It seems as if USP797/800 has been around for over a decade. Oh wait-it has. So why is December 1, 2019 causing the chaos? It is the final date to be USP<797> &<800> complaint. By now, most major hospitals have had a USP797 cleanroom built but a lot are still not compliant with both standards. The negative cleanroom has been another mind boggling standard to those compounding. Do you need a separate ante room for negative? Do you need to have special gowning equipment for personnelle? What do we do to our USP797 room to make it complaint?
There still seems to be a lot of questions swirling the mandates. A big difference between the two. USP797 is based on the CSP being safe for the individual receiving them, cleanroom design for hazardous and non-hazardous CSP. It gets into detail regarding the storage, useage, logging, testing, etc.... USP800 concentrates on the safety of personnelle that is compounding the hazardous CSP and what testing needs to be completed for their work environment to be safe for them.
Cleanetics has been involved in USP797 cleanrooms since the inception and can assist you with any questions that you may have. Our calendar for 2019 is almost full and will be accepting a few more clients for Q3/Q4. Let us be in the forefront of working with the architects and ensuring you have a compliant facility.