Industrial Training report- 3rd Year-B.Pharma- By- Dhanashree Giridhar Kolhekar.docx

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A PROJECT REPORT ON ONE MONTH
INDUSTRIAL TRAINING
WITH
LORDS Research & Life Science Laboratory Pvt. Ltd.
Training report submitted in the partial fulfilment for the Degree of Bachelor of
Pharmacy
(B. Pharmacy).
In the faculty of
Pharmaceutical Sciences Savitribai Phule Pune University (SPPU)
Submitted by
--Student name--B. Pharmacy (FINAL YEAR)
Under supervision
of
---Project guide name--:
Department of Pharmacology
ACADEMIC YEAR – (2023-24)
Sanjivani College of Pharmaceutical Education and Research

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DECLARATION BY THE CANDIDATE
I hereby declare that the Industrial Training work presented in the
project entitled, Tablet Manufacturing has been carried out by me in the
laboratories of LORDS Research & Life Science Laboratory Pvt. Ltd.’s.
Sanjivani College of Pharmaceutical Education and Research, Kopargaon
under the supervision of Mr./ Mrs/ Miss-----project-guide-name------. This
Work is original and has not been submitted for any degree, diploma or
association-ship of this or any other university.
Place: Name of student
Date:
Signature and Name of candidate

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ENDORSEMENT BY THE DEAN ACADEMIC, PRINCIPAL
This is to certify that the research work presented in this Industrial
Training project entitled, “Tablet Manufacturing” is carried out by Sonam
Sinha in the laboratories of LORDS Research & Life Science Laboratory Pvt.
Ltd.’s. Sanjivani College of Pharmaceutical Education and Research,
Kopargaon, under the guidance of ------Project- guide- name-----
Seal & Sign of the Dean academic Seal & Sign of the Principal
Name: Name:
Date: Date:

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ACKNOWLEDGEMENT
I consider it a great privilege & honour to have had the opportunity to undergo the industrial
training work in
LORDS Research & Life Science Laboratory Pvt. Ltd. Thakre Nagar, Aurangabad.
Hence, I would like to offer my heartiest thanks to Ms. Smita D. Savant, Mr. Dattatray A. Savant
(PhD) (Chairman and Managing Director of LORDS Research & Life Science Laboratory Pvt. Ltd.
I convey my heartiest thanks. I would like to thanks all trainees and staffs, who helped me very
much and without whom support and it was impossible for me to complete the industrial training
successfully. I owe deep gratitude to the Mr. Dattatray A. Savant Sir [training IN charge] 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 LORDS Research & Life Science Laboratory Pvt. Ltd. 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.
Vipul Kumar Patel Sir (Principal & director), Prof. Pendbhaje N.S. Sir [Head of Training and placement
cell of Sanjivani College of Pharmacy] and Dr. Sarita Pawar Mam [Dean Academic] of SANJIVANI
COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH ,KOPARGAON for
valuable guidance, consistence encouragement and pleasant discussion throughout.
DATE- - -2023 Dhanashree kolhekar
PLACE- Kopargaon FINAL YR. B.PHARM.
S.C.P.E.R.
[AUTONOMOUS]

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PREFACE
The induction can provide information such as the organization history. Values,
culture, service offered, customer, staff, policies and expected behaviour etc.
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.
The report is based on knowledge of topic relevant for the projects and discussions
with the inbound & outbound department in charges, and survey of the company.
The project is divided into five sections to simplify and distinguish the topics from
each other's. During the project. I have concluded some analysis which is mentioned after
each sub topics.
According to curriculum of a four-year integrated degree course of BACHELOR OF
PHARMACY each student has to undergo practical training for a period of one month in
any of the pharmaceutical industry in India.
I was directed to undergo at " LORDS Research & Life Science
Laboratory 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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INDEX
S.NO CONTENT Pg.NO
1. PROFILE OF ORGANISATION 8-11
2. COMPANY PRODUCT 12-13
3. RAW MATERIAL 14-15
4. PRODUCTION SECTION 16
5. TABLET MANUFACTURING 17
6. SIZING 18-21
7. POWDER BLENDING 22-23
8. GRANULATION 24-26
9. DRYING 27-29
10. TABLET COMPRESSION 30-34
11. PACKAGING 35-37
12. QUALITY CONTROL 38-42
13. MICROBIOLOGICAL SECTION 42-43
14. EQUIPMENT AVAILABLE AT
SITE
44-45
15. MY LEARNING AT COMPANY 46
16. CONCLUSION 47

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PROFILE OF ORGANISATION
Lords Research and life science laboratory private limited is the science and discovery-based company located
in Shendra MIDC area, in the Maharashtra state. It is well connected by road, rail and air to Mumbai.
Profile:
 Company name: M/S Lords Research & Life Science Laboratory Private Limited
 Status: Private Limited company
 Established date: Jun.2010
 Registration status: Registered with Registrar of the companies
 ROC Registration (DIN) No: U73100MH2010PTC203343
 Investment: 5 crores
 Annual sales: more than 10 lakhs.
 Financial targets: to be a multi crores company
 Number of employees: 07
 Partners – None
Lords Research and life science laboratory private limited is the science and discovery-based company,
working in Research, development, production, scientific education, training and skill developments of
Pharmaceutical, Nutraceutical, Biotechnology, genomics, phytochemical, herbal, tissue culture, Space,
Astronomy, and Medicinal plant sectors. People around the world trust the product and technology of company.
Looking at the trouble and difficulties faced by the academician and pharmaceutical manufacturer, loan licence
manufacturer and professional interested in manufacturing and marketing the product in market for getting the
overall information to related field. Our company has introduced supports to the pharma professionals’ services.
Company gives prime importance to safety, health. 300 Sq. meter area is built up area at site. Dense tree
plantation and gardens is the speciality of site.
Company has advanced technology production facility and well-equipped Chemical, Physical, tissue culture,
microbiology, genomics and herbal laboratory. Company has its own science and discovery museum, Space and
astronomy towers, telescopes, models, experimental instruments and books for reference. Company has its own
Botanical/Biodiversity/Medicinal/Herbal Garden and nursery. Company has highly qualified scientists and
skilled work force.

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 Address:
Registered office:
Plot No. 06, Opp BH—52, N-2,
CIDCO, Thakre Nagar,
Aurangabad (MS) India 431006.
Work / Factory:
Lords Research & Life Science Laboratory Private Limited
196, Behind Auric Building, Sector 4,
DMIC, Shendra MIDC, Ladgaon,
Aurangabad, (MS) India- 431001.
 Phone and fax numbers: 9890005771, 9552515071.
 Email- Contact@lordsgreen.com
 Website-
http://www.lordsgreen.com/
Organization structure:
Director
Manager/scientist
Supervisor/assistant
Working staff
Directors:
1) Ms. Smita D. Savant
2) Mr. Dattatrya A. Savant (PhD).

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ESTABLISHMENT: Established in the year June,2010.
Mission:
 To be amongst the top healthcarecompanies.
 To ensure betterqualityoflife for people by providing the
bestinhealthcare,Pharma andalliedproductsofhighest standards.
Vision:
 Emergeasaqualityproducer,visible,competitiveand committedmember
of global healthcare industry.
Ethics:
 At lord’s research and life science lab, we strive for excellence on ethical ground.
Our work principle are guided by regulatory norms and ethics. We adhere to set
policies, procedures and values.
 All officers, employees, contract workers, vendors orpeople associated with lord’s
research and life science are required to read, understand and abide by our code of
conduct. According to our company policy, we do not tolerate any illegal or unethical
practice or any other conducts which violate our principle.
 We believe in transparency in all our actions and business dealings.
 We are proactive in ensuring that our values are understood
and implemented correctly.
Values:
 We value “All our employees, customers, bankers, depositors
and suppliers” as our prime assets.
 We believe that Integrity, Honesty, Tolerance and
Patiencearethe fundamentalvirtuesinbusiness.
 We actively promote “Holistic Human Development” as part of
building intellectual capital in our organization.
 We are committed to building a culture of “Excellence” and “World class”
standards through benchmarking and continuous enhancement of our performance
standards.

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COMPANY PRODUCT
Following are the product futuristic to shape the future of human health.
1) Respiratory division
a) Adulsa cough syp.
b) Eucasa cough and cold syp.
c) Lordex dry cough syp.
2) Nutritional division
a) Spirulina tablets
b) Lorfolic tablet
c) Loravit multivitamin syp
3) Neurospinal division
a) Neurovita syrup and capsules
b) Lorcin 500 tablet
c) Lorfen tablet 200mg, 400mg
4) Gastro division
a) Gut clear tablet
b) Lorkid tablet
5) Skin and hair
a) Beutalor hair oil
b) Beutalor skin gel
c) Dermo clear cream
6) Child and mother care products
7) Antibiotics
a) Lorflox tablet 400mg
b) Lorthrocin 500mg tablet
Following support offered to colleges and Pharma Company
1) Loan license Manufacturing
2) Formulation development
3) Technology transfer
4) Analytical methods development
5) GMP audit
1. Loan license manufacturing
 Manufacturingoftablet,capsules,injections,liquid orals, ointment, powder on
loan license basis
 Manufacturing, Packaging and analytical procedures establishment.
Formulation and Packing development.
 FDA licensing processes.
 Allguidanceforstartingpharmaceutical manufacturing and
marketing.

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2. Formulation development
 Formulation development for tablet, capsule, injection, liquid orals, ointment and
dosage forms.
 Technology transfer of all dosage forms.
 Dossier preparation for regulatory registration.
3. Technology transfer
 Technology transfer of all dosage forms.
 Dossier preparation for regulatory registration.
 Process validation of all dosage forms.
4. Analytical methods development
 Analytical method development and validation for raw material, packing materials, in
process good and finished goods as per current regulatory requirements.
 Method development and method validation for physical,
 chemical, instruments and microbial analysis.
 Method verification for pharmacopeia and non-compendia methods.
5. GMP Audits
 Facilitysetup,modificationandpreparationfor regulatory audits suchas:
o State FDA
o CDSCO
o MHRA
o WHO GMP
o USFDA
o Other regulatory agencies.
o SOP and other documentation for GMP audits
o Training for audit preparation and audit facing.

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RAW MATERIAL STORE
A raw material also known as a feedstock or most correctly unprocessed material, is a basic material that is used
to produce goods, finished products, energy or intermediate materials which are feedstock for future finished
products. As feedstock, the term connotes these materials are bottleneck assets and are highly important with
regards to producing other products.
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, sapropterindi hydrochloride, lanreotide acetate, nicotinic acid,
etc. In contrast pharmaceutical excipients are the pharmaceutically inert substances which help in delivering the
active ingredients. anti- adherents, binders, coatings, disintegrants, fillers, etc.

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STEPS INVOLVE IN RAW MATERIAL STORE
 Receiving
 Sampling
 Storing
 Dispensing
RECEIVING
 Raw material is supplied by vendors by placing order
 After receiving the raw material check he "Observation on pack".
 Segregate the raw material according to batch number.
 Pre entry cleaning of raw material by vacuum cleaner.
 Weighing of the raw material.
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 —
 Ambient: Not more than 35 o
C
 Controlled temperature room: 15 — 25 0
C
 cold room: 2- 8 0
c
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.

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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 0
C + 2 0
C 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.

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TABLET MANUFACTURING
 The manufacture of oral solid dosage forms such as tablets is a complex multi-stage process under
which the starting materials change their physical characteristics a number of times before the final
dosage form is produced.
 Traditionally, tablets have been made by granulation, a process that imparts two primary requisites to
formulate: compatibility and fluidity. Both wet granulation and dry granulation (slugging and roll
compaction) are used. Regardless of whether tablets are made by direct compression or granulation,
the first step, milling and mixing, is the same; subsequent steps differ.
 Numerous unit processes are involved in making tablets, including particle size reduction and sizing,
blending, granulation, drying, compaction, and (frequently) coating. Various factors associated with
these processes can seriously affect content uniformity, bioavailability, or stability.
 Tableting is a method of pressing medicine or candy into tablets. Confectionery manufacture shares
many similarities with pharmaceutical production.
 A powder or granule mixture is prepared, a dye Mold is filled, and then the mixture is compressed and
ejected. While drug tablets are constrained to shapes and sizes that can be swallowed easily, candy tablets
are designed to be chewable and can take a wider variety of shapes and sizes.

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SIZING
- Sizing (size reduction, milling, crushing, grinding, pulverization) is an important step in the process of
tablet manufacturing.
In manufacturing of compressed tablets, the mixing or blending of several solid pharmaceutical
ingredients is easier and more uniform if the ingredients are about the same size. This provides a greater
uniformity of dose. A fine particle size is essential in the case of lubricant mixing with granules for its
proper function.
Advantages of smaller tablets are as follows:
• Increased surface area, which may enhance an active ingredient's dissolution rate and hence
bioavailability
• Improved tablet-to-tablet content uniformity due to a larger number of particles per unit weight
• Controlled particle size distribution of dry granulation or mix to promote better flow of mixture in
tablet machine
• Improved flow properties of raw materials
• Improved colour and/or active ingredient dispersion in tablet excipients
• Uniformly sized wet granulation to promote uniform drying
The following problems may arise if the process is not controlled properly:
• A possible change in polymorphic form of the active ingredient, rendering it less or totally inactive, or
unstable
• A decrease in bulk density of active compound and/or excipients, which may cause flow problem and
segregation in the mix
• An increase in surface area from size reduction may promote the adsorption of air, which may inhibit
wettability of the drug to the extent that it becomes the limiting factor in dissolution rate
Various types of machines may be used for the dry sizing or milling process, depending on whether gentle
screening or particle milling is needed. The range of equipment employed for this process includes:
• Fluid energy mill
• Colloidal mill
• Ball mill
• Hammer mill
• Cutting mill
• Roller mill
• Conical mill

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Fluid Energy Mill - Principle, Working:
A fluid energy mill is also known as a pulveriser, micronized, or jet mill. It is used for fine grinding and close
particle size control. The reduction of the particles takes place by the attrition and impact mechanism by the air
or inert gas introduced through the nozzles present in the chamber. This mill is mainly used to grind heat-
sensitive materials to the fine powder.
Principle of Fluid Energy Mill:
It operates on the principle of impact and attrition. The inlet and outlets are attached with the classifier which
prevents the particles to pass until they become sufficiently fine, Fig.1(a). It helps in the determination of
particle size and shape. The speed of air/inert gas is directly related to efficiency. Solids introduced into the
stream through the inlet result in a high degree of turbulence, impact, and attritional forces occurring between
the particles. This erratic motion between the feed and air results in the breakdown of particles. This mill
involves no heat generation and is hence used to grind heat-sensitive material.
Working of Fluid Energy Mill
The feed introduced into the fluid energy mill is pre-treated to reduce the particles size to the order of 100
meshes. This enables the process to yield a product as small as 5 micrometre’s or less. Despite this, mills
capable of output up to 40 kg/h are also available. Air or inert gas is injected as a high-pressure jet through
nozzles at the bottom of the loop.
The powder particles in the mill are accelerated to high velocity by gas pressure. The kinetic energy of the air
and the resulting turbulence due to high pressure causes inter-particle collision and attrition due to particle-wall
contact resulting in particle size reduction up to 5 µm. Size reduction in this mill also depends on the energy
supplied by compressed air that enters the grinding chamber at high speed. The fluidized effect carries particles
to a classifier zone where the larger particles are retained until they become sufficiently fine. Fine particles are
collected through a classifier.

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BALL Mill- principle, working
The ball mill’s basic concept dates back to prehistoric times when it was used to grind flint for pottery. A
pharmaceutical ball mill is a type of grinder that is used to grind and combine materials in the production of
different dosage forms. Impact reduces the size of the balls as they fall from near the top of the shell. Ball mills
are commonly used in single stage fine grinding, regrinding, and as the second stage in two-stage grinding
circuits. Ball mills are available in both wet and dry designs, depending on the application. Ball mills have been
constructed with standard final product diameters ranging from 0.074 mm to 0.4 mm in diameter.
Principle of Ball Mill
The size reduction in the ball mill is a result of fragmentation mechanisms (impact and attrition) as the balls
drop from near the top of the shell. Mixing of feed is achieved by the high energy impact of balls. The energy
levels of balls are as high as 12 times the gravitational acceleration. The rotation of the base plate provides the
centrifugal force to the grinding balls and the independent rotation of the shell to make the balls hit the inner
wall of the shell. Since the shell is rotating in alternate (one forward cycle and one reverse cycle) directions, a
considerable amount of grinding takes place in addition to homogenous mixing. The operating principle of the
ball mill consists of the following steps: In a continuously operating ball mill, the feed material is fed through
the central hole into the drum (shell) and moves there along with the grinding media (balls)

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Working of Ball Mill:
Several types of ball mills exist. They differ to an extent in their operating principle. They also differ in their
maximum capacity of the milling shell, ranging from 0.010 litres for planetary ball mill, mixer mill, or
vibration ball mill to several 100 litres for horizontal rolling ball mills. The steps involved in the working
process of ball mill are as follows:
i. Initial stage: The powder particles are get flattened by the collision of the balls. It leads it changes in
the shapes of individual particles or clusters of particles being impacted repeatedly by the milling balls
with high kinetic energy.
ii. Intermediate stage: Significant changes occur in comparison with those in the initial stage.
iii. Final stage: Reduction in particle size takes place. The microstructure of the particle also appears to
be more homogenous on a microscopic scale than those at the initial and intermediate stages.
iv. Completion stage: The powder particles possess an extremely deformed metastable structure.
USES
i. Small capacity ball mills are used for the final grinding of drugs or for grinding suspensions.
ii. The high-capacity ball mills are used for milling ores prior to the manufacture of pharmaceutical
chemicals.
iii. Ball mills are an efficient tool for grinding many brittle and sticky materials into fine powder.
The hard and abrasive as well as wet and dry materials can be ground in the ball mills for
pharmaceutical purposes.
iv. Powders for ophthalmic and parenteral products can be reduced in size.
v. Ball mill is used for the milling of pigments and insecticides for industrial purposes.
vi. Ball mills are also used in the manufacture of black powder.
vii. Blending of explosives is an example of an application for rubber balls.
viii. For systems with multiple components, ball milling has been shown to be

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POWDER BLENDING
The successful mixing of powder is more difficult than mixing liquid, as perfect homogeneity is difficult
to achieve. Another problem is the inherent cohesiveness and resistance to movement between the
individual particles. The process is further complicated in many systems by the presence of substantial
segregation influencing the powder mix. This arises from the difference in size, shape, and density of the
component particles. The powder/granules may be blended at the pre-granulation and/or post-granulation
stage of tablet manufacturing. Each process of mixing has an optimum mixing time, and longer mixing
may result in an undesired product. The optimum mixing time and speed must be evaluated. Blending
prior to compression is normally achieved in a simple tumble blender. This be a fixed blender into which
the powders are charged, blended and discharged. It is now common to use a bin blender from which the
container (bin) can be removed and brought directly to other processing steps. In special cases of mixing a
lubricant, overmixing should be particularly monitored. The various blenders used include the "V"
blender, oblicone blender, container blender, tumbling blender, and agitated powder blender.
Nowadays, to optimize the manufacturing process, particularly in wet granulation, various improved
pieces of equipment which combines several processing steps (mixing, granulation and/or drying) are
used. These are the mixer granulator and high shear mixing machine.
Types of Blenders and its Working: -
Many types of Blenders are used for mixing granules of different1 drugs. That’s why the selection of the
design of the blender plays a very important role in every pharmaceutical industry. A blender is used to
achieve a uniform blending of dried powder/ Granules. there are many types of blenders in
pharmaceutical plant. Here we are discussing the technical blenders: -

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In pharmaceutical manufacturing, blenders are a crucial unit function because it’s necessary for the
uniform distribution of a drug’s ingredients .it is obvious that the amount of active pharmaceutical
ingredients (API) in the finished solid dosage form is crucial.
The blenders work on the principle of moving or revolving the different types of shaped vessels at a
specific RPM of 2RPM to 20RPM with the help of the electrical motor and gearbox with a supporting
piler that holds the revolving vessels. This process is called the blending process of the bulk drug.
Generally blending step of bulk drug start after the drying of the bulk drug batch. After blending the batch
was directly shifted to the compression machine for the generating tablets.
TYPES OF BLENDERS: -
1. V-type Blender: -Design of this blender is V -shaped and this is used for mixing or helping
to achieve the uniform mixing of granules of drug.
2. Mass Blender: - when a product is a lumpy mass, wet or dry granules then we generally,
select this mass – type blender.
3. Octagonal Blender: - It has an octagonal shaped body and is used for drug granule mixing.
4. Vertical Blender: - vertical type blender selected in case of mixing of solid-drugs, powder,
and granules it gently lifts the material upward direction and blends the same.
5. Double cone Blender: - this is selected in case of dry powder with heavy and abrasive material.
6. Conta Blender: - for mass beachies.
CRITICAL PARAMETER: -
1. product recipe
2. RPM
3. Time
4. Utility controls
5. Alarm set points
6. S. Tubular Railing at entrance point with gate.
7. The gate is interlocked with the drive, through a proximity switch.
8. All rotating parts are covered by S.S Guards.
9. 0∘
stopping the electromechanical brake

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Granulation
The granulation process is "any process whereby small particles are gathered into larger, permanent
masses in which the original particles can still be identified." This definition is of course particularly
appropriate to a pharmaceutical granulation where the rapid breakdown of agglomerates is important to
maximize the available surface area and aid in solution of the active drug. The granulation process of size
enlargement used within the pharmaceutical industry has its roots in ancient times. The practice of
delivering medicinal powder by hand rolling into a pill by using honey or sugar has been used for
centuries.
It is still the practice to deliver the botanical and herbal extract in homoeopathic and Ayurveda branches of
medicine, which are still practiced in India along with allopathic medicine. The term "granulated" material
is derived from the Latin word”," meaning grained. The granular material can be obtained by direct size
enlargement of primary particles, or size reduction from dry compacted material in modern times,
granulation technology has been widely used by a wide range of industries, such as coal mining, and
agrochemical These industries employ agglomeration techniques to reduce dust, provide a case of
handling, and enhance the material's ultimate utility.
The development of pharmaceutical granulation was driven by the invention of the tablet press by W.
Brocked on in 1843. Subsequent improvements in the tablet machinery were patented in the United States
by J. A. Mc. Ferran (1874), T. J. Young 1874), and J. Dunton (1876). The demands on the granulation
properties were further enhanced in the 1970s as high-speed tablet and capsule filling machines with
automated controls were introduced. The continuous refinements in the regulatory requirements such as
low-dose products requiring blend uniformity/content uniformity necessitated knowledge and technology
to produce the required granule characteristics.
The high-speed compression and capsule filling machines require a uniform flow of material to the dies or
filling stations that produce pharmaceutical dosage form.
Granulation is an example of particle design. The desired attributes of the granule are controlled by a
combination of the formulation and the process.
Granulation methods can be divided into two major types: wet methods which utilize some form of liquid
to bind the primary particles, and dry methods which do not utilize any liquid
1-Receive the raw material as BMR from Raw material store
2-Shiting of raw material (API & EPI) in sifter

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DRYING: -
Drying is an important step in the formulation and development of a pharmaceutical product. It is
important to keep the residual moisture low enough to prevent product deterioration and ensure free
flowing properties. The commonly used dryers include the fluidized-bed dryer, vacuum tray dryer,
microwave dryer, spray dryer, freeze dryer, turbo-tray dryer, and pan dryer.
Drying is the process of removing the presence of solvents (i.e., water or other liquids) in a formulation
with the presence of heat. The final product of this unit operation is a dry solid mass or powders. This
process is widely used in the pharmaceutical field, from research and development phase until
large-scale manufacture.
It is important to have a good understanding of this process’ impact on the quality attributes of the active
pharmaceutical ingredient (API) in order to guarantee it will not have any adverse impact on the drug’s
safety and efficiency, thus, providing high quality final products.
All drying processes of relevance to pharmaceutical manufacturing involve evaporation or sublimation of
the liquid phase and the removal of the subsequent vapor.
Drying of Wet Solids:
Convective Drying of Wet Solids: This method utilizes dynamic convective dryers (e.g., Fluidized-bed
dryer) to obtain good contact between the warm drying air and wet particles in the fluidized-bed dryer.
The fluidized-bed dryer was developed for the process of fluidization to improve the efficiency of heat
transfer and vapor removal, as compared with the older static tray dryers. This fluidized bed dryer also
allows the efficient transfer of the latent heat of evaporation from the air and into the drying solid.
Advantages of fluidized-bed drying:
o Shortens drying time via the efficient heat and mass transfer, allowing high product output with
small footprint.
o Minimizes heat challenge to thermolabile materials
o The turbulence in a fluidized bed causes some gnaws the surface of the granule, thus, producing a
more spherical free-flowing product.

28
APPLICATION
In the manufacturing of pharmaceuticals, the last stage of processing is drying, which is carried out for one or
more of the following applications:
1) Drying is used to remove excess moisture or other volatiles from coatings and various substrates.
2) It is used to reduce and control moisture levels in solid materials in the manufacture of many materials.
3) It is most important in the processing of highly thermolabile products which are not stable in liquid form.
The lyophilization enables longer shelf life of thermolabile materials and make them suitable for storage
and transport of the product. For example, drying of biological products such as blood plasma, vaccines,
enzymes,
microbiological cultures, hormones and antibiotics
4) Drying is used to make the material easy or more suitable for handling and processing. In the
manufacturing of bulk drugs or for large-scale production of synthetic drugs, drying is essential to get free-
flowing materials. For example, dried aluminium hydroxide, spray-dried lactose, etc.
5) It has applications in avoiding or eliminating moisture that initiates corrosion and decreases the product or
drug stability. For example, to avoid deterioration or contamination of crude drugs of animal and vegetable
origin, synthetic and semi-synthetic drugs.
6) It is used to maintain and improve good properties such as flowability, compressibility etc. of a
material. For example, drying fresh plants such as belladonna leaves, nux vomica before subjecting
them to size reduction.
7) It is used in the production of tablets and granules to improve tablet properties
especially, compression of viscous and sticky material
8) Drying is used to improve solubility of materials by modifying their physical form. For example, milk and
coffee extract is dried to convert them into instant soluble power form.
9) Drying is necessary to make material light in weight that help to reduce the cost of transportation of large
volume materials (liquids).
10) Drying is used as the final step in evaporation, filtration, and crystallization and to preserve materials from
environmental factors.
11) Drying is used to maintain and improve shelf life of thermolabile and hydrolytic substances for longer
period of time. It is necessary to avoid deterioration of blood products, skin and tissue that undergo
microbial decomposition.
12) Drying significantly decreases rate of chemical reactions as well as chances of microbial attack or
enzymatic actions and thus improves stability.

29
MECHANISM OF DRYING PROCESS
The process of drying does not mean only removal of the moisture but the physical structure and the appearance
of material has to be preserved. Drying is governed by the principles of heat and mass transfer. When a moist
solid is heated to an appropriate temperature, moisture vaporizes at or near the solid surface. The heat required
for evaporating moisture from the drying product is supplied by hot air or a gas. Drying involves diffusion in
which the transfer of moisture to the surrounding medium takes place by the evaporation from the surface. As
some of the moisture from the surface vaporizes more moisture is transported from bulk of the solid to its
surface. This movement by diffusion of moisture in a solid takes place by a various mechanisms depending
upon the nature and type of the solid and its state of aggregation. Wide variety of solids are handled for drying
such as crystalline, granular, beads, powders, sheets, slabs, filter-cakes etc. The mechanism involved in moisture
transport in those solids is classified as:
(i) Transport by liquid or vapours diffusion.
(ii) Capillary action, and
(iii) Pressure-induced transport
A specific mechanism that involves in drying a specific solid depends on its nature, pore structure and the rate
of drying. More than one mechanism may come into play and dominate at different stages of drying of the same
material.
There are various common terms used in designing of drying systems. Moisture content of a substance which
exerts as equilibrium vapours pressure less than of the pure liquid at the same temperature is referred to as
bound moisture. Moisture content of the solid which exerts an equilibrium vapour pressure equal to that of pure
liquid at the given temperature is the unbound moisture.

30
Tablet compression
After the preparation of granules (in wet granulation) or sized slugs (in dry granulation) or mixing of
ingredients (in direct compression), they are compressed to get the final product. The compression is done
either by a single-punch machine (stamping press) or by a multi-station machine (rotary press). The tablet
press is a high-speed mechanical device. It squeezes the ingredients into the required tablet shape with
extreme precision. It can make the tablet in many shapes, although they are usually round or oval. Also, it
can press the name of the manufacturer or the product into the top of the tablet.
 Stage 1: Top punch is withdrawn from the die by the upper cam. Bottom punch is low in the die
so powder falls in through the hole and fills the die.
 Stage 2: Bottom punch moves up to adjust the powder weight. It raises and expels some powder.
 Stage 3: Top punch is driven into the die by upper cam. Bottom punch is raised by lower cam.
Both punch heads pass between heavy rollers to compress the powder.
 Stage 4: Top punch is withdrawn by the upper cam. Lower punch is pushed up and expels the
tablet, which is removed from the die surface by surface plate.
 Stage 5: Return to stage 1.
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

31
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-
Tablet testing
The physical properties of a tablet are tested either by manual or automated sampling and IPC testing (in-
process control). Tablet "hardness", also called "breaking force", is tested to assure that the tablet's
strength will survive all further processes, such as dedusting, coating and packaging. The hardness value
of a tablet gives an early indication of the tablet's disintegration time. Further measured parameters are
weight, thickness, diameter, disintegration time, friability, and abrasion.
Friability and abrasion testing is performed in rotating testing drums, designed according to the
pharmacopeia. The measured parameter is weight loss before and after testing and tumbling the tablets at
a particular time and speed. In the friability test drum tablets are being carried up by a "shovel" and
dropped. Tablets are also not allowed to fall apart during the test. In the abrasion test, drum tablets are not
falling/dropping, but rolling on the ground of the test drum and losing weight due to the friction between
tablets.

32
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
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 sub coating 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 lustre is produced.

33
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.
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 is 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.
Physical features of compressed tablets: -
Compressed tablets can be round, oblong, or unique in shape; thick or thin; large or small in diameter; flat
or convex; unscored or scored in halves, thirds, or quadrants; engraved or imprinted with an identifying
symbol and/or code number; coated or uncoated; coloured or uncoloured; one, two, or three layered.
Tablet diameters and shapes are determined by the dies and punches used in compression. The less
concave the punches, the flatter the tablets; conversely, the more concave the punches, the more convex
the resulting tablets. Punches with raised impressions produce recessed impressions on the tablets;
punches with recessed etchings produce tablets with raised impressions or monograms. Logos may be
placed on one or on both sides of a tablet, depending on the punches.

35
Packaging
Tablets must be packaged before they can be sent out for distribution. The type of packaging depends on
the formulation of the medicine.
Blister packs are a common form of packaging. They are safe and easy to use, and the user can see the
contents without opening the pack. Many pharmaceutical companies use a standard size of blister pack.
This saves the cost of different tools and changing the production machinery between products.
Sometimes the pack may be perforated so that individual tablets can be detached. This means that the
expiry date and the drug's name must be printed on each part of the package. The blister pack itself must
remain absolutely flat as it travels through the packaging processes, especially when it is inserted into a
carton. Extra ribs are added to the blister pack to improve its stiffness.
Pharmaceutical packaging plays a number of important roles when shipping sensitive and tightly
regulated products. Not only must it protect the contents from physical damage, but should ensure zero
alteration is made to the chemical composition. Which is often achieved through primary, secondary and
tertiary packaging. With a wide range of pharmaceutical products available on the market, both standard
and bespoke packaging can be manufactured to meet product demands. From temperature-controlled
solutions, to tamper evident tape and customs labelling, even the most delicate medicines can be shipped
safely.
Here, we explore types of pharmaceutical packaging and the benefits they have for your products.
Primary, secondary and tertiary packaging
When breaking down the types of pharmaceutical packaging available, this can be done through primary,
secondary and tertiary packaging. We can then dive into these types further and explore the products used
within.
Primary pharmaceutical packaging: Whether it be a drug, medicine, or other formulation,
primary pharmaceutical packaging is used in direct contact with the product to protect its chemical
composition.
Let’s take a look at some examples:
• Vials – A glass or plastic container used to contain liquid, solid or a powder dosage form.
• Ampoules – Similar to vials, ampoules are smaller glass containers (sometimes plastic) used for
packaging liquids.
• Blister packaging – A thermoformed plastic with cavities for tablets or capsules, sealed on the
open side with plastic or aluminium foil.
• Strip package – Formed around the tablet or capsule, each content is protected individually for an
increased shelf life. An alternative form of blister packaging.
The type of primary packaging used all depends on the form and chemical composition of your product.
Capsules and tablets are often secured in blister and strip packages, while liquids are usually placed in
vials or ampoules.

36
Secondary pharmaceutical packaging: The main purpose of secondary packaging is for brand
awareness as well the display and handling of products. As an example, secondary packaging would be
the branded boxes used to display products in supermarkets.
Secondary packaging also plays a vital role in the distribution and protection of pharmaceuticals. Think of
it in this way, secondary packaging is used to protect the primary packaging, which is protecting the
product. A glass vial wouldn’t last long if packed directly into a shipping case, would it?
Secondary packaging is typically found in the form of bespoke cartons. Not only are they easily
customizable, helping with brand awareness, but offer good protection and can be recyclable too.
The benefits of secondary packaging
When tackled properly, secondary pharmaceutical packaging can have major benefits on your business,
these include:
• Building your brand
• Increasing sales
• Simplifying your shipping process
• Reducing damaged
Tertiary pharmaceutical packaging: Tertiary packaging comes into play with the need for
transportation. It’s designed to absorb any physical impacts, as well as any moisture and dust problems
along the way.
Put simply, tertiary solutions are used to protect both the product and packaging that sits beneath it during
transportation. This may include:
• Cardboard boxes
• Shrink film
• Stretch wrap
• Wooden and plastic pallets
The benefits of tertiary packaging
An optimized tertiary packaging solution should look to combine products as tightly and compact as
possible, while using minimal materials and without causing strain or damage to products. This helps to:
• Increase pallet stability
• Decrease CO2 emissions
• Lower transport costs
• Save on material waste
• Protect the product

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Blister packaging Vials packaging Sachet packaging
Bottle Packaging Ampoules Packaging

38
Quality control
It 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.
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
1) Reference standard or primary standard
2) 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 tests are performed for different material. The types of tests performed for each material are as
follows
1. Size and Shape test
2. Colour 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

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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.
2. Organoleptic Property Colour of product must be uniform. Non-uniformity of colour on the tablet is
called Mottling.
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 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.
Hardness for compressed tablet is 5 to 8 kg.
Pfizer tester

40
4. Friability
Monsanto tester
 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 loses less than 0.5 to 1.0 % of the Tablet weigh
are consider acceptable.
5. Weight Variation test (U.S.P.)
 Take 20 tablets and weighed individually.
 Calculate average weight and compare the individual tablet weight to the average.
 The tablet passes the U.S.P. test if no more than 2 tablets are outside the percentage limit and if no tablet
differs by more than 2 times the percentage limit.
6. 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 labelled drug content and the 10th
tablet may not contain less than 75% and more than 125% of the
labelled content.
 If these conditions are not met, remaining 20 tablets assayed individually and none may fall outside of
the 85 to 115% range.

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7. 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
screens at the bottom end.
 To test for disintegration time, one tablet is placed in each tube and the basket rack is positioned in a I-L
beaker of water, simulated gastric fluid or simulated intestinal fluid at 37 ± 2 0
C such that the tablet
remains
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.
 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
8. 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 o
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.
9. HPLC
 Most widely used separation technique
 Broad applicability organic & inorganic
 Can be very sensitive, accurate & precise
 Suitable for separation of non-volatile species

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10. Chromatography
It 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 gm 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 um 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. FT-infrared (IR) Spectroscopy
It uses a beam of infrared light to analyse the structure of organic compounds. Whereas NMR analyses the
atoms present, IR instead analyses 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-midand far-infrared, named for their relation to the visible spectrum. The far-infrared,
approximately lying adjacent to the microwave region, has low energy and may be used for rotational
spectroscopy. The mid- infrared, approximately may be used to study the fundamental vibrations and associated
rotational vibrational structure. The higher energy near-IR, approximately can excite over tone or harmonic
vibrations. The names and classifications of these sub-regions are merely conventions. They are neither strict
division nor based on exact molecular or electromagnetic properties.
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.

43
Following processes are carried out in microbiology laboratory: Sterility Testing
1) Antimicrobial Efficacy Testing (AFT)
2) Microbial Limits Testing
3) Bioburden Determination
4) Endotoxin (LAL) Testing
5) Environmental Monitoring and Identification Water Analysis
Microbiological Testing of Non-sterile Products
For a variety of reasons, we have seen a number of problems associated with microbiological contamination of
topical drug products, nasal solutions and inhalation products.
The USP Microbiological Attributes Chapter provides little specific guidance other than "The significance of
microorganisms in non-sterile pharmaceutical products should be evaluated in terms of the use of the product,
the nature of the product and the potential hazard to the user." The USP recommends that certain categories be
routinely tested for total counts and specified indicator microbial contaminants. For example, natural plants,
animals and some mineral products for Salmonella, oral liquids for E. coli, topical for Aeruginosa and S. aureus
and articles intended for rectal, urethral or vaginal administration for yeasts and Molds. A number of specific
monographs also include definitive microbial limits.
Microbiological testing may include an identification of colonies found during the Total Aerobic Plate Count
test. Again, the identification should not merely be limited to the USP indicator organisms.
The importance of identifying all isolates from either or both Total Plate Count testing and enrichment testing
will depend upon the product and its intended use.
Obviously, if an oral solid dosage form such as a tablet is tested, it may be acceptable to identify isolates when
testing shows high levels. However, for other products such as topical, inhalants or nasal solutions where there
is a major concern for microbiological contamination, isolates from plate counts as well as enrichment testing
should be identified.
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.

44
Following are the equipment available at site for work, production anddevelopments.
Production: Tablet, capsule, liquid orals, ointments, cream, paste, powder, cosmetics, injections,
suppositories, andherbal.
Sr.No. Code Name of Machine
1 LP-101 Sieve sifter
2 LP-102 Liquid/injection mfg. tank
3 LP-103 Stirrer
4 LP-104 Ampoule washing
5 LP-105 Ampoulefillingsealingdevice
6 LP-106 Ampoule clarity inspection cabinet
7 LP-107 Liquid filling machine
8 LP-108 Vial sealing machine
9 LP-109 Bottle cap sealing machine
10 LP-110 Planetary mixer
11 LP-111 Double cone blender
12 LP-112 Tablet compression machine
13 LP-113 Tablet counter
14 LP-114 Tablet coating pan
15 LP-115 Tablet polishing pan
16 LP-116 Capsule filling machine
17 LP-117 Capsule tube filling machine
18 LP-118 Collapsible tube filling machine
19 LP-119 Collapsible tube sealing machine
20 LP-120 Lip stick mould
21 LP-121 Suppository mould
22 LP-122 Industrial percolator
23 LP-123 Soxhlet extractor
24 LP-124 Distillation unit
25 LP-125 Pulverisor

45
Laboratory:
Quality control, Research and Development
Physico-chemical, microbiological, biotechnology, genetics, phytochemical
and tissue culture.
Sr.No. Code Name ofMachine
1 LC-501 Microscope
2 LC-502 Hot air oven
3 LC-503 Incubator
4 LC-504 Autoclave
5 LC-505 Laminar air flow unit
6 LC-506 Water still distilled water
7 LC-507 Antibiotic zone reader
8 LC-508 Colony counter pern
9 LC-509 Colony counter
10 LC-510 Melting point apparatus
11 LC-511 Digital pH meter
12 LC-512 Waterbath rectangular
13 LC-513 Heating mantle
14 LC-514 Magnetic stirrer
15 LC-515 Lab stirrer
16 LC-516 UV chromatography
cabinet
17 LC-517 TLC apparatus
18 LC-518 Bulk density apparatus
19 LC-519 Research polarimeter
20 LC-520 Abbe refractometer
21 LC-521 TDS/conductivity meter
22 LC-522 Hot plate
23 LC-523 Centrifuge
24 LC-524 Vacuum pump
25 LC-525 KFR auto titrator
26 LC-526 Tablet DT apparatus

MY LEARNING AT LORDS RESEARCH & LIFE SCIENCE LABORATORY PVT.
LTD.
The overall objective of industrial training is to involve student in practical studies which are ongoing
process prevailing in pharmaceutical industry. I had gone through my industrial training at LORDS
Research & Life Science Laboratory Pvt. Ltd. There I was employed at tablet production
department as a trainee where particularly production of different tablets taking place, I performed my
industrial training in the following procedure
 At very first day my industrial training, I observed that how raw material are kept and stored I
learned how each raw material that I used for formulating our dosage form must undergo various
quality checks at next day of my training, we received our quality report of our raw material that
taught me how a drug is assayed before manufacturing to get assure about quality and maintaining
the standards.
 At day three I carried out weighing of chemicals for the manufacturing and then we started the
procedure of manufacturing tablets. All raw materials were dispensed according to batch formula.
 Next day sizing or grinding of all raw materials was carried out to ensures the uniformity size of
the excipient and active pharmaceutical drugs using fluid energy mill.
 Then it is transferred to ‘v’ cone blender for successful mixing of excipients with APIs.
 tableting is carried out by dry granulation using a roll compaction machine by compacting primary
particles into larger granules and formation of slug takes place.
 Then proper residual moisture level is maintained using fluidized-bed dryer.
 Next, I preformed tableting process by using multi-station machine. It squeezed the ingredients
into the required tablet shape with extreme precision
 It is a continuous process until the required quantity of tablets are produced. I also preformed
quality assurance parameter to check the physical parameter of the tablets which are record in the
following pages
 Then after the production quality control department carried out various quality parameter and
issues the report of the quality levels
 Then after the report sugar coating of tablet is carried out in pan coating machine.
 After that dried tablets are processed for packaging mostly blister packs are used for packing
materials and the required information are also printed on it.
 Then our worthy chemist sir has taught us how sample was to be checked and finally the product
left for storage area.
 At last, I want to tell you that learned that industrial training has provide me a great knowledge and
how many efforts and knowledge are to be used to prepare a good and a safer pharmaceutical
product.

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 clarity 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 CCMP guidelines are to be strictly followed in the industries in each and every
section. And the similar guideline was seen followed in LORDS Research & Life Science
Laboratory Pvt. Ltd. Thakre Nagar, Aurangabad. It helped us to acquire knowledge on punctuality,
regularity and working environments in industries.
With experience, knowledge, and skills acquired during industrial training. I will be prepared to face
the challenging pharmaceutical market.
The friendly working environment in LORDS Research & Life Science Laboratory Pvt.
Ltd. Thakre Nagar, Aurangabad. Will remain in our mind in near future. Here we gained experience and
knowledge that will be definitely it for a suitable job without delay as soon as we complete our course.
We also learned soft skills appropriate to use in the work environment & also improvise cue
communication skills. We assessed career ability, knowledge, and confidence as well as enhanced our
marketability to be more competitive.
Hence, we can say that our goal of attending the industrial tour is fulfilled We acknowledge the great
help "
LORDS Research & Life Science Laboratory Pvt. Ltd.” Thakre Nagar, Aurangabad."

Industrial Training report- 3rd Year-B.Pharma- By- Dhanashree Giridhar Kolhekar.docx

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