1.0 Purpose: To lay down the procedure for cleaning and storage of filling accessories.
2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and storage of filling accessories at the production department.
3.0 Responsibility:
3.1 Operator shall carry out the operation process.
3.2 Officers shall be responsible to supervise the process.
3.3 Head Production/ Designee shall be responsible for the implementation of SOP.
3.4 Head-QA shall be responsible for overall compliance with SOP.
4.0 Safety Consideration.
4.1 Wear safety equipment (goggles, Gloves, and mask) While handling the hot WFI.
4.2 Take care while handling the glass accessories.
5.0 Procedure:
5.1 Cleaning of filling accessories:
5.1.1 Clean as per SOP “cleaning of filling accessories for sterilization“.
5.2 Storage of filling accessories:
5.2.1 After drying, pack the filling accessories in star pack pouches with the help of the pouch sealing machine individually and paste the status label “CLEANED” as per the “Status labeling” SOP.
5.2.2 Transfer the star pack pouches containing washed filling accessories to the change part items store.
6.0 Abbreviations:
QA: Quality Assurance
SOP: Standard Operating Procedure
DPB: Dynamic Pass Box
LAF: Laminar Air Flow
WFI: Water for Injection
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