Biosafety Cabinet; Purpose
To establish the ideal operation of Bio-safety Cabinet to confirm that the air are free from any microorganisms & any particle in order to favor microbiological test.
Biosafety Cabinet; Scope
This SOP applies for operation of Bio-safety Cabinet, Model: AC2-4E1 in Microbiology Section at XX Pharmaceuticals Limited.
Definitions
- BSC : Bio-safety Cabinet
- DOP : Dioctyl Phthalate
- HEPA : High Efficiency Particulate Air.
- IPA : Iso Propyl Alcohol.
- PAO : Poly alpha olefin.
Responsibilities
The roles and responsibility is as follows
Executive, Microbiology
Operation, cleaning & disinfection and performance checking of Bio-safety Cabinet
Manager, Microbiology
- Ensure Operation, cleaning & disinfection, performance checking and application of sound technical information.
- Review that SOP is technically informative.
Head of Quality Assurance
Take initiative to Approval of SOP
Procedure:
Instructions
- Do not wipe HEPA filter side of BSC.
- Do not turn on UV light without full cover of slash.
- Move always gently during operation of BSC to minimize air turbulence.
- Care should be taken that water do not enter into HEPA filter through working station of down flow.
Operating Procedure
- Press UV light button to turn on the UV light.
- Wait for 30 minutes.
- Press light button to turn on.
- Pull up front slash at 50% open position. Open position (%) will be indicated on the display.
- If show alarm, adjust position of slash.
- Press FAN button to start up and wait for 3 minutes.
- After 3 minutes, fan will be automatically started and
- Use 70% ethanol/IPA to wipe all the surfaces of workstation, except in front of HEPA filter.
- Use 70% ethanol to wipe all materials (Glassware’s, containers and other articles) before bringing them inside the Bio-safety Cabinet.
- Start the work.
- Use 70% ethanol to wipe again entire platform after finishing work.
- Press light button to turn off.
- Pull down to cover front slash at 0% open position. Open position (%) will be indicated on the display.
- Press UV light button to turn on the UV light
- Wait for 30 minutes to disinfect the whole cabinet.
- After 30 minutes, press UV light button to turn off.
- Disconnect the power plug of the cabinet.
Performance Check
- Check the performance of HEPA filter by monitoring the Particle count and Microbial count once in a year and prepare the report in Annexure-I & Annexure-II
- Check efficiency of HEPA filter by DOP/PAO test once in six months and prepare the report in Annexure-I & Annexure-II
Maintenance
- Inform to the supplier or Engineering Department for maintenance, if Bio-safety Cabinet shows any mechanical, electrical or any others fault.
- After maintenance, check HEPA filter efficiency & monitor Particle Count and microbial count.