VALIDATION OF BLISTER PACKAGING MACHINE PV

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instrument validation

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VALIDATION OF BLISTER PACKAGING MACHINE:

VALIDATION OF BLISTER PACKAGING MACHINE PRESENTED BY: ANUJA JAGTAP (QAT) GUIDED BY: DR.V.P.PATEL 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 1

CONTENT:

CONTENT Validation Packaging Equipment Qualification Blister packaging for tablets Blister Packaging Operation Critical parameters or Steps Blister packaging Blister packaging component Blister packaging machine Strip packing References 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 2

VALIDATION:

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. 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 3

Packaging Equipment Qualification:

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 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 4

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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 installed. In this engineering drawing should be checked and updated as appropriate. 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 5

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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. 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 6

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BLISTER PACKAGING FOR TABLET 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 7

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3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 8

Blister Packaging Operation:

Blister Packaging Operation 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 9

Critical parameters or Steps:

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 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 10

Blister packaging::

Blister packaging: 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 11

i] Blister packaging component…:

i] Blister packaging component… The forming film (Forming films account for approximately 80–85% of the blister package) The lidding material (liding materials make up 15–20% of the total weight of the package) Heat seal coating The printing ink 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 12 The four basic components of pharmaceutical blister packages are;

Ii] Blister packaging machine…:

Ii] Blister packaging machine… 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 13 I) Thermoform Blistering machine: Example : ALU-PVC machine

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II] Cold Forming Blistering machine: Example: ALU-ALU Machine Operation sequence involves; 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 14

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3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 15 1. Bottom foil uncoiler 6. Cover foil uncoiler 11. Discharge conveyor 2. Cold forming station 7. Cooling & slitting 3. Feeding device 8. Draw Off 4. Empty checker 9. Punching 5. Sealing & Embossing 10. Waste foil coiler

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3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 16 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

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3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 17 FIG 3:Thermo-cold forming Machine

Strip packing: :

Strip packing: 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, polyvinylchloride. 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 18

References:

References Pharmaceutical validation master plan by Sayed Imtiaz Haider, St. Lucie Press www.ijpqa.com 3/23/2017 VALIDATION OF BLISTER PACKAGING MACHINE 19

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