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Senior Member
Posts: 1
Registered: ‎01-03-2017

Viable Air Sampling Results for ISO 7 Buffer Room

We recently underwent our biannual recertification for our cleanroom and 2 air samples exceeded action levels in our hazardous buffer room. The results indicated 12 cfu microccocus and 14 cfu micrococcus. Repeat testing revealed 14 cfu microccocus in one location. In reviewing the micro report, it appears that only 500 L of air was sampled and the CFU number recovered was doubled to calculate the CFU/L. Is this appropriate? The room contains a BSC, has 113 ACPH, -.07 pressure dif. We have recleaned the room with decon spore. Looking for advice on how to further remedy this. 


Eric Ferro, PharmD, BCPS

Posts: 28
Registered: ‎03-04-2011

Re: Viable Air Sampling Results for ISO 7 Buffer Room

Eferro98 ( green sports car) Reccomend retesting "using an active air sampling device,  test at least 1 cubic meter or 1,000 liters of air from each area sampled."  If your actionable cleaning was appropriate, you should pass. If not it may be worth re-writing the plan.


Good Luck


Blueman2 ( the shark)