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“ REPORT ON INDUSTRIAL VISIT ”
MANGALAYATAN UNIVERSITY
(DEPARTMENT OF PHARMACY)
(2018-2022)
SUBMITTED TO
PROF.(Dr.) DEV PRAKASH
{PRINCIPAL}
SUBMITTED BY
ANSHIKA MAHESHWARI
(20180310)
MANGALAYATAN UNIVERSITY
INSITITUTE OF BIOMEDICAL EDUCATION & RESEARCH
DEPARTMENT OF PHARMACY
ALIGARH, UTTAR PRADESH
DECLARATION
I here by declare that this project was “ REPORT ON INDUSTRIAL VISIT ” is a
bonafide and genuine work carried out by us under the supervision and guidance of
PROF. (Dr.) DEV PRAKASH principal at Mangalayatan University, Aligarh,Uttar
Pradesh. It is further certified that no part of this work has been submitted either inpart or
full for the award of any other degree/ diploma by me to this or any other university.
DATE: ANSHIKA MAHESHWARI
(20180310)
Place: Aligarh
CERTIFICATE OF SUPERVISOR
This is to certify that the report entitled “ REPORT ON INDUSTRIAL VISIT ” is submitted
by Anshika Maheshwari. It is a visit industry carried out by the candidate under my
supervision..
Date:
Place : Aligarh
CERTIFICATE
This is to certify that report entitled “INDUSTRIAL
VISIT ” have been submitted by ANSHIKA
MAHESHWARI to the Mangalayatan University.
Date: Principal/Director
Evaluation Certificate
This is to certify that this report has been evaluated.
Internal Examiner External Examiner
Signature
Name
Designation
Date
PREFACE
This report is prepared at Uttar Pradesh Evertouch Healthcare Pharmacy in
KOSI KOTWAN , MATHURA.
The Uttar Pradesh Evertouch Healthcare, is a Joint Enterprise of Center &
Uttar Pradesh government; producing pharmaceutical dosage products
and distributing it in Uttar Pradesh government hospital.
This report aims at identifying important inbound and outbound process
for product formulation and its problems. The report is based on
knowledge of topic relevant for the reports and discussions with the
inbound & outbound department in charges, and survey of the company.
The report is divided into five sections to simplify and distinguish the
topics from each others. During the report, I have concluded some
analysis which is mentioned after each sub topics.
COMPANY PROFILE
Evertouch healthcare was established organization Situated at Mathura, Uttar Pradesh,
India-281403which established in year 2011. It started its journey with a vision to make
world a better place as we understand that human health is very important and crucial. We
always make sure that we have the best resources required to prepare reliable, effective
medicines and quality medicine.
We engage in the research, development, manufacturing, sourcing, marketing, and
distribution of high-quality pharmaceutical products. We are a fully integrated company
with in-house business development, R&D, manufacturing and regulatory compliance
capabilities.
With the assistance of latest equipment’s, the automated and modern production process
has beenprepared. We offer a complete range of products with prompt and reliable
assistance for all our customers.
Consequently, our large-scale production capacities, highly qualified production, and
quality control staff, state of art WHO-GMP certified manufacturing facility combines to
give a perfect environment foroutsourcing or contract manufacturing pharmaceutical
products. This synergy allows us to provide thehighest quality products to our clients in a
timely manner that is extremely cost competitive.
Export Facilities: we have WHO-GMP certified plant with COPP of Cephalosporines
and Penicillin formulations.
Facilities
In our well-established premises, we have set up all advanced tools, equipment and
machines used for preparing the Pharmaceutical Medicines. All equipment is properly
labeled so that we can ensure qualitymanufacturing process. In addition, we keep our
premises hygienic ensuring zero contamination. We have Five units over their under
control of Evertouch Healthcare Group. Followings are the details of Plants.
Evertouch Healthcare (GMP Certified
Unit)
Plot No. J-82, UPSIDC Kosi Kotwan,
Mathura
Manufacturer of Oral Liquids (Syrup, Drops, Suspensions), External Preparations like
Hand Sanitizer ,Hand Wash and Capsules in (Drug)
Evertouch Bio-Remedies (WHO-GMP
Certified Unit)Plot No. I-1/5, UPSIDC Kosi
Kotwan Mathura
Manufacturer of Tablets, Capsules and Dry Syrups in Beta Lactum Only
(Drug)Evertouch Herbalcare (GMP-Certified Unit)
Plot No. K-30, UPSIDC Kosi Kotwan Mathura
Manufacturer of All ayurvedic (Herbal)
Preparations
Evertouch Lifecare
Plot No. J-85, UPSIDC Kosi Kotwan Mathura
Manufacturer of Syrup, Drops, Suspensions , and Sachets in (Under FSSAI License)
CONTENTS:-
1. Tablet section
Tablet
Ingredients used in tablet formulations
Granulation
Blending
Sieving
Dryer
Tablet punching
Tablet coating & type of coating
Some common problem in tabletting
Evertouch healthcare Product list (Tablet)
2. Capsule section
Capsule
Type of capsule
Additives
Manufacture ofheard gelatin capsule
Filling of heard gelatin capsule
Finishing
Evertouch healthcare product list (capsule & powder)
3. Syrup section
Syrup
Type of syrup
Additives
Filling
Labeling
Packaging
Evertouch healthcare product list
4. Quality control
Quality Assurance & Quality Control in Pharma Industry
Quality Control work (Summary
Quality control department
Chemical section
Instrumental section
Micro-biological section
5. Packing section
Packaging & it’s type
The purposes of packaging and package labels
Tablet
TABLET SECTION
A tablet is a mixture of active substances and excipients, usually in powder form, pressed or
compacted intoa solid. The excipients include binders, Glidants (flow aids) and lubricants to
ensure efficient tabletting, disintegrates to ensure that the tablet breaks up in the digestive tract;
sweeteners or flavors to mask the tasteof bad-tasting active ingredients; and pigments to make
uncoated tablets visually attractive. A coating may be applied to hide the taste of the tablet's
components, to make the tablet smoother and easier to swallow, and to make it more resistant to
the environment, extending its shelf life.
Advantage :
• Production aspect
ď‚· Large scale production at lowest cost
ď‚· Easiest and cheapest to package and ship
ď‚· High stability
ď‚· User aspect (doctor, pharmacist, patient)
ď‚· Easy to handling.
ď‚· Lightest and most compact.
ď‚· Greatest dose precision & least content variability.
ď‚· Coating can mark unpleasant tastes & improve pt. acceptability.
Disadvantages:
• Some drugs resist compression into dense compacts.
• Drugs with poor wetting, slow dissolution, intermediate to large dosages may be
difficult orimpossible to formulate and manufacture as a tablet that provide adequate
or full drug bioavailability.
• Bitter taste drugs, drugs with an objectionable odor, or sensitive to oxygen or moisture
may requireencapsulation or entrapment prior to compression or the tablets may require
contain.
Ingredients used in tablet formulations
1 .Drugs.
2. Fillers, diluents, bulking agent:
 To make a reasonably sized table
3. Binders:
 To bind powders together in the wet granulation process.
 To bind granule together during compression.
4. Disintegrates :
 To promote breakup of the tablets.
 To promote rapid release of the drug.
5. Lubricants:
ď‚· To reduce the friction during tablet ejection between the walls ofthe tabletand
the walls of the die cavity.
6. Glidants:
 Reducing friction between the particles.
 To improve the flow properties of the granulations
7. Antiadherants :
 To prevent adherence of the granules to the punch faces anddies.
8. Dissolution (enhancers and retardants)
9. Wetting agents
10. Antioxidants
11. Preservatives
12. Coloring agents
13. Flavoring agents
Granulation
The act or process of granulating : the condition of being granulated. 2 : one of theminute red
granules of new capillaries formed on the surface of a wound in healing.
Type of granulation:
1. wet granulation
2. Drygranulation
(Instrumentation of Granulations)
Blending:-
Powder to be used for encapsulation or to be granulated must be well blended to ensure good drug
distribution.
Inadequate blending at this stage could result in discrete portion ofthe batch being either high or
low inpotency.
Steps should also be taken to ensure that all the ingredients are free of lumps and agglomerates.
For these reasons, screening and/or milling of the ingredients usually makes the process more reliable
and
Equipment used for blending :-
 V-blender
 Double cone blender.
 Ribbon blender
 Slant cone blender
(Double cone blender)
Scale up considerations :
 Time ofblending
 Blender loading
 Size of blender
Sieving :
Separation of a mixture of various-sized particles, either dry or suspended in a
liquid, intotwo or more
portions, by passing through screens of specified mesh sizes.
Importance of sieving :
The sieving process gives three fractions of granules:
ď‚· Very coarse granules, which return back to the milling process.
ď‚· Very fine fraction, which return back to the compaction.
ď‚· Fraction with optimal dimensions for following manufacturing steps.
(Equipment used for sieving)
Industrial Sifter and Sieving Machine
Dryer :
In the pharmaceutical sector the fallowing dryers are use:
1. Static Oven,
2. RotaryDrier,
3. Fluidized Bed Drier,
4. VacuumOven,
5. Microwave Drier,
6. SprayDrier,
7. Rotary Atomizer,
8. I.R Drier.
TABLET PUNCHING
A tablet press is a mechanical device that compresses powder into tablets of uniform size and
weight. Apress can be used to manufacture tablets of a wide variety of materials, including
pharmaceuticals, illicit drugs, cleaning products, and cosmetics. To forma tablet, the granulated
material must be metered into a cavity formed by two punches and a die, and then the punches
must be pressed together with great force tofuse the material together.
Tablets coating:
The coating in tablets, which is additional step in the manufacturing process.
Objectives:
To makes the taste, odor, or color of the drug.
To provide physical and chemical protection for the
drug.To control the release of the drug from the
tablet.
To protect the drug from the gastric environment of the stomach with an acid resistant enteric coating.
Advantages :
Produce tablets in a single step process in relatively short period of time. Process enables functional
coatingsto be incorporated into the dosage form.
Disadvantages :
There are environmental and safety implications of using organic solvents as well as their financial
expense.
Evert touch product list (Tablets)
S.N. Tablets
1. Cefixime Dispersible Tablets, 100mg
2. Cefixime Tablet 200 Mg
3. Cefixime Moxifloxacin Tablet
4. Becowal B-Complex With Zinc Lactic Acid Bacilcapsules
5. Montelukast & Levocetirizine Syrup
6. Azithromycin Oral Suspension 100mg
7. Cefixime And Ofloxacine Tablets
8. Cefixime And Lactic Acid Bacillus Tablets
CAPSULE SECTION
CAPSULE SECTION
Capsule is solid dosage forms in which one or more medicinal and or inert substances are enclosed
within a small shell or container generally prepared from a suitable form of gelatin. Depending
upon their formulation, the gelatin capsule shells may be hard or soft.
Characteristics:
1. May be swallowed whole by the patient.
2. May be inserted into the rectum for drug release and absorption from the site.
3. The contents may be removed from the gelatin shell and employed as a pre measured medicinal
powder, the capsule shell being use to contain a dose of the medicinal substance.
4. Elegance.
5. Ease of use.
6. Portability.
7. Tasteless shell to mask the unpleasant taste/odor of the drug.
8. Permits physician to prescribe the exact medication needed by the patient.
9. Conveniently carried.
10. Readily identified.
11. Easily taken.
12. tasteless when swallowed.
13. Commonly embossed or imprinted on their surface the manufacturer’s name and product code readily
identified.
Components of Capsules:
1. Gelatin.
2. FD & C and D & C colorant.
3. Sugar.
4. Water - 12 to 16 % but may vary depending on the storage condition.
5. Sulfur dioxide (.15%) - prevent decomposition during manufacture.
6. Opaquants/Opacifying agent - titanium dioxide.
Type of capsule
The two main types of capsules are-
1. Soft Gelatin or Soft Gel Capsule
2. Hard Gelatin Capsule
1-Soft gel encapsulation:
Cod liver oil soft gel capsules.
In 1834, Mothes and Dublanc were granted a patent for a method to for a method to produce a single-
piece gelatin capsule
that was sealed with a drop of gelatin solution. They used individual iron moulds for their process, filling
the
capsules individually with a medicine dropper. Later on, methods were developed that used sets of plates
with pockets to form the capsules. Although some companies still use this method, the equipment is not
produced commercially any more. All modern soft-gel encapsulation uses variations of a process
developed
by R.P. Scherer in 1933. His innovation was to use a rotary die to produce the capsules, with the filling
taking place by blow molding. This method reduced wastage, and was the first process to yield capsules
with highly repeatable dosage.
Capsule size:
Capsule Filling Machine:
Evert touch Product list (Capsules)Sr.
Products
1. Calcitrol, Omega3 Fatty Acid, (EPA DHA), Methylcobal Folic Acid,
Boron, Calcium Carbonate Capsules
2. Acipeen Lycopene With Multivitamins, Multiminerals Antioxidant
Capsules
SYRUP SECTION
Syrup:
Syrup is a nearly saturated aqueous solution of sugar such as sucrose in water, with or without
medicinal or flavouring ingredients.
➢ When the syrup contains some added medicinal substances, it is called medicated syrup.
➢ Flavoured syrup is one which is not medicated but contains flavoured substances, and it is used as
flavoured vehicle.
➢ It is important that the concentration of sucrose approach but not quite reach
the saturated point.
➢ In dilute solution, sucrose provides an excellent nutrient for many microorganisms.
➢ Its concentrated solution on the other hand, retards their growth. However, a saturated
solution may lead to crystallization of a part of the sucrose under conditions of changing temperature.
Types of Syrup:
1. Simple Syrup
2. Medicated Syrup
3. Flavored syrup
1 )Simple Syrup: When Purified Water alone is used in making the solution of sucrose, the preparation is
known as “syrup,” or “simple syrup.
2) Medicated Syrup: A medicinal or therapeutic syrup that contains active ingredients.
Example – cough syrup. Flavored syrup - Syrup flavored withflavorings, but not medicinal
substances.
3) Flavored syrup: Flavored syrups typically consist of a simple syrup, that is sugar (fully
mixed with water while heated), with naturally occurring or artificial (synthesized)
flavorings also dissolved in them. A sugar substitute may also be used.
Advantage:
1. Appropriate for anypatient, whatever the age .
2. The most natural and easiest route of administration 3..
Economical and safe to the patient
4. No nursing is required, which means the patient can take it with no help
5. The liquid dosage form is expected for certain types of products like cough medicines.
Disadvantages Of Syrup:
1. Delayed onset of action because absorption takes time compared to some otherdosage forms like
solutions
2. Not suitable in emergency and for unconscious patients
3. Not convenient for a patient with a gastrointestinal disorder such as diarrhea, constipation,
ulceration, and hyperacidity in stomach.
4. Can’t avoid first pass metabolism.
EquipmentSyrup:
Syrup Filling :
Syrup filling machine has both capping and labeling capabilities.
This provides a complete pharmaceutical packaging solution for many industriesthat
need to package syrup products.
In this guide, we will discuss the uses, benefits and different types of this machine.
I will also highlight essential factors when purchasing the machine, among otherareas.
Syrup filling machine
Uses of Liquid Syrup Filling
Machine
These machines are very importantin the current industrial world, where
population explosion has greatly increased the demand for goods.
It offers an opportunity for fast, accurate, cost-effective and safe product filling
with minimum wastage.
Some of the varieties are fully automated, providing minimum human contact with
theproducts, thus reducing productcontamination during the process.
BENEFITS OF SYRUP MACHINE
This equipment has become very useful in the current fast-growing economic
world.
Most industries processing liquid product have adopted it for various reasons,
although it has some setbacks just like other machines. In fact, there has been
significant developments in automatic liquid filling line machines.
Below are some of the benefits that the syrup filling machine offers to its users. It
is cost-effective since human labour is reduced, especially for the automated
machine, where the filling is entirely mechanized. The machine has different
parts for bottle handling and positioning.
Liquid filling machine
One of the main responsibilities of the Food and Drug Administration (FDA) is regulating the labeling
standards for pharmaceutical, medical, nutraceutical, and dietary products. We’ve compiled a list of
guidelines so you can better understand pharmaceutical labels and healthcare product labeling.
Whether you’re labeling prescription drugs or medical devices – all pharmaceutical and healthcare
products must be labeled correctly for consumer safety.
Properly Labeling Pharmaceutical and
Healthcare Products
Instrumentation of automatic Syrup bottle, filling, capping, labeling :
Capping of Syrup:
Packaging of Syrup : Packagingofpharmaceuticals isacriticalprocess.Plastics areunanimously
usedforsoliddosagepackaging. Dueto theirnumerous advantages overglass,they arenowbeingconsidered
as an alternative to packaging of liquid dosage forms also. Cough syrups are preparations containing
antitussivedrugs,andaremostcommonlypackagedinglassbottles.Theinteractivenatureofplasticsmakes
it essential that a detailed study be carried out before their use for any pharmaceutical packaging. The present
workreports thestability andsuitability ofpackaging antitussivesyrup inplasticcontainers.
Evertouch healthcare list (Syrup)
Sr. Product
1. Acicof-Dx Dextromethorphan Chlorpheniramine Maleatesyrup, 100 Ml
2. Fexofenadine Hydrochloride Syrup
3. Acicof-Dx Dextromethorphan Chlorpheniramine Maleate
4. Acicof-Lx Levosalbutamol, Ambroxol Guaiphenesin Syrup, 100 Ml
5. Acicof-T Ambroxol Hcl, Terutaline Sulphate, Guaiphenesin Menthol Syrup,100
mi
6. Azithromycin Oral Suspension
7. Ondansetron Hydrochloride Oral Solution, In Uttar Pradesh
8. Aceclofenac & Paracetamol Syrup
9. Aceecal Calcium Suspension
10. Cefaclor Oral Suspension
11. Amarcef-50 Cefixime Oral Suspension
Quality control
Quality control:
Quality Assurance & Quality Control in Pharma Industry
QA: It is the sum total of the organized arrangements with the objective of ensuring that
products will be of the quality required for their intended use.
GMP: Is that part of Quality Assurance aimed at ensuring that products are consistently
manufactured to a quality appropriate to their intended use.
QC: Is that part of GMP concerned with sampling, specification & testing, documentation &
release
procedures which ensure that the necessary & relevant tests are performed & the product is
released for use
only after ascertaining its quality.
Quality Assurance (QA) Management Procedure:
1. How to write Standard Operating Procedure:
SOP describes standard SOP format that you can use immediately for your quality procedure.
SOP has instructions on how to write a formal operating procedure for your systems which
your people can follow every day.
2.Quality Documentation Management and Change Control:
This SOP describes how to generate new quality documents or change control of existing
documents, review of quality documents, satellite file management, and role of document
author, approver, document control officer and satellite file administrator.
3.Documentation Rule for GMP Documents:
This SOP describes the principles to be followed in GMP documents, entry of data and
information, signature requirements and correction technique of incorrectly entered data or
information.
4.Quality Documentation-Control, Tracking and Distribution:
In this SOP you will find mainly the role of document control officer during the initiation,
creation circulation and approval of new quality related documents.
It also describes the procedure of modification and review of existing document using a
documentation database.
Management of existing and superseded documents is also a part of this procedure.
You will see all the forms referred during the instruction are attached at the end of the
procedure.
5.Shelf Life of Product:
This simple SOP describes the meaning of shelf life and provides on how to interpret shelf
lives and storage conditions for your raw materials from the Certificate of Analysis, determining
expiry date for your finished products by use of raw material date of manufacturing and their
shelf lives.
Quality Control work (Summary)
Sampling of active pharmaceutical ingredients, Excipients, finished product & packing
material etc.
1. Testing of API (Active Pharmaceutical Ingredients).
2. Testing of excipients.
3. Testing of sample process.
4. Testing of finished products.
5. Testing of packing material.
6. Stability studies of finished product.
7. Maintenance and calibration of instruents
7. Procurement of chemicals and glass ware.
8. Procurement of reference standard.
9. Procurement of maintenance of clusters for microbiological testing.
10. To certificate analysis.
11. To study products complaints.
12. To destroy the control sample after six month of the date of expiry.
Quality control department
1. Quality control sampling section:
Responsibilities:-
To draw the sample of RM from store.
To draw the samples of F.G. from production department.
To keep control sample for reference & for stability studies.
Final inspection of each batch.
2. Quality control chemical section:
Responsibilities:-
Complete analysis of all RM/ process & F.G. sample as per prescribed standard.
To send report to production, store, Q C office.
To carry out stability testing etc.
Instrument maintenance and calibration.
3. Quality control microbiology section:
Responsibilities:-
Microbiological analysis of RM/process/FG/sample.
To send report to production, store, QC office.
Quality control packaging material test.
To carry out stability testing.
4. Quality control office:
Responsibilities:-
To make certificate of analysis of R.M. &finished products.
To maintain & keep records of analysis & certificate of analysis.
WORKING OF QUALITY CONTROL :-
VALIDATED SAMPLING SYSTEM
VALIDATED ANALYTICAL
INSTRUMENT ANALYTIAL
VALIDATED METHOD VALIDATED
ANALYSIS
SUCCESSFUL ANALYSIS
PACKAGING SECTION
Packaging Section :
Packaging is the science, art and technology of enclosing or protecting products for distribution,
storage,
sale, and use. Packaging also refers to the process of design, evaluation, and production of
packages.
Package labeling or labeling is any written, electronic, or graphic communications on the
packaging or on a separate but associated label.
Types of packaging:
There are two types of packaging-
1. Primary packaging.
2. Secondary packaging.
1-PRIMARY PACKAGING:-
It is the packing which is in contact with medicament (capsule or tablet).
a) Blister packaging:-
• In this PVC and Al Foil is used for packaging.
• Sometimes Al foil is used wholly for packaging.
 Thickness of Al foil = 0.025mm ± 10%.
 Thickness of PVC = 0.25 mm ±10%.
ď‚· The blister package is formed by heat- softening a sheet of thermoplastic resin and
vacuum drawing the softened sheet of plastic into a contoured mold.
• Blister packaging machine consist of-
ď‚· Feeder (vibrator).
ď‚· A guide track.
ď‚· A forming dies.
ď‚· Forming heater.
ď‚· Sealing heater.
ď‚· Cutter.
ď‚· Printing registration controller.
Bister packaging
TEMPRATURE:
ď‚· Forming heater = 140Âş-170Âş C.
ď‚· Sealing heater = 170Âş-200Âş C.
B) Strip packaging:-
ď‚· The strip package is form by feeding to webs of a heat sealable flexible film through
either a heated crimping roller or a heated reciprocating platen. In this the product is
drop into the pocket formed prior to forming the final set of seals.
ď‚· Machine:-
• It consist of –
ď‚· Hopper.
ď‚· Disc.
ď‚· Channel (chute).
ď‚· Two rollers (for Al foil).
ď‚· Cutter (center cutter).
ď‚· Conveyer belt.
ď‚· Thermostat.
ď‚· Selector.
ď‚· When primary (strip & blister) packaging is done. The strips & blisters are subject for
secondary.
2-SECONDARY PACKAGING:-
It is the packaging which is in contact with the primary packaging.
It involved –
• Cartoons (printed).
• Corrugated boxes (CB).
• White board box.
• Corrugated boxes consist of 3 ply or 5 ply or 7 ply as per requirement.
• When secondary packaging is complete a BOPP tape (Bio Oriented Poly Propylene
Tape) is use for sticking.
The purposes of packaging and package labels :
Packaging and package labeling have several objectives:
Physical protection - The objects enclosed in the package may require protection from,
among other things, shock, vibration, compression, temperature, etc.
Barrier protection - A barrier from oxygen, water vapor, dust, etc., is often required.
Permeation is a critical factor in design. Some packages contain desiccants or Oxygen
absorbers to help extend shelf life. Modified atmospheres or controlled atmospheres are
also maintained in some food packages. Keeping the contents clean, fresh, and safe for
the intended shelf life is a primary function.
Containment or agglomeration - Small objects are typically grouped together in one
package for reasons of efficiency. For example, a single box of 1000 pencils requires
less physical handling than 1000 single pencils. Liquids, powders, and granules need
containment.
Information transmission - Packages and labels communicate how to use, transport,
recycle, or dispose of the package or product. With pharmaceuticals, food, medical, and
chemical products, some types of information are required by governments.
Marketing - The packaging and labels can be used by marketers to encourage potential
buyers to purchase the product. Package design has been an important and constantly
evolving phenomenon for several decades. Marketing communications and graphic
design are applied to the surface of the package and (in many cases) the point of sale
display.
Convenience - Packages can have features which add convenience in distribution,
handling, stacking ,display, sale, opening, reclosing, use, and reuse.
Portion control - Single serving or single dosage packaging has a precise amount of
contents to control usage. Bulk commodities (such as salt) can be divided into
packages that are a more suitable size for individual households. It is also aids the
control of inventory: selling sealed one-liter-bottles of milk, rather than having people
bring their own bottles to fill themselves.
Packaging machines:
A choice of packaging machinery includes, technical capabilities, labor requirements,
worker safety, maintainability, serviceability, reliability, ability to integrate into the
packaging line, capital cost, flexibility (change-over, materials, etc.), energy usage,quality
of outgoing packages, qualifications (for food, pharmaceuticals, etc.), throughput,
efficiency, productivity, High speed conveyor with bar code scanner for sorting transport
packages.
Label printer applicator applying a label to adjacent panels of a corrugated box.Packaging
machines may be of the following general types:
• Blister packs, skin packs and Vacuum Packaging Machines.
• Bottle caps equipment, Over-Capping, Lidding, Closing, Seaming and Sealing Machines.
• Cartooning Machines.
• Box, Case and Tray Forming, Packing, Unpacking, Closing and Sealing Machines.
• Cleaning, Sterilizing, Cooling and Drying Machines.
• Conveyors, Accumulating and Related Machines.
• Feeding, Orienting, Placing and Related Machines.
• Filling Machines: handling liquid and powdered products.
• Package Filling and Closing Machines.
• Form, Fill and Seal Machines.
• Inspecting, Detecting and Check weigh Machines.
• Palletizing, De palletizing, Unit load assembly.
• Product Identification: labeling, marking, etc.
• Wrapping Machine.
SUMMARY
Evertouch healthcare helped us to imbibe the detailed information about
tablet section, liquid section,capsule section & packaging section.
This industrial report provided a valuable learning experience in the
carrier exploration process and gave us unexpected benefit. Now I
have evaluated the class room taught facts and ideas and applied
them to the real life situation. We came to know about many things
such as the GMP (Good Manufacturing Process), the Current Good
Manufacturing Process (CGMP).the basic laboratory requirement for
product validation, the variety of machine used in the large scale
industries of medicine etc. These and many other factors cause the
enhance of my knowledge and have created a lifelong interest to
learning through an exposure to new educational experience
Reference
1. Tablet-
ď‚· Pharmaceutics. The science of dosage forms design. (M.E.
Aulton)
 The theory and practice of industrial pharmacy.
 Pharmaceutical dosage forms : Tablets. Volume 2.
 Pharmaceutical dosage forms and drug delivery systems.
ď‚· Pharmaceutical Manufacturing Handbook Production and
Processes.
2. Coating
ď‚· http://www.touchbriefings.com/pdf/17/pt031_p_rajabi_siahboo
mi.pdf
ď‚· http://www.pharmpedia.com/Tablet:Tablet_coating#Aspects_of_tablet
_coating
ď‚· http://www.dipharmatech.com/pharmaceutical_technical_articl
es.html
 http://www.roehm.com/en/pharmapolymers.html

3. Capsule-
ď‚· L. Lachman, H.A. Lieberman, J.L. Kanig (1986). The Theory and
Practice ofIndustrial Pharmacy (Third Ed.). Lea & Fibiger,
Philadelphia.
 http://www.wikipedia.org.
4. Syrup :
ď‚· Tyler James Wiltgen (August 2007). "An Economic History of the
United StatesSugar Program" (PDF). Archived (PDF)
fromtheoriginal on 2015-02-09. Masters thesis.
ď‚· "Foodwithout Thought: How U.S. Farm Policy Contributes to
Obesity". Institute for Agriculture and Trade Policy. November 2006.
Archived from theoriginal on 2007-09-27.
5. 4. Quality control-
ď‚· Ashutosh kar, Pharmaceutical analysis, theory, methodology and drug
assay.

volume 2,
 www.ich.org
 www.fda.gov


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Industrial VISIT report

  • 1. “ REPORT ON INDUSTRIAL VISIT ” MANGALAYATAN UNIVERSITY (DEPARTMENT OF PHARMACY) (2018-2022) SUBMITTED TO PROF.(Dr.) DEV PRAKASH {PRINCIPAL} SUBMITTED BY ANSHIKA MAHESHWARI (20180310) MANGALAYATAN UNIVERSITY INSITITUTE OF BIOMEDICAL EDUCATION & RESEARCH DEPARTMENT OF PHARMACY ALIGARH, UTTAR PRADESH
  • 2. DECLARATION I here by declare that this project was “ REPORT ON INDUSTRIAL VISIT ” is a bonafide and genuine work carried out by us under the supervision and guidance of PROF. (Dr.) DEV PRAKASH principal at Mangalayatan University, Aligarh,Uttar Pradesh. It is further certified that no part of this work has been submitted either inpart or full for the award of any other degree/ diploma by me to this or any other university. DATE: ANSHIKA MAHESHWARI (20180310) Place: Aligarh
  • 3. CERTIFICATE OF SUPERVISOR This is to certify that the report entitled “ REPORT ON INDUSTRIAL VISIT ” is submitted by Anshika Maheshwari. It is a visit industry carried out by the candidate under my supervision.. Date: Place : Aligarh
  • 4. CERTIFICATE This is to certify that report entitled “INDUSTRIAL VISIT ” have been submitted by ANSHIKA MAHESHWARI to the Mangalayatan University. Date: Principal/Director
  • 5. Evaluation Certificate This is to certify that this report has been evaluated. Internal Examiner External Examiner Signature Name Designation Date
  • 6. PREFACE This report is prepared at Uttar Pradesh Evertouch Healthcare Pharmacy in KOSI KOTWAN , MATHURA. The Uttar Pradesh Evertouch Healthcare, is a Joint Enterprise of Center & Uttar Pradesh government; producing pharmaceutical dosage products and distributing it in Uttar Pradesh government hospital. This report aims at identifying important inbound and outbound process for product formulation and its problems. The report is based on knowledge of topic relevant for the reports and discussions with the inbound & outbound department in charges, and survey of the company. The report is divided into five sections to simplify and distinguish the topics from each others. During the report, I have concluded some analysis which is mentioned after each sub topics.
  • 7. COMPANY PROFILE Evertouch healthcare was established organization Situated at Mathura, Uttar Pradesh, India-281403which established in year 2011. It started its journey with a vision to make world a better place as we understand that human health is very important and crucial. We always make sure that we have the best resources required to prepare reliable, effective medicines and quality medicine. We engage in the research, development, manufacturing, sourcing, marketing, and distribution of high-quality pharmaceutical products. We are a fully integrated company with in-house business development, R&D, manufacturing and regulatory compliance capabilities. With the assistance of latest equipment’s, the automated and modern production process has beenprepared. We offer a complete range of products with prompt and reliable assistance for all our customers. Consequently, our large-scale production capacities, highly qualified production, and quality control staff, state of art WHO-GMP certified manufacturing facility combines to give a perfect environment foroutsourcing or contract manufacturing pharmaceutical products. This synergy allows us to provide thehighest quality products to our clients in a timely manner that is extremely cost competitive. Export Facilities: we have WHO-GMP certified plant with COPP of Cephalosporines and Penicillin formulations. Facilities In our well-established premises, we have set up all advanced tools, equipment and machines used for preparing the Pharmaceutical Medicines. All equipment is properly labeled so that we can ensure qualitymanufacturing process. In addition, we keep our premises hygienic ensuring zero contamination. We have Five units over their under control of Evertouch Healthcare Group. Followings are the details of Plants.
  • 8.
  • 9. Evertouch Healthcare (GMP Certified Unit) Plot No. J-82, UPSIDC Kosi Kotwan, Mathura Manufacturer of Oral Liquids (Syrup, Drops, Suspensions), External Preparations like Hand Sanitizer ,Hand Wash and Capsules in (Drug) Evertouch Bio-Remedies (WHO-GMP Certified Unit)Plot No. I-1/5, UPSIDC Kosi Kotwan Mathura Manufacturer of Tablets, Capsules and Dry Syrups in Beta Lactum Only (Drug)Evertouch Herbalcare (GMP-Certified Unit) Plot No. K-30, UPSIDC Kosi Kotwan Mathura Manufacturer of All ayurvedic (Herbal) Preparations Evertouch Lifecare Plot No. J-85, UPSIDC Kosi Kotwan Mathura Manufacturer of Syrup, Drops, Suspensions , and Sachets in (Under FSSAI License)
  • 10. CONTENTS:- 1. Tablet section Tablet Ingredients used in tablet formulations Granulation Blending Sieving Dryer Tablet punching Tablet coating & type of coating Some common problem in tabletting Evertouch healthcare Product list (Tablet) 2. Capsule section Capsule Type of capsule Additives Manufacture ofheard gelatin capsule Filling of heard gelatin capsule Finishing Evertouch healthcare product list (capsule & powder) 3. Syrup section Syrup Type of syrup Additives Filling Labeling
  • 11. Packaging Evertouch healthcare product list 4. Quality control Quality Assurance & Quality Control in Pharma Industry Quality Control work (Summary Quality control department Chemical section Instrumental section Micro-biological section 5. Packing section Packaging & it’s type The purposes of packaging and package labels
  • 12. Tablet TABLET SECTION A tablet is a mixture of active substances and excipients, usually in powder form, pressed or compacted intoa solid. The excipients include binders, Glidants (flow aids) and lubricants to ensure efficient tabletting, disintegrates to ensure that the tablet breaks up in the digestive tract; sweeteners or flavors to mask the tasteof bad-tasting active ingredients; and pigments to make uncoated tablets visually attractive. A coating may be applied to hide the taste of the tablet's components, to make the tablet smoother and easier to swallow, and to make it more resistant to the environment, extending its shelf life. Advantage : • Production aspect ď‚· Large scale production at lowest cost ď‚· Easiest and cheapest to package and ship ď‚· High stability ď‚· User aspect (doctor, pharmacist, patient) ď‚· Easy to handling. ď‚· Lightest and most compact. ď‚· Greatest dose precision & least content variability.
  • 13. ď‚· Coating can mark unpleasant tastes & improve pt. acceptability. Disadvantages: • Some drugs resist compression into dense compacts. • Drugs with poor wetting, slow dissolution, intermediate to large dosages may be difficult orimpossible to formulate and manufacture as a tablet that provide adequate or full drug bioavailability. • Bitter taste drugs, drugs with an objectionable odor, or sensitive to oxygen or moisture may requireencapsulation or entrapment prior to compression or the tablets may require contain. Ingredients used in tablet formulations 1 .Drugs. 2. Fillers, diluents, bulking agent: ď‚· To make a reasonably sized table 3. Binders: ď‚· To bind powders together in the wet granulation process. ď‚· To bind granule together during compression. 4. Disintegrates : ď‚· To promote breakup of the tablets. ď‚· To promote rapid release of the drug. 5. Lubricants: ď‚· To reduce the friction during tablet ejection between the walls ofthe tabletand the walls of the die cavity. 6. Glidants: ď‚· Reducing friction between the particles. ď‚· To improve the flow properties of the granulations
  • 14. 7. Antiadherants : ď‚· To prevent adherence of the granules to the punch faces anddies. 8. Dissolution (enhancers and retardants) 9. Wetting agents 10. Antioxidants 11. Preservatives 12. Coloring agents 13. Flavoring agents Granulation The act or process of granulating : the condition of being granulated. 2 : one of theminute red granules of new capillaries formed on the surface of a wound in healing. Type of granulation: 1. wet granulation 2. Drygranulation (Instrumentation of Granulations) Blending:- Powder to be used for encapsulation or to be granulated must be well blended to ensure good drug distribution. Inadequate blending at this stage could result in discrete portion ofthe batch being either high or low inpotency. Steps should also be taken to ensure that all the ingredients are free of lumps and agglomerates. For these reasons, screening and/or milling of the ingredients usually makes the process more reliable and
  • 15. Equipment used for blending :- ď‚· V-blender ď‚· Double cone blender. ď‚· Ribbon blender ď‚· Slant cone blender (Double cone blender) Scale up considerations : ď‚· Time ofblending ď‚· Blender loading ď‚· Size of blender
  • 16. Sieving : Separation of a mixture of various-sized particles, either dry or suspended in a liquid, intotwo or more portions, by passing through screens of specified mesh sizes. Importance of sieving : The sieving process gives three fractions of granules: ď‚· Very coarse granules, which return back to the milling process. ď‚· Very fine fraction, which return back to the compaction. ď‚· Fraction with optimal dimensions for following manufacturing steps. (Equipment used for sieving) Industrial Sifter and Sieving Machine
  • 17. Dryer : In the pharmaceutical sector the fallowing dryers are use: 1. Static Oven, 2. RotaryDrier, 3. Fluidized Bed Drier, 4. VacuumOven, 5. Microwave Drier, 6. SprayDrier, 7. Rotary Atomizer, 8. I.R Drier. TABLET PUNCHING A tablet press is a mechanical device that compresses powder into tablets of uniform size and weight. Apress can be used to manufacture tablets of a wide variety of materials, including pharmaceuticals, illicit drugs, cleaning products, and cosmetics. To forma tablet, the granulated material must be metered into a cavity formed by two punches and a die, and then the punches must be pressed together with great force tofuse the material together.
  • 18. Tablets coating: The coating in tablets, which is additional step in the manufacturing process. Objectives: To makes the taste, odor, or color of the drug. To provide physical and chemical protection for the drug.To control the release of the drug from the tablet. To protect the drug from the gastric environment of the stomach with an acid resistant enteric coating. Advantages : Produce tablets in a single step process in relatively short period of time. Process enables functional coatingsto be incorporated into the dosage form. Disadvantages : There are environmental and safety implications of using organic solvents as well as their financial expense. Evert touch product list (Tablets) S.N. Tablets 1. Cefixime Dispersible Tablets, 100mg 2. Cefixime Tablet 200 Mg 3. Cefixime Moxifloxacin Tablet 4. Becowal B-Complex With Zinc Lactic Acid Bacilcapsules 5. Montelukast & Levocetirizine Syrup 6. Azithromycin Oral Suspension 100mg 7. Cefixime And Ofloxacine Tablets 8. Cefixime And Lactic Acid Bacillus Tablets
  • 19. CAPSULE SECTION CAPSULE SECTION Capsule is solid dosage forms in which one or more medicinal and or inert substances are enclosed within a small shell or container generally prepared from a suitable form of gelatin. Depending upon their formulation, the gelatin capsule shells may be hard or soft. Characteristics: 1. May be swallowed whole by the patient. 2. May be inserted into the rectum for drug release and absorption from the site. 3. The contents may be removed from the gelatin shell and employed as a pre measured medicinal powder, the capsule shell being use to contain a dose of the medicinal substance. 4. Elegance. 5. Ease of use. 6. Portability. 7. Tasteless shell to mask the unpleasant taste/odor of the drug. 8. Permits physician to prescribe the exact medication needed by the patient.
  • 20. 9. Conveniently carried. 10. Readily identified. 11. Easily taken. 12. tasteless when swallowed. 13. Commonly embossed or imprinted on their surface the manufacturer’s name and product code readily identified. Components of Capsules: 1. Gelatin. 2. FD & C and D & C colorant. 3. Sugar. 4. Water - 12 to 16 % but may vary depending on the storage condition. 5. Sulfur dioxide (.15%) - prevent decomposition during manufacture. 6. Opaquants/Opacifying agent - titanium dioxide. Type of capsule The two main types of capsules are- 1. Soft Gelatin or Soft Gel Capsule 2. Hard Gelatin Capsule
  • 21. 1-Soft gel encapsulation: Cod liver oil soft gel capsules. In 1834, Mothes and Dublanc were granted a patent for a method to for a method to produce a single- piece gelatin capsule that was sealed with a drop of gelatin solution. They used individual iron moulds for their process, filling the capsules individually with a medicine dropper. Later on, methods were developed that used sets of plates with pockets to form the capsules. Although some companies still use this method, the equipment is not produced commercially any more. All modern soft-gel encapsulation uses variations of a process developed by R.P. Scherer in 1933. His innovation was to use a rotary die to produce the capsules, with the filling taking place by blow molding. This method reduced wastage, and was the first process to yield capsules with highly repeatable dosage.
  • 23. Evert touch Product list (Capsules)Sr. Products 1. Calcitrol, Omega3 Fatty Acid, (EPA DHA), Methylcobal Folic Acid, Boron, Calcium Carbonate Capsules 2. Acipeen Lycopene With Multivitamins, Multiminerals Antioxidant Capsules
  • 24. SYRUP SECTION Syrup: Syrup is a nearly saturated aqueous solution of sugar such as sucrose in water, with or without medicinal or flavouring ingredients. ➢ When the syrup contains some added medicinal substances, it is called medicated syrup. ➢ Flavoured syrup is one which is not medicated but contains flavoured substances, and it is used as flavoured vehicle. ➢ It is important that the concentration of sucrose approach but not quite reach the saturated point. ➢ In dilute solution, sucrose provides an excellent nutrient for many microorganisms. ➢ Its concentrated solution on the other hand, retards their growth. However, a saturated solution may lead to crystallization of a part of the sucrose under conditions of changing temperature. Types of Syrup: 1. Simple Syrup 2. Medicated Syrup 3. Flavored syrup 1 )Simple Syrup: When Purified Water alone is used in making the solution of sucrose, the preparation is known as “syrup,” or “simple syrup.
  • 25. 2) Medicated Syrup: A medicinal or therapeutic syrup that contains active ingredients. Example – cough syrup. Flavored syrup - Syrup flavored withflavorings, but not medicinal substances. 3) Flavored syrup: Flavored syrups typically consist of a simple syrup, that is sugar (fully mixed with water while heated), with naturally occurring or artificial (synthesized) flavorings also dissolved in them. A sugar substitute may also be used. Advantage: 1. Appropriate for anypatient, whatever the age . 2. The most natural and easiest route of administration 3.. Economical and safe to the patient 4. No nursing is required, which means the patient can take it with no help 5. The liquid dosage form is expected for certain types of products like cough medicines. Disadvantages Of Syrup: 1. Delayed onset of action because absorption takes time compared to some otherdosage forms like solutions 2. Not suitable in emergency and for unconscious patients 3. Not convenient for a patient with a gastrointestinal disorder such as diarrhea, constipation, ulceration, and hyperacidity in stomach. 4. Can’t avoid first pass metabolism.
  • 26. EquipmentSyrup: Syrup Filling : Syrup filling machine has both capping and labeling capabilities. This provides a complete pharmaceutical packaging solution for many industriesthat need to package syrup products. In this guide, we will discuss the uses, benefits and different types of this machine. I will also highlight essential factors when purchasing the machine, among otherareas. Syrup filling machine
  • 27. Uses of Liquid Syrup Filling Machine These machines are very importantin the current industrial world, where population explosion has greatly increased the demand for goods. It offers an opportunity for fast, accurate, cost-effective and safe product filling with minimum wastage. Some of the varieties are fully automated, providing minimum human contact with theproducts, thus reducing productcontamination during the process. BENEFITS OF SYRUP MACHINE This equipment has become very useful in the current fast-growing economic world. Most industries processing liquid product have adopted it for various reasons, although it has some setbacks just like other machines. In fact, there has been significant developments in automatic liquid filling line machines. Below are some of the benefits that the syrup filling machine offers to its users. It is cost-effective since human labour is reduced, especially for the automated
  • 28. machine, where the filling is entirely mechanized. The machine has different parts for bottle handling and positioning. Liquid filling machine One of the main responsibilities of the Food and Drug Administration (FDA) is regulating the labeling standards for pharmaceutical, medical, nutraceutical, and dietary products. We’ve compiled a list of guidelines so you can better understand pharmaceutical labels and healthcare product labeling. Whether you’re labeling prescription drugs or medical devices – all pharmaceutical and healthcare products must be labeled correctly for consumer safety. Properly Labeling Pharmaceutical and Healthcare Products
  • 29. Instrumentation of automatic Syrup bottle, filling, capping, labeling : Capping of Syrup:
  • 30. Packaging of Syrup : Packagingofpharmaceuticals isacriticalprocess.Plastics areunanimously usedforsoliddosagepackaging. Dueto theirnumerous advantages overglass,they arenowbeingconsidered
  • 31. as an alternative to packaging of liquid dosage forms also. Cough syrups are preparations containing antitussivedrugs,andaremostcommonlypackagedinglassbottles.Theinteractivenatureofplasticsmakes it essential that a detailed study be carried out before their use for any pharmaceutical packaging. The present workreports thestability andsuitability ofpackaging antitussivesyrup inplasticcontainers. Evertouch healthcare list (Syrup) Sr. Product 1. Acicof-Dx Dextromethorphan Chlorpheniramine Maleatesyrup, 100 Ml 2. Fexofenadine Hydrochloride Syrup 3. Acicof-Dx Dextromethorphan Chlorpheniramine Maleate 4. Acicof-Lx Levosalbutamol, Ambroxol Guaiphenesin Syrup, 100 Ml 5. Acicof-T Ambroxol Hcl, Terutaline Sulphate, Guaiphenesin Menthol Syrup,100 mi 6. Azithromycin Oral Suspension 7. Ondansetron Hydrochloride Oral Solution, In Uttar Pradesh 8. Aceclofenac & Paracetamol Syrup 9. Aceecal Calcium Suspension 10. Cefaclor Oral Suspension 11. Amarcef-50 Cefixime Oral Suspension
  • 32. Quality control Quality control: Quality Assurance & Quality Control in Pharma Industry QA: It is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use. GMP: Is that part of Quality Assurance aimed at ensuring that products are consistently manufactured to a quality appropriate to their intended use. QC: Is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining its quality. Quality Assurance (QA) Management Procedure: 1. How to write Standard Operating Procedure: SOP describes standard SOP format that you can use immediately for your quality procedure. SOP has instructions on how to write a formal operating procedure for your systems which your people can follow every day.
  • 33. 2.Quality Documentation Management and Change Control: This SOP describes how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, and role of document author, approver, document control officer and satellite file administrator. 3.Documentation Rule for GMP Documents: This SOP describes the principles to be followed in GMP documents, entry of data and information, signature requirements and correction technique of incorrectly entered data or information. 4.Quality Documentation-Control, Tracking and Distribution: In this SOP you will find mainly the role of document control officer during the initiation, creation circulation and approval of new quality related documents. It also describes the procedure of modification and review of existing document using a documentation database. Management of existing and superseded documents is also a part of this procedure. You will see all the forms referred during the instruction are attached at the end of the procedure. 5.Shelf Life of Product: This simple SOP describes the meaning of shelf life and provides on how to interpret shelf lives and storage conditions for your raw materials from the Certificate of Analysis, determining expiry date for your finished products by use of raw material date of manufacturing and their shelf lives. Quality Control work (Summary) Sampling of active pharmaceutical ingredients, Excipients, finished product & packing material etc. 1. Testing of API (Active Pharmaceutical Ingredients). 2. Testing of excipients. 3. Testing of sample process. 4. Testing of finished products. 5. Testing of packing material. 6. Stability studies of finished product.
  • 34. 7. Maintenance and calibration of instruents 7. Procurement of chemicals and glass ware. 8. Procurement of reference standard. 9. Procurement of maintenance of clusters for microbiological testing. 10. To certificate analysis. 11. To study products complaints. 12. To destroy the control sample after six month of the date of expiry. Quality control department 1. Quality control sampling section: Responsibilities:- To draw the sample of RM from store. To draw the samples of F.G. from production department. To keep control sample for reference & for stability studies. Final inspection of each batch. 2. Quality control chemical section: Responsibilities:- Complete analysis of all RM/ process & F.G. sample as per prescribed standard. To send report to production, store, Q C office. To carry out stability testing etc. Instrument maintenance and calibration. 3. Quality control microbiology section: Responsibilities:- Microbiological analysis of RM/process/FG/sample. To send report to production, store, QC office. Quality control packaging material test.
  • 35. To carry out stability testing. 4. Quality control office: Responsibilities:- To make certificate of analysis of R.M. &finished products. To maintain & keep records of analysis & certificate of analysis. WORKING OF QUALITY CONTROL :- VALIDATED SAMPLING SYSTEM VALIDATED ANALYTICAL INSTRUMENT ANALYTIAL VALIDATED METHOD VALIDATED ANALYSIS SUCCESSFUL ANALYSIS
  • 36. PACKAGING SECTION Packaging Section : Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages. Package labeling or labeling is any written, electronic, or graphic communications on the packaging or on a separate but associated label. Types of packaging: There are two types of packaging- 1. Primary packaging. 2. Secondary packaging. 1-PRIMARY PACKAGING:- It is the packing which is in contact with medicament (capsule or tablet). a) Blister packaging:- • In this PVC and Al Foil is used for packaging. • Sometimes Al foil is used wholly for packaging. ď‚· Thickness of Al foil = 0.025mm ± 10%. ď‚· Thickness of PVC = 0.25 mm ±10%.
  • 37. ď‚· The blister package is formed by heat- softening a sheet of thermoplastic resin and vacuum drawing the softened sheet of plastic into a contoured mold. • Blister packaging machine consist of- ď‚· Feeder (vibrator). ď‚· A guide track. ď‚· A forming dies. ď‚· Forming heater. ď‚· Sealing heater. ď‚· Cutter. ď‚· Printing registration controller. Bister packaging TEMPRATURE: ď‚· Forming heater = 140Âş-170Âş C.
  • 38. ď‚· Sealing heater = 170Âş-200Âş C. B) Strip packaging:- ď‚· The strip package is form by feeding to webs of a heat sealable flexible film through either a heated crimping roller or a heated reciprocating platen. In this the product is drop into the pocket formed prior to forming the final set of seals. ď‚· Machine:- • It consist of – ď‚· Hopper. ď‚· Disc. ď‚· Channel (chute). ď‚· Two rollers (for Al foil). ď‚· Cutter (center cutter). ď‚· Conveyer belt. ď‚· Thermostat. ď‚· Selector. ď‚· When primary (strip & blister) packaging is done. The strips & blisters are subject for secondary.
  • 39. 2-SECONDARY PACKAGING:- It is the packaging which is in contact with the primary packaging. It involved – • Cartoons (printed). • Corrugated boxes (CB). • White board box. • Corrugated boxes consist of 3 ply or 5 ply or 7 ply as per requirement. • When secondary packaging is complete a BOPP tape (Bio Oriented Poly Propylene Tape) is use for sticking. The purposes of packaging and package labels : Packaging and package labeling have several objectives: Physical protection - The objects enclosed in the package may require protection from, among other things, shock, vibration, compression, temperature, etc. Barrier protection - A barrier from oxygen, water vapor, dust, etc., is often required. Permeation is a critical factor in design. Some packages contain desiccants or Oxygen absorbers to help extend shelf life. Modified atmospheres or controlled atmospheres are also maintained in some food packages. Keeping the contents clean, fresh, and safe for the intended shelf life is a primary function. Containment or agglomeration - Small objects are typically grouped together in one package for reasons of efficiency. For example, a single box of 1000 pencils requires less physical handling than 1000 single pencils. Liquids, powders, and granules need containment. Information transmission - Packages and labels communicate how to use, transport, recycle, or dispose of the package or product. With pharmaceuticals, food, medical, and chemical products, some types of information are required by governments. Marketing - The packaging and labels can be used by marketers to encourage potential buyers to purchase the product. Package design has been an important and constantly evolving phenomenon for several decades. Marketing communications and graphic design are applied to the surface of the package and (in many cases) the point of sale display. Convenience - Packages can have features which add convenience in distribution, handling, stacking ,display, sale, opening, reclosing, use, and reuse.
  • 40. Portion control - Single serving or single dosage packaging has a precise amount of contents to control usage. Bulk commodities (such as salt) can be divided into packages that are a more suitable size for individual households. It is also aids the control of inventory: selling sealed one-liter-bottles of milk, rather than having people bring their own bottles to fill themselves. Packaging machines: A choice of packaging machinery includes, technical capabilities, labor requirements, worker safety, maintainability, serviceability, reliability, ability to integrate into the packaging line, capital cost, flexibility (change-over, materials, etc.), energy usage,quality of outgoing packages, qualifications (for food, pharmaceuticals, etc.), throughput, efficiency, productivity, High speed conveyor with bar code scanner for sorting transport packages.
  • 41. Label printer applicator applying a label to adjacent panels of a corrugated box.Packaging machines may be of the following general types: • Blister packs, skin packs and Vacuum Packaging Machines. • Bottle caps equipment, Over-Capping, Lidding, Closing, Seaming and Sealing Machines. • Cartooning Machines.
  • 42. • Box, Case and Tray Forming, Packing, Unpacking, Closing and Sealing Machines. • Cleaning, Sterilizing, Cooling and Drying Machines. • Conveyors, Accumulating and Related Machines. • Feeding, Orienting, Placing and Related Machines. • Filling Machines: handling liquid and powdered products. • Package Filling and Closing Machines. • Form, Fill and Seal Machines. • Inspecting, Detecting and Check weigh Machines. • Palletizing, De palletizing, Unit load assembly. • Product Identification: labeling, marking, etc. • Wrapping Machine.
  • 43. SUMMARY Evertouch healthcare helped us to imbibe the detailed information about tablet section, liquid section,capsule section & packaging section. This industrial report provided a valuable learning experience in the carrier exploration process and gave us unexpected benefit. Now I have evaluated the class room taught facts and ideas and applied them to the real life situation. We came to know about many things such as the GMP (Good Manufacturing Process), the Current Good Manufacturing Process (CGMP).the basic laboratory requirement for product validation, the variety of machine used in the large scale industries of medicine etc. These and many other factors cause the enhance of my knowledge and have created a lifelong interest to learning through an exposure to new educational experience
  • 44. Reference 1. Tablet- ď‚· Pharmaceutics. The science of dosage forms design. (M.E. Aulton) ď‚· The theory and practice of industrial pharmacy. ď‚· Pharmaceutical dosage forms : Tablets. Volume 2. ď‚· Pharmaceutical dosage forms and drug delivery systems. ď‚· Pharmaceutical Manufacturing Handbook Production and Processes. 2. Coating ď‚· http://www.touchbriefings.com/pdf/17/pt031_p_rajabi_siahboo mi.pdf ď‚· http://www.pharmpedia.com/Tablet:Tablet_coating#Aspects_of_tablet _coating ď‚· http://www.dipharmatech.com/pharmaceutical_technical_articl es.html ď‚· http://www.roehm.com/en/pharmapolymers.html  3. Capsule- ď‚· L. Lachman, H.A. Lieberman, J.L. Kanig (1986). The Theory and Practice ofIndustrial Pharmacy (Third Ed.). Lea & Fibiger, Philadelphia. ď‚· http://www.wikipedia.org.
  • 45. 4. Syrup : ď‚· Tyler James Wiltgen (August 2007). "An Economic History of the United StatesSugar Program" (PDF). Archived (PDF) fromtheoriginal on 2015-02-09. Masters thesis. ď‚· "Foodwithout Thought: How U.S. Farm Policy Contributes to Obesity". Institute for Agriculture and Trade Policy. November 2006. Archived from theoriginal on 2007-09-27. 5. 4. Quality control- ď‚· Ashutosh kar, Pharmaceutical analysis, theory, methodology and drug assay.  volume 2, ď‚· www.ich.org ď‚· www.fda.govď€