Separate HVAC Unit for Microbial Lab

Dear Members,
Based on EU- GMP or PICs is that mandatroy to consider separate air-handling units for microbiological laboratory (ies) other than those for supplying other laboratories i.e. physicochemical Lab and office? Any suggestions would be appreciated.

I think the main question is where is the air coming from? Are there returns from the lab, which could mix with fresh air before being pumped to other areas? When doing “segregation” assessment for areas with sensitive chemicals, always discuss the air supply (returns location, returns filtering, fresh air, and roof exhaust location). For example if the exhaust on the roof is near an intake, you might have two air handlers, but they are definitely mixing air.

Overall there is guidance for any highly sensitizing agent such as a beta lactam (penicillin). But that is the highest risk. I’m less sure about other guidances. But it should be designed based on a risk-based approach.

Please note that most labs and manufacturing areas are supplied with HEPA air, while most offices are not. Also there are typically no HEPA filters on returns, unless you design them in due to possible contamination issues that need to be mitigated (for the scenario you have described). Anyway HEPAs might not be small enough pore size to filter out chemicals anyway, depending on the chemical.

Can the air be mixed with other labs? Maybe. Can the air be mixed with offices? Ask yourself if you want your lab’s exhaust air blowing on your head all day, and you’ll probably have the answer. (Again the air might not have bad chemicals in it, so it may be fine).