The document summarizes Supriya Kumari's one month industrial training report at NAVKAR LIFESCIENCE Pvt. Ltd. It includes an overview of the company and its vision, sections within the pharmaceutical plant including tablet, capsule and oral liquid production, and quality control processes. Key areas covered are tablet manufacturing involving granulation, compression and coating, capsule filling, and quality control equipment used to test raw materials and finished products. The report provides insights into various unit operations and aims to fulfill the requirements for Supriya's B.Pharma degree.
1. INDUSTRIAL TRAINING REPORT
COMPLETED AT
NAVKAR LIFESCIENCE Pvt. Ltd.
Submitted in partial fulfillment of the requirement of the degree of
B.PHARMA in
Department of Pharmacy Dr. B.R. Ambedkar University, Agra-
282002
Submitted by: Submitted To:
KUMARI SUPRIYA Dr. JAYBIR SINGH
B. Pharma VII-SEM Assistant Professor
Roll No- 158287361009 Dept. Of Pharmacy
DBRAU, AGRA (U.P.)
2. Acknowledgement
First of all, I praise God, the almighty, merciful and passionate, for
providing me this opportunity granting me the capability to proceed
successfully.
There are no word to express the feeling of gratitude I have in my
heart for respected H.O.D. Prof. Brijesh kumar Tiwari sir and other
faculty of Dept. of Pharmacy, Dr.B.R. ambedkar University, Agra.
I am hearty thankful to the staff of NAVKAR LIFESCIENCE Pt.
Ltd. Production Manager Mr. Arvind Yadav, Mr. Manoj Kumar,
Mr. Pankaj Yadav And others , who helped and teached me about
all progress in the plant during complete session of one month .
I am also thankful to Mr. Kamlesh Mishra, Managing Director to
allow me to join his esteemed plant.
I am also thankful to ROHIT YADAV& TAPSYA PAL. We worked
as a team and guided me completing this work.
Last but not the least I would also like to thank all my friends for their
support.
KUMARI SUPRIYA
B.PHARMA VII-SEM
Roll No- 158287361009
3. DEPARTMENT OF PHARMACY
Dr. B.R. Ambedkar University, Agra (U.P.)
I.B.S. Khandari, Agra-282002
CERTIFICATE
This is to certify that the Industrial Report Submitted by
KUMARI SUPRIYA D/O Mr. BRIJ LAL (B.Pharm VII-
Sem.) is a record bonafide work carried out be his in this
department in the partial Pharmacy of Department of Pharmacy,
I.B.S. Khandari, Dr. B.R Ambedkar University, Agra, in the
session 2015-2019.
Prof. Brijesh kumar Tiwari
Head of Department
4. About Company
The company currently occupies a good reputation due to its
passion and commitment in the field of Pharma manufacturing,
marketing in domestic market as well as exports wise in
National market.
NAVKAR Lifescience is an ISO 9001-2000+ HACCP, WHO
Compliance, GMP Certified Company, with its state of art
manufacturing plant located at Baddi, Himanchal Pradesh the famous
holy city in India.
Navkar lifescience is equipped with ultra-modern manufacturing
facilities, certified as per the latest C-GMP norms and complies with
the latest schedule âMâ.
The unit is managed by experienced, technical competent Staff for
Quality Control along with a team of expert technicians and more
over with expert Quality Assurance team to insure that systems and
processes remain in compliance with latest standards.
Vision:-
Our vision is to be a leading pharmaceutical company with a global
presence. Focusing in innovating the best in class therapeutics that
should be economically viable to patients.
Mission:-
Navkar lifescienceâs mission is to become a leader in research &
development of novel drugs and delivery systems.
Navkar is focused to improve the lives of patients by developing
innovative medicines that address unmet and inadequate medical
needs.
5. Values:-
We aim to deliver the "Best Quality Each Time, Every Time."
We give "Honesty And Transparency" as the highest regards.
We believe in "Inspiring People To Work" not command them.
Our core values propel us to Improve Quality of lives
by "Innovations."
âWe value our customer & aim throughout for "Customer
Satisfaction.
Directorâs Desk:-
We believe that access to quality health care is a right not privilege.
Our endeavor is to ensure the availability of world-class products at
affordable price. Standing with our commitments to provide better
and still better services, we are committed to provide quality
medicines to Medical fraternity and exceed their expectations.
Brand Of Navkar Lifescience
S.N Brand Name Salt Name
1. Inbact 4.5 gm Piperacillin&Tazobactum
2. Hepato-Well Syrup Hepatoprotective
3. Valcit Calcitonin(Nosal Solution)
4. Santok-4G Omega-3 Capsule
5. HG-zyme Pepsine Syrup
6. Content
1. Dosage form.
īˇ Solid Dosage( Tablet, Capsule &Powder)
īˇ Semi Solid Dosage(Cream,Ointment,Paste)
īˇ Liquid Dosage (Parentral,Syrup & suspension)
īˇ Gas (Aresol & Inhelor)
2. Classification of Dosage form.
3. Section & Subsection in Plant.
4. Tablet section.
īˇ Introduction.
īˇ Manufacturing Process.
īˇ Process Problem.
īˇ Tablet Granulation.
īˇ Other ingredient.
īˇ Coating pan.
īˇ Flow chart for Tablet Production.
īˇ Equipment Used in Tablet Production.
5. Capsule section.
īˇ Introduction.
īˇ Manufacturing process.
īˇ General excipients.
īˇ Flow chart for capsule Production.
īˇ Equipment for Capsule.
6. Quality control & Quality Assurance.
īˇ Introduction.
īˇ Equipment used in Quality control.
7. Storage Facility.
8.Raw Material Store.
7. Dosage form
Dosage forms (also called unit doses) are pharmaceutical
drug products in the form in which they are marketed for use, with a
specific mixture of active ingredients and inactive components
(excipients), in a particular configuration (such as a capsule shell, for
example), and apportioned into a particular dose. For example, two
products may both be amoxicillin, but one is in 500 mg capsules and
another is in 250 mg chewable tablets. The term unit dose can also
sometimes encompass non-reusable packaging as well (especially
when each drug product is individually packaged), although the FDA
distinguishes that by unit-dose "packaging" or
"dispensing". Depending on the context, multi(ple) unit dose can
refer to distinct drug products packaged together, or to a single drug
product containing multiple drugs and/or doses.
8.
9. SECTIONS AND SUBSECTIONS:
In Plant
1. Raw Materials Store.
2. Granulation Section.
a. Mass Mixer.
b. Fluid Bed Dryer.
c. Multi Mill.
d. Sifter.
e. Octagonal Blender.
3. Tablet Section.
a. Compression.
b. Coating and Polishing.
c. Final Inspection.
4. Capsule Section.
a. Filling Machine. (hand operated)
b. Polishing and Inspection.
5. Packing Section.
a. Strip Packaging Machine.
b. Blister Packaging Machine.
6. Oral Liquid Section.
a. Liquid Processing.
I. Stirrer.
II. Filter Press.
b. Bottle Washing and Drying.
c. Filling, Sealing and Packing.
d. Checking Section.
e. Labelling Section.
12. TABLET SECTION
īļ Raw Material Mixing
īļ Milling
īļ Granulation
īļ Additives Mixing
īļ Compression
īļ Tablet Coating
īļ Packing
INTRODUCTION
Section (1)-OPERATIONS EMPLOYED IN TABLET
MANUFACTURING:
1. Mixing: -A process that tends to result in randomization of
dissimilar particle with in a system.
Mixing Mechanisms of Solid Mixing:-
I. Convective mixing
II. Shear mixing
III. Diffusive mixing
2. Milling:- Milling is mechanical process. of reducing the particle
size of solids.
Type of Mills
13. S.N Type Action Used for Material
1 Cutter cutting Fibrous,Crude animal&
vegetable
2 Hammer Impact Acetanilide,Ascorbic acid.
3 Roller Pressure Antibiotics,Boric acid, etc
4 Fluid energy Attrition and
impact Sodium acid
phosphate,Sodium
benzoate,urea,vitmins etc.
3. Drying: -The removal of liquid from a surface in to an
unsaturated vapour phase.
Purpose: It is most commonly used in Pharmaceutical
Manufacturing as a Unit process in preparation of granules
which can be dispensed in bulk or converted into Tablets or
Capsule.
Fluidized bed dryers:- These are of two types:
1. Vertical
2. Horizontal
a. A fan mounted in upper part of apparatus induces the fluidizing air
stream.
b. The air is heated to the required temperature in air heater and own
upwards through the wet material, which is contained in drying
chamber fitted with mesh support at the bottom.
14. c. The unit described is batch-type dryer and the drying chamber is
removed from the unit to permit charging and dumping.
d. Dryer capacity ranges from 5kg to 200kg.
e. The average drying time is about 20 to 40min.
Section:- (2):- TABLETS
Tablets represent Unit dosage forms, in which one usual dose of the
drug has been accurately placed. Compressing a formulation
containing a drug or drug with excipient on stamping machines called
press, makes the tablets.
īˇ . The compression machines are designed with following basic
component: -
1) Hopper(s) for holding and feeding granulation to be
compressed.
2) Dies that define the size and shape of tablet.
3) Punches for compressing the granulation with in the dies .
4) Cam tracks for guiding the movement of punches.
5) A feeding mechanism for hopper into the dies.
Section (3): Processing problems
1 ) Capping: It is the partial or complete separation of top or ttom
crowns of Tablet from the main body of Tablet.
2 ) Lamination: -It is the separation of a Tablet in to two or more
distinct layers. Usually these processing problems are readily apparent
immediately after compression.
3) Picking & Sticking:- âPicking' is used to describe the surface
material from a Tablet that sticking to and being removed from the
Tablet's surface by a punch.
4) Mottling:-it is an unequal distribution of colour on a Tablet, with
light or dark areas standing out in an otherwise uniform surface.
15. Section (4): Tablet granulation
īˇ Basic characteristics: The characteristics of Tablet, that make it
a popular dosage from, are:
a) Compactness
b) Physical stability
c) Rapid production capability
d) Chemical stability
e) Efficacy
Manufacture of Granules; -
īˇ Dry Granulation method
īˇ Wet Granulation method
Section (5): Other ingredients
īļ Diluents: - Diluents are fillers designed to make up the required
bulk of the tablet when the drug dosage itself in inadequate to
produce this bulk
īļ Binders and adhesives:- These material are added either dry or
in liquid form, during wet granulation to form granules or to
promote cohesive compact for directly compressed Tablets.
E.g.-Acacia, Tragacanth. Gelatin starch paste etc.
īļ Disintegrants: A disintegrant is added to facilitate a break up or
disintegration of the Tablet. E.g-Microcrystalline cellulose
(MCC), Ac-Di-sol
(new material in cellulose class)/cross liked from of sodium
carboxymethyl cellulosel, Polyvinyl pyrrolidone.
Section: (6)
16. Advantages:-
īļ The Tablet is an essentially tamperproof dosage form.
īļ These are Unit Dosage form, and they offer the greatest forms
for the greatest dose precision and least content variability .
īļ They are the lightest and most compact of all Oral dosage form.
Disadvantages:
īļ Some drugs resist compression in to dense compacts, owing to
their amorphous nature or flocculent, low density character.
Section (7): Tablet Coating
Two common methods: -
1. Pan coating
2. Press coating
īļ The Coating process is the last critical step in tablet production
cycle.
īļ The type of process chosen depends on type of coating that is to
be applied.
Coating pan:
īļ The Standard Coating pan is circular metal pane mounted
angularly on a stand.
īļ Pan is 8 to 60 inches in dia and rotated on its horizontal axis by
a motor
īļ Coating solution is applied to the Tablets by ladling or spraying
the material on to the rotating Tablet bed.
17. FLOW CHART FOR TABLET PRODUCTION
RAW MATERIAL
SIFTINO BY SIFTER
MIXING BY OCTAGONAL BLENDER
MASS MINER (binding materials added)
FLUID BED DRYER
MULTI MILL
FLUID BED DRYER
24. CAPSULE SECTION
CAPSULE:-
īļ Capsules are the Solid Unit Dosage form, in which the Drug
substance is enclosed in a water soluble shell made from
Gelatin.
īļ Capsule form is used for the administration of drugs with
unpleasant odor and taste and in special conditions, to achieve
the desired mode of release of medicaments.
Demerits of Capsule form :
1. Hygroscopic Drugs cannot be administered in Capsule form, as
they turn brittle by absorbing water present in Gelatin shell.
2. Concentrated Preparations are not suitable to administer in the
Capsule form. Types of Capsule:
i. Hard Gelatin Capsule
ii. Soft Gelatin Capsule.
General Excipients used in filling of Capsules:
25. īļ Diluents: These are used to increase the bulk of medicaments.
The commonly used diluents are Lactose, Mannitol, Sorbitol,
Starch etc.
īļ Absorbents : Absorbents such as Oxides and Carbonates of
Magnesium and Calcium, and Kaolin are added to the
powdered drug in casc of medicaments resulting in Eutectic
mixtures.
īļ Lubricants: These are used to ensure smooth flow of powder
during filling Few examples of Lubricants are Talcum,
Magnesium stearate and Calcium stearate.
īļ Antidusting compounds: These are used to reduce the dust
resulting during the process of manufacturing, especially in
Case of Potent drug.
Flow chart for production of Capsules
Issued raw material (Tested)
Sifter (Sieving)
Octagonal Blender (Mixing)
Mass mixer (Proper mixing with additives)
Fluid bed dryer (Drying)
Multi mill (Size reduction)
Fluid bed dryer (Drying)
Granulator (Granulation)
Samples send to Q.C.
Filling machine (Capsule filling)
29. QUALITY CONTROL AND QUALITY ASSURANCE :-
Quality of any goods is the essence which characterizes its usefulness
and which distinguishes its image. The criticality of quality in case of
drug is almost significance since these are used essentially for the
mitigation of disease in human being and there for, it assumes
indispensable role in the service of humanity and the consumer in
general.
Quality Assurance :
It is the sum total of the organized arrangement made with the object
of ensuring that product witl be of quality required for its intend use.
Thus quality assurance is the most vital organization of many
pharmaceutical industries.
Equipments usc in quality control unit:
1.Polarimeter Used to mesure specific notation of optically
active substance.
2.Karl Fischer Used to determine moisture content.
3.pH meter Used to measure pH of the substance.
4.M.P. Apparatus Used to determine melting point of the
substance.
5.D.T. Apparatus Used to calculate the time required for
complete disintegration of a tablets.
30. 6.Friability test
Apparatus
Used to measured friability of a tablets.
7.Dissolution rate test Used to measure dissolution rate of
tablets/capsule.
8.Hardness tester Used to measure Hardness of the tablet.
9.Drying oven Used to drying purpose.
10.Electronic balance Used to Weighing of material.
11.Conductivity meter Used to measure conductivity of material.
12.Visible
spectrophotometer
Used to analyse the raw material and finished
product for % purity /Assay content.
13.Hot Plate Used for heating of element.
14.Laboratory
centrifuge
Used to sepration of solid from liquid.
31. Fig.12- Melting point Apparatus.
Fig.13-Friability Test Apparatus.
Tablet hardness testing:- is a laboratory technique used by
the pharmaceutical industry to test the breaking point and structural
integrity of a tablet "under conditions of storage, transportation, and
handling before usage" The breaking point of a tablet is based on its
shape. It is similar to friability testing, but they are not the same thing.
32. Tablet hardness testers first appeared in the 1930s. In the 1950s, the
Strong-Cobb tester was introduced. It was patented by Robert
Albrecht on July 21, 1953. and used an air pump. The tablet breaking
force was based on arbitrary units referred to as Strong-Cobbs. The
new one gave readings that were inconsistent to those given by the
older testers. Later, electro-mechanical testing machines were
introduced. They often include mechanisms like motor drives, and the
ability to send measurements to a computer or printer.
Fig.14- Hardness tester. (Monsento)-Tablets
33. Fig.15-hardness tester. (pfizer)-Tablets
Dissolution testing
In the pharmaceutical industry, drug dissolution testing is routinely
used to provide critical in vitro drug release information for
both quality control purposes, i.e., to assess batch-to-batch
consistency of solid oral dosage forms such as tablets, and drug
development, i.e., to predict in vivo drug release profiles.[1]
The main objective of developing and evaluating an IVIVC is to
establish the dissolution test as a surrogate for human studies, as
stated by the Food and Drug Administration (FDA). Analytical data
from drug dissolution testing are sufficient in many cases to
establish safety and efficacy of a drug product without in vivo tests,
following minor formulation and manufacturing changes (Qureshi and
Shabnam, 2001). Thus, the dissolution testing which is conducted in
dissolution apparatus must be able to
provide accurate and reproducible results.
34. Fig.16- Dissolution Test Apparatus.
An orally disintegrating tablet or orally dissolving tablet (ODT) is
a drug dosage form available for a limited range of over-the-
counter (OTC) and prescription medications. ODTs differ from
traditional tablets in that they are designed to be dissolved on the
tongue rather than swallowed whole. The ODT serves as an
alternative dosage form for patients who
experience dysphagia (difficulty in swallowing) or for where
compliance is a known issue and therefore an easier dosage form to
take ensures that medication is taken. Common among all age groups,
dysphagia is observed in about 35% of the general population.
Fig.17-Disintigration testing Apparatus.
37. STORAGE FACILITY
The following storage facilities are available with each factory
īˇ Row Material Store -Row material quarantine
-Approved raw material area
īˇ Finished Goods Store and approved Finished Goods Area.
īˇ Packing Material Store -Packing Material quarantine
approved packing material Area
Striking Features
īļ Efficient Store management and Inventory Control in
all the stores. The regularity and punctuality add to the
perfection.
īļ Record, are maintained in a regular and systematic
manner.
īļ Adequate space and space utilization is also observed.
Fig.22- Storage Area.
38. 1.RAW MATERIAL STORE
The prime function is to receive store and issue the raw
material utilized in production.
Raw material quarantine is for the store of raw material just received
from various outside sources This material is then checked by quality
control persons and is name / store when it complies with the
standard, it is named "Approvedâ and is displaced in approved raw
material area/store.
2.FINISHED GOODS STORE
The prime function is to store goods in their final container after
quality control chocking and sealing.
The sealed cartons after proper checking and transferred to approved
finished goods store from where it is dispatched to outside.
3-Packing Material Store :-
The chief function is to store the packing material to be used for the
unit and final packing of finished product. This is well illustrated by
the list of packing material in the packing material store.
Poly venylchloride Foil - Pilfer proof cap
Bottles - Aluminium foil
Label for Bottles
Every material after receipt is first recorded and then sent to
the quality control dept for further inspection and approval. The
quality control Incharge has to collect samples and report it back to
store Incharge, the approved material is then properly stored.
40. CONCLUSION
During the training at Navkar Lifescience Pvt. Ltd Baddi,
Himanchal Pradesh. I have know the various processes employing in
industry for the Production, Washing, Drying, Packing, Dispatch &
Laboratory. Of Navkar Lifescience Pvt. Ltd
The training has provided me intensive knowledge of various
manufacturing process & problem occurring during the production.
This training has also provided me the knowledge & details of various
quality control processes involved during the production of various
medicine of Navkar Lifescience.