2. Introduction
Selection criteria for packaging material
Characteristics of packaging material
Types of packaging
Types of packaging materials
Validation Protocol
VMP
Sampling and testing
Q.A. aspects
Blister Packaging
Strip Packaging
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3. Definition
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Packaging :
may be defined as the collection of different components (e.g.
bottle, vial, closure, cap, ampoule, blister) which surround
the pharmaceutical product from the time of production until
its use.
Packaging Validation :
to confirm that the resulting product from a specified
packaging process consistently conforms to product
attributes requirements.
5. 5
•Must meet tamper resistance
requirements
•Must be FDA approved
•Must be non toxic
•Must not impart odor/taste to the
product
•Must not reactive with the product
•They must protect the preparation from
environmental conditions
6. 6
1. Primary packaging is the material that first envelops the
product and holds it. This usually is the smallest unit of
distribution or use and is the package which is in direct
contact with the contents.
Eg: Ampoules,Vials ,Containers ,Syringe ,Strip package,
Blister packaging.
7. 7
2. Secondary packaging is outside the primary
packaging – perhaps used to group primary packages
together.
Eg: Paper and boards, Cartons
8. 8
3. Tertiary packaging is used for bulk handling ,
warehouse storage and transport shipping. The most
common form is a palletized unit load that packs tightly
into containers.
9. Apart from primary and secondary packaging, two types of
special packaging are currently in use, as follows:
• Unit-dose packaging.
This packaging guarantees safer medication by
reducing medication errors; it is also more practical for the
patient.
• “Device” packaging.
Packaging with the aid of an administration device is
user-friendly and also improves compliance. This type of
packaging permits easier administration by means of devices
such as pre-filled syringes, droppers, transdermal delivery
systems, pumps and aerosol sprays.
Such devices ensure that the medicinal
product is administered correctly and in the right amount.9
11. 11
Packaging
Materials
ADVANTAGES DISADVANTAGES
GLASS • suitable for sterilization
• relatively non- reactive
• easily labeled
• relatively heavy
• fragile so easily broken
METALS Impermeable to moisture, gases, odors,
light, bacteria, and shatterproof
• Liable to corrosion
• Less flexible.
RUBBERS Used to form closures • Risk of product absorbing on
or in to a rubber.
• Has certain degree of
moisture & gas permeation
PLASTICS • Flexible
• No risk of breakage
• Light in weight
• Not chemically inert
• May possess an electrostatic
charge which will attract
particles.
FIBROUS
MATERIAL
Provides physical protection especially to
items like metal collapsible tubes
FILM,
FOILS and
LAMINATE
• can extend the storage period of drugs.
• suitable for packing moisture-sensitive
drugs
12. Short description of the process with a summary of
the critical processing steps or critical parameters
to be monitored during validation.
Additional testing intended to be carried out
e.g. with proposed acceptance criteria and
analytical validation as appropriate.
Sampling plan — where, when, how and how many
samples are taken.
Details for recording and evaluation of results.
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13. The change control process used Validation Master
Plan will include key elements of the validation
program-
Company’s validation policy
Organizational structure of validation activities
Summary of facilities, systems, equipment and
processes validated/to be validated. All critical
equipment, systems, devices, software must be
identified and listed.
Defines nature & extent of testing, test procedures
Documentation format (e.g. protocol and report)
Planning and scheduling
Change control process
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14. Sampling :
To check the correctness of the label, packaging
material or container references.
Detecting adulteration of the medicinal product.
The sampling procedure should be described in a
written protocol.
Testing :
Visual inspection (cleanliness, defects)
Tests to identify the material
Dimensional tests
Physical tests
Chemical tests
Microbiological tests 14
15. To ensure that patients and consumers receive high-quality
drugs.
The quality management system must take the following
considerations into account if the required quality of
packaging is to be obtained:
— the requirements of the national authorities and the
relevant legislation
— the product
— the production process
— the manufacturers’internal policies (safety, marketing,
etc.).
Bad packaging which is the result of deficiencies in the
quality assurance system for packaging can have serious
consequences, and packaging defects can create problems15
16. Blister pack:
“Blister pack or bubble pack is a term for several
types of pre-formed plastic Packaging used for small
consumer goods, foods, and for pharmaceuticals”
Blistering:
“Blistering is the process of making Blisters or
enclosing the tablets & capsules into preformed
plastic packing”
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17. 17
The four basic components of pharmaceutical blister
packages are;
• The forming film (Forming films account for
approximately 80–85% of the blister package)
• The liding material (liding materials make up 15–20%
of the total weight of the package)
• Heat seal coating
• The printing ink
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Heating the plastic
Thermoforming it into blister
cavities
Loading the blister with the
product
Placing lidding material over the
blister
Heat-sealing the package
I) Thermoform Blistering machine:
Example : ALU-PVC machine
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II] Cold Forming Blistering machine:
Example: ALU-ALU Machine
Operation sequence involves;
Installing the Aluminium Foil
Cold forming it into blister
cavities via punch pins
Loading the blister with the
product
Placing lidding material over
the blister
Heat-sealing the package
22. 22
III] Thermo-cold forming blistering machine:
Eg: ALU-Tropical Machine Operation:
The Operation sequence involves;
Heating the plastic
Thermoforming it into blister cavities
Loading the blister with the product
Placing liding material over the blister
Heat-sealing the package
Installing the aluminium foil
Cold forming it into blister Pouch & seal it on
thermoformed blister to give extra protection
Cutting into individual blisters
24. It is commonly used for the packaging of tablets and
capsules. A strip package is formed by feeding two
webs of a heat sealable flexible film through a
heated crimping roller .The product is dropped into
the pocket formed before forming the final set of
seals. A continuous strip of packets is formed which
is cut to the desired number of packets in length.
The materials used for strip package are cellophane,
polyester, polyethylene, polypropylene,24
25. Industry
Constantly challenged to reduce costs
New markets and new packs add complexity to the
operation
An ever changing regulatory environment demands
compliance.
To ensure pack integrity, manage complexity, maximize
efficiency and minimize costs; appropriately designed
packs, running in validated packaging lines, are a
business necessity rather than a regulatory requirement.
If validation is well planned and documented, then GMP
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26. Visible costs
e.g., waste, returned /
recalled goods
……………………………
…………… ……
Invisible/Hidden costs
e.g., wrong decisions, non-
trained workers,
Non-standardized
process,unsuitable
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Importance of Validation : Cost of
Quality
27. 27
Quality is designed and built
into the
process/method/equipments/premises
Functionality, consistency and
repeatability
is confirmed by
Validation
28. Pharmaceutical Process Validation, Third Edition,
Ira R.Berry & Robert Nash, Marcel Decker Inc.
Pharmaceutical Validation Master Plan by Syed
Imtiaz Haider, St. Lucie Press
www.ijpqa.com
www.pharmaceuticalvalidation.blogspot.in
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