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SOP for Preparation of Aluminum Seals at Vaccine Formulation

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Standard Operating Procedure for Aluminum Seals used in production floor at Vaccine Formulation Plant.

SOP for Preparation of Aluminum Seals

1.0 Purpose:

To lay down a procedure for the preparation of Aluminum Seals.

2.0 Applicable:

This procedure is applicable for the preparation of Aluminum Seals at the Production Floor of the Vaccine Formulation Plant.

3.0 Responsibility:

3.1 The line coordinators who are trained in the processes shall carry out the operation process.
3.2 Officer / Sr. Officer shall supervise the process.
3.3 The Production Manager/designee shall be responsible for the implementation of SOP.
3.4 The head of Quality Assurance/designee shall be responsible for ensuring the compliance of the SOP.

4.0 Safety considerations:

4.1 Wear safety equipment (Goggles, Gloves, and mask) during the process.

5.0 Equipment:

5.1 Bung Processor cum Autoclave
5.2 LAF
5.3 Box cutter, scissors
5.4 Dynamic Pass Box
5.5 Pouch sealing machine

6.0 Materials and reagents:

6.1 Filtered 70% IPA

7.0 Procedure FOR for Preparation of Aluminum Seals:

7.1 Bring the approved and issued corrugated boxes of Aluminum seals to the corridor in front of the material airlock.
7.2 Open the corrugated boxes with the help of a cutter/ scissors and take out the Poly bags containing the aluminum seals.
7.3 Clean and disinfect the outer surface of poly bags with 70% filtered IPA.
7.4 Transfer the poly bags from the dynamic pass box as per SOP.
7.5 Carry the boxes to Rubber Stoppers, Seals Preparation area.
7.6 Cut the poly bags with the help of a cutter/ scissors and pack the seals in steri. pouches in small lots under the laminar flow station, in quantities mentioned below
13mm Flip off seals > 2500 seals/pack
20mm Flip off seals > 1500 seals/pack
7.7 Stack the bags on the shelves of the Bung Processor cum Autoclave as Per SOP.
7.8 Sterilize Aluminum seals as per SOP.
7.9 After completion of the cycle unload the steri pouches at Buffer zone under LAF.

8.0 Distribution:

Master Copy – Archived with Quality Assurance Department
Controlled Copy – Production Department
Subsequent controlled copies – Department (s) making requisition

9.0 Abbreviations:

LAF: Laminar Air Flow
ID No. : Identification Number
Rev.: Revision
SOP: Standard Operating Procedure
IPA: Iso Propyl Alcohol
DPB: Dynamic Pass Box
EQP: Equipment

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