Pharmacy OneSource Blog

Part 3 - Eric Kastango and Kate Douglass answer your questions on CriticalPoint’s 2017 USP Study Results: Why Don’t We Embrace Better Practice?

Posted on 11/29/17

This week we wrap up our Q and A sessions from our recent webinar CriticalPoint’s 2017 USP Study Results: Why Don’t We Embrace Better Practice? Today’s questions and answers focus on:

  • Inside the Cleanroom
  • Gloves and Garbing
  • State Compliance and Third party testing

Inside the Cleanroom

 

We had a vendor tell us recently that we should be storing our sterile wipes and sterile alcohol bottle inside the hood. I was previously taught that we needed to keep items and clutter inside the hood to a minimum. We keep our hood completely clear when not in use. Does 797 mention anything about this?

 

Yes, that's best practice. Whatever form of sterile IPA is used inside the ISO 5 area is best stored there so that you minimize the number of times you are removing your hands from the PEC. Anything stored in the PEC must be part of daily cleaning (so whether spray bottle or package of pre-saturated wipes, it would be cleaned with a germicidal detergent and followed by sterile IPA when daily cleaning is performed). Also take care to spray your gloved hands to the side and not directly at the HEPA filter. You can also keep a spray bottle of sterile IPA outside the PEC on the cart to use to sanitize hands when you are outside of the PEC.

The techs are asking for a stool to sit on while compounding. Can a stool be added to the clean room? Does it have to be all steel? Thank you.

 

We do not recommend anti-fatigue mats (difficult to clean properly) so we do recommend chairs for cleanroom staff. They must be cleanable. Stainless steel will stand up to cleaning agents the best but you can use other metal as long as it stands up (does not rust, corrode, flake or lose its finish) and you may have to replace them more frequently. In order to accommodate all staff, they must have a height adjustment and for comfort we strongly recommend a foot rest. Most of the cleanroom chairs or stools have 6 wheels which are very difficult to clean and really lengthen the monthly cleaning process. We are trialing some stools we love that have an adjustable height, foot rest, are stainless steel and have a pedestal bottom. We've only had them about 4 months but so far, so good. Just search amazon or google. Buy one and trial it.

Would it be correct to draw the conclusion that nothing with grooved surfaces should be installed on the deck of an isolator?

 

In general yes, but would be helpful to know what you are specifically referring to. All surfaces inside the PEC must be cleaned. Where the sides and deck come together might be referred to as a groove and that cannot be helped. Anything installed must be cleanable, moved daily during cleaning. When you say "installed" it gives us the idea it's something that doesn't normally come with the PEC so whatever you are talking about must be smoke tested to determine how that item influences the uninterrupted flow of unidirectional first-air.

GLOVES and GARBING

What about using globe box? Do you still use sterile gloves?

 

Yes, 797 does require all compounding to be performed using sterile gloves. Sterile gloves are donned immediately before compounding over the isolator gloves inside the main chamber of the compounding isolator. Please visit CriticalPoint's website to access an instructional video https://www.criticalpoint.info/videos/ on this subject. The term glove boxes is more associated with isolators used in laboratories. Sterile compounding pharmacies should say "compounding isolators" which are two kinds: Compounding Aseptic Isolators (CAIs) or Compounding Aseptic Containment Isolators (CACIs). At some point in the future, those names will likely be changed to Restricted Access Barriers (RABs) per the 2015 version of the Proposed Chapter 797.

I think it would be good to remind attendees that they should apply sterile gloves over the gauntlet gloves in an isolator.

 

Thank you. We agree and believe we did that.

Could you address wearing street clothing into buffer room? I have seen pharmacists wearing short skirts with bare legs and sandals, with shoe covers and gown over.

 

Bare skin other than our neck and face is unacceptable. Scrubs are not inherently better than street clothes UNLESS staff don freshly laundered scrubs when they get to work. If they wear skirts (some religious sects forbid women from wearing pants), they must wear hosiery. Ankles must be covered so "no see um" tennis socks are also not desirable and we teach people to wear crew socks. Sandals are never acceptable for any reason.

How is this to be done when using a containment isolator since the sterile gloves are attached to the PEC?

 

If you have a compounding isolator with a one piece gauntlet (glove and sleeve in one piece) you need to purchase sleeves to which gloves are attached separately. One piece gauntlets are reserved for use in laboratories (by far the largest user of isolators). Pharmacies must ask for sleeves with separate gloves. Often the isolator manufacturer will send you "thicker" gloves which we don't recommend using. Those thick gloves are meant to be reused for a period of time. We recommend that the primary gloves attached to the sleeves are changed at least daily during daily cleaning and be changed with regular sterile gloves you would use to compound with (so either regular sterile or sterile gloves tested to ASTM 6978-05 if HD). When compounding sterile gloves are donned inside the isolator over the sterile gloves attached to the isolator gloves.

What about the annual testing is still 3 times

 

No. INITIAL gloved fingertip sampling occurs initially for new employees to make sure that they can don sterile gloves without contaminating them. From that point on, testing is performed AT LEAST annually or semiannually (depending on risk level) during compounding of media fills. That is called ONGOING gloved fingertip sampling. CriticalPoint strongly believes that more frequent surface sampling and gloved fingertip sampling randomly at the end of the compounding day during compounding is the very best way to maintain and measure staff vigilance with aseptic technique and behavior inside the ISO Class 5 space. At this time it is only required immediately after media fill testing. Since it is a very inexpensive test, we recommend it monthly on a random basis for every staff member.

Do you do a pump of Avagard each time you change gloves before donning new pair (ie every 30 mins when doing hazardous prep)?

 

Yes, best practice would be to reapply the alcohol-based surgical hand rub with persistent activity used at your location each time you don new sterile gloves. As soon as we put our gloves on, our hands start to sweat and microbes can grow.

Is it currently a requirement to gown when using an isolator?

 

There is a lot of confusion about garbing and isolators. First, if you are using a compounding aseptic containment isolator (CACI), then yes. In that case, full HD PPE must be worn because it is worn to protect the operator from the environment and the drugs and it has the advantage of protecting the CSPs too. For nonhazardous sterile compounding where a compounding aseptic isolator (CAI) is used, aside from performing hand hygiene and donning sterile gloves over isolator gloves to perform compounding, there is no requirement for additional garb IF the isolator company provides data that demonstrates that the compounding isolator is able to maintain ISO class 5 conditions both during compounding AND material transfer. These are not "magic boxes" and the environment in which they are placed and the procedures used for material handling and transfer have a large impact on potential bioburden. Our best practice recommendation is that a low-linting gown (or sleeves), mask and head cover are worn during material transfer.

Certain states (i.e. Texas) require a different garbing order than specified in USP 797. Which order should we comply?

 

Pharmacies must follow their state pharmacy laws that govern sterile compounding practice. Work with your state board of pharmacy if you have suggestions or want to pursue something slightly different. Share your rationale. State Boards of Pharmacy welcome engaged and knowledgeable practitioner input.

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.

 

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