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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,PUNE

Dr. D. Y. Patil Institute of Pharmaceutical Science and Research, Pimpri, Pune

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CONTENT Introduction Of Packaging Characteristics Of Packaging material Role Of Packaging Key Areas That Affects Packaging Process Validation Of Packaging

Packaging Equipment QualificationPackaging Process Validation

Example Of Packaging ProcessBlister Packaging For TabletSecondary PackagingCheckweigher

Bibliography

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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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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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ROLE OF PACKAGING ProtectionAgainst physical damageAgainst biological contaminationsFrom all external influences that can alter the properties of

product Identification of product Convenience in use for medical staff and patient A marketing tool

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SEVERAL KEY AREAS THAT AFFECT PACKAGING PROCESS

Packaging Material

Packaging Equipment

Packaging Line Layout

Training Of Operators

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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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Secondary packaging material: material which comes in contact with primary packaging material

E.g. Paper and card board boxes

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Printed Packaging materials: All packaging material which have anything printed on it

E.g. labels, medicinal literatures

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Tertiary packaging material : used for bulk handling , warehouse storage and transport shipping

E.g. carton boxes

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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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PACKAGING LINE LAYOUT

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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 Device

Check Device

Label Check Device

Seal Check Device

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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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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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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.

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Pharmaceutical packaging validation

Packaging Equipment Qualification

Design Qualification (DQ)

Installation

Qualification (IQ)

Operational

Qualification (OQ)

Performance Qualification(PQ)

Packaging process validation

PACKAGING VALIDATION

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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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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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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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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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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.

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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.

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BLISTER PACKAGING FOR TABLET

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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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BLISTER PACKAGING OPERATION

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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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SECONDARY PACKAGING

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Primary packaging Delivery

Cartonner

Closer / Sticking

Outside labeling

Product passed

Carton Delivery Leaflet Insert Delivery

Visual checking system

Visual checking system

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CHECKWEIGHER

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CHECKWEIGHER

Primary and/ or Secondary Packaging delivery

Checkweigher

Product passed

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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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