{"id":901,"date":"2012-04-23T08:30:26","date_gmt":"2012-04-23T15:30:26","guid":{"rendered":"https:\/\/hartleymedical.com\/blog\/?p=901"},"modified":"2020-09-11T12:48:20","modified_gmt":"2020-09-11T19:48:20","slug":"a-usp-797-compliant-clean-room","status":"publish","type":"post","link":"https:\/\/hartleymedical.com\/a-usp-797-compliant-clean-room\/","title":{"rendered":"A USP 797 Compliant Clean Room"},"content":{"rendered":"

As we have stated in the past, not all compounding pharmacies are the same. This applies to clean rooms as well. The first thing to know is that there are different levels of clean rooms. The International Standards Organization (ISO) classifies clean rooms based on the number of contaminants per-cubic-meter. The lower the ISO rating, the cleaner the environment.<\/p>\n

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Hartley Medical’s USP compliant sterile preparation area consists of three areas: 1) a gowning room, 2) an ante room, and 3) a sterile preparation room. To meet USP 797 guidelines, a buffer room should be ISO Class 7 or better (less than 352,000 particles-per-cubic-meter), and the gowning room and ante room should be Class 8 or better (less than 3,520,000 particles-per-cubic meter). And, since workers are the largest contamination source, all rooms should be isolated through the use of sealed doors and pathways. Hartley Medical exceeds<\/em><\/strong> USP guidelines by utilizing an ISO Class 6 sterile prep-room, and ISO 7 for ante and gowning rooms. Access in and out of this preparation area, as well as from room-to-room inside, is through sealed, self-closing doors.<\/p>\n

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