Just a few decades ago, little regard was given to the safe handling of and sterile preparations for hazardous drugs. It often fell on each facility to create their own regulations, which could mean the only preparation for compounding was a hand wash and, if chemotherapy was handled, a pair of gloves.
Early cleanrooms were just as rudimentary. Hoods were placed next to air conditioning wall units, negative pressure hazardous hoods were next to regular hoods, and hazardous compounds were mixed in the same areas as antibiotics. As the importance of sterile preparation for the safety of both patients and staff became well known, pharmacists were given the difficult task of improving spaces that could not accommodate evolving standards—often with pushback from colleagues and with little budget to do so.
Today, guidance such as USP <797> and <800> mandates specific standards to ensure that cleanrooms are as safe as possible for sterile compounding. While these standards help guide the design of these spaces, there are still challenges and considerations beyond compliance when remodeling or creating a cleanroom. Pharmacy leaders should consider the following as they begin their journey to design a cleanroom suite.
Examining existing cleanrooms at other institutions can be a good starting point when creating plans for a new suite. However, creating a layout is not a one-size-fits-all approach—what works at a 1,000-bed hospital might not at a 200-bed hospital system. Similarly, budgets will vary by hospital size and need.
When securing budget and space, use facts about the importance of sterile preparation as the impetus for change. Error rates, statistics, and even anecdotal evidence can be used to stress the need for timely and adequate resources when speaking to those who make the financial decisions at a facility. Once these parameters are established, be mindful of how much space is allocated. When possible, look to similar-sized hospitals with up-to-date and efficient cleanrooms as an example of how to best use the space you have. If needed, scale back while keeping the core concept of what is done in a bigger hospital to ensure that needs of your patients are met.
Just as important as designing a cleanroom is maintaining it. This holds true not just for the buffer room, but also for the additional rooms in the suite as well. The fit and finish should be the same in every room throughout; for example, if the cleanroom has vinyl flooring and double epoxy marine paint on the walls, so should the adjacent rooms in the compounding suite. Also expand this concept to the dedicated segregated compounding areas; the finishes in these spaces should mirror those of the cleanroom suite.
This method is not only helpful in promoting efficient cleaning, but also in making it easier for staff as they learn to navigate policies and procedures to keep the cleanroom and nearby areas sterile. Because every area is set up the same way, staff can easily transition from one area to another with no special training or tools required.
See the SIDEBAR for more direction on cleaning the cleanroom.
When redesigning currently existing cleanrooms, it can be challenging to find enough space for all the necessary equipment and tools. It is important to not overlook aspects that may be given less consideration, such as storage. If possible, try to reserve space within the cleanroom for a closet or similar spot dedicated to cleaning supplies as well as extra personal protective equipment stock. Ensuring these items are close at hand helps support compliant practice among compounding staff members.
Cleanrooms need not be the only source for storage of medications and supplies. Sometimes it is preferable that items are kept outside of the cleanrooms and brought in as needed through pass-through doors in order to save space in the room itself. This decision should be made prior to construction.
Expert and Stakeholder Consultation
One of the most important steps in renovating or building a cleanroom is consulting an expert to review the architectural plans at their final stages. This step is key to ensuring a design will be approved by the board of pharmacy. The review should be completed by a professional who is well-versed in architecture, pharmacy needs, and regulatory compliance. Some items that will be reviewed at this stage include dimensions, HVAC system and sink locations, whether the current HVAC system will be able to handle the room requirements, and calculations to ensure they are correct. Even subtle changes suggested by these groups can make a big impact on ensuring board approval.
It is also key to consult other stakeholders within the hospital who will be servicing the cleanroom. For example, the in-house engineering department will be most familiar with the specifics of the facility and can help advise the design and placement of the HVAC system. It is especially important that this team, and others like it, be involved in these types of decisions if they will be tasked with maintaining the system. Developing a good relationship with other departments can also help ensure that any urgent needs are addressed quickly; for example, the engineering manager can help facilitate any urgent repairs rather than having to wait to be scheduled.
Once the design is approved by an architect, workflow considerations can begin. In a general workflow, consider how the staff will work with the least number of steps. For example, a segregated compounding area will require that the staff gather their supplies in the work area, don shoe covers, perform necessary steps for hand hygiene, then enter the compounding room. In the cleanroom, staff gathers supplies, cleans them, places them inside the respective pass-throughs, then proceeds to enter the anteroom for hand hygiene and garbing. Once inside the respective cleanrooms, alcohol-based hand scrub is performed before donning gloves.
Layout will need to accommodate these steps in this particular order. As such, the placement of sinks, pass-throughs, and storage areas should support this flow.
Design of a safe, efficient cleanroom should be guided by more than just regulatory compliance. Plans need to be tailored to each facility’s specific space and budget. Details such as storage, cleaning, and training should be considered while still in the planning stages. Experts and stakeholders should be consulted prior to presenting plans to the pharmacy board to ensure a smooth approval, and that nothing is missed. A cleanroom that begins with compliance requirements and ends with careful attention to detail is one that functions safely and efficiently for pharmacy staff.
Carlos M. Marin, RPh, BCSCP, is the supervisor for sterile preparations and hazardous drugs at Overlook Medical Center in Summit, NJ. He received his pharmacy degree from St. John’s University College of Pharmacy. Carlos possesses 35+ years’ experience in preparing sterile preparations and hazardous drugs and is a former CEO of a compounding pharmacy that prepared sterile specialty IVs and total parenteral nutrition for local hospitals. He has taught both pharmacists and technicians the art of sterile preparations, and lectures on this subject and nutrition support.
Cleaning the Cleanroom
Overlook Medical Center (OMC) is a 500-bed facility that operates with two full cleanrooms and three outpatient infusion cancer satellites. Of these sites, two of the offsite satellites and the main cleanroom were recently renovated in 2020. OMC has a fastidious cleaning routine dedicated to maintaining a sterile environment within its cleanroom suite. The schedule breaks all tasks into three assigned timeframes—daily, weekly, and monthly (see the TABLE).
Pharmacy staff receive cleanroom cleaning training when first onboarded, and then again as part of their annual refresher course. During the onboarding process, new staff first review training modules on an e-learning dashboard. Next, they are partnered with a seasoned pharmacy member and given a list of tasks to complete. After this list is thoroughly reviewed, the trainee is given a hands-on practical exam which incorporates media fill, finger-tip, and surface sampling tests. Once the practical exam is passed successfully, the trainee continues to work with their experienced partner for a monitoring period, at which point new staff is encouraged to ask questions, review any issues that might arise, and learn from their partner. The trainee is assessed by peers during this time; once all IV staff mentors determine the new team member is ready, he or she will begin to take on more of the daily and monthly responsibilities on their own.
The daily cleaning of the rooms is completed 3 times within a 24-hour period by pharmacy staff—once toward the end of each shift. This includes wiping down the interior surfaces of the hood, floors, pass-throughs, inside the garbage container, and any high-touch surface areas. In the hazardous drug rooms, this cleaning is conducted with a sporicidal agent and in the nonhazardous areas, a one-step germicidal agent is used. Additionally, the anteroom is cleaned using a sporicidal agent on all high-touch surfaces. In addition, the sink and floors are cleaned and dried. Since the act of cleaning can disturb the air inside the cleanrooms, no compounding occurs for at least 30 minutes post-cleaning.
Pharmacy staff are also responsible for the weekly cleaning tasks. This process encompasses a deep cleaning of all the items addressed during the daily cleaning with the addition of wiping down all the shelving in the cleanroom. Furthermore, the hoods and isolators are opened and deep cleaned inside and out by staff wearing respirators. This provides an opportunity to inspect the engineering controls for any issues. In the past, cleaning staff found pitting on the stainless steel of the isolators, which left unaddressed, can lead to rust. By switching to a sporicidal disinfectant and cleaner, we were able to alleviate that problem. Over time, a film will develop on the surfaces cleaned with the sporicidal agent; thus, those surfaces are also wiped with sterile water for irrigation when this film appears.
Outsourced Cleaning Tasks
Given the extensive time required for a thorough monthly cleaning, tasking compounding staff with this responsibility has a significant impact on productivity. As such, the monthly cleaning is outsourced to a cleaning company overseen by pharmacy leadership. All of the weekly cleaning tasks mentioned above are once again deep cleaned, as well as ceilings, walls, backs and tops of the hoods, and any other surfaces not addressed during the daily or weekly cleaning. All of the specific cleaning products are provided by OMC.