- To lay down a procedure for cleaning of laminar air flow units.
- This SOP is applicable for cleaning of laminar air flow units of Dry Powder Injectable facility.
- Officers or above – Production.
- Production Head Shall be responsible for the implementation and compliance of the SOP.
- LAF : Laminar Air Flow
- SOP : Standard Operating procedure
- Switch off the Laminar Air Flow Unit after completion of day’s activities.
- Wipe the outer surface of Laminar Air Flow Unit with dry lint free mope.
- Clean the outer surface of Laminar Air Flow Unit by wiping with lint free mope soaked in water for injection.
- Clean the outer surface of Laminar Air Flow Unit by wiping with lint free mope soaked in filtered disinfectant solution. Disinfectants used shall be rotated weekly as per SOP.
- Dry the outer surface of Laminar Air Flow Unit by wiping with lint free mope.
- This SOP is applicable for the LAF Units located in following locations:
|Sr. no.||Location||Room Name|
|1||Garment washing area LAF||Garment Washing Room|
|2||Equipment washing LAF||Equipment Washing & Sterilization Room|
|3||Vial washing machine LAF.||Vial washing and sterilization room|
|4||Bung processor cum steam sterilizer LAF||Equipment Washing & Sterilization Room|
|5||Vial sealing machine LAF||Vial sealing Room|
|6||Sampling room LAF||Sampling Room|
- Cleaning of the prefilters of the Laminar Air Flow units is to be done as per SOP on cleaning of prefilter of LAF, Dynamic Pass Box and garment cubicle on monthly frequency or whenever the differential pressure reading on the Magnehelic gauge is found outside the specified limits.
- Record the cleaning details as per SOP on Equipment operation, cleaning & maintenance Log book.
- Forms and Records (Annexures)
- Not Applicable
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
Date Revision Number
Reason for Revision
– 00 New SOP