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).
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). 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 to help sweep out any particles. Helmer refrigerators do not release any additional particles into the environment, however, the hazardous products stored inside the refrigerator may.
Ensure 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.
This infographic highlights the most important information relating to your USP <800> refrigerator.
OTHER BLOGS YOU MIGHT BE INTERESTED IN...
- Complying with USP 800: Refrigerators in Your Negative Pressure Hazardous Drug Room
- Rate of USP <797> & USP <800> Compliance
- USP <800> Refrigerator Frequently Asked Questions Answered
- USP <800> Hazardous Drugs – Handling in Healthcare Settings Drives Pharmacy Renovations
Helmer Scientific’s medical-grade refrigerators are safe for the use for the storage of hazardous drugs in your clean room. If you have questions about placing a refrigerator in your clean room, download our USP <800> Refrigerator FAQ.