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Steve Milstead, PharmD, BCSCP

Monthly Cleaning Considerations for Sterile Compounding Environments: Avoiding Cross-Contamination

Updated: Apr 7, 2023

It’s well understood that the best technique for cleaning sterile compounding environments is to start at the cleanest point of buffer room, from top to bottom and working outward to the dirtier areas of the anteroom. However, this blog will introduce additional cleaning techniques to be considered to reduce potential cross contamination from the actual cleaning process itself.


Review of Cleaning Agents:


Before getting started, it is important to review that monthly cleaning entails cleaning and disinfecting and must incorporate a sporicidal agent. There are many one-step EPA-registered sporicidal disinfectant cleaners on the market that should considered to reduce fatigue of the compounders and downtime of the IV room. Ensuring that the dwell time is observed for any given product used is of upmost importance. Additionally, the use of only sterile cleaning agents, wipers, etc. are required for cleaning inside the PEC. Although, the use of sterile cleaning agents for areas outside the PEC is not required, it is strongly recommended to reduce any bioburden that could be introduced into the environment from the manufacturer.


Preparatory Cleaning:


With review of cleaning agents aside, we will introduce the concept of “Cleaning Preparation” while recognizing that no compounding should occur during any cleaning process. Preparation entails cleaning of doorframes and door jams prior to starting monthly cleaning of the environments. These areas are of particular concern for the environment since air consistently flows through the cracks and crevices driven by positive and negative pressures. The areas of doorframes and door jams are collection grounds for dust, debris, and microbial growth. Opening the door for too long, loosing pressure, brushing up against these areas can cause contamination of compounding areas. Therefore, it is important to include these areas in the monthly cleaning process.


Since there is a risk of losing pressure during the cleaning of doorframes and door jams, cleaning these areas first should be considered to prevent contamination of the environments later during the cleaning process. (Note: All efforts should be made not to lose pressure however these areas need to be cleaned thoroughly to reduce potential contamination).


The anteroom entrance door should be cleaned first followed by the door entrances into buffer rooms (positive pressure entrance done prior to negative pressure entrance). This may seem backwards, but it is a simple dilution process. If contamination is introduced, pressures and ACPH will help remove contamination with eventual elimination of any contamination from the act of cleaning each of the compounding areas.


Traditional Cleaning with Consideration to Negative Pressures:


Once all doorframes and door jams are cleaned and disinfected traditional monthly cleaning may start, cleaning positive pressure areas prior to negative pressure areas. After cleaning and disinfecting the mop, start in the cleanest part of the positive pressure buffer room, from top to bottom and moving outward. Start with the ceilings and walls, exterior of PECs, passthroughs, tables, carts, etc., ending with floors but prior to cleaning of negative pressure areas.


Cleaning the negative pressure buffer room last goes against the traditional thought of cleaning from cleanest to dirtiest but consideration must be made for the dynamics of negative pressure. Negative pressure environments draw in air from adjacent areas therefore anything stirred up during cleaning may potentially be introduced into the negative pressured environment, causing contamination of the area. Saving negative pressure areas for last (even though it’s a buffer room) ensures that the room is left in its cleanest state at the conclusion of cleaning. (It is important to ensure that there is a dedicated mop for these negative pressure environments).


It is important to remember that every surface is to be cleaned, including interior of trash bins, underside of shelving, wheels, and castors, etc. Also, not forgetting any irregular surfaces that may require extra attention and cleaned by hand (temperature controls, alarm mounts, wall vents, other protrusions, etc.).


As the last step, the compounder must doff and discard all garb used for cleaning. Next the compounder garbs and preforms hand hygiene and must clean and disinfect the interior of the PECs with the one-step sterile EPA-registered sporicidal cleaner disinfectant followed by sterile IPA 70% prior to compounding.


Residue Removal:


Before concluding this topic, it is important to address residue removal. All cleaning products leave residue and overtime these residues become sticky and trap dirt, debris, and microbial growth that is detrimental to the compounding environment.


This isn’t such an issue with regularly “touched-up” areas where IPA is used for intermittent cleaning throughout the daily workflow of the IV room. However, areas of concern are ceilings, walls, shelving and particularly floors of the compounding environment. Ceilings, walls, and shelving are usually only cleaned and disinfected once a month and may be able to go longer prior to residue removal. However, strict assessment of floors, which are cleaned and disinfected daily, must be made. How often residue removal is done for these areas (especially floors) depends on the cleaning and disinfecting products used and will be different for each facility. One facility may need to remove floor residues weekly while another may be monthly or even quarterly. The facility will need to assess and incorporate in the SOPs for cleaning.


There are several proven methods to remove residues from surfaces. Use of sterile IPA is one of the best ways to remove residues however, this is not the go to agent for floors and probably not the best for painted walls and ceilings. Sterile water for injection (or irrigation) can be used for floors and other surfaces that sterile IPA is not ideal. Note: Since sterile water is not a sporicidal, the best practice would be to use the sporicidal agent after the use of sterile water.


The process in respect to floors: Simply apply the sterile water generously with a clean mop and allow it to sit for some time to loosen and dissolve residues. Next, dry mop the area to remove residue (changing the mophead as often as needed to ensure the mop is dry enough to remove residue instead of spreading them around). Then, follow this process with application of sporicidal. If residues are removed regularly and not allowed to build up, this is a pretty simple process. However, removing residues that get out of hand can be extremely time consuming and may even require professional cleaning and shut down of the clean room.


Note: Although it requires more time, once a cleaning and disinfecting agent is applied and after the dwell time is observed, dry wipe the remaining cleaning product. This may increase the amount of time between residue removals.


Even though by nature the act of cleaning and disinfecting is to remove contamination, it is imported to assess processes to ensure that potential cross contamination is limited during the cleaning process.


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