Beruflich Dokumente
Kultur Dokumente
“FORMULATION”
JULY-2009
INDEX
INTRODUCTION
Ipca is a fully integrated, rapidly growing Indian
pharmaceutical company with a strong thrust on
exports. Ipca's APIs and Formulations produced at
world class manufacturing facilities are approved by
Forbes, a leading US business magazine, selected Ipca in 2003 among its top 200
successful, rising companies outside USA, with sales under USD 1 Billion. Over 19,000
companies were considered by Forbes, and of the 18 companies from India that figured in
this list, only four were from the 'Indian Pharmaceutical Sector'. Ipca happens to be one
of them. Subsequently, Ipca was selected by FORBES in this prestigious list for two
consecutive years; 2004 and 2005.
From a modest income of Rs. 0.54 crores in 1975-76, the net income has soared to Rs.
753.30 crores in 2005-06 with exports accounting for Rs. 401.83 crores. The net profit for
the year ending 31st March, 2006 stood at Rs. 63.98 crores. Formulations constitute 67
percent of the total income for 2005-06. Today, Ipca is one of the biggest manufacturers
in the world of APIs Atenolol (Antihypertensive), Chloroquine Phosphate (Antimalarial),
Furosemide (Diuretic) and Pyrantel Salts (Anthelmintic) right from the basic stage. Ipca
is also one of the largest suppliers of these APIs and their intermediates world over.
HISTORY
One of the first modern pharma factories of yesteryears was commissioned by Ipca at
Mumbai in 1969.
Currently, this premise where Ipca started its operations, houses the Registered Office of
the company. Key departments like International Marketing, R&D (Formulations) and
Analytical Development Lab are located here.
MILESTONES
2008 January - 'Ipca Who' Brochure wins ABCI Gold Award, (Association of Business
Communicators of India) 48th annual Awards for Excellence in Creative Business
Communications.
February - Tonira Pharma's Nandesari unit (API plant at Baroda) receives US-
FDA approval.
May - WHO-Geneva re-approved Ratlam API manufacturing unit for the third
time.
- Ipca Labs has been awarded third position in case-study presentation during the
"10th National Suggestion Summit" organized by INSSAN-Northern Indian
Chapter (NIC), New Delhi.
June - Ipca Labs became the first company to launch formulation brand HCQS
(Hydroxy Chloroquine Sulphate) in Kenya after innovator brand.
- Ipca Labs bags Topmost Exporter Award. D&B - ECGC Indian Exporters
Excellence Award - Topmost Exporter of Pharmaceutical Large Sector.
- Ipca Labs receive approval from US Food and Drugs Administration to manufacture
Propranolol Hydrochloride Tablets.
- 'Breakthrough in the treatment of Migraine', a public seminar sponsored by Ipca Laboratories for
Migrainers.
- Tonira Pharma's API manufacturing plants situated at Ankleshwar and Nandesari receive
PMDA-Japan approval.
2007 January - Ipca - Ranbaxy Alliance received U.S. FDA marketing approval for
Atenolol Tablets
- Ipca's New Biotech Research & Development Unit was inaugurated at Mumbai.
June - Ipca - Ranbaxy Alliance received U.S. FDA marketing approval for
Hydroxychloroquine Sulfate Tablets (HCQS).
July - Ipca - Ranbaxy Alliance received U.S. FDA marketing approval for
Hydrochlorothiazide (HCTZ) Tablets.
August - Ipca - Ranbaxy Alliance received U.S. FDA marketing approval for
Metformin HCl Tablets.
October - Ipca has been awarded by Forbes Inc., as one of the 'Best under a
Billion' Forbes Global's 200 Best Small Companies, 2007. In the past, company
has received same award for three consecutive years' 2003, 2004 and 2005.
December - Ipca - Ratlam received 2nd prize in the 'National Energy conservation
award-2007' in Drug and Pharmaceuticals sector from the Bureau of Energy
efficiency under the Ministry of Power, Government of India, New Delhi.
2006 Ipca launches Fixed dose ACT combination and stops manufacturing of single
ingredient Oral Artemisinin derivatives.
Ipca enters into strategic alliance with Ranbaxy Pharmaceuticals Inc. for the U.S
market.
2005 Merger of Innotech Pharma Limited with Ipca Laboratories Limited in August,
2005.
Forbes Asia, a leading US business magazine selected Ipca, for the third
consecutive year as one among the first 200 'Best under a Billion Company' in
Asia.
2004
Commissioned new formulation plant at Silvassa.
Received 'Lifetime Achievement Award' for the year 2002-03 from CHEMEXIL
(Basic Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council) for
export promotion over the years.
API manufacturing facility at Ratlam (M.P.) inspected by US-FDA and the facility
was found to be in compliance with global GMP requirements. The plant and the
facilities have been recommended for manufacturing Atenolol, Propranolol
Hydrochloride, Hydroxychloroquine Sulphate and Chloroquine Phosphate.
Forbes Asia, a leading US business magazine selected Ipca<, for the second
consecutive year as one among the first 200 'Best under a Billion Company' in
Asia.
Forbes, a leading US business magazine, selected among its top 200 successful,
rising companies outside USA, with sales under USD 1 Billion.
2001 Awarded 'Trishul' the highest award conferred by CHEMEXIL (Basic Chemicals,
Pharmaceuticals & Cosmetics Export Promotion Council) for outstanding export
performance.
Athal, Kandla and Ratlam plants received the prestigious approval from MCC
(Medicines Control Council) South Africa.
1986 Ipca's First APIs Plant for manufacturing of Chloroquine Phosphate, set up at
Ratlam.
1985 Production of Pyrantel Pamoate API commenced for the first time in India.
Commenced manufacturing of Injectables at the Ratlam formulations unit.
1982 The first company, after Eli Lilly, to develop a preconstituted formulation of
Erythromycin Estolate (Eltocin® Liquid).
Industrial training: IPCA, Ratlam
- 10 -
1981 R&D Active Pharmaceutical Ingredients and R&D Formulation development
department set up to provide technology based products.
1978 Launched formulations of Metoclopramide under brand namd 'Perinorm®' for the
first time in India.
1976 Started domestic marketing operations, the first company to offer sugarcoated
Chloroquine tablets.
CHAIRMAN
Mr. R. S. Hugar
MANAGING DIRECTOR
Mr. Premchand Godha
Industrial training: IPCA, Ratlam
- 11 -
EXECUTIVE DIRECTORS
Mr. A. K. Jain
Mr. Pranay Godha
DIRECTORS
Mr. M. R. Chandurkar
Mr. Babulal Jain
Dr. V. V. Subba Rao
Mr. V. A. Gore
BACKGROUND*
OTHER AFFILIATIONS*
Brescon Corporate Advisors Ltd.
Kaygee Investments Pvt. Ltd.
BACKGROUND*
Ajitkumar Bhanwarlal Jain B.Sc., A.C.A, serves as Chief Financial Officer of Ipca
Laboratories Ltd. Mr. Jain serves as the Head of Accounts, IT, Costing & Taxation,
Chemical R & D at Ipca Laboratories Ltd. Mr. Jain joined Ipca Laboratories Ltd. as Chief
ANNUAL COMPENSATION*
BOARD OF DIRECTORS Salary 2,280,000
MEMBERSHIPS* Total Annual Compensation 2,280,000
R. S. HUGAR (69)
Chairman, Ipca Laboratories Ltd.
25
BACKGROUND*
R. S. Hugar served as Managing Director of Global Trust Bank Ltd. since April 12, 2001.
Mr. Hugar served as Managing Director of Corporation Bank for 3 yrs. Mr. Hugar's
illustrious career in Banking started at Bank of Maharashtra from January, 1967 where he
worked for over 25 years in various capacities. He served as General Manager and Chief
Vigilance Officer of Union Bank of India, Mumbai, a special assignment from Government
of India for 3 ½ years, he made significant ...
EDUCATION
Master's Degree
University of Pune
OTHER AFFILIATIONS
Global Trust Bank Ltd.
University of Pune
Zicom Electronic Security Systems Ltd.
Dewan Housing Finance Corp. Ltd.
VRL Logistics Ltd
BACKGROUND*
Babulal Jain has been Non-executive Independent Director of Ipca Laboratories Ltd.
since 1988. Mr. Jain is a practicing Chartered Accountant by profession. He has
professional experience of nearly 33 years years in the field of Audit, Finance, Company
Law and Taxation. His professional knowledge and vast experience has been of immense
benefit to Ipca Laboratories Ltd.
BACKGROUND*
Varanasi Venkata Subba Rao served as Advisor to the Department of Science &
Technology (DSIR), Government of India. Dr. Rao has rich experience of 35 years in the
field of science and technology. He has been a Non-Executive Independent Director of Ipca
Laboratories Ltd. since September 2000. Mr. Rao is a postgraduate in Chemistry from
Andhra University and PhD in Chemistry from University of Pune and has also carried out
post-doctoral research in Surface Chemistry in ...
BOARD OF DIRECTORS
Industrial training: IPCA, Ratlam
- 17 -
MEMBERSHIPS* TOTAL COMPENSATION*
2000-Present Total Annual Cash Compensation 130,000
Non-Executive Independent Director, Member of Total Calculated Compensation 130,000
Remuneration & Compensation Committee and
Member of Audit Committee
Ipca Laboratories Ltd.
.
EDUCATION*
PhD
University of Pune
Master's Degree
Andhra University
OTHER AFFILIATIONS*
University of Pune
Andhra University
M. R. CHANDURKAR (71)
Non Executive Director and
Member of Shareholders / Investors Grievance Committee, Ipca Laboratories Ltd.
This person is connected to 6 board members in 1 different organizations across 1 different
industries.
BACKGROUND*
M. R. Chandurkar served as Managing Director of Ipca Laboratories Ltd. from 1983
to March 2008. Mr. Chandurkar served as Resident Manager of Navbharat, a Hindi Daily
before he joined Ipca Laboratories Ltd. Under his leadership Ipca Laboratories Ltd. Mr.
Chandurkar has been a Non Executive Director of Ipca Laboratories Ltd. since 1975. He
has made tremendous growth in the International Marketing. Mr. Chandurkar is a
Commerce graduate.
ANNUAL COMPENSATION*
BOARD OF DIRECTORS Salary 3,360,000
V. A. Gore 70
Independent Non-Executive Director,
Chairman of Audit Committee and
Chairman of Share Transfer & Shareholders Grievance Committee, Apar Industries Limited
BACKGROUND*
V. A. Gore has been Non-executive Independent Director of Ipca Laboratories Ltd.
since April, 2000. Mr. Gore has been a Director of Uniflex Cables Ltd. since August 30,
2008. He has been Independent Non-Executive Director of Apar Industries Limited since
September 18, 2004. He serves as an Independent Non-Executive Director of Gujarat
Borosil Ltd. He started his career as an Assistant Administrative Officer with Life Insurance
Corporation of India, where he worked in ...
Industrial training: IPCA, Ratlam
- 19 -
BOARD OF DIRECTORS
MEMBERSHIPS*
2008-Present
Director, Chairman of Shareholders/Investors
Grievance Committee and Member of Audit
Committee
Uniflex Cables Ltd.
2000-Present
Non-Executive Independent Director, Member of
Audit Committee and Member of Remuneration &
Compensation Committee
Ipca Laboratories Ltd.
1994-Present
Independent Non-Executive Director, Chairman of
Audit Committee and Chairman of Share Transfer
& Shareholders Grievance Committee
TOTAL COMPENSATION*
Apar Industries Limited
Independent Non-Executive Director, Chairman of Total Annual Cash Compensation 182,500
Remuneration Committee and Member of Audit Total Calculated Compensation 182,500
Committee
Gujarat Borosil Ltd.
EDUCATION*
Master's Degree
Jamnalal Bajaj Institute of Management Studies
Other Education
University of Mumbai
OTHER AFFILIATIONS*
Ipca Laboratories Ltd.
Jamnalal Bajaj Institute of Management Studies
University of Mumbai
Gujarat Borosil Ltd.
Uniflex Cables Ltd.
HEALTH
Illustration:-
- Medical checkups.
- Medical camps.
SAFETY
We are committed to put our efforts to find out unsafe places and unsafe acts for improving
safety of the people at workplace and road safety for general public.
ILLUSTRATION:-
EMPLOYEES:-
We will deliver a competitive and fair employment environment and the opportunity
to develop and advance subject to personal performance and business opportunity.
ILLUSTRATION:-
- Employee education and skill development programs.
- Personal effectiveness programs.
CUSTOMERS:-
Our business and existence depend upon our customers. Every employee is
responsible for ensuring that any contact with our customers and the public at large reflects
professionalism, efficiency and honesty. We will constantly strive to provide high
quality service, products and good value for money.
ILLUSTRATION:-
ILLUSTRATION:-
SUPPLIERS:-
We regard suppliers as our partners and work with them to help us achieve our policy
aspirations in the delivery of our products and services.
We will encourage our suppliers and contractors to adopt responsible business policies and
practices for mutual benefit.
ILLUSTRATION:-
COMMUNITY AT LARGE:-
PRODUCT LIST
Formulations > BELARUS > Brand Names
MARKETING
Ipca is 16th largest Pharmaceutical Company in India. (Source Economic Times ET-500
Oct-07 issue).
Ipca has been awarded by Forbes Inc., as one of the "Best under a Billion" Forbes
Global 200 Best Small Companies, 2007. In the past, we have been awarded, for 3
consecutive years 2003, 2004 and 2005.
Ipca is a "Recognised Trading House" with an export turnover of about US$ 134
million for the year 2007-08.
Formulations account for 64% of export turnover. Ipca is among India's largest
formulation exporters with a growth of 11% in 2007-08.
Ipca has overseas offices in Russia, Kazakhstan, Ukraine, Vietnam, Kenya, Philippines,
Columbia & Sri Lanka.
Ipca also has subsidiaries in USA, U.K., South Africa, Nigeria, Brazil, Mexico, Australia
and New Zealand.
The current focus is on registering dossiers in UK, EU, CEE, South Africa, Australia,
New Zealand and filing on ANDAs in USA. Sales of generics to regulated markets
constituted 64% of total formulations exports during 2007-08.
Ipca's field force promotes its formulation brands in Cambodia, Kenya, Kazakhstan,
Mauritius, Myanmar, Oman, Russia, Sri Lanka, Sudan, Tanzania, Ukraine, Vietnam, Yemen
and a few other countries. Sales of Branded formulations has steadily grown from around
16% of formulations export in 2000-01 to 36% in 2007-08.
Industrial training: IPCA, Ratlam
- 32 -
The R & D expenditure during the financial year 2007-08 was Rs.42.9 crores (4% of
turnover). Around 152 patents have been filed, out of which 27 patent applications have
been granted which includes 25 from India and 2 from US.
Ipca's stature as a quality-driven pharmaceutical major, and therefore a dependable and
dynamic partner continues to grow with each passing day - bringing it closer to its vision to
be a Global generic player in all major developed and developing markets, through
enhanced geographical reach and product expansions.
The company's dynamism and foresight is evident in its strong thrust on backward
integration by manufacturing the APIs for many of its Finished Dosage Forms. Thus,
ensuring cost competitiveness and reliability of supplies giving it a distinct advantage in
the Pharmaceutical Industry. Ipca's facilities have been approved by most of the discerning
regulatory authorities including UK-MHRA, Australia-TGA, South Africa-MCC and Brazil-
ANVISA.
In the United Kingdom, Ipca's Finished Dosage Forms are already being sold. The
company has already initiated dossier filings for several generic products backed up by a
strong pipeline which will also be offered in EU countries and other developed nations.
In Anti-Malarials, which has been a traditional strong hold, Ipca has kept pace with the
latest concepts of Artemesenin based combination therapy (ACT) based on
recommendations from International forums including WHO.
Gastroenterologicals, Cold and Cough Preparations, Dermatologicals are the other main
segments.
Ipca has been playing a leading role in the domestic Active Pharmaceutical
Ingredients (APIs) and Drug Intermediates (DIs) market, with over 20 years of experience
in the Antimalarial and Antihypertensive therapeutic segments. We are the first
manufacturer in India for APIs like Atenolol, Pyrantel Pamoate and Hydroxychloroquine
Sulfate. Our domestic pharmaceutical customers include Alembic, Bayer, Cipla,
Dr.Reddy’s, Merck, Nicholas Piramal, Pfizer, Ranbaxy, and Wockhardt, among others.
FORMULATIONS MARKETING
The speciality-focussed restructuring of Ipca’s domestic marketing strategy has given birth
to 8 self-administered marketing divisions. Results are encouraging; in 2007, our domestic
formulations business has grown at the rate of 16% against an industry growth of 14%
during the same period (ORG-IMS).
Brands like Glycinorm, HCQS, Lariago, Malirid, Movon, Pari, Perinorm, Ramcor, Solvin,
Sultax, Tenolol, Tenoric, and Zerodol have become brand leaders in their respective
therapeutic segments, and 4 of these are also rated among the Top 300 Indian Brands (all
categories) by ORG-IMS.
DOMESTIC DIVISIONS
Divisio
n
The largest of Ipca’s divisions, handling the largest number of brands, this division
manages our newer Antimalarials, Antihypertensives, Antibacterials, Non Steroidal Anti-
Inflammatory Drugs (NSAIDs) and Cough preparations. Recently it launched Zerodol
(Aceclofenac), a country first. Some of the other leading brands managed by this division
are: Tenolol (Atenolol), Larither (Artemether), Roxeptin (Roxithromycin), and Tenoric
(Atenolol + Chlorthalidone).
Division
Division
The focus of this division is on Cardiovascular and Antidiabetic segments and it currently
manages 24 brands. Through the introductions of newer dose and dosage forms, the
division focuses on fulfilling the need for dose-titration, which is an essential component
in the management of diabetes and cardiovascular diseases. Some of the leading brands
managed by it are: Glycinorm (Gliclazide), Glycinorm-M (Gliclazide + Metformin),
Lisoril (Lisinopril), Simlo (Simvastatin), Calchek (Amlodipine), Piomed (Pioglitazone),
Metagard CR (Trimetazidine Controlled Release) and X’tor (Atorvastatin).
Divisio
n
Bionova’s focus area is Dermatology. It has already made its mark by leading in the oral
anti-acne segment with brands like Azifast (Azithromycin) and Acutret (Isotretinoin). Also
offered are fast growing brands like Leset (Levocetirizine) and Nipcan (Fluconazole).
Division
Innova marks Ipca’s entry into the Indian Neuropsychiatry segment. Already to its credit
are segment leaders such as Pari (Paroxetine), Sove (Zolpidem), and Ozapin MD
(Olanzapine Mouth Dissolving). Recently, Innova launched Pari CR – India ’s first
Paroxetine with Controlled Release Technology, an international patent for which have
been filed.
Division
A super-speciality division, Activa was the countries first Rheumatology and Orthopaedic
– focused division. It markets a growing portfolio of dynamic brands, including: HCQS
(Hydroxychloroquine Sulfate), Folitrax (Methotrexate), Saaz (Sulfasalazine), and Movon
(Aceclofenac), the first Aceclofenac in India . Today, Activa is a leader in its segment with
a 39% market share, and is also Ipca’s fastest growing division.
Divisio
n
Division
Ipca's youngest division, Altus caters to the need of intensivists, both surgical and non-
surgical, with a basket of oral and injectable Antibiotics like Keftragard, Keftragard V,
Lactagard, Lactagard 2:1, Tazofast, Primegard, Keftra, Foloup, Supraheal and Sultax
(Sulbactum + Cefotaxime), a world first.
MANUFACTURING FACILITIES
India.
Aurangabad (Maharashtra)
Operational since 1997.
Manufacturing plant for Active Pharmaceutical
Ingredients and Drug Intermediates.
One of the largest manufacturers of Drug
Intermediates;3,4-Trimethoxy Toulene (TMT)
and 6-Methoxy-2-Napthaldehyde (6MNA). »»
Dehradun (Uttaranchal)
Kandla (Gujarat)
Operational since 1993.
Facility approved by UK-Medicines and Healthcare products
Regulatory Agency (MHRA), Australia-Therapeutic Goods
Administration (TGA), South Africa-Medicines Control Council
(MCC), Brazil-Brazilian National Health Surveillance Agency
(ANVISA), Oman-Ministry of Health(MOH), Uganda-National Drug
Authority (NDA) and Tanzania-Food & Drugs Authority (FDA).
Formulations manufacturing plant for betalactam tablets, capsules
and dry powders. »»
Formulations Plant
Operational since 1983.
Formulations plant manufacturing Tablets, Liquids and
Injectables.
Facility approved by Brazil-Brazilian National Health
Pithampur
Formulations plant manufacturing Oral Solid dosage forms. »»
Research & Development units at Ratlam and Indore are also supported by facilities required for
scale up of the processes from grams to kilo as well as to Pilot level.
Strengths:
Analytical developments:
New method developments.
Method validations for getting products registered in Regulated
Markets.
Process Research:
Process development/improvements to make products competitive and profitable in the long run
by giving major emphasis on:
Non-infringing processes
2. Formulation Development
Our Formulation Development Laboratory located at Mumbai has been gearing up for a state-
of-the-art R&D facility (in line with the US-FDA requirements). The current R&D activities are
also approved by the Department of Science and Technology, Government of India. The
laboratory is well equipped with various ultramodern equipments and technologies required for
conducting high quality research activities.
R&D in this area attempts to improve the efficiency with which the medicine is absorbed in the body. Novel
Drug Delivery Systems (NDDS) efforts are directed towards:
Ipca’s Research concentrates on sustained, delayed and pulsatile release. The company introduced a novel
bilayer tablet for an antidiabetic combination.
Ipca’s R & D laboratory has filed patents across the world for products based on the NDDS. Ipca’s strength in
this segment of R&D puts the company in an excellent position to compete in the growing markets for
generic drugs in Europe and USA.
CLINICAL RESEARCH
Clinical research is an integral part of pharmaceutical development and hence
importance of clinical research is self evident. It has been the endeavour at Ipca to publish
the clinical trials, which are being carried out by Ipca. Publication of clinical studies in
IPCA’S
WORLD-CLASS FACILITIES APPROVALS:
USFDA
MHRA-UK
TGA AUSTRALIA
NIP HUNGARY
ANVISA BRAZIL
INVIMA COLOMBIA
INSTITUTO NACIONAL DE VIGILANCIA DE MEDICAMENTOSY ALIMENTOS
PIC GERMANY
SNO. DEPARTMENT
01. TRAINING
Industrial training: IPCA, Ratlam
- 49 -
02. GRANULATION
03. COMPRESSION
04. COATING
05. PRIMARY PACKING
06. FINAL PACKING
07. LIQUID
TRAINING
In the field of human resource management, training and development is the
field concerned with organizational activity aimed at bettering the performance of
individuals and groups in organizational settings. It has been known by several names,
including employee development, human resource development, and learning and
development.[1]
TRAINING
This activity is both focussed upon, and evaluated against, the job that an individual
currently holds.[3]
EDUCATION
This activity focusses upon the jobs that an individual may potentially hold in the
future, and is evaluated against those jobs.[3]
DEVELOPMENT
This activity focusses upon the activities that the organization employing the
individual, or that the individual is part of, may partake in the future, and is almost
impossible to evaluate.[3]
The "stakeholders" in training and development are categorized into several classes. The
sponsors of training and development are senior managers. The clients of training and
development are business planners. Line managers are responsible for coaching, resources,
and performance. The participants are those who actually undergo the processes. The
facilitators are Human Resource Management staff. And the providers are specialists in the
field. Each of these groups has its own agenda and motivations, which sometimes conflict
with the agendas and motivations of the others.[4]
The conflicts are the best part of career consequences are those that take place between
employees and their bosses. The number one reason people leave their jobs is conflict with
their bosses. And yet, as author, workplace relationship authority, and executive coach, Dr.
John Hoover[5] points out, "Tempting as it is, nobody ever enhanced his or her career by
making the boss look stupid." [1] Training an employee to get along well with authority and
The initial training was to visit the plant and get acquaint with the officials and the work
conditions there, we reported to the concerned department and the our concerned incharge
told us about the different procedures to be performed in the formulation area.
GOWNING:
It is the procedure to be followed by the individual before entering the concerned
area of manufacturing or production area. The individual has to perform following
procedure.
1. Wear a neat and clean apron.
2. Wear head cover, nose mask, shoes/ shoe cover.
3. Sterilize the hands with disinfectant solution.
4. On exit remove the apron and the other accessory in the gowning room and put in
thrash bin.
The procedure helps in preventing and injury to the employee and avoid and contamination
of product with hair, fibers dirt and dust. The whole procedure is written in room as the
SOP(standard operating procedure). And the instruction in the SOP should be strictly
followed and reviewed periodically.
Then the instruction to be followed in the production area was instructed as follows:
1. Material should not handle with naked hands, only after the gloves are put.
2. Don’t handle the machine which you don’t know how to operate.
3. Maintain discipline and abide by the rules and regulations.
GRANULATION
Granulation is the process in which the raw materials are mixed and the mixed with
the slurry and a paste is made which is then fed to dryer and then fed to granulator. This is
finally converted to granules of suitable size. Granulation helps to get the mass of the give
size which can be compressed as per the specification
Sifting
(Size separation)
Granulator
(Slurry + raw material)
Blender
(Mix lubricant and granules)
ORDER REQUISITION
Order requisition document which contain the records of the details of the new batch
or order to be taken. It is the BMR of the whole batch which contains the information and
basic procedure which need to be done. The whole details of BMR is taken in coming
section.
Industrial training: IPCA, Ratlam
- 53 -
The order requisition is sent to the raw material department which dispense the
required quantity of material and label it. There are two labels on the material
On individual material
On container.
Once the material arrives it is kept in RW day store. And depending on batch requirement
send to the formulation.
Raw material is dispensed in the lot size after the clearance from the QC/QA department
and are labeled with following details.
LABEL:
Date:
AR No. Material Name:
Weight: Gross Wt. Batch No:
Id No.: Tare Wt. Batch Size:
Stage: Net Wt.
Checked By Dispensed By
Once the material is handed to the supervisor its his duty to weigh the material and
mention in the BMR, if the weight are correct as per the given specification the material is
forward to sifting.
SIFTER:
VACUUM SIFTER
Vacuum sifters are the one shown in figure above, and make the use of the vacuum for
the separation process.
It contains following parts
Lid: to cover the assembly so as to create a vacuum and aid sifting
Outlet: connected to granulator so as to transfer the material to granulator.
Sieve: it is the main part it is fitted with different size sieve so that proper size can be
separated.
Inlet: material is feed from this part; the material is sucked through the pipe under
vacuum.
WORKING
The sifter uses the vacuum concept in which the material; is sucked in through the
inlet and passed through sieve and then the material of required is passed through and
the remaining particles are left.
Working
The material is poured on the sieve and vibrator is switched on, the particles
moves in random direction and the particles get separated. The separated particles get
collected in the outlet.
GRANULATOR
Salient Features:
Homogeneous binder distribution, Short batch time and reduce cleaning time. Maximize
CIP effectiveness. Air purges sealing system for main stirrer shaft and granulator shaft. All
WORKING:
The working is as follows, the material is feed from the vacuum sifter
and collected in the container and then the speed and time is set and it is allowed to rotate,
after that the slurry is made and poured in it and rotated again for proper mixing. Once the
time is completed the mass is analyzed and then taken out.
The resulting phenomenon is called fluidization. Fluidized beds are used for
several purposes, such as fluidized bed reactors (types of chemical reactors), fluid
catalytic cracking, fluidized bed combustion, heat or mass transfer or interface
modification, such as applying a coating onto solid items.
WORKING:
The slurry is taken in the container and then fixed in the given position in the FBD
and the parameter is set and then at regular interval sampling is done and LOD is check so
that optimum drying can be done. Once the required LOD is attained the material is send
for blending.
BLENDER
Industrial training: IPCA, Ratlam
- 59 -
OCTAGONAL BLENDER
Blending is the process in which two parts are mixed together and a homogenous mass is
produced. The lubricant is mixed here and the final granulation is completed then it is ready
for compression.
The blender contains following parts
Inlet: it is connected to a pump from were the material is feed in the granulator.
Blender: it the container were the actual mixing is done, it is octagonal in shape.
Control: it contains basic control which is used to adjust the speed, time and
temperature.
Outlet: it is the spot from were the material is taken out.
WORKING
The material is sucked in the container by pump and then the controls are set as per
the given parameter. On the completion of the cycle the material is send to the
compression unit.
SLURRY
COMPRESSION
Granules
Hopper
Die
Punch
Exit
IPQC
The” ipqc” parameters in the tablet compression are the
Industrial training: IPCA, Ratlam
- 64 -
TABLET HARDNESS
The hardness is the important parameter in the tablet and is analyzed by two apparatus:
Digital hardness meter: the tablet is placed in the cavity provide in the meter and then
gradually force is applied to it and the force at which the tablet
breaks is noted.
Simple Mechanical Hardness: Meter the tablet is placed in the cavity given and the knob is
rotated until the tablet is fixed this is initial reading, now the knob is
tightened until the tablet breaks; this is final reading, from which
the harness is calculated
TABLET DIMENSIONS
VERNIER CALIPERS
BULK DENSITY
COATING
Industrial training: IPCA, Ratlam
- 66 -
There are many ways to coat tablets. Sugar coating was one of the earliest methods, and the
process is still widely used in the confectionery industry. Wurster coating is another means.
It employs a cylindrical chamber in which tablets are suspended by air and a coating
solution is introduced into the air stream. Fluid-bed coating is a similar process. Dry
coating is the technique of making a tablet within a tablet. But the principle means of
applying a coating to pharmaceutical and nutraceutical
COATING SOLUTIONS
Film coatings are a mixture of solids and liquids. For many years, the liquid component of
coatings was a volatile solvent, such as alcohol or other quick-drying substances like
methylene chloride. While solvent-based coatings performed well in many respects, they
presented problems in handling, operator safety, recovery, and odor. They could even make
the finished tablets smell like solvent, which is not a desirable side effect. Solvent-based
coatings are still used in some applications, but water based, or aqueous, coatings have
largely replaced them .As a result, coating has become much more challenging, because
water-based coatings are much less forgiving. You must apply the coating and remove the
water before it can jeopardize the integrity of the tablet.
Coating equipment
A modern tablet coating system combines several components: a coating pan, a spraying
system, an air handling unit, a dust collector, and the controls. The coating pan is actually a
perforated drum that rotates within a cabinet. See Figure 1. The cabinet enables you to
control airflow, air temperature, air pressure, and the coating application. The spraying
system consists of several spray guns mounted on a manifold, a solution pump, a supply
tank and mixer, and an air supply. The pump delivers the coating solution to the guns,
where it combines with atomizing air to create a fine mist that is directed at the bed of
tablets in the coating pan. The air handling unit heats and filters the air used to dry the
coating on the tablets. Depending on your circumstances, it may include a humidifier or
dehumidifier. The dust collector extracts air from the coating pan and keeps a slightly
negative pressure within the cabinet. The controls enable you to orchestrate the operation of
all the components to achieve the desired results. of the liquid component. It might think of
film-coating tablets as spray-painting a bunch of golf balls. You can envision that it’s best
to spray them lightly and evenly so that successive light coatings lock together. That’s how
tablet coating works. Once the base coating is applied, you can increase the rate of solution
addition and the pan speed proportionately. Typically, it takes about 20 minutes before you
can increase the spray rate and pan speed significantly. Soft tablets and tablets that are very
COATING MACHINE
CONSTRUCTION
PAN (DRUM)
The machine contains a huge drum of various sizes 60inch, 48inch, 36inch. With varying
capacity. The drum is made of stainless steel. The pans are perforated so that the air can
move in and out it contains baffles which helps in the mixing of the tablets and easy and
even coating.
SPRAY GUN
The spray gun is shown in the figure above it is a nozzle type assembly used to spray the
coating solution on the tablet. The tablets are constantly in firing line of spray gun and get
coated by the solution.
CONTROLS
The controls contains the parameter setting for the temperature of inlet, outlet to attain a
good and dried coat with low moisture content, time of cycle, no. of cycles, RPM of pan
spray volume spray time.
WORKING
The fig of working can be seen above. The solution is placed in container and feed to spray
gun, the tablet is feed in the pan the parameter is set as per given specifications and the
machine is switched on regularly the sample is taken out and checked for weight gain.
Weight gain parameter: The weights of 20-25 tablets are taken and the initial weights are
subtracted and the calculated value is matched with standard.
Appearance: the physical appearance is checked at regular interval of time for
any visual imperfection
This is machine which is used as the pack the material using both side aluminum foil. The
design is shown in the figure it contains following parts and the working can be explained
as below:
The film which is used to form the blister is the thick one and the sealing film is thin one.
The thick film is subjected to thermal treatment to produce the blisters of required
dimensions. Once the blisters are formed the tablet is filled in the blisters and then the
covering film is put, finally the sealing is done with suitable temperature.
The controls are available which is used to set the parameter of the machine related to
speed temperature and size of blisters.
The machine is show in the figure and contains the simple parts the working can be
explained below.
The tablet is feed from the hopper the PVC foil is subjected to thermal treatment which
produces the blisters in the foil and then the tablet is filled in the blister and then the sealing
is done with the aluminum foil. The controls are available to set the process parameters.
Once the pack is sealed the cutter cuts the strips of given size and then send to final packing
Here the man is need to check the tablets and sort them out and remove the malformed.
The machine is used as a blister packing machine; the important quality is that it can be
used to pack both PVC and aluminum packing. The most widely used machine today due to
its versatility.
The working is similar to other blister packing machine there is same slot for the aluminum
foil and PVC foil the temperature is set and blister are produce and the process is similar to
that of the simple blister packing machine.
The tablet is feed from the hopper the PVC foil is subjected to thermal treatment which
produces the blisters in the foil and then the tablet is filled in the blister and then the sealing
is done with the aluminum foil. The controls are available to set the process parameters.
Once the pack is sealed the cutter cuts the strips of given size and then send to final packing
Here the man is need to check the tablets and sort them out and remove the malformed.
The material for packing is ordered as per the size of the lot and the request is made by the
proper order form which is send to material manager which is then relive the material. In
the case when the material is in excess the left material is send back to the material
manager which is mentioned in the form provided by the MM.
The material then arrives in the quarantine area which is verified and then send for the
printing.
A rubber stereo is the one which contains the details engraved on it and it is embossed on
the paper or the given surface.
A special printing machine is used to print the stereo in which the labels and cartoons both
can be printed. The labels and the cartoons are arranged in the slot and the machine prints
the details on the material regularly ink levels are checked and refilling is done.
The product to be packed (tablet/ capsules strips) are verified so that no empty strip can be
packed this is done by two persons who physically inspect the product so that it don’t
contain can empty strip or any breakage of any printing errors or the other errors, the
product with errors are removed. In case the empty strip or the cartoon with less no of strip
goes the weight variation helps to sort out them.
Product packing
The product is then packed in the outer cartoon in the given request and then sealing is
done is per requirement. The helps the product to pack easily and then transport and
storage
The cartoons are then weighted so that in case there is less material or more material it can
be sorted out. This is done by simple balance. The weight of one pack is standardized and
then all are verified on the basis of that reading. This sorts out the any anomaly in the
product.
Cartoon packing
Now the cartoon are packed in the big cartoon and they are labeled in such a way as per
given specification. And sent to the ware house from there it is dispatched as per the deliver
specification.
The fig above shows a simple liquid filling machine the working of which is as follows:
The liquid to be filled is stored in a big tank above and then desired quantity is
released to be filled in the bottles. The bottles which are initially cleaned and washed are
arranged in the required fashion by the concerned labor and then the bottle flow to the
filling unit and the liquid is filled in the bottles. After that the bottles are then send forward
were they are capped and incase plastic caps are to be placed are put on it. Nextly they are
sent to the labeling assembly and were label is placed on then, and finally they are packed
in individual container and then finally packed in cartoons with suitable details mentioned
on then like
Batch no.
Date of manufacture
Date of expiry
Address of manufacturer
Industrial training: IPCA, Ratlam
- 80 -
CONCLUSION