Is your Cleanroom Cleanable?
Shortcomings in design, buildout materials, and furnishings that impact cleanability in your pharmacy cleanroom
In December 2021, we touched on the pharmacy cleanroom cleaning guide and the importance of setting up a routine, types of cleaning, as well as solutions to effectively clean and sanitize the classified environments. Of course, having policies and a set routine plays a major part in the long-term sustainability of the cleanroom, but is the room itself and the equipment/furnishings aiding in your efforts, or are they working against you? Is your pharmacy cleanroom cleanable?
Below, we have provided a few often overlooked details that play a large role when it comes to workflow and overall cleanability.
Placement of the Cleanroom Suite Entrance within the Pharmacy: Is the location of the cleanroom (particularly the entrance via the Ante Room) around high traffic areas? Avoiding high traffic areas within the general pharmacy to access the cleanroom suite can significantly reduce the volume of “dirty” air around the entrance and help prevent particles and contaminants from entering the environment.
Design to Support Workflow: High volume of staff traffic within the cleanroom suite is a major risk of introducing unwanted particles and contaminants to the classified space. Humans are the dirtiest element within the cleanroom and should be kept to a minimum at all times. Reducing the amount of non-essential cleanroom staff can aid in your efforts of maintaining a clean environment. Incorporating pass-through cabinets as well as exterior pharmacist check stations eliminates the extra non-cleanroom essential personnel from entering the suite. Interlocking pass-throughs further support the maintaining of pressure differentials and the integrity of how materials are entered into the cleanroom.
Placement of Low Wall Air Returns Around Equipment/Technology: As technology continues to advance, so does health care’s reliance on electronic devices. Incorporating television monitors, computers, and printers for compounding equipment are now considered in the design phase. Carefully evaluate their placement in relation to the compounding area as well as low wall air returns. Ensure that the low wall air return placement is in close proximity; this ensures that any particles produced by the equipment are immediately sent to a HEPA filter for removal and to avoid out-of-specification air quality in the classified spaces.
Mobility of Equipment: The ability to easily move equipment and furnishings makes the cleaning efforts more manageable and effective, hence, the majority of all cleanroom furnishings and equipment should be on wheel casters. Placing a clean bench an inch off the wall with no wheel casters virtually makes the wall, and the back side of the hood impossible to clean. Furthermore, providing bumpers with the wheel casters aids in the possibility of accidental scrapes and hits to your walls systems. If specific equipment needs to be connected via exhaust channel (i.e. Biological Safety Cabinets) or is a large robot and cannot be placed on wheel casters, consideration should be given of proper placement of at least 12-inches away from walls and other unmovable objects to allow space for cleaning.
The Type of Stainless-Steel Matters: Last month we covered Understanding the types of Stainless-Steel in the Pharmacy Cleanroom 304 vs. 316 which taught us that the type of stainless-steel used in your equipment and furnishings can last longer over time due to the harsh cleaning agents required by USP, reducing the amount of rust and corrosion.
Eliminate Wire Racks/Shelving: Efficiency is everything in today’s work environment. This also includes cleaning the cleanroom environment. While the cleaning team must be extremely thorough in their process, they must practice efficiency to keep cleaning costs low and cleanroom downtime at a minimum. Wire racks and shelving for storage do not support efficiency from a time or chemical perspective. To appropriately clean, each individual wire must be saturated and wiped by each pass within the cleaning cycle, eating up time and solution. Converting to solid surface units allow for quicker and easier cleaning, saving time and money.
Built-In Counters: When regulatory standards and clearing requirements of a pharmacy cleanroom weren’t as strict, built-in wood/particle board cabinets and counter tops were very popular. We still see these today in older cleanrooms. These cabinets are not fully sealed and have exposed wood and/or particle board from drill holes and underneath the counter tops. These built-ins are also hard to clean and contain many cervices where dirt and particles can hide. Consideration should be given toward removing all built-in wood/particle board cabinets and counters and replacing with mobile stainless-steel tables, carts, and shelving.
Designing a pharmacy cleanroom is a large undertaking and taking shortcuts to save money, or speed up the process can work against you in the long-term by missing some of these small, yet important, details. Cleaning the environment is one, if not the most important element to keeping a classified pharmaceutical cleanroom in operation and compliant with regulatory standards. Taking the time to carefully analyze the layout, workflow, and furnishings can aid in those efforts to keeping a cleanable cleanroom. Seek support by regulatory officials, pharmacy cleanroom specialist, and consultants as you plan you next pharmacy cleanroom environment.