Laminar Air Flow Operating Procedure; Purpose
To confirm that the air are free from any microorganisms and any particle in order to favor of microbiological test.
Laminar Air Flow Operating Procedure; Scope
This SOP applies for operation and cleaning of Laminar Air Flow, Model: AHC-4D1 in Microbiology Section at XX Pharmaceuticals Ltd.
Definitions/Abbreviations
[] DOP: Dioctyl Phthalate
[] HEPA: High Efficiency Particulate Air
[] LAFWS: Laminar Air Flow Work Station
[] LAF: Laminar Air Flow
[] PAO: Poly-alpha-olefin
Responsibilities:
The roles and responsibility is as follows
Executive/ Senior Executive, Microbiology
Operation, cleaning and disinfection and daily performance check.
Manager, Microbiology
- Confirm Operation, cleaning and disinfection and performance checking.
- Confirm that SOP is technically informative & application of sound knowledge.
- Confirm that Laminar Air Flow is suitable for working.
Head of Quality Assurance
Take initiative to Approval of SOP
Procedure:
Instructions
- Do not wipe HEPA filter side of LAFWS.
- Do not move rapidly in a sweeping motion during operation of LAF to minimize air turbulence.
- Do not use any disinfectant containing chlorine-based substances as this may be corrosive of the stainless steel.
- Do not use Bunsen burner & aerosol generating instruments whenever possible as they interfere with airflow.
- Do not turn on UV lamp without the front cover setting.
Operating Procedure:
- Switch on the main power.
- Set the front cover & make sure that the clean bench is fully closed & the interlock is working effectively.
- Press UV/Exit button to turn on the UV lamp. UV can only be turned on when fan and light both are off.
- Wait for around 60 minutes.
- After 60 minutes, remove front cover from LAFWS.
- Turn on Fan/Up button to start fan.
- Press to turn on Light/Down to illuminate light.
- To turn electrical socket of inner cabin, Press Socket/Set button
- Use 70% Ethanol/IPA to wipe the work surface.
- Before continuing the work, Leave LAF for 10 minutes
- After 15 minutes, wipe all materials with 70% ethanol before bringing them inside the LAF Hood.
- Start the work.
- Work in cleaned bench in a slow & controlled manner.
- Move hands in & out of the work zone opening slowly.
- Use 70% ethanol to wipe again the entire platform after end of the work,
- Press Fan/Up button to turn off the fan.
- Press Light/Down Turns off the light.
- Set front cover and press UV/Exit button to turn on the UV lamp to decontaminate the work bench.
- Switch off the UV/Exit to turn off the UV lamp after 30 minutes.
Cleaning Procedure
Work surface and wall
Clean work surface & walls with appropriate 5% Dettol/ Savlon solution.
Exterior surface
- Use a damp cloth to clean the exterior surface, predominantly on the front & top in order to remove dust that accumulated there.
- Use fresh with Sterile Purified Water (which is sterilized at 1210C for 15 minutes or filtered by 0.2 µm) to eliminate any remaining of cleaning agent.
- Use MEK (Methyl-Ethyl-Ketone) solution to eliminate stubborn stains or spots on the stainless steel surface. In such cases, wash the stainless steel immediately afterwards with clean water and liquid detergent. Then use polyurethane cloth or sponge for washing.
Microbiological Performance Check
- Check performance of HEPA filter by monitoring Particle count & Microbial count before conducting sterility test.
- For non-sterile preparation, check performance of HEPA filter by monitoring the particle count & microbial count in every six months.
HEPA Filter Integrity Test
- Check efficiency of HEPA filter by DOP (Dioctyl Pthallate)/PAO(Poly Alpha Olefin) test once in a year.
Maintenance
- If LAF exhibits any mechanical, electrical or any others difficulty, notify to the supplier or Engineering Department for repairs.