Pharmacy OneSource Blog

Part 2 - Eric Kastango and Kate Douglass answer your questions from the CriticalPoint’s 2017 USP Study Results: Why Don’t We Embrace Better Practice webinar

Posted on 11/16/17

This week, we continue our question and answer forum from our recent webinar, CriticalPoint’s 2017 USP Study Results: Why Don’t We Embrace Better Practice? Today’s edition includes questions related to:

  • Fingertip and surface sampling
  • Air sampling
  • General questions / General USP 797 questions
  • State Compliance and Third party testing

 

Fingertip and surface sampling

With ongoing fingertip sampling, if a sample is only collected after media fill, how do you know that the contamination was not introduced when donning sterile gloves during the garbing process if fingertips are not collected after garbing? If someone fails ongoing glove fingertip sampling, would it be worth resampling after garbing and after media fill after retraining the individual?

 

If they have passed initial GFS then you know they are able to do it correctly (should be done 3 consecutive, but distinct instances of hand hygiene and garbing). For instance, not good to do hand hygiene and garbing and put gloves on, sample, then take gloves off, put on new gloves, then take sample...etc. We also believe that it should be consecutive samples. So for instance, if they pass instance #1, pass instance #2, fail instance #3, then they need to start over. Three consecutive times (in our opinion) demonstrates true mastery versus someone who does pass, fail, pass, fail, and then pass to get their 3. Now to answer your question, the answer is that's a great idea! It's far more likely that they picked up the CFU during all the staging of components into the PEC, touching their face or mask without realizing and failing to sanitize their hands, failing to sanitize the deck, etc. If someone fails ongoing, it's an AWESOME idea to go back and do both types of sampling to review the importance with them but it will also be necessary to review all aspects of aseptic technique and observe them the next day while they are compounding to see if they do what's right when they are not being watched. If it's a tenured compounder who has never had a failure before, there's no reason to remove them from compounding but would reteach, discuss, observe them, and resample the next day while they are compounding (but not when they know it's coming up). We would also take a surface sample of the DCA since that's the more likely source of contamination to their gloves and resample them randomly at least once during the next month. There's no correct answer, but it's important to have a policy on how to handle failures and rationale for actions taken in the training record.

Can you use paddles instead of plates for the gloved finger pad and surface sampling?

 

We prefer to use 100 mm setting plates for all gloved fingertip sampling to provide adequate space for a full sample of each finger pad and thumb. In our opinion, paddles do not provide adequate space for sampling since the flat portion of each finger pad must be rolled onto the agar. Viable air sampling and Surface sampling are performed with 55mm contact plates.

What products do you use for fingertip and surface sampling? Do you have a specific manufacturer and product numbers?

 

We use Tryptic Soy Agar with neutralizers added (lecithin and polysorbate 80) for all sampling. We prefer to use 100 mm setting plates for all gloved fingertip sampling to provide adequate space for a full sample of each finger pad and thumb. In our opinion, paddles do not provide adequate space for sampling since the flat portion of each finger pad must be rolled onto the agar. Viable air sampling and Surface sampling are performed with 55mm contact plates. There are a wide variety of manufacturers of media.

 

 

 

What is the maximum CFU for Surface sampling during PV?

 

Action Levels for Surface and Air Sampling are clearly noted in USP <797>.

Is it better to use round plates or square paddles for SS? Does it matter? Same question for fingertip testing.

 

We use Tryptic Soy Agar with neutralizers added (lecithin and polysorbate 80) for all sampling. We prefer to use 100 mm setting plates for all gloved fingertip sampling to provide adequate space for a full sample of each finger pad and thumb. Paddles do not provide adequate space for sampling. Viable air sampling and Surface sampling are performed with 55mm contact plates. Based on experience, there are other issues with paddles as well which we discuss in more depth at our live training classes.

For Initial GFT would you recommend redoing it for all compounding personnel when a new or remolded cleanroom has been constructed?

 

Great question. Initial Gloved Fingertip sampling isn't testing the environment, it's testing whether staff possess the psychomotor skills to successfully don gloves without contaminating them. Unless staff are donning gloves differently (say you switched from using an isolator to using LAFWs), there would be no requirement to do so. On the other hand, comprehensive environmental monitoring must be performed to measure whether you have achieved and can maintains a microbial state of control in the new space. So sampling will include viable air and surface sampling in all ISO classified air based on a risk under dynamic conditions (during compounding). We would also perform at least ongoing gloved fingertip sampling during dynamic conditions also (since that tests both operator aseptic technique and the cleanliness of the environment).

Most people think that the first ongoing GFT doesn't need to be done until annual competencies are done at the beginning of year 2 for low /med risk compounders. Shouldn't it be done with the initial media fill since the ongoing demonstrates a different skill set?

 

Absolutely! As we said earlier, the Initial GFS is performed to measure the person's ability to don sterile gloves without contaminating them. The Ongoing GFS tests so many more skills. It tests their ability to keep their gloves clean during material handling, compounding, and measures the quality of their aseptic technique and personal conduct within the ISO class 5 environment. After they pass their initial GFS (3 consecutive but discrete times they perform hand hygiene and garbing to go into the Buffer Room) which we hope occurs for new employees who are observing compounding and learning how to do media fills, learning how to clean, stage, etc. THEN when they are ready to do their initial media fill testing which must be passed before they compounding CSPs for human use, an ongoing GFS must be taken immediately after they complete the media fill units (and not immediately after their gloves were sanitized). We recommend taking a surface sample in the DCA first and then the GFS of each hand. In this case the surface sample, provides direct information about their ability to keep the DCA sanitized.

What does GFS look like with a barrier isolator (having only 1 staff member able to be in the chamber)?

 

Please visit the CriticalPoint website to view the instructional video on this subject.

 

 

 

AIR SAMPLING

We are using two different media for Air sampling, TSA and SDA for same locations. For ISO Class 7 and 8 areas, we only sample 400L of air. Do i need to combine CFUs from both plates and report them as one number? Do i need to convert that CFU count to per 1000L when I am recording data in Simplifi?

 

We will try to point you in the right direction but a comprehensive answer to this question is beyond the scope of this forum. We strongly suggest you contact a Pharmaceutical Microbiology firm for in-depth instruction and advice. CAG-009 has provides guidance on reporting counts when two plates are used to sample.  Essentially, you must decide what information you want to get from the data you collected.  The Action Levels required by Chapter are per plate as long as each plate reflects a sample that is 1000 liters in size. If you sample only 400 liters than you would need to convert the CFU level to a 1000 liter equivalent for each plate. The recommended Action Levels per plate come from Table 2 in the Chapter and are: ISO 5 >1; ISO 7 > 10 and ISO 8 >100. Also remember that when counting CFUs from viable air sampling, it is vital to follow the air sampler's instructions for use. Depending on the air sampler and the number of holes in the air sampler, there is a statistical adjustment called "most probable number" that adjusts for the potential of more than one organism going through one hole of the sampler. Please be sure to read the instructions for the sampler that you use.  As a reminded, fungal agar is only required for viable air sampling from facilities that perform high risk compounding.
Though not currently required, CriticalPoint strongly recommends that samples be read daily. Mark each discrete CFU on the bottom of the plate with a black sharpie. By reading each day, you are better able to identify discrete colonies that may form adjacent to CFUs already present. If they are left to the end to read, one colony may obliterate another, resulting in an inaccurate and incorrectly low number of colonies counted.

Please address humidity issues. high and low

 

Chapter 797 currently is silent on humidity requirements in controlled sterile compounding environments. The proposed chapter 797 (2015) references maintaining relative humidity below 60%. CriticalPoint follows that recommendation and maintains its rooms at below 60% RH. Higher humidity tends to promote microbial growth.

General USP 797 Questions

What is your advice for BOPs that are holding pharmacies to a higher standard than 797 / best practices? WA state here if that gives you any idea of what we are against

 

We strongly recommend that those Boards of Pharmacy promulgate regulations (or impose additional quality assurance requests) that are based on solid science. Please work cooperatively with your state boards of pharmacy if you think you are being asked to meet unreasonable standards. I know that some states are requiring pharmacies to perform some end product testing or product related media fill testing in a manner that does not meet USP 71 (either statistically with insufficient sample size of 1 or 2 CSPs; type of testing by using direct inoculation versus membrane filtration for filterable CSPs, as well as methodologically such as being performed without method suitability). All we can suggest is that you thoughtfully put together the science and submit it to the proper authorities and ask for a dialogue. We all want the same thing which is improved patient safety.

How much of the draft USP 797 do you expect to change before it is finalized?

 

We have no way of knowing. We do expect significant change to the cleaning, environmental monitoring and personnel sampling sections but other than that, we do not know. When the revision is issued, please participate by providing your comments to things you'd like to see modified. Please provide alternative language and evidence based back up for your suggestions.

Many detractors from USP 797 cite that there is no science to support the standard. Has any research been published to support USP 797 requirements?

 

Thanks for this question but I thought these doubts had been put to rest. Specific elements of the chapter are based upon science and extrapolated (and considerably eased) from cGMP sterile manufacturing standards which have been extensively researched. When we provide our live training such as a core offering the Sterile Compounding Boot Camp, the rationale for chapter requirements as well as our Best Practice Recommendations are EXTENSIVELY referenced, with identification to specific elements and how they are supported by science. CriticalPoint will be launching a Peer Network in the near future (visit https://www.criticalpoint.info/tools-resources/peer-network/) and all members will be able to access a 22 page (and growing) list of references to the science.

General Questions

  

Where can we find more information on the "bootcamp" you referenced earlier?

 

Please visit our website. Information on Boot Camp can be found here: http://www.criticalpoint.info/activities/?filter-activity-type=1702

When will the ES training be available and will it tie into boot camp?

 

The Sterile Compounding Boot Camp is our core live training offering which seeks to provide a comprehensive overall understanding of 797 and best practices of sterile compounding. The live training on Environmental Monitoring will be offered several times in 2018. It is 2 full days and builds upon the Boot Camp content. It will have lectures but is very hands on with many lab experiences that will allow the learner to practice all the skills necessary. Visit our website for more information.

Have you guys worked with ASHP or viewed their training materials since a lot of hospitals use ASHP materials for training?

 

Yes we have viewed the ASHP training materials but we did not have input into them.

Can you send a link to the previous webinar that you talked about?

 

http://info.pharmacyonesource.com/webinar-investigation-remediation-environmental-personnel-sampling-excursions

Could you please review a best practice doffing procedure from leaving the negative pressure room?

 

These activities are not described in detail in USP 800. There are a series of 3 articles published in Pharmacy Purchasing & Products Magazine (PPPMag) that cover all aspects of nonhazardous and hazardous sterile compounding donning and doffing. At our request, the folks at PPPMag have put them up together at one URL which is as follow: pppmag.com/garbing resource

State compliance and third party testing

Ohio consistently has terrible compliance numbers in your study for all elements compared to other states. Could this be contributed to the State BOP's level of inspection? Ohio has historically been pretty hands off... Do you notice that the more compliant states have a BOP that pays more attention to USP 797 compliance?

 

Remember that the findings in our study represent those who chose to participate in our study so we can't really draw that conclusion. We think most of the state boards have been working hard to improve their knowledge relative to sterile compounding and many states have one or more representatives who have successfully met the requirements for the CISCI (Certification in Sterile Compounding for Inspectors) credential awarded by NABP and CriticalPoint. We are counting on the state boards to hold pharmacies accountable to their state's pharmacy regulations.

What are your thoughts on having a third party conduct ongoing GFS and Media fill testing?

 

Whether personnel or environmental sampling, we believe that with some additional education pharmacy can and should conduct this sampling themselves. Whether the pharmacy chooses to outsource some or all of the additional activities (establishing a personnel sampling and environmental monitoring plan; incubation, reading, identification, conducting investigations and implementing remediation) themselves or in concert with a third party is up to them. Since we believe both types of sampling should be conducted more frequently, there is a better value proposition if the pharmacy conducts the sampling themselves but believe all need to work with an appropriately licensed and credentialed laboratory that have microbiologists with expertise in pharmaceutical microbiology (that is the microbiology of a pharmaceutical compounding environment).

FYI, state board inspectors don't want that testing spread out a lot. They want it grouped to the same time of the year every year, at least our inspector in FL has preferred that.

 

Certainly some inspectors have different preferences but we teach the inspectors that from a training perspective, training is more effective and sampling is more objective when sampling is conducted throughout the year. Personnel sampling also gives additional information about the environment in which the sampling is occurring and is much more appropriately spread out throughout the year.

 
Join us again next week for the final installment of our webinar Q and A session, when we’ll be answering questions about gloves and garbing, inside the cleanroom and state compliance and third party testing.

View Webinar Recording

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