Class II Biosafety Cabinet - Impact Assessment

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Hello All,

We’re performing an impact assessment for a Class II Biosafety Cabinet.

One of the 7 questions is, “Does the system have direct contact with the product (e.g. air quality)?”

Our thinking is, this is yes. Because the product is exposed to the air (downflow) within the cabinet. If the air wasn’t sterile, then the product would potentially become contaminated.

Hence, we would deem the biosafety cabinet as a direct impact system.

We would appreciate other people’s opinion on this…i.e. is it a direct impact system?

2

Yes typically if the product is exposed to the environment then it would be Direct Impact. Typically the Bio safety Cabinets have IQ and OQ protocols that are executed.