Air recoveries of between 11 to 20 CFUs are consistently made in a facility’s ISO 7 anteroom and are identified to be typical of human skin flora. HEPA leak testing and certification of the room is performed and passes. The surface testing in the room consistently exhibits little to no growth. Which of the following is true?

Question

A. No further action is needed because 11 is still close to the action level
B. They should clean and resample until passing results are obtained
C. An investigation must be performed because the action level is exceeded
D. HEPA filters should promptly be changed
E. The facility should switch from using a sporicidal agent for material disinfection to sIPA exclusively
F. The facility should install a free-standing air purifier for additional filtration
G. Assessment of the technique and process used for collecting air samples should be performed to verify if contamination of the sample is being made during collection
H. c and g

Answer 1

The correct answer is H. c and g.

Here's the reasoning:

• C. An investigation must be performed because the action level is exceeded: If consistent air recoveries of 11 to 20 CFUs are being observed, and depending on the established action levels for that facility, an investigation may be warranted. If the action level for CFUs in an ISO 7 environment is exceeded, it necessitates further inquiry into the source of those CFUs, especially since they are concerning human skin flora.

• G. Assessment of the technique and process used for collecting air samples should be performed to verify if contamination of the sample is being made during collection: It’s critical to assess the sampling technique to ensure that the CFU counts are not artificially elevated due to contamination during the sampling process.

Therefore, both actions—conducting an investigation because the action level is approached/exceeded and assessing the sampling technique—are necessary responses to the observed data in the ISO 7 anteroom.