Validation of Packaging operations

1. A SEMINAR ON
VALIDATION OF
PACKAGING
OPERATIONS
Presented by: Guided by:
MR. GOMTESH MILIND DOSHI Dr. S.S CHITLANGE
M.Pharm.1st year[QAT] Sem-II Principal & Professor
Roll No. 526 Dr. D Y Patil IPSR,PIMPRI,PUNE1
Dr. D. Y. Patil Institute of Pharmaceutical Science
and Research, Pimpri, Pune

2. CONTENT
 Introduction Of Packaging
 Characteristics Of Packaging material
 Role Of Packaging
 Key Areas That Affects Packaging Process
 Validation Of Packaging
Packaging Equipment Qualification
Packaging Process Validation
 Example Of Packaging Process
Blister Packaging For Tablet
Secondary Packaging
Checkweigher
 Bibliography
2

3. PACKAGING
Pharmaceutical packaging has to be carried out for the purpose
of the safety of the pharmaceutical preparations in order to keep
them free from contamination, hinder microbial growth, and
ensure product safety through the intended shelf life for
the pharmaceuticals.
Packaging :
may be defined as the collection of different components
which surround the pharmaceutical product from the time of
production until its use.
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4. CHARACTERISTICS OF PACKAGING MATERIALS:
o Must be FDA approved
o Must be non toxic
o Must not impart odor/taste to the product
o Must not reactive with the product
o They must protect the preparation from environmental
conditions
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5. ROLE OF PACKAGING
 Protection
Against physical damage
Against biological contaminations
From all external influences that can alter the properties of
product
 Identification of product
 Convenience in use for medical staff and patient
 A marketing tool
5

6. SEVERAL KEY AREAS THAT AFFECT
PACKAGING PROCESS
 Packaging Material
 Packaging Equipment
 Packaging Line Layout
 Training Of Operators
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7. TYPES OF PACKAGING MATERIAL
 Primary packaging material: material which directly
comes in contact with medicinal product
E.g.: Ampoules,Vials ,Containers ,Syringe ,Strip package,
Blister packaging.
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8.  Secondary packaging material: material which comes
in contact with primary packaging material
E.g. Paper and card board boxes
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9.  Printed Packaging materials: All packaging material
which have anything printed on it
E.g. labels, medicinal literatures
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10.  Tertiary packaging material : used for bulk handling ,
warehouse storage and transport shipping
E.g. carton boxes
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11. PACKAGING EQUIPMENT
 Packaging equipment carries higher contribution towards
the packaging quality of pharmaceutical product.
 In case of older equipment, they have greater the number
of stages and lower efficiency.
 In modern technology packaging equipment enhances
the productability as well as quality.
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12. PACKAGING LINE LAYOUT
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13. Product feeder
Packaging
material
Weigh check Carton closer
Check Device
Product in carton
(feeder)
Labeling
operation
Device (Product
counter)
Filling
operation
Sealing
operation
Leaflet
inserter
Check Device
Weigh Check
Device
Check DeviceCheck Device
Label Check
Device
Seal Check
Device
13

14. PACKAGING LINE LAYOUT
Layout of packaging line should be:-
Easy to access for operators, operational engineers, and
validation personnel
 Perform line clearance between batches of product as
well as different products
 Cleaning of the line is must be easy and controllable
manner.
 Ability to manage quick change over.
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15. TRAINING OF OPERATORS
 Training of operators and engineers on packaging line is
integral part of equipment installation and qualification.
 Supplier should identified training needs and provide
appropriate training.
 It is important to periodically review training
requirements
 Record of training and experience should be maintained.
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16. VALIDATION
 Packaging validation is establishing documented
evidence, which provide high degree of assurance that a
specific packaging process performed, will consistently
produce a pack, which meets predetermined
specification.
 Validation must be performed by person with the
necessary education, background, training, experience
and qualification.
 Validation program must be documented and approved.
16

17. Pharmaceutical
packaging
validation
Packaging
Equipment
Qualification
Design
Qualification
(DQ)
Installation
Qualification
(IQ)
Operational
Qualification
(OQ)
Performance
Qualification
(PQ)
Packaging
process
validation
PACKAGING VALIDATION
17

18. PACKAGING EQUIPMENT QUALIFICATION
User requirement specification:-
Prepare prior to purchase of equipment
Specification includes
 Purpose of equipment
 Target production rate
 Size & location of equipment
 Safety consideration
 Types of maintenance required
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19. Design Qualification:-
DQ protocols is for conformance of the system to URS and
GMP requirements
Installation Qualification:-
IQ protocol is checklist to ensure that the system or
equipment is properly is properly installed.
In this engineering drawing should be checked and updated as
appropriate.
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20. Operational Qualification:-
OQ protocol will challenge to system to demonstrate that it can
operate within specified parameters.
Challenge the upper and lower operating limits, to test the process
and system.
Performance Qualification:-
PQ should performed in normal daily operation
 Testing of each piece of equipment
 Test interaction between different pieces of equipment
 Test all critical steps.
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21. PACKAGING PROCESS VALIDATION
 Packaging process validation is performed when new
product is being packed for the first time on existing
packaging line, using current or new packaging material.
 Packaging process validation should start with
preparation of protocol called Validation protocol.
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22. VALIDATION PROTOCOL:
 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. 22

23. TESTS PERFORMED BY MEDICAL LAB
 Toluidine blue test:- for detecting seal leaks in porous
medical packaging by dye penetration
 Visual inspection test:- for determining integrity of seals
packaging by visual inspection e.g. of defects: unsealed areas,
non homogeneous area
 Immersion test:- sample is placed in a container filled with
water for 20 sec., it is verified that no air bubbles escape from
the sealing or the packaging.
 Accelerated aging :- packaging samples are placed in the
thermo-regulated chamber at 55°C for accelerated aging.
During the whole aging time, temperature of the chamber is
monitored. After aging, the packaging are tested. 23

24. 24

25. Film delivery (PVC Sheet)
Heat treatment to PVC sheet
Blister forming from PVC sheet
Filler- Tablet filling to blister
Sealing of blister by alluminium foil
Cutting of blister
Rejection system
Secondary Packaging
Printing labeling
details on
Alluminium foil
Alluminium foil
Delivery
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26. BLISTER PACKAGING OPERATION
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27. CRITICAL PARAMETERS OR STEPS
 Optimization of temperature
 Packaging machine speed optimization
 Verification of film forming and sealing temperature
 Verification of packaging machine speed
 Efficiency of tablet feeder
 Blister formation inspection system efficiency
 Printing efficiency
 Blister cutting efficiency
 Blister counting efficiency
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28. SECONDARY PACKAGING
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29. Primary packaging Delivery
Cartonner
Closer / Sticking
Outside labeling
Product passed
Carton Delivery Leaflet Insert
Delivery
Visual checking
system
Visual checking
system29

30. CHECKWEIGHER
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31. CHECKWEIGHER
Primary and/ or
Secondary
Packaging
delivery
Checkweigher
Product passed
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32. BIBLIOGRAPHY
1) Chitlange S. S., Chaudhari P. V., Shirsat A.K., and
Sangshetti J. N., “Pharmaceutical Validation”,
Suyog Publication, 1st edition,2014, Page no. 9.1-
9.11.
2) M.A. Potdar “Pharmaceutical quality assurance”, Nirali
publication, 4 rd edition, 2015, Page no.8.31-8.38
3) Agallow J., Frederick J., “Validation of pharmaceutical
processes” CRC Press, 3 rd edition, Page no.429-442
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