1.0 Purpose: To lay down a procedure for the preparation of Aluminum Seals.
2.0 Aim: This Standard operating procedure is applicable for the preparation of Aluminum Seals in the Production area.
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 Production Manager/designee shall be responsible for the implementation of SOP.
3.4 Head of Quality Assurance/designee shall be responsible for ensuring compliance with this SOP.
4.0 Safety Considerations:
4.1 Wear safety equipment (goggles, gloves, and masks) during the process.
5.0 The Equipment:
5.1 Bung Processor cum Autoclave
5.2 LAF (Laminar Air Flow)
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 and preparation of 70% IPA
7.1 Bring the approved and issued corrugated boxes of Aluminum seals in front of the material airlock.
7.2 Open the corrugated boxes with the help of a cutter/ scissors and take out the Polybags 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 in the area from the dynamic pass box.
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 packed the seals in steri pouches in small lots under a laminar flow station, in quantities as per requirements.
7.7 Stack the bags on the shelves of Bung Processor cum Autoclave.
7.8 Sterilize Aluminum seals.
7.9 After completion of the cycle unload the steri pouches at the Buffer zone under LAF.
LAF: Laminar Air Flow
ID No. : Identification Number
SOP: Standard Operating Procedure
IPA: Iso Propyl Alcohol
DPB: Dynamic Pass Box