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Occasional Visitor
Posts: 1
Registered: ‎10-07-2010

Initial surface sampling requirement

Does the initial surface sampling and post-media fill fingertip sampling need to have zero cfu in order to pass?  I understand (and it is very clear in 797) that the initial 3 fingertip samplings that occur immediately after donning sterile gloves must have zero cfu in order to pass.  However, the language is less clear regarding the surface sampling that occurs after the compounding procedure and the fingertip sampling that occurs after completing the media fill.  Again, my question only relates to the initial training of personnel - I believe the chapter clearly sets a passing requirement of >3cfu for the follow-up samplings.

Thanks, eric

Posts: 1,168
Registered: ‎02-23-2010

Re: Initial surface sampling requirement



Thanks for the email.  Once all of the initial qualification activities are completed successfully, the surface sampling after compounding procedures and fingertip sampling after a media fill defaults to the suggested CFU count (>3 is an actionable finding) found in the chapter.  Eric K's opinion-->You don't want to find any CFUs in the hood.  The fingers should be at zero or 1.   The language in the USP needs to streamlined.  Hope this helps.  

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Frequent Advisor
Posts: 61
Registered: ‎05-18-2011

Re: Initial surface sampling requirement

In this line of questions, USP 797 is clear on finger tip incubation (p 30 of 63 in USP 797 chapter). It also specifically states the incubation period for media fill (same page), But under surface sampling (page 31 of 63), it does not specifically state incubation requirements. Is this the same as for glove tips (30-35degrees for 48-72 hours.) It does not specifically state in the article in the Clinical Microbiology newsletter "Microbial Monitoring in the Pharmacy" which is a great reference. I have a meeting with our network lab director and pharmacy director in Jan and I want to have all my info solid.

Thanks. The lab has agreed to incubate the plates for our network and I want to have definitive information for them.