1.0 Purpose: To lay down a procedure for the preparation of rubber bungs.
2.0 Aim: This Standard Operating Procedure is applicable for the preparation of rubber bungs.
3.0 Responsibility:
3.1 Operator/ Sr. Operator is responsible for carrying out the operation process.
3.2 Officers/Executives shall be responsible to supervise the process.
3.3 Production-Head/Manager shall be responsible for the implementation of SOP.
3.4 Head-Quality Assurance shall be responsible for final approval and compliance of the SOP.
4.0 Safety Consideration:
4.1 Take care while handling the Ready For Sterilization rubber bung pack.
4.2 Always Open the Steri Pack under LAF.
4.3 Do not damage or prink the rubber bung pack.
5.0 Procedure:
5.1 Bring the approved and issued corrugated boxes of ready for sterilization rubber bungs to the Passage/ corridor area
5.2 Open the corrugated boxes with the help of a cutter/ scissors and take out the Poly bags containing the ready for sterilization rubber bungs.
5.3 Prepare the 70 % IPA solution to the Disinfectant.
5.4 Clean and disinfect the outer surface of poly bags with the help of 70 % IPA v/v.
5.5 Transfer the poly bags from the dynamic pass box.
5.6 Carry the boxes to Rubber Stoppers, Seals Preparation area.
5.7 Apply 70% IPA v/v on the surface of the Polybag.
5.8 Carefully cut the outer poly bag with the help of scissors.
5.9 Apply 70 % IPA v/v on the surface of the inner poly bag.
5.10 Stack the bags in the full carriage of Bung Processor cum Autoclave.
5.11 Sterilize rubber bungs as per SOP “Preparation material for sterilization“.
5.12 After completion of the cycle unload the carriage at the Buffer zone area.
6.0 Abbreviations:
HOD: Head of the Department
SOP: Standard Operating Procedure
IPA: Iso-Propyl Alcohol
v/v: Volume By Volume
LAF: Laminar air flow
%: Percentage
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