SOP on cleaning of Aspirator assembly and disposal of waste raw material collected during filling operation.
- Objective
- To lay down the procedure for cleaning of aspirator assembly and disposal of waste raw material collected during filling operation.
- Scope
- This SOP is applicable for cleaning of aspirator assembly and disposal of waste raw material in Dry powder Injectable facility.
- Responsibility
- Officers or above (Production) shall be responsible for cleaning of Aspirator assembly and disposal of waste raw material collected during filling operation.
- Accountability
- Production-Head shall be accountable for the compliance of the SOP.
- Abbreviations
- SOP : Standard Operating Procedure
- Procedure
- Aspirator assembly is used for collection of waste raw material from the pistons of filling machine through vacuum system.
- Remove the SS container and vacuum filter from the Aspirator assembly.
- Transfer the SS container and vacuum filter to equipment washing and sterilization room LAF Unit through dynamic pass box in filling room and in cooling Room.
- Clean and sanitize the Aspirator assembly by wiping with Lint free duster soaked in 20% Virosil Pharma.
- Collect waste raw material from SS container in a polybag, also collect waste raw material from the vacuum filter by gentle tapping with hand.
- Prepare 2% NaOH solution in a container and dip SS container and vacuum filter in it for 30 minutes.
- After 30 minutes drain the waste solution to ETP through drain point No IV in equipment washing and sterilization room.
- Wash the SS container and vacuum filter under running purified water to remove any remnants of previous product.
- Dry the vacuum filter by using compressed air in equipment wash and sterilization room.
- Sterilize the SS container and vacuum filter in filling machine parts load as per Sop on sterilization of vial filling & bunging machine parts (PI-SP-059).
- Bring the sterilized SS container and vacuum filter to filling room through Dynamic pass box and reassemble it to Aspirator assembly.
- Deactivate waste raw material by mixing with 2 % NaOH solution and drain the contents to ETP through drain point No IV in equipment wash and sterilization room.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision
– 00 New SOP
