Kate Douglass, MS, RN, QP503A qualified and
Abby Roth, CMQ/QE, QP503A qualified
This article is Part 1 of a 3-part series discussing USP <797> compliant cleaning and disinfecting. The authors answer pharmacists’ questions regarding cleaning principles; their answers are based on USP chapter requirements, but focus heavily on best practices.
Pharmacy cleaning and disinfection requirements are discussed in both the 2008 and 2019 versions of USP Chapter <797>, so it might be surprising to learn that questions regarding implementing the requirements still abound in 2020. However, because USP chapters provide a high-level overview, pharmacy is often required to interpret the specifics of the chapters on their own. Researching cleaning agents and materials, and properly sequencing the physical steps in the cleaning and disinfection processes, can seem overwhelming. Nevertheless, it is important to understand that the activities associated with contamination control and the daily and monthly cleaning of sterile compounding environments are just as important as the practice of safe sterile compounding itself.
FDA’s 2018 draft guidance, titled Insanitary Conditions at Compounding Facilities,1 details insanitary conditions observed in compounding facilities and applies to both 503A pharmacies and 503B outsourcing facilities. This document should be required reading for every pharmacist, as it essentially provides a checklist for the pharmacy of conditions to look for in their facility.
Pharmacy Purchasing & Products: What are the overriding principles that drive effective cleaning?
Kate Douglass and Abby Roth: Cleaning is generally performed from top to bottom, back to front, and side to side, essentially cleanest to dirtiest. For example, the daily clean is performed starting from the cleanest areas (the PECs) and working to the dirtiest areas (the floors). However, for the monthly clean there is no way to clean from top to bottom (ceiling to floors) while simultaneously cleaning from cleanest (PECs) to dirtiest (floors). Therefore, each pharmacy must specify the sequence of the cleaning activities best suited for their operation in standard operating procedures (SOPs), and then ensure that all workers perform those activities identically.
In the event that outside environmental services (EVS) staff is designated to perform the monthly cleaning, we recommend that EVS be assigned to clean the ceiling, walls, furniture, and floors, while pharmacy maintains responsibility for cleaning the PECs once EVS is finished.
In addition, note that personnel should clean the irregular surfaces inside the PEC or secondary engineering control (SEC) first, followed by the flat surfaces. Examples of uneven surfaces on the walls include door frames, door handles, clocks, intercoms, window frames and ledges, gaskets around the floor, and the returns area. Once the irregular surfaces are cleaned and disinfected, a mop should then be used to clean the flat surfaces. We favor cleaning with unidirectional overlapping strokes to reduce the incidence of skip spots.
PP&P: What types of agents should be used for cleaning?
Douglass and Roth: For daily cleaning, we recommend using an EPA-registered, one-step bactericidal disinfectant cleaner. USP <797> (2019) requires that the monthly cleaning be performed with a sporicidal agent; an EPA-registered, one-step sporicidal disinfectant cleaner is recommended. Only EPA-registered, one-step agents effectively clean and disinfect in one step. If not using an EPA-registered, one-step agent, then separate cleaning and disinfection steps must be performed, significantly increasing the time required to clean.
To be effective, the surfaces being cleaned and disinfected must remain wet for the entire dwell time (or contact time) specified by the manufacturer. Information about dwell time and the agent’s compatibility with certain surfaces, such as stainless steel and sheet vinyl, will be difficult or impossible to find for non-EPA registered agents; thus, it is best to use EPA-registered products and follow critical directions.
PP&P: Can bleach be used for the monthly cleaning?
Douglass and Roth: Bleach (sodium hypochlorite) cannot be used for the monthly cleaning, as it is not a cleaning agent. Because bleach alone does not contain a detergent, it cannot effectively remove dirt and debris, which is the key to cleaning a surface. When bleach is mixed correctly (at least 5000 parts per million), it does have sporicidal properties. But before an agent can be used to disinfect, the surface must first be cleaned. If bleach is used as the monthly sporicidal agent, all surfaces would also need to be cleaned with a cleaning agent that contains a surfactant/detergent first. This results in the entire cleanroom suite requiring two applications of agents to comply with the monthly cleaning requirements.
Also, note that with repeated use, bleach causes harmful effects on the physical plant.
PP&P: Does monthly cleaning need to be completed in 1 day?
Douglass and Roth: There is no requirement that the monthly cleaning be performed in 1 day, nor should there be. When done right, the monthly cleaning is a resource-intensive operation. As part of an overall effort to quantify the cost of quality, every pharmacy should measure how many hours it takes to complete the monthly cleaning.
It is important to note that when USP <797> requires that specific areas be cleaned and disinfected on a monthly basis, this means approximately every 30 days. We recommend that each pharmacy evaluate the number of rooms, the size of the spaces, and the complexity of their operation (eg, cleaning automated compounders and multiple pieces of furniture will require additional time) as well as how many staff members must be devoted to cleaning. Once this is clear, create a schedule based on what can be reasonably accomplished.
This information must be recorded in written SOPs and documentation forms and then implemented. Following is one possible approach:
The required surfaces must be cleaned and disinfected about every 30 days according to a schedule developed to work in your setting. Remember to use an EPA-registered, one-step sporicidal disinfectant cleaner on all surfaces cleaned and disinfected during the monthly cleaning. After the contact time of the agent has been achieved, all interior surfaces of the PEC must be wiped with sterile IPA. We also recommend wiping each staging cart (the cart next to the PEC that the compounders use), as well as any other work surfaces. You may choose to wipe windows with sterile IPA to remove residues for aesthetic reasons, but it is not required.
PP&P: What is a terminal clean?
Douglass and Roth: In patient care areas, terminal clean refers to the cleaning conducted in a patient room when a patient is discharged and before a new patient can be admitted to that room. This term does not apply to pharmaceutical compounding spaces; instead, we use the term monthly clean to refer to cleaning every surface in a space with a sporicidal agent.
PP&P: What is a triple clean?
Douglass and Roth: Triple clean (or 3 time clean) literally means cleaning the target surfaces three times. Triple cleans are always performed on equipment (PECs or furniture) introduced into a cleanroom suite that is in a state of control and after the post-construction clean is completed in a new or renovated physical plant. The first cleaning should be performed with an EPA-registered, one-step bactericidal disinfectant cleaner, followed by two rounds of an EPA-registered, one-step sporicidal disinfectant cleaner. The two applications of the sporicidal agent are suggested in order to compensate for any portions of surfaces inadvertently missed. Each application must achieve the manufacturer’s stated dwell/contact time prior to the next application of the cleaning agent.
PP&P: Is a triple clean required after a microbial excursion (ie, action level exceeded)?
Douglass and Roth: USP <797> does not require a triple clean after a microbial excursion because in most cases, it would not be beneficial. Cleaning that is done as part of the excursion investigation must be based on the number and types of microorganisms recovered. In these instances, a pharmaceutical microbiologist or an infection preventionist can help determine appropriate next steps.
Consider that in some cases, you may have already done a monthly clean and 10 to 15 daily cleans between the time the samples were collected and when you received the results. In this situation, there may be no need to do any additional cleaning, since the monthly clean would have been done with a sporicidal agent, destroying all microbes and their spores. The microbial excursion is much more likely to be related to improper or inconsistent work practices (eg, hand hygiene and garbing or material handling).
If you still feel additional cleaning is warranted, a monthly clean is the maximum that would be required, unless you have determined the situation truly warrants a triple clean.
Kate Douglass, MS, RN, QP503A qualified, is the vice president and chief development officer of CriticalPoint, LLC, a health care training and development company. She is a co-author of CriticalPoint’s Interactive USP Chapter <797> and <800> Gap Analysis Tools and co-director of the USP Sterile Compounding Compliance Study. Kate has personally supervised the design, engineering, and build of pharmacy compounding facilities that met or exceeded USP requirements.
Abby Roth, CMQ/QE, QP503A qualified, is the director, learning and development at CriticalPoint, LLC. In her current role she develops curriculum for CriticalPoint’s e-learning modules and live training classes. She is a faculty member for the Sterile Compounding Boot Camp Live Training Series. Prior to joining CriticalPoint, Abby served as the director of microbiology for Clinical IQ, LLC, and as a quality director at a contract microbiology laboratory specializing in environmental monitoring.
Effective cleaning requires an understanding of the concept of contamination control. Although this term is not mentioned in USP <797>, understanding ways to reduce contamination from entering controlled compounding environments directly relates to cleaning and disinfection. Reducing the number of particles and microorganisms that enter the compounding area lowers the burden on cleaning activities. Also, by preventing the entry of contamination, the risk to the final compounded sterile preparation (CSP) and to patients is reduced.
There are three components of contamination control:
➊ Hand hygiene and garbing
➋ Material handling
➌ Personnel conduct in the compounding environment
Hand Hygiene and Garbing
Because pharmacy personnel introduce the most particles and microorganisms into the cleanroom, proper hand hygiene and garbing are critical to contamination control. Note that even when correctly garbed, humans continue to shed particles, as garb is not able to contain all of the contamination that personnel generate.
Material handling is not addressed in the currently enforceable version of <797> (2008); however, the 2019 version (now postponed) adds specific requirements for material handling in Section 8, titled Introducing Items Into the SEC and PEC. Lack of appropriate and consistent material handling is frequently a cause for microbial excursions. Therefore, we strongly recommend wiping all items before introduction to the buffer room, or to the inside of the perimeter line of the segregated compounding area (SCA), with an EPA-registered, one-step sporicidal disinfectant cleaner, which significantly reduces the potential for microbial excursions. Note that using any sporicide requires proper implementation of cleaning agent vapor containment and vapor-limiting work practices.
Improper conduct of personnel inside the compounding spaces negatively affects the air quality and increases the potential for the introduction of contamination into the PECs. Appropriate work practices and workflows must be used to minimize the number of components and supplies housed in the ante-room, buffer rooms, and inside the perimeter of the SCAs. Careful staging of patient preparations (or batches) outside the SEC, with an independent double check in place, can prevent additional trips out of the buffer room.
Finally, note that personnel must move slowly and deliberately in the compounding space and talking must be kept to a minimum while inside the controlled environments. Compounding personnel should not speak while they are compounding and facing the LAFW.
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