1.0 Purpose: To lay down the procedure for cleaning and preparation of filling machine accessories for sterilization.
2.0 Applicable: This Standard Operating Procedure is applicable for the cleaning and preparation of filling machine accessories for sterilization on the Production Floor.
3.0 Responsibility:
3.1 The operator shall carry out the cleaning and preparation process.
3.2 officers/Executives shall supervise the process.
3.3 Manager Production for implementation of SOP.
3.4 Head QA shall be responsible for the final authorization for compliance with this SOP.
4.0 Procedure:
4.1 Cleaning of filling accessories in case of Batch to Batch:
4.1.1 Receive the used filling accessories in the washing area through the dynamic pass box connecting to the respective washing area.
4.1.2 Paste the status label “TO BE CLEANED”.
4.1.3 Dip the filing accessories (which are directly in contact with the product) in 1N NaOH for 40 to 45 minutes.
4.1.4 Clean the glass accessories first with purified water and then wash the remaining accessories.
4.1.5 Wash the inner as well as the outer surface of filling accessories with high pressure of purified water.
4.1.6 Second wash the filling accessories with hot WFI from the outer and inner surfaces.
4.1.7 Send the final wash rinse sample to QC for testing.
4.1.8 Keep the cleaned accessories in racks.
4.1.9 If any one of the tests fails follow the cleaning steps again till to comply.
4.1.10 After getting the release report from QC paste the label in accessories “CLEANED”.
4.1.11 Pack all the accessories.
4.1.12 Keep the filling accessories under LAF for the next batch.
4.2 Cleaning of filling accessories in case of Product to Product:
4.2.1 Repeat step no 4.1.1 to 4.1.6
4.2.2 Then keep the washed accessories in the decontamination autoclave for decontamination as per SOP “decontamination autoclave“.
4.2.3 Repeat Step no. 4.1.4 to 4.1.12.
4.3 Preparation of filling accessories:
4.3.1 Prepare and pack the filling accessories.
4.3.2 Sterilize the filling accessories as per SOP “Packing of material for sterilization“.
4.3.3 Unload the sterilized machine parts and keep them under LAF.
4.3.4 If the material remains unused for 48 hours it should be sent back to the preparation area for repacking & sterilization.
4.4 Storage:
4.4.1 If the filling accessories are not in use then they should be stored in racks along with the status label as per SOP.
4.4.2 Before sterilization go for final rinse with WFI and pack in steri pouch with the help of pouch sealing machine.
5.0 Abbreviations:
No. : Number
QA: Quality Assurance
Rev.: Revision
SOP: Standard Operating Procedure
LAF: Laminar Air Flow
WFI: Water For Injection
QC: Quality Control
DPB: Dynamic Pass Box
PR: Production
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