Q&A with Fran McAteer, MS, MBA
Vice President
Microbiology Research Associates, Inc

Pharmacy Purchasing & Products: What is the value of consistent environmental monitoring in a pharmacy cleanroom? 
Fran McAteer: Essentially, a comprehensive environmental monitoring program provides immediate feedback on the state of USP <797> compliance for critical IV preparation. Environmental monitoring can exhibit consistent asepsis within compounded sterile preparations (CSPs), as well as delineate potential contamination trends, providing the pharmacy with a forecasted opportunity to take action. Such programs also quickly demonstrate personnel proficiency, cleaning efficacy, equipment validation, and design verification of primary and secondary engineering controls (PECs and SECs). Simply put, a low cost environmental monitoring and testing program can provide a plethora of USP <797>-compliance information spotlighting the quality of sterile preparations utilized in patient care services.

PP&P: What are some common problems related to cleanroom practices that affect the quality of environmental monitoring? 
McAteer: Excessive staff or equipment movement will change airflow patterns and this can negatively affect monitoring efforts. Likewise, disinfecting a site immediately before sampling can provide false negatives. Room conditions—dynamic (in operation) or static (at rest)—also will render different baselines and fairly obvious activities such as trash pickup, construction, or repairs will invariably skew results. From a practitioner standpoint, incomplete PPE garbing, non-sterile gloves, etc will exhibit more viable particles, and any gaps in room integrity, such as HEPA filter or ceiling panel leakage, also will exhibit higher particle counts.

PP&P: Are there additional risks that can result in false negative monitoring results?
McAteer: False negative results during monitoring activities can be catastrophic, so steps must be taken to ensure the quality of your program. For example, microbiological media must be refrigerated (2-8°C) before use and expiration dating must be noted and maintained. To avoid false negatives, environmental monitoring media must demonstrate low-level organism growth and recovery in order to be validated. This is known as growth promotion and should be performed by an independent lab or by the media manufacturer before incorporating that media into your program. Furthermore, media plates should be placed in critical product exposure areas, not in areas of low use. As mentioned, sites should never be disinfected prior to environmental monitoring sampling.

PP&P: How should environmental monitoring data be recorded, trended, and managed over time?
McAteer: Simple spreadsheets can suffice, but more elaborate software programs are available. The value of adopting such programs likely depends on the size and sophistication of your pharmacy operation. In any case, action level data always should be documented. Graphical presentations can help to visualize this process and will clearly show improvement (or regression). Most important, environmental monitoring data and trends must be communicated among IV pharmacists, technicians, and cleaning staff on a regular basis in order to sustain positive environmental control.

PP&P: What level of detail should you achieve with your policy and procedure for cleanroom cleaning, in general?
McAteer: It is generally logical that the more detailed the program is in writing, the more robust it will be in practice. Specifically, it is important to establish basic policies and procedures (P&Ps) that address the types of disinfectants that will be used, their contact time, the frequency of cleaning, and whether disinfectants will be rotated. From a broader viewpoint, the scope of documentation must be established, as well as the assignment of task responsibility. Will internal pharmacy staff perform the cleaning and monitoring necessary for compounding areas? Will housekeeping or environmental services staff be involved? Will the facility contract with a third party provider for cleaning and monitoring, or will there be a combination of outside and inside staff? All of these options should be explored in order to select the right approach for your operation. 

PP&P: What factors should pharmacy consider when deciding from among these options?
McAteer: The main concept to consider is whether the individuals responsible for cleaning and monitoring have a working knowledge of both the substances they are cleaning, as well as the substances being used to perform the cleaning. With this in mind, environmental services staff may be familiar with the cleaning agents, but may require training and education on the hazardous or otherwise sensitive materials used in the pharmacy, as well as the requirements for working in an ISO-7 cleanroom. For pharmacy staff, it is the opposite situation; they are familiar with technical compounding, but may be wary of having to perform routine cleaning functions.

PP&P: How can <797>-compliant cleaning and monitoring activities provide benefits beyond the pharmacy?
McAteer: The implementation of stronger disinfection programs in operating rooms and surgical areas is compelling because of the potential for immediate and dramatic benefits to patient care. When it comes to cleaning and disinfecting these areas, <797>-compliant monitoring programs would demonstrate the efficacy of the processes on a highly quantifiable level. Other potentially ameliorable processes for surgical areas include quantifying microbial kill rates based on disinfection type, frequency, contact time, and surfaces against known microbes isolated in ORs through environmental monitoring testing. 

In the pharmacy, <797> practitioners have really become champions for better infection control and better overall quality of IV medication production. They should be proud of this legacy and stewardship. However, in order for concepts such as those put forth by <797> to make a real impact in saving patient lives, these ideas need to reach beyond the pharmacy to places such as surgical operating rooms, IV therapy areas, imaging, cauterization labs, etc.

It is important to note that just because the air in a cleanroom or operating room is filtered, that does not necessarily ensure the room is free of contaminants. When considering operating and surgical areas, there is often a high patient turnover rate, and the constant introduction of blood and bacterial contaminants begets the need for P&Ps that ensure efficacy in addressing these areas. Operating rooms are an area of health care practice that would likely benefit from some simple adjustments to cleaning and monitoring practices. Performing environmental monitoring in surgical areas would have a direct impact on reducing hospital acquired infections (HAIs) and positively affect patients from a front-line perspective. It also would complement existing <797> programs benefitting pharmacy compounding. 

PP&P: What products and materials used to clean and monitor a pharmacy cleanroom would lend themselves to use outside the pharmacy?
McAteer: Specialized products, materials, and equipment intended for use in a cleanroom must all be cleanroom compliant, meaning they must be low particulate, non-shedding, easily cleanable, and in some cases, sterile. In the surgical setting, all of these factors are usually not required, but by introducing them, you are able to institute a greater degree of microbial contamination control.

PP&P: Regarding PPE and engineering controls in particular, what information should be included in policies and procedures?
McAteer: Any practitioner using a cleanroom for its intended purpose should be cognizant of proper cleanroom-centric procedures, operations, and conduct when it comes to maximizing the efficacy of PPE and engineering controls. The following are basic essentials for cleanroom P&Ps:

• Establish proper PPE products and the sequence for garbing. This should include an understanding of USP <797> guidance of garbing proficiency, both for hand hygiene and the garbing sequence.
• Define the physical cleanroom layout and the placement of ISO-5 class PECs. The relationship among PECs must take into account the relative criticality of products to be manipulated therein, so a PEC used to handle chemotherapy should be placed in negative pressure and apart from a PEC used for non-hazardous preparations. TPN production areas also should have enough space for pumps and equipment.
• Delineate how materials should be used and how personnel should conduct themselves while in the cleanroom. All employees assigned to the cleanroom should be able to apply strict aseptic techniques to reduce the risk of tactile contamination. This includes the proper procedures for garbing, hand hygiene and gloving, frequent disinfection practices, and working at a calculated, deliberate pace in order to minimize the production of both viable and non-viable particulates.

When addressing cleaning and disinfecting specifically, the focus of P&Ps should be on the establishment of a correct cleaning sequence, using a top down approach and working from the furthest point in the cleanroom toward the anteroom door in order to minimize cross contamination. Although activities such as floor mopping may seem straightforward and rote, they should be handled in a thoughtful and sensitive manner. For example, it is vital to separate the mopping procedure into two distinct actions; the mop head and the solution used for disinfecting must remain separated from the mop head and solution used for rinsing. Individual mop strokes should be unidirectional and slightly overlapping. Several specialized cleaning suppliers offer double and triple bucket rigging and interchangeable mop heads to assist in this practice.

Whether to institute a disinfectant rotation program into your cleaning P&Ps is another issue to resolve. If rotation is preferred, it is best to use products that are effective against multiple microbes. For example, rotating among phenol-based and bleach-based products, or introducing a quaternary ammonium compound can help eliminate a wide variety of microorganisms. If a rotation policy is introduced, the frequency (monthly, quarterly, etc) must also be established. The idea behind rotation is to avoid having certain microorganisms develop resistance to one cleaner or another. It is important to note that there is much discussion and debate over whether to rotate products, so performing proper due diligence to address your own specific needs is suggested.

PP&P: How can pharmacy determine the risk of developing cleaning product resistance?
McAteer: This topic has been covered in published literature, but the ultimate scenario is to actively use environmental monitoring results to determine whether the action levels of microbial growth are being consistently suppressed in the cleanroom. If, for example, the results of environmental monitoring indicate mold growth month after month, chances are the adoption of a sporicidal solution into the cleaning process will resolve this issue. This is why environmental monitoring is so important—the results should dictate or at least influence the frequency of cleaning and disinfection procedures in all engineering controls used in the pharmacy. Another method is to perform a Disinfectant Efficacy Study (refer to USP Chapter <1072> - Disinfectants and Antiseptics). These studies demonstrate lethality utilizing disinfectants, surface environmental monitoring isolates, and contact times.

PP&P: What is the best way to approach scheduling for cleaning so as not to interfere with compounding workflow?
McAteer: The facility must take precautions when scheduling cleaning and disinfection activities, and especially trash collection in a cleanroom. A general rule is to avoid these activities during peak compounding hours, which tends to run from early morning to midafternoon. This can be especially tricky if the facility uses environmental services personnel for cleaning activities and that department’s schedules have not been synced with pharmacy compounding schedules. Having environmental services staff emptying trash bins at the same time that technicians are working on TPN in a critical hood is a nightmare scenario. Certainly, these schedules should be worked out such that cleaning and refuse collection is performed during off-peak hours, perhaps at night when the cleanroom is inactive or far less busy.

PP&P: Given the potential for miscommunication with environmental services, is it better to keep cleaning activities within the pharmacy department?
McAteer: This also can be a sensitive subject, because, in general, cleaning and disinfecting activities are not a fundamental aspect of pharmacy technician expertise. Because of this, requiring technician staff to perform cleaning and disinfecting may not be well accepted. Furthermore, many pharmacies do not want to take the technician’s focus away from the meticulous activities involved in compounding medications. If you view this from an overall patient-safety perspective, the value of avoiding interruptions and allowing technician staff to fully focus on detailed compounding activities is paramount. Another factor that must be taken into account is staff capacity. Some pharmacies, particularly in large-scale hospitals and health systems, may have a full complement of technicians practicing at different defined levels, and can therefore afford to assign certain staff to cleaning and disinfecting activities. However, for pharmacies that are already working to capacity, it can be difficult for the pharmacy to add new technicians to address actions such as cleaning and disinfection.

In any case, environmental services staff with the expertise to engage in cleaning and disinfecting can be brought in to complement technician activities. If a combination of pharmacy and environmental services staff is employed, it is wise to introduce the latter to USP <797> training, compliant cleanroom cleaning processes, garbing proficiency, disinfectant preparation, cleaning schedules, frequency, contact times, and cleaning documentation. After this training, walk the staff through and teach them about gowning and cleanroom conduct. I have found that air and surface microbial testing demonstrations seem to emphasize the criticality of the cleaning process. These demonstrations should then be followed by an initial direct observation of procedure in the cleanrooms noting any inconsistencies or errors.

A third option is to engage a cleanroom cleaning company to ensure proper cleaning and disinfecting processes are in place. These practitioners have clearly defined expertise in regard to cleanroom cleaning and can provide compliant materials and equipment, recommend disinfectants, and introduce sound procedures. If this route is chosen, the facility would be wise to conduct some type of assessment of the vendor’s capabilities. This should include demonstrable knowledge of <797> guidelines, active accreditations, client references, a list of materials and equipment to be used, and any quality control functions.

PP&P: What are the important differences between cleaning specific engineering controls and cleaning the cleanroom?
McAteer: When working with ISO-based, stand-alone technologies such as biological safety cabinets (BSCs) and laminar airflow workbenches (LAFWs), they come with specific cleaning and disinfection procedures. USP <797> indicates that these devices should be cleaned at least once per shift (more if there is a spill), so most facilities perform this using 70% isopropyl alcohol (IPA). It is important to use a sterile IPA for these devices. On top of this, many facilities also utilize a sporicidal solution, such as bleach, or a peracetic acid solution, weekly in order to kill bacteria and fungal spores.

PP&P: What are the best indicators of an inefficient cleaning program?
McAteer: The clearest and most compelling evidence of a substandard cleaning and disinfecting program will present itself through environmental monitoring trending practices. If agar plates and air samplers indicate the presence of or increases in the presence of mold and other bacterial counts in specific areas, this is a clear indication of inefficient cleaning. Thus, instituting and maintaining a robust environmental monitoring program is part and parcel to maintaining a sterile environment, and that would constitute the primary feedback system for cleaning efficacy.

Outside of environmental monitoring, be sure to observe devices and surfaces for any obvious residue or corrosion. Likewise, any sort of new construction or facility upgrades that are associated with the cleanroom (directly or indirectly) would signal a potential increase in contamination risk, and would clearly call for an increase in frequency of cleaning, disinfection, and monitoring until construction is complete.

Fran McAteer, MS, MBA, is vice president at Microbiology Research Associates, Inc, an FDA-registered microbiology testing laboratory specializing in USP <797> compliance, consulting, environmental monitoring, clean room certification, ACD validation, and CSP sterility and endotoxin testing. Fran has expertise and experience in implementing USP <797> compliance programs and acts as a consultant for numerous hospitals. Fran can be reached at (978) 263-2624.