I’ve received some other (good) questions about cleaning that honestly weren’t covered in my previous post (FOUND HERE). Let’s talk about rotating disinfecting agents first.

Bacterial Resistance

I believe the idea of rotating disinfecting agents is based on the idea of microbial resistance to antibiotics. However, the organisms in our cleanrooms are not in a situation that is absolutely ideal. In our body, microorganisms are under ideal conditions and mostly likely very actively growing. Organisms on surfaces in our cleanrooms are less likely to be thriving to say the least. USP Chapter <1072> acknowledges this and states the following:

“The development of microbial resistance to antibiotics is a well-described phenomenon. The development of microbial resistance to disinfectants is less likely to occur at significant levels, as disinfectants are more powerful biocidal agents than antibiotics. In addition, they are normally applied in high concentrations against low populations of microorganisms usually not growing actively, so the selective pressure for the development of resistance is less profound. However, the most frequently isolated microorganisms from an environmental monitoring program may be periodically subjected to use-dilution testing with the agents used in the disinfection program to confirm their susceptibility, as there are real differences among different species in resistance to the lethal effects of different sanitizers.”

The lesson to be learned: with our current understanding based on research rotating agents is unnecessary.

Other cleaning questions

Here’s questions from an email I recently received:

  1. We have an ISO 8 anteroom that leads into both the positive pressure and negative pressure rooms. We make everyone wear goggles who goes into the negative pressure room. I am wondering…what would be the proper donning and doffing of goggles. USP 800 says all PPE that enters the negative pressure HD room cannot exit the negative pressure room. So my question is…
    – do the goggles need to stay in the HD negative pressure room?
    – if so, is it ok that they are being garbed after all the other PPE has been put on (kind of goes against the flow of donning PPE properly if you are re-touching your head and face area)
    – if the goggles do not need to stay in the HD room do they need to be deactivated, decontaminated, cleaned, and disinfected in the same way that the chemo hood does?
  2. Does the trash in the chemo need to be deactivated, decontaminated, cleaned, and disinfected in the same way that the chemo hood does prior to bringing it out of the hood and placing it into the trash that is outside of the hood?
  3. In what order does the final CSP product need to be decontaminated. With the outer gloves still on? Or do you take the outer gloves off and then decontaminate the final CSP product? Also, does it need to be decontaminated in the same way…again, as the chemo hood?

My thoughts

A lot of this comes down to workflow. I’ll answer the questions in the order listed above:

  1. You could leave goggles in the cleanroom, but they should be cleaned and disinfected (and sterilized?) between use (also decon, deactivate etc). Possible solution would be to put in plastic bag and/or clean off before taking them out (when done compounding). To don the goggles, you’ll put on your first pair of gloves; put on in between gloves. The second set (of sterile chemo gloves) should be donned before compounding begins.
  2. Bring large ziplock plastic bags into the hood with you, when you have trash…put in the bag, seal then toss in your hazardous waste bin that should be nearby.
  3. I’d decon the outside of the final prep before it leaves the hood…When finished compounding, take off first set of gloves (put gloves in aforementioned zip lock bag), decontaminate then put in bag for delivery to floor…? Just a thought. Once you’re finished with compounding, take off first set of gloves inside hood, clean prep, bag…now you and your first set of gloves can leave hood. The goal should be that you not exit the hood until everything is finished (as this breaches containment when you bring hands back and forth in and out…potentially contaminating things outside of the hood).

Everything I’m saying above should have a little bit of experimenting before completely changing practice/policy etc. “Validate” your cleaning processes and procedures (also gowning) to make sure you’re on the right track.  There’s various analytical tests you could do to make sure your technique is good. Using either total organic carbon testing or HPLC both before and after cleaning procedures would be a good way to determine the effectiveness of your technique and agents. Any decent study would replicate at a minimum of 3 times to validate the procedure (once one as been decided upon). If you’re not comfortable designing an experiment to figure out your cleaning procedures there’s plenty of experts out there who’ve actually done this for decades; it’s okay to consult with someone who’s expert in cleaning validations.

Basically, compound something you normally compound with and swab the final prep, the hood…after you’ve decontaminated, deactivated, cleaned and disinfected. Send to lab, repeat. If there’s no residue, perfect. If there is…is it an acceptable level? How do you determine that? Good question, not sure! Unfortunately, there’s not a lot of data that establishes max contamination levels. This is something you’ll need to do based on SDSs and clinical knowledge. I will say if there IS any information it’ll be located on the chemical’s SDS under section 8 “Exposure Controls.” I believe you’ll have a difficult time finding occupational exposure limits for many of the cytotoxic chemicals we work with.

Here’s an example of an SDS (cyclophosphamide). – CLICK HERE

More questions…

“What about the trash bins located in the clean room outside of the BSC? Do I need to deactivate, decontaminate, clean, and disinfect those as well before they leave the anteroom?”

My thoughts:

I would give a quick wipe down of anything taken out of the BSC…at the very least. If/once you’ve validated a procedure then just use that. Keep in mind this is just going into the trash so not that big of a deal; this is just to make sure you’re not spreading chemo around outside of the bsc.

Trash bins…incorporate cleaning into your cleaning routine. If and when they need to be brought out like when they’re taken for destruction, then yes I would give a decent wipe down before being brought out through the rest of the pharmacy. How often do you clean? Up to you…and 797/800 of course…weekly? Monthly?
This should ACTUALLY be dictated by an environmental sampling program…to determine how often you should be cleaning (show me the data! Data should drive most things in the cleanroom – how we operate, how often we clean, how and what we clean with).
Normally, we’re most concerned with not allowing contaminants to get into our cleanroom and of course with hazardous it’s a two way street. You don’t want particulates and microorganisms going in and you also don’t want chemo coming out. Your procedures and applicable policies should be designed around this basic concept.

One last question…cleaning ORDER

“In what direction should the floors, ceiling, walls be cleaned in the anteroom to a negative pressure hazardous drug room? I keep reading that cleaning should follow the direction of the furthest corner of the room from the door, making your way towards the door. Others have argued that cleaning the anteroom should start at the anteroom door making your way to the chemo room since the negative pressure in that room is sucking in the dirty particles from the anteroom into that room and also to avoid potentially dragging any residual chemo that may be at the negative pressure room door out towards the anteroom door. Your thoughts?”

My thoughts

THIS IS WHAT I DO and may or may not be necessary for your situation:

Daily: we clean and disinfect floors, hoods and horizontal surfaces (tables and pass-throughs).

Weekly: environmental (surface) sample locations in cleanroom, ID to genus if necessary

Monthly: whole room clean

When you clean the whole room…Cleaning needs to be done starting in the cleanest area (your iso 5 hoods), then working from top to bottom in the room from the farthest point from the door working your way OUT of the room – toward the door.

Empty trash
Clean surfaces like carts, tables and wheels of…
empty and clean all shelf containers and contents
Ceiling, walls and floor (starting farthest from door) of buffer area(s) working toward exit
Anteroom (cleaning any shelves, tables etc like above)
Exit cleanroom
As far as the residue question…just thinking it through…
I have a different mop for each room, PLUS separate mops for cleaning the walls and ceilings then another for floors. So I have 2 mop systems per room.
This solves the issue of bringing residue from one area to another because each area will have a dedicated mop system (2 technically) which minimizes cross contamination between areas.

Contamination Control

Much of this comes down to contamination control. Melissa Stefko, senior director of Quality for the 503A/B Well Pharmacy Network, and I will be offering a LIVE webinar October 19th at 1PM EST where many of the concepts I’ve described above will be discussed in more detail. Sign up HERE for the webinar…when you sign up you’ll have access to the webinar recording for a year and I’m also including 2 other webinars in addition (one in November and again in December – topics include: Hazardous Drug Compounding Workflow and Stability Studies). Also, these webinars will be translated and subtitled in Spanish.

Subscribe to PharmacyInspection.com!

About the Author:

Seth DePasquale is a pharmacist and co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.

This site uses Akismet to reduce spam. Learn how your comment data is processed.