Hi,

I’m working on a project of clean room building for R & D use and I need advices about environmental monitoring. We plan to build a 100m2 clean room, grade B or C according to BPF (equivalent GMP) depending on the conditions of use.  We are interested in getting rapid results of airborne contamination but we don’t know how we should perform the controls. Can anyone give feedbacks/information?

Thank you in advance,

Claire

We also had such issues in my lab. We needed to perform rapid analyses of biological contamination. We also wanted to asses the non cultivable flora. After testing several equipments we chose the Coriolis air sampler because it was easy to use and gave good result. With this method, airborne particles are concentrated into a liquid media, which allows getting results in few hours by skipping to the incubation period.

Hope that helps.
Andreas

Thank you for your help.
It helps me to understand what kind of analysis I have to perform.

You need to understand what type of air borne viable you are trying to resist and then get some Agar settlement plates loaded with the correct bio culture for placement in the process.

These will then be placed in strategic places after room construction and cleandown. The correct location will be defined by doing an assessment into the most Hazardous part of the process (HACCP) . Hazard Analysis Critical Control Point. 

You then need to have the cultures processed by a bio lab to establish the background bio burden. You will repeat this a few times to identify and fix their hot spots before start up.

When in action you can use an automatic airborne impinger sampler to monitor their process in terms of cfu. sq deci.m.  Its  a very complicated process and they have to keep strict records of all their results, including the straight forward particle counts.

Regards,
Dick Gibbons (committee member of the BSI LB I 30 in the UK and convenes 14644 part 8 and 10 for Chemical contamination)