- Objective:
- To lay down a procedure on operation and cleaning of sterile garment cubicle.
- Scope
- This SOP is applicable for the operation and cleaning of sterile garment cubicle.
- Responsibility
- Officers or above – Production.
- Accountability
- Production Head.
- Abbreviations
- SOP : Standard Operating Procedure.
- LAF : Laminar air flow
- U.V. : Ultra violet
- Procedure
- Operation:
- Sterile garment cubicle is installed between the change room and cooling zone of sterile area and is used to keep the sterile garments, sterile mopes and goggles.
- Switch on the blower and U.V. light from the front panel switches, 30 minutes before the start of activities.
- Check the interlocking of doors is working properly.
- Ensure that megnehelic gauge reading is within the specified limits of 8 to 15 mm of water.
- To load the sterile dress/goggles/sterile mopes press the door open switch on the front panel of the cubicle from the cooling room side.
- After loading close the doors of the cooling room side.
- To unload the sterile dress/goggles/sterile mope press the door open switch on the front panel of the cubicle from the third change room side.
- After unloading close the doors of the third change room side.
- Record the UV burning hours and differential pressure in the format (specimen attached with Annexure-1).
- Cleaning of the garment cubicle.
- Cleaning of the sterile garment cubicle is to be done daily before the start of activities.
- Remove any material from the sterile garment cubicle.
- Clean and sanitize the entire sterile garment cubicle with lint free mope soaked in 20 % verosil pharma.
- In case of any material is to be kept in the garment cubicle, wait for at least 30 minutes before loading it.
- Check the differential pressure and if found outside the limits (8 mm to 15 mm of water) clean the pre filters as per SOP on cleaning of Pre-filters of LAF Unit ,Garment cubicle, Dynamic pass box.
- Forms and Records (Annexures)
- Record of differential pressure and Burning hours of U.V Light (Sterile Garment cubicle) – Annexure-1
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision
– 00 New SOP
Annexure-1
Record of differential pressure and Burning hours of U.V Light (Sterile Garment cubicle)
| Date | Differential pressure
In mm of water |
No of hours burnt | Cumulative hours burnt | Done by | Checked by | Remarks |
