USP797 has been a mandate that originated in the early 2000's. The need arose after illnesses and in some cases, death, were caused due to microbial contamination of compounded sterile preparations. The standards have gone through several changes since 2004 and will continue to evolve. The biggest challenge was noticed in the hospital sector. Prior to USP797, hospital compounding was practiced but not in a cleanroom environment. This left the hospital pharmacists in charge of building cleanroom environments to meet the USP797 mandate and ensuring the rooms met the regulations. Inspections were conducted by State Boards of Pharmacy and JACHO. This mandate will continue to make changes as challenges arise.
What are ISO 14644-1 and Federal Standard 209E?
Levels of ISO 14644-1 Standards. The acceptable amount of 0.5microns allowed in the ambient air.
Welcome to Our Website!
We are always adding new features and updating our content to bring you the most up to date information about our company. Check back often for updates.