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Frequent Advisor
pattik
Posts: 29
Registered: ‎05-18-2011

Glove tips for isolators

For clarification, the plates we use for finger tips and surface sampling are from Valiteq. We chose these plates because based on the literature from the company, they do only needed to be incubated at RT and did not require the use of an incubator, making it easier for us. The instructions from the company state to incubate them at RT (23-25 degrees centigrade) as follows: 48 hrs, 96hr, 1 week and 2 weeks. The company instructions do state that these can be used for surface sampling and glove tips. From Valiteq website:

"Contact plates contain tryptic-soy agar for direct sampling of surface bacterial and fungal microbial contaminants. Fast, efficient, press and cover for sampling of compounder glove tips and environmental surfaces."

My question is exactly how long to finger tips have to be incubated? I have reviewed a lot of literature from previous webinars and I see that it states to incubate glove tips for only 48 hours. This would help a great deal if glove tips are only incubated 48 hours. Please clarify the correct incubation time for glove tips and surface sampling as well.  Thanks!! PAtti

Expert
EricKastango
Posts: 568
Registered: ‎02-23-2010

Re: Glove tips for isolators

Patti,

 

It is best to refer to the chapter (USP 797) for specific direction.  It states:

 

Air Sampling Frequency and Process—Air sampling shall be performed at least semiannually (i.e., every 6 months) as part of the re-certification of facilities and equipment. If compounding occurs in multiple locations within an institution (e.g., main pharmacy, satellites), environmental sampling is required for each individual compounding area. A sufficient volume of air shall be sampled and the manufacturer's guidelines for use of the electronic air sampling equipment followed. Any facility construction or equipment servicing may require that air sampling be performed during these events. Incubation Period—At the end of the designated sampling or exposure period for air sampling activities, the microbial growth media plates are recovered and their covers secured (e.g., taped), and they are inverted and incubated at a temperature and for a time period conducive to multiplication of microorganisms. TSA should be incubated at 30 to 35 for 48 to 72 hours. Malt extract agar or other suitable fungal media should be incubated at 26 to 30 for 5 to 7 days. The number of discrete colonies of microorganisms are counted and reported as cfu and documented on an environmental sampling form. Counts from air sampling need to be transformed into cfu per cubic meter of air and evaluated for adverse trends.

Gloved Fingertip Sampling—All compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (zero cfu) no less than three times before initially being allowed to compound CSPs for human use. Immediately after the compounding employee completes the hand hygiene and garbing procedure (e.g., donning of sterile gloves prior to any disinfection with sterile 70% IPA), the evaluator will collect a gloved fingertip and thumb sample from both hands of the compounding employee onto appropriate agar plates by lightly pressing each fingertip into the agar. The plates will be incubated for the appropriate incubation period and at the appropriate temperature (see Incubation Period). After completing the initial gowning and gloving competency evaluation, re-evaluation of all compounding personnel for this competency shall occur at least annually for personnel who compound low- and medium-risk level CSPs and semi-annually for personnel who compound high-risk level CSPs using one or more sample collections during any media-fill test procedure before they are allowed to continue compounding CSPs for human use. Immediately prior to sampling, gloves shall not be disinfected with sterile 70% IPA. Disinfecting gloves immediately before sampling will provide false negative results. Plates filled with nutrient agar with neutralizing agents such as lecithin and polysorbate 80 added shall be used when sampling personnel fingertips. Personnel shall “touch” the agar with the fingertips of both hands in separate plates in a manner to create a slight impression in the agar. The sampled gloves shall be immediately discarded and proper hand hygiene performed after sampling. The nutrient agar plates shall be incubated as stated below (see Incubation Period). Results should be reported separately as number of cfu per employee per hand (left hand, right hand). The cfu action level for gloved hands will be based on the total number of cfu on both gloves, not per hand. Incubation Period—At the end of the designated sampling period for compounding personnel competency assessment activities (surface or personnel), the agar plates are recovered and covers secured and they are inverted and incubated at a temperature and for a time period conducive to multiplication of microorganisms. TSA with lecithin and polysorbate 80 shall be incubated at 30 to 35 for 48 to 72 hours.

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Frequent Advisor
pattik
Posts: 29
Registered: ‎05-18-2011

Re: Glove tips for isolators

I guess what I am trying to say is that I am aware of what USP 797 says but it differs, for incubation temps. I presume what you are saying is that regardless of what the company literature states (incubate at RT), to follow the USP 797 and incubate at 30-35 (which would require the purchase of an incubator) for 48 hours. This is what I need to know. I thought perhaps I could continue to incubate at RT as per the company literature but shorten the time of incubation to reflect USP regs of 48 hours, which would be easier for us.

 

Thanks,

Patti