SOP on cleaning of Aspirator assembly and disposal of waste raw material collected during filling operation.

December 19, 2019January 28, 2023 Pharma Editor

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

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