Share Training Report
Share Training Report
Project / Training Report submitted in partial fulfilment of the requirements for the award
of the Degree of
Bachelor of Pharmacy
by
(1906304021)
DEPARTMENT OF PHARMACY
QUANTUM SCHOOL OF HEALTH SCIENCES
QUANTUM UNIVERSITY, ROORKEE
DECEMBER 2022
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DECLARATION
I MD JAVED ANSARI, the under-mentioned, solemnly declare that this internship report on ELFIN DRUG
PVT.LTD. is my original work. I further declare that I have strictly observed reporting ethics and duly discharged
copy-right obligation and properly referred all outsourcing of materials used in this report and nothing is confidential
in this report in respect of the company of my internship. I take the responsibility for all legal and ethical
requirements regarding this report.
………………………
(Signature of students)
Md. Javed Ansari
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ACKNOWLEDGEMENT
I consider it a great privilege & honor to have had the opportunity to undergo the industrial
training work in Elfin Drugs Pvt. Ltd. Hence, I would like to offer my heartiest thanks to Mr.
Dilpreet Singh, (Managing Director, Elfin Drugs Pvt. Ltd).
I convey my heartiest thanks to Mr. Kulwinder Singh Gill (Plant Head), Mr. Balwinder
Singh (RM Store Manager), Mr. Rajveer Kaur (Production Manager), Mr. Akhilesh Tiwari
(Manager, QC), Mr. Mukesh Kumar (Finished Product Manager) for their most valuable suggestions,
constant encouragement, and affectionate guidance during the period of this training.
I would like to thanks all trainees and staffs, who help me very much and without whom support
and guidance it was impossible for me to complete the project successfully.
I owe deep gratitude to the Mrs. Rohit Singh (HR Manager) and Ms. Himani Negi (Sales
Marketing) 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 Elfin Drugs for extending their
constant cooperation which went a long way towards the completion of this Training and Report.
I consider it my to convey me deep sense of gratitude and pay respectful regards towards Dr.
Santosh Kumar Verma (Director) of Quantum School Of Health Science for valuable guidance,
consistence encouragement and pleasant discussion throughout.
My special thanks to Dr. Himanshu Chaurasia (Asst. Professor, Quantum School Of Health
Science), Mrs. Anjali Dixit (Asst. Professor, Quantum School Of Health Science), Mrs. Mudita
Mishra who advised me to join this Pharmaceutical Industry for better experience and knowledge.
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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.
I was directed to undergo at “Elfin Drugs Pvt. Ltd.” And this report contains a brief
description of the above pharmaceutical industry which was observed during the training program.
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TABLE OF CONTENTS
1. Profile of Organization 7
2. Sections in Elfin 8
3. Tablet Section 12
4. Capsule Section 20
5. Liquid Section 25
6. Ointment Section 30
7. Parenteral Section 33
9. Microbiology Section 42
11. Conclusion 47
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Elfin Drugs Pvt. Ltd. Is a company, established in 1999, that promises good health for all by
providing quality medicines at affordable prices and committed to care the people for keeping good
health.
They have won many accolades in the domestic and international pharmaceutical domain.
They are engaged in manufacturing of pharmaceutical products for acute care market, etc.
They are a leading group of companies that is headed by an experienced management involved in
the diverse field of pharma industry and is situated at the excise free zone in Himachal Pradesh
which is conducive for a pharma industry to grow.
Their commitment towards quality, rich industry experience together with ethical business values
have taken us a long way in gaining a global recognition.
They possess an image of a widely recognized manufacturer of injectable, latest tunnel system for
dry and liquid injectable, liquid syrups, dry syrups, eye / ear / nasal drops, pre-filled syringes.
MISSION
Honor our pledge to continuously improve and strive towards the highest quality standards in all
aspects of our business.
Optimize the talents of our employees within a learning organization with an environment that
reward commitment, creativity, and performance.
Value teamwork among our employees, business associates, and customers as an integral factor
in our continued business success.
Innovate continuously to develop new cutting-edge pharmaceutical and healthcare technologies
and products.
Dedicate ourselves to total customer satisfaction in order to consistently deliver outstanding
value to our customer and stakeholders.
VISION
Our vision is to become a technology-based Indian pharmaceutical company & to emerge out
as a strong player in the domestic & international market.
To keep improving the quality of life by offering value-added novel products that are
technologically innovative, cost-effective and of superior quality, surpassing expectations of
customers across the globe.
SOCIAL RESPONSIBILITY
At Elfin, we believe that contributing back to the society is not only a RESPONSIBILITY but
a COMMITMENT. Our little value added to the betterment of society is a part of our mission, in line
with our commitment to human health. Through the years, Elfin has strived to make the world around
it a better place. Corporate Social Responsibility (CSR) is not just an integral part of our business but
devotion; the promise of a brighter future for every life we touch.
We consider it our duty to contribute a share of our earnings towards health benefits to the less
privileged, rural welfare to make life easier for rural poor and several charitable activities to do our
part towards the welfare of society as a whole.
MD JAVED ANSARI Page 7
ROLL NO. – 1906304021
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Rural Welfare
Apart from regular medical initiatives, we have also been working in the domain of rural upliftment
having built several Community halls in the vicinity of several hospitals. These community halls
are used by relatives of patients admitted in the hospitals especially government-run hospitals. The
patients’ relatives are provided with free accommodation and subsidized meals while they are busy
taking care of the patient. We have also developed waiting areas in government hospitals to provide
seating areas to patients and their families.
Eye Camps
Our CSR efforts are focused on ‘how to not turn a blind eye’ to a common yet growing medical
concern in India. India is home to a quarter of world’s blind with cataract being the leading cause
of this problem. Our free eye camps have helped make a very simple yet vital procedure accessible
to needy patients, averting the need for them to face a bleak yet highly preventable long-term reality
– a life without sight.
We continue to conduct large eye care camps in various villages where we provide underprivileged
people with free cataract operations and eye checkups through the services of eye specialists and
surgeons. All patients undergoing eye operations are also provided with adequate post-operative
care. In 2012, our dedicated team was instrumental in achieving over 11,000 cataract surgeries
successfully.
SECTIONS IN ELFIN
Pharmaceutical raw materials comprise substrates or elements that are used for manufacturing
different types of drugs e.g. endocrine disorder drugs, musculoskeletal system drugs, anti-infective
drugs viz. cephalexin, penicillin, ampicillin, cephradine, etc. Pharmaceutical excipients and
ingredients or raw materials used to manufacture drugs are extracted from different sources. These
sources could be natural or synthetic. Recently, many of the raw materials previously derived from
natural sources are being produced synthetically in part or even biotechnologically. This is so because
manufacturing them artificially is economical, safer and much quicker. Pharmaceutical raw materials
are manufactured using different types of acids, alcohols, esters, phenones, pyridines, etc.
Pharmaceutical raw materials are essential to producing pharmaceutical drugs and include
active pharmaceutical ingredients (APIs) also known as bulk active are pharmaceutically active and
have desired pharmacological effects on the body e.g. alvimopan, sparfloxacin,
sapropterindihydrochloride, lanreotideacetate, nicotinic aicd, etc. In contrast pharmaceutical
excipients are the pharmaceutically inert substances which help in delivering the active ingredients
e.g. anti-adherents, binders, coatings, disintegrants, fillers, etc.
Receiving
Raw material is supplied by vendors by placing order.
Sampling
Before sampling get line clearance by QA person.
OC person test the sample of raw material under LAF by different tests and fill it in
“Observation on sampling are and pack” and “Certificate of analysis”.
Warehouse operators will paste the labels of “Approved label” and “Sampled label”.
Next sent raw material for storing.
Storing
The raw material is stored at 3 different temperature zones –
o Ambient: Not more than 35 0C
o Controlled temperature room: 15 – 25 0C
o Cold room: 2 – 8 0C
Dispensing
Raw material is picked for dispensing according to “Material pick list for process order” and
dispensed according to BMR prepared by QA personnel.
Selection of raw material is done according to “First expiry first dispense”.
Raw material is dispensed from dispensing booth under LAF to the production area.
PRODUCTION SECTION
General Instructions and Precautions –
Ensure area and equipment cleanliness before starting the manufacturing operations.
Check and ensure that all manufacturing equipment and other required accessories are clean
ready for use.
Wear gloves and nose mask during all manufacturing process.
Counter check the weights of all ingredients before using in the batch.
Get line clearance from QA for manufacturing.
Air handling unit (AHU) system should be kept ON throughout the manufacturing process.
Temperature should be kept between 25 0C + 2 0C and relative humidity should be kept between
50 + 10%.
Ensure that QC approval purified water is being used for manufacturing purpose.
Always transfer solution to the manufacturing vessels through 20 meshes.
During the preparation of product, no other product processing should be done in the same area.
Whenever sifting through SS mesh is involved; check the mesh integrity before and after use.
All critical aspects during manufacturing like temperature, duration of mixing, weight, etc. must
be checked and recorded by the supervisor.
Supervisor to ensure completion of all in-process records during various stages of manufacturing
operations till completion of the batch.
Release from QA should be taken from all in-process tests mentioned in batch manufacturing
record.
No over writing is allowed in batch manufacturing record. If initial data is wrong entered, cancel
the data by single stroke arrow and put initials. Record reasons for change as footnote on the same
page.
All details whatever is necessary should be recorded in batch manufacturing record (BMR).
Send a test request to QC after manufacturing is completed.
Check all polyethylene bags before and after material loading for black particles and sealing.
Check calibration of respective equipment/machine before use.
A. Active Ingredients: ornidazole IP, Folic acid, pantoprazole sodium, 13elrin13ize acid,
azithromycin, cefixime, metformin, vitamin B6,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.
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.
6. Drying moist granules.
7. Screening dry granules with lubricant and disintegrants.
8. Mixing screened granules with lubricant and disintegrants.
9. Tablet compression.
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.
DIRECT COMPRESSION
1. Milling of drugs and excipients.
2. Mixing of ingredients.
3. Tablet 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 2-4 times for each revolution of the head, providing double mixing action.
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.
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 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.
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 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 non-enteric 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.
Primary Packaging – It is the material that first envelope the product and holds it. This usually is
the smallest unit of distribution or use and is the package which is in direct contact with the content.
Secondary Packaging – It is outside the primary packing and may be used to prevent pilferage or to
group primary packages together.
TYPES OF PACKAGING
1) BLISTER PACKING
2) STRIP PACKING
1) Blister Packing: 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 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. 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.
Types of Capsules
1) Hard Gelatin Capsule
2) Soft Gelatin Capsule
The hard capsule is also called “two piece” as it consists of two pieces in the form of small cylinders
closed at one end, the shorter piece is called the “cap” which fits over the open end of the longer
piece, called the “body”.
The soft gelatin capsule is also called as “one piece”. Capsules are available in many sizes to
provide dosing flexibility.
Unpleasant drug tastes and odors can be masked by the tasteless gelatin shell.
The administration of liquid and solid drugs enclosed in hard gelatin capsules is one of the most
frequently utilized dosage forms.
Features
Low investment.
Benefit ration simple to operate can be handled by UN skilled labor.
All the loading plates are made of s.s.304 quality.
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 lever is operated to lock the caps and bodies.
The loading tray is then removed and filled capsules are collected.
Features
Fill weight accuracy
Formulation yields
Maintenance free operation
Operator ease and safety
Innovative features
Automation of loading station – This eliminates the need for continuous operator attention as
solid state control circuitry provides automatic stoppage of the loading table after completion of
one cycle, each of 60 strokes.
Automation of filling station – This, again, is a revolutionary feature that eliminates the need for
continuous operator attention. Motorized. Swing-in and swing-back of the drug hopper after one
filling cycle results in reduced operator fatigue.
Pneumatic closing station – This utilizes an electronic sensor which activates a pneumatic
cylinder to carry out the closing operation resulting in ease of operation and reduced operator
fatigue.
Vertical Closing – Vertical closing of filled capsules reduces reject rates and powder spillage.
This is critical for pellet filling. This is achieved by having two speeds for auger and nine speeds
for filling table operation.
Modular type hopper provides easy and fast dismantling for cleaning. Change-over times
between batches are reduced.
Filled capsule output capacity can be increased using our ring loading station. This allows
existing SA-9 installations to be upgraded for extra production.
Output
Capsule Size 00 0 1 to 5
No. of Holes/ Loading Ring 360 420 480
Output Per hour 21,600 25,200 48,960
With ring loading system 36,700 42,840 48,960
Output per hour
Output
Model – A 40 40,000 capsules per hour for powder & 30,000 capsules per hour for pellets.
Model – A 90 90,000 capsules per hour for powder & 70,000 capsules per hour for pellets.
POLISHING OF CAPSULE
Features
Fill weight accuracy
Formulation yields
Maintenance free operation
Operator ease and safety
Innovative features
Feeding Machine – This section consists of a stainless steel hopper and a vibrator with powder
collector. As the capsules pass through the vibrator, some amount of powder gets collected in the
stainless steel collector.
Inspection Machine – This part of the machine with a conveyor belt and vary speed drive. Above
this machine there is a lighting source to inspect the capsules minutely. The capsules move on the
conveyor belt and while moving they revolve around their axis due to angular guides. This total
visual inspection can be undertaken by an operator to sort out defective capsules. The defective
capsules are sorted manually by hand.
PROCESS CONTROL
This system consists of a closed circuit manufacturing facility from feeding of Sugar / Water
Phase to loading the Volumetric Liquid Filling Machine.
The Sugar and Water, are load with vacuum system or by mechanical system or manually.
The Sugar Syrup Vessel is supplied with high speed stirrer & electrical heating (In small model) /
steam heating facility (In bigger size model).
The sugar syrup is prepared at required temperature & is transferred to Manufacturing Vessel by
vacuum or by transfer pump.
The product during emulsion formation is re-circulated through In-Line Homogenizer or Liquid
Transfer Pump.
The capping machines are ideal for application in pharmaceutical, liquor, food, agrochemical,
edible oil, lube oil and other packaging applications.
Cap Sealing machines are equipped with hopper feeder for standard height of caps to feed the cap
on to the bottle neck for online capping.
This machine is fully automatic and is complete with Rotary Cap Feeding Hopper and built-in Slat
Conveyor.
The bottles are fed in a vertical position. As soon as the bottle strikes the end-chute, a cap from the
shoe of the automatic cap feeder is placed on the bottle and passed to the sealing head for sealing.
The sealing head seals the bottles and later conveys them to the slat conveyor for onward transfer
to inspection machine.
The guide rails and stainless steel slat conveyor can be adjusted to accommodate various shapes
and diameter of bottles.
A limit switch with actuator mechanism is provided for sensing bottle-topple.
The machine is provided with variable speed mechanism for speed adjustment.
Volume of powder is sucked in to the port of powder wheel during vacuum according to the
piston length different fill size can be achieved.
The excess powder is doctored off by a doctor blade, now doctor blades can be add from outside
also without removing powder hopper.
When powder wheel indexes further and remain in the port due to the vacuum till it reaches just
vertical position.
The time dose of Compressed air, sterilized low pressure Nitrogen Gas sequentially flushes out
powder from the port of powder wheel in to the funnel.
Funnel will be equipped with square rod to break the solid slug of powder and powder will start
to fill inside bottle, which is moving with funnel.
In this model Bottle is getting around 5 to 6 second filling time.
Bottles further move with funnel and reaches to exit star wheel, which is infeed star wheel for eight
head ROPP cap sealing machine, while rotating star wheel bottle picks up the cap from exit end of
chute, ROPP caps kept in orientation unit, automatically orient caps in right direction before
entering into delivery chute.
And Bottle is entering below the sealing head, consist of four rollers. Two rollers properly Skirts,
Spins and Seals the cap and simultaneously another two roller performs perfect threading
according to bottle neck diameter.
After sealing operation, sealing head moves upward with cam and bottle enters into exit star wheel.
Move further on conveyor belt for next operation.
PROCESS CONTROL
All waxes and oils are dissolved in the wax phase vessel separately
All aqueous phase materials are added in the water phase vessel and processed separately.
Both phase vessels are jacketed and are provided with motor driven propeller type of agitators
which facilitate thorough mixing.
Once the phases are ready, they are transferred to the main Ointment manufacturing vessel by
opening respective valves.
This transfer takes place through filters and pipelines due to the vacuum created within the main
vessel with the aid of a pump.
The Ointment Manufacturing vessel is provided with anchor type of stirrer along with Teflon
scrapper at the ends, the agitator is driven by dual speed motor.
A built-in high speed emulsifier ensures proper emulsification of the ointment, The MIMIC
feature in the control panel controls the time of emulsification with the aid of timers.
The finished product is transferred to storage vessels by means of the bump pump.
Transfer from storage vessel to the filling hoppers is achieved by means of reciprocating
metering pumps at the required rate.
Special scrappers are provided for transfer of the complete product and to avoid wastage.
1. PLANETARY MIXER
Planetary Mixer is used in various applications such as Ointments, Pharmaceutical Creams,
Cosmetic Creams, Ceramics, Ink Pastes, Color Pigments, Rubber, Compounds etc.
Planetary Mixer is useful for thorough mixing of ointments, creams, lotions, toothpastes etc. in
sterile or non-sterile conditions.
Intimate and homogeneous mixing of products is employed by planetary motion of beaters and
centrally located homogenizer.
Product container provided with jacket to heat and cool for circulation of steam / cold water. Mixer
is also designed to operate under vacuum to remove air entrapment in product during mixing.
High speed dispenser suitable for homogenizing the product with independent drive at the center
of top dish
Product bowl mounted on castor wheels for easy portability, washing & transporting mixed
materials.
Jacketted bowls available for heating or cooling of products during mixing.
Provision to mix materials under vacuum for de-aeration purpose.
Double beaters open type to cover full cross section of products in bowl.
For ointments / paste / cream / lotions etc. high speed emulsifier provided for homogeneous
mixing and to produce lustrous product.
Motorized drive assembly for lifting and lowering.
Needs comparatively smaller area for installation.
Electrical control panel with back up fuses and indicator lamps for easy process control.
The tube then travels through the individual pressing, crimping and coding stations after which it
is ejected out at the ejecting station.
In case of lami/plastic tubes, after the filling station, the tube travels to the hot air blowing station
where hot air is blown onto the inside of the end of the tube by a nozzle having holes on its
periphery.
The tube then goes to the sealing station where the tube is pressed and sealed. It then travels to the
dual coding & trimming station where the tube is first coded with metal stereos on the seal and the
irregular shape at the tube end is trimmed by a set of blades.
It is then ejected out at the next station.
PARENTERAL SECTION
Parenteral preparations are sterile products those are administrated by injection into the body. They
may be directly administrated or they may be diluted before administration.
Parenteral preparations are prepared by the methods that maintain their sterility, avoid the
introduction contaminants and microbial growth.
The Parenteral preparations those are in the form of liquids require the base to dissolve them. Water
for Injection is commonly used in Parenteral preparations.
Other auxiliary substances may be added to increase the stability and usefulness of the preparation.
Those substances at the added concentration they should not have any adverse effect or cause
toxicity. No coloring agent may be added to the Parenteral preparation for the purpose of coloring.
Parenteral preparations which are packaged in multiple-dose containers may contain suitable
antimicrobial preservatives in the appropriate concentration to inhibit the microbial growth in the
containers. The preservative effectiveness should be demonstrated before the production of
Parenteral preparation.
When the active ingredients have the chances of oxidative degradation, a suitable antioxidant may
be added and/or the air in the container may be evacuated or displaced by nitrogen or other suitable
inert gas.
Containers
Containers for Parenteral preparations should be made from materials that are transparent to permit
visual inspection of the contents of the containers and should not adversely affect the quality of the
preparation under the storage conditions, handling and use. These may be packed in glass ampoules
vials or bottles or in other containers such as plastic bottles.
Fig 18. Vials Filling with Rubber Stoppering, Capping & Labeling Machine
Closures
Vials or bottles are closed with closures that are having a good seal to prevent the access of micro-
organisms and other contaminants and a part or the whole of the contents of the container can be
withdrawn without removal of the closure. The material of which the closure is composed must be
compatible with the preparation and must allow the passage of a needle with the minimal shedding
of particles and to ensure that the hole is resealed when the needle is removed.
Fig 20. Dry Injectable Powder Filling & Rubber Stoppering Machine
Inspection
According to Good Manufacturing Practices, each final container of a Parenteral preparation
must be individually inspected for visible foreign material.
If any foreign material is found, the container should be rejected.
Labeling
The labeling of the containers of Parenteral preparations should be done in a manner that the area
should be uncovered to inspect the content of the container. The label of any Parenteral preparation
should contain the name of preparation, amount of active ingredient, storage conditions and the
amount of diluents to be used to get the specified concentration of the active ingredient.
1. Injections
Injections are sterile solutions those are prepared by dissolving the active ingredients and any
added substances in Water for Injection or in a suitable non-aqueous base, or in a mixture of
both if they are miscible.
Injections that are suspensions may show sediment but should be readily dispersible on
shaking. The suspension should remain stable to deliver a homogenous dose of each withdrawal
from the container.
2. Infusions
Infusions are sterile aqueous solutions with water as the continuous phase. They are free from
pyrogens or bacterial endotoxins, are usually made isotonic with blood and do not contain any
added antimicrobial preservatives.
3. Powders for injection
Powders for injection are sterile solid substances those are distributed in their final volume
when shaken with the appropriate volume of sterile WFI to form a clear particle-free solution.
4. Concentrated Solutions for injection
Concentrated Solutions for injection are sterile solutions that are administered by injection or
by intravenous infusion only after dilution with water for injection.
5. Implants
Implants are sterile solid preparations of size and shape suitable for implantation into tissues
to release the active ingredient for a long time period. They are filled individually in sterile
containers.
Equipment Required
The following equipment’s is recommended:
a) Manufacturing area
Storage equipment for ampoules, vials bottles and closures.
Washing and drying equipment.
Dust proof storage cabinet
Water still.
Mixing and preparation tanks or other containers.
Mixing equipment where necessary.
Filtering equipment.
Hot air sterilizer.
b) Aseptic filling and sealing rooms
Benches for filling and sealing.
Bacteriological filters.
Filling and sealing unit under laminar flow work station.
c) General Room
Inspection table.
Leak testing table.
Labeling and packing benches.
Storage of equipment including cold storage and refrigerators if necessary.
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.
One of the most important elements in QC laboratory program is the quality and assurance of
the standard which are used. The standard can be broadly defined into two categories –
Reference standard or primary standard
Working standard or secondary standard
The working standard are those obtained from reliable source and whose purity and strength have
been optimized through test, generally compared with the reference standard. The quality control
section performs different control measure and test procedures to verify the product and material
quality. The tests are performed by the QC personnel and the results are matched with a reference
standard.
Different types of test are performed for different material. The types of test performed for each
material are as follows –
1. Size and Shape test
2. Color test
3. Hardness test
4. Friability test
5. Weight Variation test
6. Content uniformity test
7. Disintegration test
8. Dissolution test
9. HPLC
10. IR Spectroscopy
11. UV Spectrophotometer
1. Size and Shape – Thickness is + 5% of standard value control to facilitate packaging. Shaped
tablet requires slotted punches because of the non-uniformity force during compression.
3. 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 2nd and 3rd 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:
a) Monsanto Tester
b) Strong-Cobb Tester
c) Pfizer Tester
d) Erweka Tester
e) Schleuniger Tester
4. 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.
Fig 24. Disintegration Test Apparatus Fig 25. Dissolution Test Apparatus
9. HPLC
Most widely used separation technique
Broad applicability – organic & inorganic
Can be very sensitive, accurate & precise
Suitable for separation of nonvolatile species
Chromatography can be described as a mass transfer process involving adsorption using a non-
polar 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. 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 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.
11. 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.
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.
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.
MICROBIOLOGY SECTION
The Guide to the Inspection of Pharmaceutical Quality Control Laboratories provided very limited
guidance on the matter of inspection of microbiological laboratories.
While that guide addresses many of the issues associated with the chemical aspect of laboratory
analysis of pharmaceuticals, this document will serve as a guide to the inspection of the
microbiology analytical process.
As with any laboratory inspection, it is recommended that an analyst (microbiologist) who is
familiar with the tests being inspected participate in these inspections.
Sterility Testing
One of the most important aspects of the inspection of a sterility analytical program is to review
records of initial positive sterility test results. Request list of test failures to facilitate review of
production and control records and investigation reports.
Particularly for the high risk aseptically filled product, initial positive sterility test results and
investigations should be reviewed.
It is difficult for the manufacturer to justify the release of a product filled aseptically that fails an
initial sterility test without identifying specific problems associated with the controls used for the
sterility test.
Examine the use of negative controls. They are particularly important to a high quality sterility
test. Good practice for such testing includes the use of known terminally sterilized or irradiated
samples as a system control.
Alternatively, vials or ampoules filled during media fills have also been used. Be especially
concerned about the case where a manufacturer of aseptically filled products has never found an
initial positive sterility test. While such situations may occur, they are rare.
In one case, a manufacturer’s records showed that they had never found positive results; their
records had been falsified. Also, the absence of initial positives may indicate that the test has not
been validated to demonstrate that there is no carryover of inhibition from the product or
preservative.
Validation
Confirmation through the provision of objective evidence that the requirements for a specific
intended use or application have been fulfilled.
Validation is one of the important steps in achieving and maintaining the quality of the final
product. If each step of production process is validated we can assure that the final product is of
the best quality.
Validation of the individual steps of the processes is called the process validation. Different dosage
forms have different validation protocols.
Analytical Balance – They are used in precise weighting of small amounts of samples and
chemicals used for preparing media and stock solutions.
Incubator – In the microbiology laboratories it is among the leading devices which are work at
different temperatures according to the purpose and the work load of the laboratory. It is used in
cultivating, multiplying and in the characterization tests of microorganisms. This device provides
the heat necessary for the growth of microorganisms.
Biosafety Cabinet – It is used in microbial inoculation and isolation studies as well as sterile
storage of materials. In addition, it is utilized for protection of user, samples and the environment
from hazardous contamination.
Refrigerator – The device is used for the storage of the stock solutions, chemicals, kits and nutrient
media that should be maintained at certain temperatures.
Magnetic Stirrer – It is a device which provides mixing and keeping the chemical solutions and
mixtures at a certain time and temperature by the help of a magnetic bar. Vortex agitates the
solutions in the tube, flask and so on in certain speed and duration.
Deep Freezer – It is used to store stock cultures in microbiology. It is a device used to store
materials which should be kept at low temperatures.
Autoclave – The main purpose of this device is to sterilize materials and media under pressure and
steam.
Inverted Phase Contrast Light Microscope – By the help of different refractive properties of the
light, Phase Contrast Light Microscope provides visibility to sub-cellular structures of
microorganisms that are examined in a liquid medium without any staining. Fluorescence
attachment is used to display objects stained with special fluorescent dyes (DAPI, FITC, Texas
Red, etc.) and that cannot be displayed with normal light microscopy techniques. It operates
according to the principle of reflective light.
Ph Meter- It is used to determine the Ph of the media prior to experiments and to monitor Ph value
during experiments. The device is used especially in the preparation of stock solutions and the
culture media used for the growth of microorganisms.
Procedure
Receive the finished good transfer ticket from production duly authorized by production
supervisor and checked by QA.
Following are to be made in finished good transfer ticket after received from production –
o Name of product
o Batch No.
o Manufacturing Date
o Expiry Date
o Quantity
o Date of transfer tickets
Verify the received goods against transfer with above details.
Ensure the all details are complete as per our requirements.
In case of any observation, intimate to production department and get it corrected.
Enter the physically verified quantity in SAP system.
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. And the similar guideline was seen followed in Elfin Drugs Pvt. Ltd.,
Nalagarh, Baddi, Himachal Pradesh. It helped us to acquire knowledge on punctuality, regularity
and working environments in industries.
The friendly working environment in Elfin Drugs Pvt. Ltd. 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 “Elfin Drugs Pvt. Ltd”.
REFERENCE
1. Elfin drugs private limited - exporter of antibiotics medicine & pharmaceutical tablets from Mohali (no
date) https://www.elfinpharma.in/. Available at: https://www.elfinpharma.in/ (Accessed: December
25, 2022).
2. CTSD India is providing best pharmaceutical industry training in: Ogoing: Elfin Drug Pvt Ltd (no date)
Join oGoing B2B Community. Available at: https://www.ogoing.com/elfinpharma/Updates/2159892
(Accessed: December 25, 2022).
3. Lal and Pyrogen testing (2018) Pacific BioLabs. Available at: https://pacificbiolabs.com/lal-endotoxin-
testing#:~:text=The%20LAL%20(limulus%20amebocyte%20lysate,important%20part%20of%20ph
armaceutical%20microbiology. (Accessed: December 25, 2022).
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https://albia.in/blog/importance-copps-pharma-company/ (Accessed: December 25, 2022).
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Drug Administration. FDA. Available at: https://www.fda.gov/regulatory-information/laws-
enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act (Accessed: December 25, 2022).
7. Medicines: Good manufacturing practices (no date) World Health Organization. World Health
Organization. Available at: https://www.who.int/news-room/questions-and-answers/item/medicines-
good-manufacturing-
processes#:~:text=What%20is%20GMP%3F,through%20testing%20the%20final%20product.
(Accessed: December 25, 2022).
8. High Performance Liquid Chromatography (HPLC) (no date) Pharmaguideline. Available at:
https://www.pharmaguideline.com/2012/12/high-performance-liquid-chromatography.html
(Accessed: December 25, 2022).
9. Affandi, T. (2020) The role of Fourier Transform Infrared (FTIR) analysis in the field of Pharmacy,
Universitas Darussalam Gontor. Available at: http://unida.gontor.ac.id/the-role-of-fourier-transform-
infrared-ftir-analysis-in-the-field-of-pharmacy/ (Accessed: December 25, 2022).
10. Ph meter principles and applications: An overview (no date) Hudson Robotics. Available at:
https://hudsonrobotics.com/ph-meter-principles-and-
applications/#:~:text=pH%20meters%20are%20used%20in,safety%20in%20pools%20and%20aquar
iums. (Accessed: December 25, 2022).
lOMoAR cPSD| 11826054