The new general chapter, USP 800 Hazardous Drugs in Healthcare Settings, has created a lot of confusion around what types of refrigerators are suitable for the hazardous drug room. Although there is no universal standard for an USP 800 compliant refrigerator, there are some important USP 800 guidelines to consider when purchasing a refrigerator for your hazardous drug room. Note that the refrigerator does not need to be a “negative pressure refrigerator.”
What the general chapter says about storage in a refrigerator:
- Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH [e.g., storage room, buffer room, or containment segregated compounding area (C-SCA)].
Nonhazardous drugs should not be stored with hazardous drugs. Antineoplastic hazardous drugs must be stored in a dedicated refrigerator, and that refrigerator must reside in a negative pressure area with at least 12 air changes per hour (ACPH). Examples of appropriate storage locations would include a storage room, buffer room, or containment segregated compounding area, all of which must be maintained under negative pressure with at least 12 ACPH for hazardous drug storage.
What the general chapter says about venting the refrigerator:
If a refrigerator is placed in a negative pressure buffer room, an exhaust located adjacent to the refrigerator's compressor and behind the refrigerator should be considered.
If the refrigerator is placed in a negative pressure buffer room, an exhaust located adjacent to the refrigerator’s compressor and behind the refrigerator should be considered. The recommendation to place low wall returns near the refrigerator is to help sweep out any particles. It’s not just the refrigerator that might produce the particles, but also the supplies stored inside the refrigerator as they are removed. Helmer refrigerators do not release any additional particles into the environment, however, the hazardous products stored inside the refrigerator may.
What the general chapter says about pass-through refrigerators:
Do not use a refrigerator pass-through. Other methods of containment (such as sealed containers) may be used if the entity can demonstrate HD containment and appropriate environmental control.
Pass-through refrigerators cannot be used in a negative pressure room. However, pass-through refrigerators are appropriate for positive pressure USP 797 clean rooms where nonhazardous compounding takes place.
As we get closer to December of 2019, facilities will continue to adapt their hazardous drug rooms to meet USP 800 compliance. Helmer upright, undercounter, and countertop refrigerators are safe for use in USP 800 hazardous drug rooms.
For further questions on Helmer refrigerators and USP 800, feel free to contact us today.
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