Beginning November 1st, 2023, state board inspectors will be able to inspect organizations to the latest USP <795>and USP <797> regulations. The biggest changes are classification changes for CSPs, beyond-use dates (BUD) changes, cleanroom personnel training, testing/cleaning requirements, and environmental monitoring changes.
Most of the important and biggest changes come from USP<797>. For years CSPs have been classified as low, medium, or high risk. The new USP <797> regulations will now classify CSPs as category 1, 2, or 3. These changes will help guide you on cleanroom design.
With the new classification system, comes revised BUD’s. To help avoid any confusion, USP presented everyone with a detailed chart to compare the old BUDs to the new BUDs (see fig. A).
Most of the important and biggest changes come from USP<797>. For years CSPs have been classified as low, medium, or high risk. The new USP <797> regulations will now classify CSPs as category 1, 2, or 3. These changes will help guide you on cleanroom design.
With the new classification system, comes revised BUD’s. To help avoid any confusion, USP presented everyone with a detailed chart to compare the old BUDs to the new BUDs (see fig. A).
All category 1 CSPs must be compounded in an ISO 5 or betterhood. That hood is your primary engineering control (PEC) and can now be placed inside an unclassified segregated compounding area (SCA). The SCA does not require a sink inside of the room but must have a sink in close proximity to the SCA. The SCA must not be next to any unsealed windows, doors the connect to the outdoors, or doors that have heavy traffic flow. The SCA must not be placed anywhere in areas that will make environmental controls difficult. While this might be a new regulation, TCA already has experience in SCA design. We are here to help you better understand the new regulations and ensure your room is built correctly the first time!
All category 2 and 3 CSP’s must be compounded in a cleanroom suite. There were no changes to facilities design for cleanroom suites in USP<797>. The preferred design is an ISO 7 buffer room with attached ISO 8ante room. You will enter the ante room on the dirty side of the line of demarcation (LOD), and the clean side of the LOD will be closer to the buffer room. The air being introduced into both the ante and buffer room must be through HEPA filter located in the ceiling. TCA’s system has been designed and built to these standards for decades and has yet to fail an initial inspection!
For more a more detailed explanation of all the new revisions for USP <797> and USP <795>, please click below.
View USP RevisionsAll category 2 and 3 CSP’s must be compounded in a cleanroom suite. There were no changes to facilities design for cleanroom suites in USP<797>. The preferred design is an ISO 7 buffer room with attached ISO 8ante room. You will enter the ante room on the dirty side of the line of demarcation (LOD), and the clean side of the LOD will be closer to the buffer room. The air being introduced into both the ante and buffer room must be through HEPA filter located in the ceiling. TCA’s system has been designed and built to these standards for decades and has yet to fail an initial inspection!
For more a more detailed explanation of all the new revisions for USP <797> and USP <795>, please click below.
As always, if you have any questions feel free to reach out to us at 970-203-0516 and/or email us at tcaoffice@traviscleanair.com. Our consultants are here to help!
