remaining powder is
filled into the bodies of the capsules. The powered tray is removed after its complete filling. The
cap holding tray is again placed in position. The plate with the rubber top is lowered and the
18. lever is operated to lock the caps and bodies. The loading tray is then removed and filled
capsules are collected.
2). AUTOMATIC CAPSULE FILLING MACHINE
Automatic Capsule Filling Machine has been designed and developed to fill hard gelatin
capsules with powder or pellets. It is an extremely durable and reliable machine that fills dosage
to the highest accuracy. It can be applicable to the wide strange of capsules at all sizes and to all
manufacturers and guarantee the integrity of all capsules.
AUTOMATIC CAPSULE FILLING MACHINE
QUALITY CONTROL SECTION
Quality control is the part of GMP concerned with sampling, specification and testing and with
organization; documentation and release procedures which ensure that necessary and relevant
tests are carried out and that materials are not released for sale or supply, until their quality has
been judged satisfactory.
Quality Control (QC) laboratory, ensures that the products are pure, safe and effective and are
released only after thorough analysis as per stringent specifications, methods and procedures
developed according to international guidelines viz. EU cGMP, MHRA, WHO, TGA, etc.
The QC department performs following activities
19. RM/PM ANALYSIS FINISHED PRODUCT ANALYSIS
Different types of test are performed for different material. The types of test performed for each
material are as follows:
1. Testing Purified water
2. Testing Water for Injection
3. Testing Uniformity of Weight of Tablets
4. Disintegration Test
5. Dissolution Test
6. HPLC – An Introduction
7. Assay of different tablet.
8. Hardness tester
9. Thickness
10. Friability
11. UV-VIS Spectrophotometer
20. 12. FT-IR Spectrophotometer
HARDNESS
Tablet requires a certain amount of strength or hardness and resistance to friability to
withstand mechanical shakes of handling in manufacture, packaging and shipping. Hardness
generally measures the tablet crushing strength. The strength of a tablet was determined by
following ways;
(a) By cracking the tablet between 2
nd
and 3
rd
fingers with the thumb acting as a fulcrum. If there
is a sharp snap, the tablet is an acceptable strength.
(b) Tablet hardness can be defined as the force required breaking a tablet in a diametric
compression. In this test the tablet is placed between two anvils, force is applied to the anvils,
and the crushing strength that just causes the tablet to break is recorded. Generally used Hardness
testers are:
(1) Monsanto Tester
(2) Strong-Cobb Tester
(3) Pfizer Tester
(4) Erweka Tester
(5) Schleuniger Tester
Hardness for compressed tablet is 5 to 8 kg.
Monsanto hardness tester
FRIABILITY
Friability of a tablet can determine in laboratory by Roche friabilator. This consist of a plastic
chamber that revolves at 25 rpm, dropping the tablets through a Distance of six inches in the
friabilator, which is then operate for 100 revolutions. The tablets are reweighed. Compress
tablet that lose less than 0.5 to 1.0 % of the Tablet weigh are consider acceptable.
21. 3. Drug Content and Release
1).Weight Variation test (U.S.P.): Take 20 tablet and weighed individually. Calculate average
weight and compare the individual tablet weight to the average. The tablet pass the U.S.P. test if
no more that 2 tablets are outside the percentage limit and if no tablet differs by more than 2
times the percentage limit.
2). Content Uniformity Test
Randomly select 30 tablets. 10 of these assayed individually. The Tablet pass the test if 9 of the
10 tablets must contain not less than 85% and not more than 115% of the labeled drug content
and the 10
th
tablet may not contain less than 75% and more than 125% of the labeled content.
If these conditions are not met, remaining 20 tablet assayed individually and none may fall out
side of the 85 to 115% range.
3). Disintegration Test (U.S.P.)
The U.S.P. device to test disintegration uses 6 glass tubes that are 3” long; open at the top and 10
mesh screen at the bottom end. To test for disintegration time, one tablet is placed in each tube
and the basket rack is positioned in a 1-L beaker of water, simulated gastric fluid or simulated
intestinal fluid at 37 ± 2
0
C such that the tablet remain 2.5 cm below the surface of liquid on their
upward movement and not closer than 2.5 cm from the bottom of the beaker in their downward
movement. Move the basket containing the tablets up and down through a distance of 5-6 cm at a
frequency of 28 to 32 cycles per minute. Floating of the tablets can be prevented by placing
perforated plastic discs on each tablet.
22. According to the test the tablet must disintegrate and all particles must pass through the 10 mesh
screen in the time specified. If any residue remains, it must have a soft mass.
Disintegration time: Uncoated tablet: 5-30 minutes
Coated tablet: 1-2 hours
4). Dissolution Test (U.S.P.): A single tablet is placed in a small wire mesh basket attached to
the bottom of the shaft connected to a variable speed motor. The basket is immersed in a
dissolution medium (as specified in monograph) contained in a 100 ml flask. The flask is
cylindrical with a hemispherical bottom. The flask is maintained at 37±0.5
0
C by a constant
temperature bath. The motor is adjusted to turn at the specified speed and sample of the fluid are
withdrawn at intervals to determine the amount of drug in solutions.
Fig. Dissolution test apparatus
HPLC
Most widely used separation technique
Broad applicability – organic & inorganic
Can be very sensitive, accurate & precise
23. Suitable for separation of nonvolatile species
Has found numerous uses in industry, clinical settings, environmental areas, pharmaceuticals,
etc.
Chromatography can be described as a mass transfer process involving adsorption using a
nonpolar stationary phase and a mobile polar phase titrating through the column. The active
component of the column, thesorbent or the stationary phase, is typically a granular material
made of solid particles (e.g. silica, polymers, etc.), 2-50 μm in size. The components of the
sample mixture are separated from each other by means of mobile phase and different degrees of
interaction with the sorbent particles based on their relative polarity. The pressurized liquid is
typically a mixture of solvents (e.g. water, acetonitrile and/or methanol). Its composition and
temperature plays a major role in the separation process by influencing the interactions taking
place between sample components and sorbent. These interactions are physical in nature, such as
hydrophobic, dipole-dipole or ionic.high performance liquid chromatography (HPLC) is a
chromatographic technique used to separate a mixture of compounds in analytical chemistry and
biochemistry with the purpose of identifying, quantifying or purifying the individual components
of the mixture. Before the invention of HPLC, chemists had column chromatography at their
disposal, and column chromatography was time consuming.To speed up a classic column
chromatography, chemists would have to use a short column for separation, however this lead to
poor separation of molecular components held within solution. The basic setup of a classic
column chromatography would include the column that varied in I.D. from 10 to 50nm and
column lengths of 50-500cm. The column was then packed with the stationary phase ranging in
particle size from 150 to 200 μm thick. Chemists, wanting to speed the separation process up,
first experimented with the introduction of a vacuum source or a high pressure source. However,
they found with the increased negative or positive pressure, the column length would have to be
increase linearly in order to acquire a valid separation that could be used for analytical data with
a high confidence level. Chemists realized that with the development of pressurized systems,
reducing the particle size would increase the efficiency. It was not until thelate 60’s that chemists
and industrial engineering process acquired adequate technology and manufacturing techniques
to develop a smaller grained stationary phase that would be cohesive with a pressurized system.
Today, HPLC has many uses including medical (e.g. detecting vitamin D levels in blood serum),
24. legal (e.g. detecting performance enhancement drugs in urine), research (e.g. separating the
components of a complex biological sample, or of similar synthetic chemicals from each other),
and Introduction Chromatography can be described as a mass transfer process involving
adsorption using a nonpolar stationary phase and a mobile polar phase titrating through the
column. The active component of the column, the sorbent or the stationary phase, is typically a
granular material made of solid particles (e.g. silica, polymers, etc.), 2-50 μm in size. The
components of the sample mixture are separated from each other by means of mobile phase and
different degrees of interaction with the sorbent particles based on their relative polarity. The
pressurized liquid is typically a mixture of solvents (e.g. water, acetonitrile and/or methanol). Its
composition and temperature plays a major role inthe separation process by influencing the
interactions taking place between sample components and sorbent. These interactions are
physical in nature, such as hydrophobic, dipole-dipole or ionic. High performance liquid
chromatography (HPLC) is a chromatographic technique used to separate a mixture of
compounds in analytical chemistry and biochemistry with the purpose of identifying, quantifying
or purifying the individual components of the mixture. Before the invention of HPLC, chemists
had column chromatography at their disposal, and column chromatography was time
consuming.To speed up a classic column chromatography, chemists would have to use a short
column for separation, however this lead to poor separation of molecular components held within
solution. The basic setup of a classic column chromatography would include the column that
varied in I.D. from 10 to 50nm and column lengths of 50-500cm. The column was then packed
with the stationary phase ranging in particle size from 150 to 200 μm thick. Chemists, wanting to
speed the separation process up, first experimented with the introduction of a vacuum source or a
high pressure source. However, they found with the increased negative or positive pressure, the
column length would have to be increase linearly in order to acquire a valid separation that could
be used for analytical data with a high confidence level. Chemists realized that with the
development of pressurized systems, reducing the particle size would increase the efficiency. It
was not until the late 60’s that chemists and industrial engineering process acquired adequate
technology and manufacturing techniques to develop a smaller grained stationary phase that
would be cohesive with a pressurized system. Today, HPLC has many uses including medical
(e.g. detecting vitamin D levels in blood serum), legal (e.g. detecting performance enhancement
drugs in urine), research (e.g. separating the components of a complex biological sample, or of
25. similar synthetic chemicals from each other), and manufacturing (e.g. during the production
process of pharmaceutical and biological products).
Shimadzu HPLC
FT-IR Spectrophotometer
Infrared (IR) Spectroscopy uses a beam of infrared light to analyze the structure of organic
compounds. Whereas NMR analyzes the atoms present, IR instead analyzes the bonds present.
NMR produces a set of sharp signals where every atom’s signal may be discerned, but IR only
produces broad absorptions which may frequently overlap. You are unlikely to be able to
completely deduce a structure using only IR. Nevertheless, IR provides a valuable tool for
probing the structure of organic molecules.
The infrared portion of the electromagnetic spectrum is divided into three regions; the near-,
mid-and far-infrared, named for their relation to the visiblespectrum. The far-infrared,
approximately 400-10cm-1(1000–30μm), lying adjacent to the microwaveregion, has low energy
and may be used for rotational spectroscopy. The mid-infrared, approximately 4000-400cm-
1(30–1.4μm) may be used to study the fundamental vibrations and associated rotational-
vibrational structure. The higher energy near-IR, approximately 14000-4000cm-1(1.4–0.8μm) can
excite over toneor harmonic vibrations. The names and classifications of these subregions are
merely conventions. They are neither strict divisions nor based on exact molecular or
electromagnetic properties.
26. Shimadzu IR apparatus
UV SPECTROPHOTOMETER
In Pharmaceutical Industry, A spectrophotometer is commonly used for the measurement of
transmittance or reflectance of solutions, transparent or opaque solids, such as polished glass.
However they can also be designed to measure the diffusion any of the listed light ranges that
usually cover around 200nm-2500nm using different controls and calibrations. Within these
ranges of light, calibrations are needed on the machine using standards that very in type
depending on the wavelength of the photometric determination.
Shimadzu UV apparatus
The basic function of a spectrometer is to take in light, break it into its spectral components,
digitize the signal as a function of wavelength, and read it out and display it through a computer.
27. The first step in this process is to direct light through a fiber optic cable into the spectrometer
through a narrow aperture known as an entrance slit. The slit vignettes the light assist enters the
spectrometer. In most spectrometers, the divergent light is then collimated by a concave mirror
and directed onto a grating. The grating then disperses the spectral components of the light at
slightly varying angles, which is then focused by a second concave mirror and imaged onto the
detector. Alternatively, a concave holographic grating can be used to perform all three of these
functions simultaneously. This alternative has various advantages and disadvantages, which will
be discussed in more detail later on. Once the light is imaged onto the detectors the photons are
then converted into electrons which are digitized and read out through a USB (or serial port) to a
computer. The software then interpolates the signal based on the number of pixels in the detector
and the linear dispersion of the diffraction grating to create a calibration that enables the data to
be plotted as a function of wavelength over the given spectral range.
CONCLUSION
Industrial training is very much essential for Pharmacy Students. It is also a great opportunity to
acquire practical knowledge. During my training period, in the industry I acquired lots of
experiences in Pharmaceutical Production and Production management. This will help me to
clarify my theory knowledge. I hope and pray that it will help me much in my future profession.
During our training period, we had seen the various instruments and apparatus in the industry.
The highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. We could acquire a lot of information regarding the latest instruments and their
working procedures.
It was taught to us that, the CGMP guidelines are to be strictly followed in the industries in each
and every section. But the same was seen not to be satisfactory in the “PHARMA FORCE
LAB”, Paonta Sahib. The workers were seen dealing the active medicaments with bare hands.
The quality control section was also of substandard. Due to lots of vacancy of chemists, they did
not do the basic tests of the solid dosage forms like assays, disintegration test, dissolution tests
etc. They are doing the same only on the paper documents, not in practice. Hence it can be said
that, the authorities are not paying much importance on the quality of the products.
Apart from all that, the training was very interesting with lots of things to be learned. It helped us
to acquire knowledge on punctuality, regularity and working environments in industries. The
friendly working environment in Pharma Force Lab will remain in our mind in near future.
Hence, we can say that our goal of attending the industrial tour is fulfilled. We acknowledge the
great help “PHARMA FORCE LAB”.