When it comes to determining what refrigerators are safe and effective for use in your hazardous drug clean room, it is important to follow the guidelines set forth by the United States Pharmacopeia (USP). This infographic highlights the most important information relating to your USP <800> refrigerator.
As stated in USP General Chapter <800>, refrigerated antineoplastic hazardous drugs (HDs) must be stored in a dedicated refrigerator in a negative pressure area with at least 12 air changes per hour (ACPH).
Ensure that the refrigerator storing your antineoplastic HDs provides optimal temperature uniformity, stability and recovery. This keeps your valuable pharmaceuticals stored at precise temperatures to ensure efficacy and safety. Pharmaceutical-grade refrigerators will have a uniformity spec of +/-1 degree C.
Do not use a refrigerator pass-thru in your HD clean room. This is specific to negative pressure rooms. Other methods of containment should be used for transferring product in and out of the HD clean room. Positive pressure clean rooms may continue using pass-thru refrigerators to enhance clean room workflows and reduce foot traffic in and out of the clean room, therefore, reducing contamination risk.
OTHER BLOGS YOU MIGHT BE INTERESTED IN...
- Interlock Pass-thru Pharmacy Refrigerators for Your USP <797> Clean Room
- USP Receives Appeals on General Chapters <795>, <797>, and <825> Postponing the Official Dates Until Further Notice
- USP <800> Compliance: 9 Webinars to Help You Prepare
- USP <800> Refrigerator Frequently Asked Questions Answered
Helmer Scientific upright, undercounter, and countertop refrigerators do not impact your clean room environment. They are safe for the storage of drugs which require refrigeration inside the clean room. If you have questions about placing a refrigerator in your clean room, download our USP <800> Refrigerator FAQ at the link below.