Can you include a refrigerator in a clean room at all? If so, what type of refrigerator? How big does it need to be? Are there special cleaning and maintenance considerations? Does it matter if the refrigerator is compressor-based or solid state?
Equipment planners and pharmacy directors have wrestled with these questions since the November 2023 updates to USP <797>.
Recently, Helmer Scientific partnered with Pharmacy Purchasing and Products (PP&P) to sponsor a webinar, where Patricia Kienle, director of accreditation and medication safety at Cardinal Health, shed some light on the topic of clean room equipment planning and design.
During her discussion, she laid out four key questions to ask to determine when, if, and what type of refrigerator to use in your sterile compounding cleanroom.
Does the refrigerator need to be inside the clean room?
Space inside the clean room will be at a premium, so every piece of equipment that is not necessary for compliance or workflow efficiency should be kept outside of the clean room.
Patricia recommends keeping refrigerators and freezers in the anteroom when possible to free up space inside the clean room. In cases where chemotherapy and other hazardous drugs are being manipulated, refrigerators must be inside a negative pressure room, though she notes this could be a negative storage area or negative buffer room rather than in the clean room.
“It's perfectly acceptable to have a refrigerator in either the anteroom or the clean room. Certainly I prefer it in the anteroom.”
Patricia also reminds pharmacy directors that any equipment placed inside of the cleanroom will require additional cleaning, which should be considered during the equipment planning process.
If the refrigerator does need to be inside the clean room or the clean room suite, consider the next question.
Does it matter what type of refrigerator is used inside the clean room?
If it the refrigerator must be inside the cleanroom suite, Patricia explained there are two different types of refrigeration: compressor-based and solid state.
“Now, refrigerators for clean rooms come either with a compressor or they may be a solid state. Both are acceptable. It's not an issue as long as it's designed correctly.”
Patricia’s comments come in response to the hypothesis that compressor-based refrigerators may generate particulates that impact air quality compliance within the clean room environment.
Helmer recently conducted an experiment in which compressor-based refrigerators from Helmer and a leading competitor were tested in a simulated clean room environment to see if particulates generated by a compressor-based refrigerator would cause a clean room to drift outside the acceptable range for ISO Class 7 compliance.
The results of the experiment showed all compressor-based models tested maintained particulate measurements within acceptable limits for ISO Class 5 compliance, two levels more stringent than the ISO Class 7 requirements in USP <797>.
Where should the refrigerator be inside the clean room?
If particulate generation remains a concern, Patricia recommends placement of compressor-based refrigerators in front of exhaust vents inside the clean room suite.
“I am a big fan of always putting an exhaust, if possible, a return if necessary, behind the compressor or refrigerator, because that would take away any of those particles that might be thrown off by that.”
Patricia also urges equipment planners to consider proximity to clean room doors, the direction and path of refrigerator doors when opened, and the spacing between equipment to ensure adequate space for cleaning.
“…remember you have to clean around all those hoods just like you have to clean around a refrigerator or anything else that would be placed in that room and six inches isn't going to get you enough room to clean it…”
What size refrigerator should be used?
The final consideration for refrigerator use in a clean room environment is size. The size of your refrigerator will depend on several factors: the overall size and available space in the cleanroom suite, the volume of drug being compounded, or the presence of a sterile storage room.
Additionally, Patricia urges pharmacy directors and equipment planners to plan for growth when selecting a refrigerator size.
“Make sure they're appropriately sized and think in the future. You know, you don't want to get things that are too big because they, you know, they may take up too much space or generate heat, things like that, but make sure that you're adequately handling and thinking about what you might be doing in the next few years. Cause you know, we don't get our IVs rooms changed every year, right?”
So, how do you decide on a refrigerator for your sterile compounding room?
- Verify the refrigerator must be located inside the clean room suite.
- Always choose medical-grade refrigerators for general pharmacy use and use inside clean room environments. Compressor or solid-state refrigerators are acceptable.
- When possible, place your refrigerator in front of an exhaust vent to carry away any particles generated.
- Plan for growth when selecting the appropriately sized refrigerator for your sterile compounding room.
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GX Solutions Pharmacy Refrigerators have been third-party validated to meet requirements for ISO Class 5 Clean Room compliance.
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