Follow
Objective: To provide a written procedure for the checks done in the Autoclave area prior to start-up.
Scope: This SOP shall be applicable for Autoclave Area.
Associated Documents: Form No. PP002-01, Daily Cleaning Report for General Production Area
Responsibility:
1. ngineering Officer/Assistant Engineering Officer shall be responsible for the checks in the Autoclave area.
2. Sr. Asst. Manager, Engineering or his/her Designee shall be accountable for the training and implementation of the procedure.
Abbreviations: Not applicable.
Precautions: Not applicable.
Procedure:
1. The Autoclave area shall be cleaned as per Form No. PP002-01.
2. Prior to start-up, the responsible officer shall complete a visual check of the following:
Non-Sterile Product Staging Area:
1. Ensure that all trolleys, which have been returned from the packaging area are empty, freely running on the rail (if jammed change the wheel) and their identification labels have been removed.
2. Also, check that the area is cleared of any bottles from the previous sub-lot (part) or lot (batch). If any such bottle is found discard it.
Autoclave Chamber:
1. Ensure that the chamber is cleaned and cleared of all trolleys and bottles. The Autoclave has been issued “CLEANED” status label (Label PA003-02).
2. Upon completion of the checks the operator fixes the display board hanged on the Sterilizer.
3. Information are received from the batch production record with the following information :
=>> Product Name
=>> Bottle size
=>> Batch Number
=>> Part Number
=>> Date
4. Before starting the operation the Responsible Officer shall make a final inspection, checks as per Form No. PA003-01
Sterile Product Staging Area:
1. Ensure that all staged trolleys, having sterilized products, which are awaiting packaging, are identified with Autoclave indicator tapes.
