Pharmacy OneSource Blog

Part 1 – Eric Kastango and Kate Douglass answer your questions on CriticalPoint’s 2017 USP Study Results: Why Don’t We Embrace Better Practice?

Posted on 11/09/17

Our recent webinar with Eric Kastango and Kate Douglass, CriticalPoint’s 2017 USP Study Results: Why Don’t We Embrace Better Practice? drew an audience of hundreds of pharmacy professionals. Of course, the main drawback to a big turnout is that, with limited time, not everyone has a chance to get answers to their questions. Fortunately, we saved the questions we didn’t get to during the event and will be answering them in our blog over the next few weeks. Today’s questions and answers relate to:

  • Cleaning
  • Job Aids shared during the webinar

 CLEANING

   

 

Is Hydrogen Peroxide Vaporization system okay to use for monthly cleaning? Is that in compliance with USP 797 and 800?

   

You can use these systems but they do NOT replace the physical act of cleaning. These types of systems are systems that disinfect and disinfection cannot occur until cleaning has taken place therefore these systems are additive. They do not save you any man hours and in fact increase them. If you have a system, it must be kept across the line of demarcation on the clean side of either your anteroom or kept in your buffer room. They take up space and the apparatus must be also be cleaned monthly. If your EVS brings them to you from outside the controlled environments, then we believe they must be triple cleaned (ending with a sporicidal) before they are brought into the controlled environments as you would clean any equipment coming into the rooms from outside.

There was talk about bleach not being a cleaning agent which I understand that bleach alone is not. What about bleach germicidal cleaner? I believe this is a cleaner and a sporicidal agent. https://www.cloroxprofessional.com/products/clorox-healthcare-bleach-germicidal-cleaners/at-a-glance/

   

It is beyond the scope of this forum to comment on specific cleaning agents. As mentioned before, there are many and they change often. We recommend you select EPA registered one-step cleaner disinfectants as your germicidal detergent to use inside PECs and to the rooms and furniture. We prefer ready to use agents but if you use a concentrate, we strongly recommend documentation of cleaning solution preparation. Any agent you use should provide dwell time information and compatibility information. If you can access this information, then your agents are acceptable.

Alternating bleach with oxivir (?). Is that an acceptable cleaning by EVS?

   

This answer is also beyond the scope of this forum. We cannot provide specific directions without knowing more information. As we've stated earlier, bleach is not a cleaning agent.

Is Virustat DC or Lysyol IC acceptable for monthly cleaning?

   

It is beyond the scope of this forum to comment on specific cleaning agents. As mentioned before, there are many and they change often. We recommend you select EPA registered one-step disinfectant cleaners as your germicidal detergent to use inside PECs and to the rooms and furniture. Virustat DC Plus and Lysol IC are both EPA-registered one-step cleaner/disinfectant. We prefer ready to use agents but if you use a concentrate, we strongly recommend documentation of cleaning solution preparation. Any agent you use should provide dwell time information and compatibility information.

If you have a Chemo Room generally Not in use. i.e. used 2 to 4 times a year. It is kept running but what level of cleaning should we do ? We obviously bdo a full clean prior to compound and parameters are monitored daily

   

IF the PECs and room are left clean (daily cleaning occurs at the END of the compounding day so that rooms are left to rest in a clean state) and they are not entered and the HVAC stays on, pressure gradients remain the same (still needs to be monitored continuously and documented daily) and the PECs are left on, then cleaning does not need to occur since there are no particle generating activities occurring. Always before starting compounding, folks must perform hand hygiene and garbing, disinfect all surfaces of deck with sterile IPA. Since in your case the rooms are used very infrequently, we would recommend performing viable air and surface sampling in the buffer room (again this assumes that the "chemo room" you mention is a fully compliant with every aspect of both 797 and 800 and is serviced by an ISO 7 positive pressure anteroom) every month when not in use (for three months) to measure the amount of microbial bioburden. We suggest you speak with a pharmaceutical microbiologist to help you develop a sampling plan to identify the exact conditions in your "chemo room" which will help you put together an appropriate plan of sanitization.

When using a germicidal or sporicidal agent to clean inside a PEC is it recommended to turn the hood off during the cleaning? This has been recommended to us.

   

No, please NEVER turn off a PEC. It may be turned off by a certifier for maintenance and testing but otherwise never turn it off. Apply the cleaning agent with an applicator that is saturated but not severely dripping. Surfaces must be thoroughly and completely wetted and remain wet, not drying completely before the designated dwell time of that agent.

How many days after monthly terminal cleaning should you perform monthly surface and viable air testing?

   

There is no specified interval. We just perform the required activities at least every 30 days but we perform sampling weekly and monthly. For the sampling locations that are trended, we do monthly sampling at the end of the compounding day under dynamic conditions the week before monthly cleaning is performed. The rationale for this is because we want to test under worst case conditions. Whether a patient has their CSP made the day after monthly cleaning or the day before monthly cleaning, the standard of care is the same so we must verify that our conditions are acceptable at their worst. This is a long complicated discussion that is beyond the scope of this forum, but hopefully that will help.

How long can you use a bottle of sterile IPA once opened?

   

Each manufacturer is different depending on the packaging and delivery system used. We use a system that remains sterile until the expiration date or until finished (whichever comes first) providing that the spray unit is assembled in ISO 5 air (we do it inside the PEC) and all components are sterile. Check with the company from which you purchase sterile IPA.

Do items that have been transported in cardboard only need to be wiped with sporicide or only if the cardboard is corrugated

   

There is data to show that over 60% of our packaging is contaminated with bacteria and 40% with spores (Cockcroft et al. Validation of Liquid Transfer Disinfection Techniques for Transfer of Components into Hospital Pharmacy Cleanrooms. Hospital Pharmacist. 2001. 8:226-32). Brown corrugated cardboard will definitely shed spores however we don't know what is on anything. CriticalPoint's best practice recommendation is that ANYTHING brought into the controlled sterile compounding environments be wiped (not sprayed) with a sporicidal agent. In addition to that, immediately before items are placed inside the PEC, they need to be wiped with sterile 70% IPA. That is not a requirement of 797. USP 797 says to wipe all items down before with a suitable agent (e.g., IPA) before they are brought into the controlled environment. The chapter does say that anything placed in the PEC must be wiped with sterile 70% IPA immediately before they are placed inside.

How many supplies should be kept in the bins in a Clean Room example one days worth / two days worth

   

The amount of supplies in a bin depends on how quickly you use them. We are assuming you are talking about "fast mover" carts inside the ISO 7 Buffer Room. For instance in a high volume PN operation, the cart may need to be restocked daily. We recommend weekly for normal operations to ensure that stock is being rotated and supply bins do not get too dirty. Certainly whether you wipe out your bins weekly or monthly, at least try to time restocking so that the bins are at their emptiest when they need to be cleaned. Each operation is different and there is no hard and fast rule but it's best to avoid bins stocked that do not turn over and the components age out and the bin gets dirty.

Do disinfectants have to be sterile? Diluting these agents exposes them to contamination. If so, leaving these dilutions in an ISO classified area (e.g. buffer room) for a week acceptable?

   

At this time cleaning agents are not required to be sterile but many are sterile. The problem is that as soon as you open the container, the container is no longer sterile. You also need to pour a single use container into a sterile pail and use sterile wipers to keep it all sterile. That, in our opinion, is overkill for pharmacy especially given limited BUDs versus 2-3 year manufacturer expiration dates. Follow the instructions for use that the manufacturer of each cleaning agent provides. If you do not follow these instructions, it will not have its intended effect. We strongly recommend use of ready to use (RTU agents) since it saves the time and cost associated with purchasing equipment to measure agents and water as well as document cleaning solution preparation and verifying that staff are performing this activity properly. Though not required by 797, CriticalPoint recommends the use of sterile water for irrigation to dilute cleaning agents intended for use inside the PEC.

If you get one CFU of fungus or spore outside of hood do you need to keep testing until zero?

   

This is not a yes or no. It depends on many things like was the fungus or spore seen elsewhere in the room, in other rooms, is this the first time, is it near a typical reservoir. I would direct you to the webinar conducted by Abby Roth and Eric Kastango titled "Investigation and Remediation of Microbial Excursions" found here: http://blog.pharmacyonesource.com/investigation-and-remediation-of-environmental-and-personnel-sampling-excursions.-written-by-criticalpoint. Eric and Abby also published answers to questions from the webinar here: http://blog.pharmacyonesource.com/eric-kastango-and-abby-roth-answer-your-questions-about-the-investigation-and-remediation-of-environmental-and-personnel-sampling-excursions. In the webinar a tool was provided that suggests the actions to take in the event of a first excursion. The Clinical IQ SOPs have a detailed policy and form that guide pharmacies through investigations and remediations and takes into account many variables. If you have access to the Clinical IQ SOPs, you can find much more information there.

What sporicidal agent do you recommend using before products are brought inside the clean room? We are currently using bleach wipes per ISMP's recommendations

   

I prefer a sporicidal that also has a surfactant for cleaning. If you are using a wipe that's more than just sodium hypochlorite and it has surfactants in it, that's great. Certainly using that wipe is better than IPA. Also using a wipe is better than spraying. Spore forming organisms are present on 40% of all component packaging so if using IPA, you would remove only about 27.6% of spores (through mechanical means) because IPA is not sporicidal. We just make our own pre-saturated wipes. We use PeridoxRTU but there are many sporicidal cleaning agents out there.

You've recommended weekly sporicidal use. Is this simply within the PECs, or are you advising the use of a sporicidal as part as all weekly cleaning activities? If so, how do you view the inevitability of destroying/corroding metals within the clean rooms with continuous, frequent use?

   

Yes that's what we recommend. We use a sporicidal that leaves very little residue (less than our germicidal detergent) and is compatible with all of the surfaces in our ante and buffer rooms. We have had no issues and we have been cleaning with this agent for over 2 years.

Do swabs have to be used on wire carts or are plates sufficient?

   

If you are careful, you can easily plate the surface of a wire rack with a plate. Just don't push down so hard that you break the media. Remember when you count the CFUs, you must report the number of CFUs per plate not per area of the plate.

I have heard of people wanting to remove the front panel of an isolator in an uncontrolled background... this is not OK can you speak to this

   

Not sure, but think you mean opening the front panel of the compounding isolator to perform daily cleaning if the isolator is in a non ISO classified SCA? We disagree. We believe that it is very difficult to comprehensively clean all surfaces inside an isolator without opening it. Firstly, an isolator cleaning tool must be used as all surfaces are not even possible to reach without one. Even with one, it is extremely difficult to clean all surfaces properly. A CAI is a positive pressure isolator so we recommend opening it to perform cleaning with (an EPA registered one-step cleaner/disinfectant or sporicidal) then close it and disinfect all surfaces with sterile IPA. In the case of a CACI (negative pressure), it is still ok (in our opinion) to open it for the decontamination phase and cleaning phase and then close for the disinfection phase. Chapter 800 REQUIRES the tray beneath the deck of a CACI (and BSC) to be cleaned at least monthly and that tray cannot even be accessed without opening the front cover of the CACI or the sash of the BSC. We believe it's better to clean thoroughly by opening than to do a poor job with it closed.

is the EPA one step cleaner / disinfectant need to be a sterile product in the ISO 5 area

   

Not sure we understand the question. Sterile IPA is a disinfectant but NOT a one-step cleaner/disinfectant. It must be used inside the PEC after all of the interior surfaces of the PEC have first been cleaned with a germicidal detergent (EPA Registered one-step cleaner/disinfectant), which does not need to be sterile if it is RTU. Any germicidal detergents that are prepared from concentrate should be diluted with sterile water for irrigation.  Sterile IPA is used inside the PEC to remove any residues and to provide additional disinfection. The IPA used inside the PECs is required to be sterile.

We are currently facing a shortage of sterile chemo gloves. Is there a way of sanitizing non-sterile chemo gloves (from Covideien)?

   

There are many manufacturers of sterile gloves so if the manufacturer is on back order, please try another. No you cannot sanitize sterile gloves (rated for ASTM 6978-05 or just regular sterile gloves).

We currently use a 3 step process to clean1. alcohol2. detergent3. Sporicidal. Can you eliminate the detergent when using a sporicidal?

   

Maybe we don't understand the question but for nonhazardous PECs: 1) cleaning agent followed by sterile IPA and for C-PECs: 1) decontamination agent, 2) cleaning agent, 3) sterile IPA. The cleaning agent is the same for the PECs and the SECs which is a germicidal detergent (EPA registered one-step cleaner/disinfectant) which we replace with a sporicidal cleaning agent once per week. The rooms are cleaned with the same EPA registered one-step cleaner/disinfectant and only need to be followed by IPA for aesthetic reasons (like on the windows or the tops of carts).

How often do your recommend cleaning waste containers in the CSP rooms? With what type of cleaner?

   

If you mean trash receptacles, we clean them with the same agents that we clean everything else with, which a germicidal detergent or sporicidal agent. They should be cleaned when they appear dirty and AT LEAST monthly. We perform our monthly clean at the CriticalPoint Center for Training and Research (CCTR) with a sporicidal cleaning agent so the inside and outside as well as the wheeled dolly they sit on are cleaned with that at least monthly. If they appear dirty in between we clean them with the germicidal detergent.

We've struggled with our Environmental Services department to order a specific germicidal detergent and are currently using Virex. Do you have examples of one step Germicidal Detergents?

   

Please review other answers to questions submitted in this webinar for more information but if you get a cleaning agent that is an "EPA-registered one-step cleaner/disinfectant" then it is a germicidal detergent. VirexTB is an EPA-registered one-step disinfectant cleaner.

In the context of the Sanitation Job Aid, have you interchanged "clean" with "disinfection"? What is the demarcation between each?

   

Cleaning is used as a "general" term but the term used should be Sanitization which is the reduction of disease causing organisms to a reasonable level. Cleaning is primarily a mechanical action (with chemical enhancement) that removes dirt and debris and gets a surface ready for disinfection. Disinfection is primarily a chemical action (with mechanical aspects) that can only occur after a surface has been cleaned and disinfection kills all microbes except spores. We will review the Job Aids to see if we want to make any changes but in general we try to use the term "disinfect" when we refer to using sterile IPA to the interior surfaces of the PECs immediately after they have been cleaned with a germicidal detergent or sporicidal agent. Thereafter we use the term "sanitize" when we refer to wiping the deck or gloves with sterile IPA.

Is there a site or linked to access the list of proper agents to clean the surface & other specific areas?

   

No, there's not a reference and we do not attempt one as there are many cleaning agents which change frequently. Our best advice is to select an agent that has been developed for use in controlled compounding environments and is an EPA-registered one step cleaner/disinfectant. This is the "germicidal detergent" then select a sporicidal agent to use as well. Understand you must be able to access a compatibility listing for your cleaning agents and need to be able to substantiate the dwell time.

Is bleach a good product for monthly cleaning?

   

No. Bleach does not have a surfactant. Bleach (sodium hypochlorite) at 5000 ppm does have a sporicidal effect but by using bleach alone you are not cleaning. Also the bleach will cause damage over time, even to paint and metal surfaces. We do think using a sporicidal agent is best for monthly cleaning but we prefer to use an EPA registered sporicidal one step cleaner/disinfectant agent. If you want to use it, you would have to clean with a germicidal detergent, apply bleach and then rinse. Bleach cannot be applied first because the surface has not yet been cleaned and the "dirt" on the surfaces will interfere with the bleach's action.

Is there a visual on how to sample with swabs. I can't visualize what to do based on the description in chapter 797

   

No, we will not be preparing a Job Aid for surface sampling with swabs.

       

In our 800 room we have a daily floor clean with Peridox. We use this room for 8 hours each day and this floor clean takes place before this shift. Is this needing to be done once compounding is complete as well? If we are doing this first thing in the morning before compounding takes place.

   

Daily cleaning should be done at the end of the compounding day so that the room is left to rest in a clean condition. We do not recommend cleaning at the beginning of the day, only the end. The only "cleaning" activity at the beginning of the day for those who have performed daily cleaning at the end of the previous day or shift, is to sanitize all interior surfaces of the PECs/C-PECs. Peridox is a sporicidal agent and there is no reason to clean with a sporicidal daily. Sporicidals are necessary but take extra precautions so we would recommend switching to a germicidal detergent for daily floor cleaning and swapping that out for Peridox once per week. IF you are using Peridox for its decontamination properties, it must be applied twice. Once as the decontamination agent for HDs and then again as the cleaning agent achieving the required 3 minute dwell time.

What is the FDA now requiring "STERILE" cleaning (germicidal and sporicidal) agents in the ISO Class-5 area? This is not currently required in USP 797/800.

   

If a 503A pharmacy is visited by the FDA, they will inspect said pharmacy according to the cGMPs (where that is required). They do not inspect or enforce 797.

Is sporicidal cleaning weekly required by 797, or is that a critical point recommendation?

   

No, it is not required by 797 at this time. USP <1072> Disinfectants and Antiseptics, recommends use of a sporicidal weekly or monthly. We imagine that 797 will have some type of recommendation regarding using a sporicidal in future revisions but do not know how often it will be. It's a CriticalPoint Best Practice Recommendation to substitute a sporicidal cleaning agent for the germicidal detergent weekly.

Our hood cleaning practice is to use a new sterile wiper for each hood surface. It's been proposed as a cost saving measure to use one sterile wiper for multiple surfaces in the hood (as long as it's not dried out) what are your thoughts on this?

   

There is no guidance on this. We believe if the wiper is not visibly dirty and is sufficiently wet so that the dwell time (contact time) of the agent can be achieved (usually 1 to 3 minutes depending on the agents you use), that is acceptable. In general, we always use a new wiper for the deck since that's the compounding surface. Other surfaces of the PEC are generally not very dirty.

What type of cleaning is required in the event of a viable air or surface sampling excursion in the room? Daily clean, monthly clean or triple clean?

   

This answer is beyond the scope of this forum but we strongly recommend that you access the webinar titled "Investigation and Remediation of Microbial Excursions" http://blog.pharmacyonesource.com/investigation-and-remediation-of-environmental-and-personnel-sampling-excursions.-written-by-criticalpointwhich covers these aspects. A triple clean not required at least initially. If you are a S797 customer, SOP-205 covers these questions. You may want to consider attending the CriticalPoint Sterile Compounding Boot Camp or the CriticalPoint Environmental Monitoring Live Training.

What type of cleaner do you recommend for glasses? We are concerned about damaging glasses.

   

The chapter is silent on this but we strongly recommend that the frames of personal glasses be cleaned with a germicidal detergent immediately before entering the anteroom or on the dirty side of the anteroom. Lenses can be cleaned with sterile IPA however if glasses have special coatings, the alcohol can damage the coatings. In that cases, we recommend a lens cleaning station be put up immediately outside the anteroom (not inside). The literature demonstrates that lenses are not as dirty as frames but that both are highly contaminated. 
Chowdhury M. Do you Know how Clean Your Eyeglasses Are? Retrieved on 9/26/17
Lange VR. Eyewear contamination levels in the operating room: Infection Risk. Am J Infection Control. 2014. Retrieved 9/26/17
We also strongly recommend that if glasses slide down the person's nose, that they outfit the glasses with an elastic holder to keep them in place. The literature shows that persons touch their face up to 23 times per hour and we have observed persons pushing up their glasses with gloved hands and often forgetting to re-sanitize. Every effort should be made to secure glasses and don head garb in a way that it never be touched or adjusted.

 

 

JOB AIDS

 

 

is there a consideration for a job aid to help select an appropriate/qualified certifier?

 

Thank you for the suggestion. Jim Wagner wrote an excellent article titled "Choosing a Certification Professional to Evaluate Your Cleanroom and Engineering Control" published in Pharmacy Purchasing & Products Magazine. https://www.pppmag.com/article/560/?search=wagner

Will you add a job-aid to go along with the GFS video with CAI use?

 

Thank you for your suggestion.

How do we get the WORD documents of the Job Aids?

 

The pdf slide deck provides you with a copy of each job aids. Alterable job aids (they were authored in Microsoft Power Point) are only available to Simplifi 797 customers and those with rights to the Clinical IQ Sterile Compounding Standard Operating Procedures.

Will the job aids be available to print?

 

The pdf slide deck provides you with a copy of each job aids. Once you download the slide deck, you can certainly print each of them as long as they remain intact with our copyright notice.

How may we receive copies of the Job Aids shown during the presentation?

 

The pdf slide deck provides you with a copy of each job aids. Alterable job aids (they were authored in Microsoft Power Point) are only available to Simplifi 797 customers and those with rights to the Clinical IQ Sterile Compounding Standard Operating Procedures.

Will the Job Aids be available to Simplifi 797 customers?

 

Yes, they will be available through the Clinical IQ Standard Operating Procedures. Give us 6 weeks or so to integrate them and get them online.

 
Be sure to check back next week, when we’ll be answering questions on fingertip and surface sampling, air sampling, general questions / general USP 797 questions and state compliance and third party testing.

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