1.0 PURPOSE:
2.0 SCOPE:
This procedure is applicable for operation and cleaning of mobile LAF trolley in injectable area of (Company name).
3.0 DEFINITION:
A Mobile LAF (Laminar Airflow) Trolley is a portable unit used in the pharmaceutical industry to ensure a sterile environment for handling sensitive products. It provides ISO Class 5 cleanliness with HEPA-filtered airflow, protecting against contaminants. Commonly used for aseptic material transfer, garments, sampling, and dispensing. Equipped with wheels, it supports GMP compliance and enhances flexibility in sterile operations outside fixed cleanrooms.
4.0 RESPONSIBILITY:
4.1 Production Operator is responsible to follow the SOP.
4.2 Production Officer/Executive is responsible for execution of the procedure.
4.3 Head-Production is responsible to ensure the compliance of the procedure.
5.0 PROCEDURE:
5.1 Precautions and instructions:
5.1.1 Only trained persons are allowed to do the operation & cleaning the mobile LAF trolley.
5.1.2 Ensure that mobile LAF trolley is cleaned prior to use.
5.1.3 Ensure that UPS of mobile trolley is properly charged before use.
5.1.4 After unloading of sterilized items (garments, goggles etc.) before shifting mobile LAF trolley from one area to other area, close its door properly.
5.1.5 During loading or unloading of the sterilized articles from mobile LAF trolley, disinfect the hands with 70% IPA.
5.2 Operations:
5.2.1 Before start of mobile LAF trolley ensure that magnehelic gauge shows “0” reading.
5.2.2 Switch “ON” the mobile LAF trolley 30 minutes before start of activity. Ensure that differential pressure across HEPA filter is in between 7-15 mm of WC.
5.2.3 Plug the power cable in the power socket and switch it “ON”
5.2.4 Switch on “Motor blower” button to run the blower system and hence the air flow starts and the motor blower light will glow. Use the same button to turn off the blower system and hence the air flow stops.
5.2.5 The reading on magnehelic gauge indicates differential pressure across the HEPA filter.
5.2.6 Open the door of the mobile LAF trolley, load the garments in the mobile trolley.
5.2.7 Transfer the mobile LAF trolley to critical area air lock room and unload the sterile garments and goggles etc. in to the dynamic pass box present between change room & air lock. During transfer, mobile trolley should run on UPS mode
5.2.8 Transfer the garments from the mobile LAF trolley to the garment cubicle.
5.2.9 Close the door of mobile LAF trolley and take it to the cooling zone. After usage give connection of main power supply to mobile LAF trolley for charging of UPS / Battery.
5.3 Cleaning procedure:
5.3.1 During cleaning never, touch the HEPA filter with any sharp object.
5.3.2 Ensure that the main supply of the mobile LAF trolley is “OFF” before starting of cleaning activity.
5.3.3 Open the door and remove all the sterilized garments, booties and goggles etc. and transfer them to under ceiling mounted LAF or garment cubicle.
5.3.4 Clean shelves with lint free cloth dipped in filtered scheduled disinfectant solution; keep it for validated contact time (10 minutes). Then clean the shelves with lint free cloth dipped in water for injection followed by dry lint free cloth.
5.3.5 Clean the inner surface, glass door and outer surface of mobile trolley with lint free cloth dipped in filtered scheduled disinfectant solution, keep it for validated contact time (10 minutes). Then clean with lint free cloth dipped in water for injection followed by dry lint free cloth.
5.3.6 Record the differential pressure across HEPA filter.
5.3.7 Record the usage and cleaning details.
6.0 ABBREVIATIONS:
SOP : Standard Operating Procedure
UPS : Uninterrupted Power Supply
LAF : Laminar Air Flow
HEPA : High Efficiency Particulate Air
Mm : Milli meter
WC : Water Column