Pharmacy OneSource Blog

Part 3 – Eric Kastango and Abby Roth answer your questions about the Investigation and Remediation of Environmental and Personnel Sampling Excursions

This week we wrap up our Q and A sessions from our recent webinar, Investigation and Remediation of Environmental and Personnel Sampling Excursions. Today’s questions and answers focus on:

  • Organisms
  • Investigative, Media and Glove Fingertip Sampling
  • Pharmacies Doing Their Own Sampling
  • External Lab Requirements
  • USP 797 and USP 800 Management
  • General USP 797 and USP 800


What is the definition of “Highly Pathogenic”?

USP 797 provides examples of categories that may have highly pathogenic organisms but does not define the term in the glossary.  It would essentially mean any organism that has a high likelihood of causing disease.  According to USP 797, examples are yeast, mold, gram negative rods and coagulase positive staphylococcus.  Some of these types of organisms can be highly pathogenic and some are not.  Additionally, spore forming bacteria were not listed, but some Bacillus species could be highly pathogenic.

What is a non-sporulating fungi?

A non-sporulating fungi is one that was not producing any reproductive bodies during the time the identification was performed.  Many labs identify mold through microscopic analysis and reproductive bodies are used to identify the organisms.

Is there a reference that we can use for which organisms are highly pathogenic or “organisms of concern”?

Depending on the condition of the patient and the route of infection any organism could be an organism of concern, so providing a list is difficult.  Mold, yeast, gram negative rods and coagulase positive staphylococcuss all need to be considered, as they are mentioned in USP 797. The only true way to know would be to identify all recovered growth to the species level.  This is well beyond what would be needed in a pharmacy clean room.  However, this information would be valuable for handling any growth in the PEC.

Do smokers tend to bring in/colonize different organisms?

Smokers may bring in different organisms, as there are many different types of bacteria found in cigarettes.  Smokers should wash their hands even before entering the ante room.  They also bring in particles on their hair and clothing.  After smoking, smokers should wait 30 minutes before reentering the clean room.


Investigative, Media and Glove Fingertip Sampling

Could you please compare advantages of MEA vs Sab Dex as media for fungal sampling?

Both agars are for the recovery of yeast and mold and both have an acidic pH to allow for optimal growth of mold and yeast, while restricting bacterial growth.  In a study by Tim Sandle titled “Comparison of different fungal agar for the environmental monitoring of pharmaceutical-grade cleanrooms,” it was determined that SDA was the superior agar for cleanroom use.  SDA is also the agar of choice for other fungal recovery tests in the USP, such as USP<61> and <62>.

We use Valiteq to test technique – always zero growth although observed technique is substandard. Is there a better product to test technique?

The media must come from a reputable manufacturer.  They should have an ISO accreditation and manufacture according to CGMPs.  The certificate of analysis they provide must indicate the media passed growth promotion.  There are many media manufactures that can meet these needs.  Companies like Hardy Diagnostics, Remel, BBL and BioMerieux are worth considering. 

For those fungal growth media are detergent inactivators like Polysorbate necessary or needed?

Any surface or gloved fingertip sample must contain neutralizers, with the most common being lecithin and polysorbate 80, regardless of the type of agar.

What is the benefit / importance of a 4 hour rest between cleaning?

A lot of particles are created during the cleaning process. It is important to give the room time to rest and allow the room to clean itself, through the use of the HEPA filters.  This helps to more easily identify if there are any issues with the engineering controls when you perform the static sampling.

For resampling 2 more times during distinct but consecutive occurrences, what do you mean by “distinct”?

Distinct means separate times.  Personnel should not be doing all three sets in one day, right after one another. An example would be doing the initial glove fingertip sampling each day for the three consecutive days the person would be entering the clean room.   

Any guidance on how to perform glove fingertip testing when using an isolator PEC since not in laminar flow hood so not using sterile gloves inside hood/

Sterile gloves would still be donned over isolator gloves.  The person being tested would have to move all materials into the isolator don the sterile gloves over the isolator gloves and would then have to test themselves.  The sterile paper from the gloves can be used to open the lids of the plates.  Aseptic technique needs to be considered.


Pharmacies Doing their Own Sampling

Do facilities have their own air sampler device? And pull their own air samples?

Many pharmacies have purchased samplers and are taking their own samples.  This gives the freedom to sample more frequently and to sample in a more timely manner after an excursion.  Just be sure that the person(s) sampling have been appropriately trained.

Are you saying you can do your own air and surface sampling and not use the certification company’s services. This would be OK? The environmental sampling training is complete via the Critical Point eLearning for environmental sampling? Would this satisfy the chapter requirements?

Yes, pharmacy should perform their own air and surface sampling.  This allows for more timely retesting in the event of an excursion.  This also eliminates the need to train an outside party on your garbing and material transfer procedures.  Critical Point covers EM in the boot camp.  However they are in the process of creating another EM class that would provide a certificate of qualification.  Training can also be done at your location through Clinical IQ.


External Lab Requirements

When selecting a LAB to work with, what certifications are required? Can I partner with my hospital laboratory to quantify CFUs and for genus/species identification?

We recommend using a laboratory that has experience processing pharmaceutical EM samples.  They should have an ISO 17025 accredited and are registered with the FDA.  Many hospital labs are Clinical Laboratory Improvement Amendments (CLIA) accredited.  The requirements are pretty stringent.  There are locations that might be CLIA exempt and that would be because the laboratory that has been licensed or approved by a State where CMS has determined that the State has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA requirements and the State licensure program has been approved by CMS. 

The biggest issue is how CLIA defines lab.  Laboratory means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

Based on that definition, CLIA accreditation would not cover EM samples.  However, based on the CFR’s, if the lab has CLIA and treats EM samples as they do clinical samples in terms of SOP’s, documenting, investigation, etc. they might be able to adequately process them.


USP 797 and USP 800 Management

I am wondering if you have any recommendations for the number of people to have “in charge” of the needed education and oversight of USP 797/800 in a large hospital/system (greater than 500 beds)

Having a dedicated and consistent number of personnel who can focus on sterile compounding and the related quality assurance procedures is better than rotating people through the tasks. 1-2 people may be needed depending on the number of staff that are being managed in addition to having responsible for compliance.


General USP 797 and USP 800

Is there a date when the next version of USP 797 is set to be out for public comment?

It is not known when 797 will be released for public comment.

Is there any discussion to push back USP 800 to coordinate with USP 797 as well as giving sites time to make the facility changes due to financial concerns that are needed

USP 800 will be effective as is on July 1, 2018.  USP 800 came out in 2016 and the official date was delayed until 2018 in order to give sites time to make the needed changes.  The USP 797 revision is taking USP 800 information into consideration.


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