Referring to sterile compounding procedure, USP 797 sets standards such as maintaining a clean facility, irrefutable knowledge of sterilization, testing air quality, educational training and stability requirements for sterile compound handlers. These standards include guidelines, procedures and compliance with sterile practices, according to EMLab P&K.
USP 797 references chapter 797 of the United States Pharmacopeia Formulary. These standards are enforceable and apply to settings such as hospitals, pharmacies, clinics, and family practices and other institutions. They relate to anyone storing, preparing or transporting compounded sterile preparations, including nurses, doctors, pharmacy technicians and pharmacists, states EMLab P&K.
Sampling of air and surface atmosphere happens while designating a facility or clean room suitable for sterile processing. Depending on the test results, a room receives the designation of suitability for handling exposed sterilized containers, closing operations or closures, which receives a designation of ISO 5. The room adjacent must qualify as an ISO 8, which means suitable for garbing. ISO 8 rooms include operating room anterooms, advises EMLab P&K.
Complying with USP 797 standards requires adjusting procedures for greatest control over manufacturing. Performing a risk assessment, gap analysis and devising an action plan ensure the lowest level of risk for aseptic manufacturing. Action plan items such as gloving procedures and air quality monitoring address viable and nonviable particulates in the sterile environment, according to EMLab P&K.