Northern Air Flow would like to assist your pharmacy by assuring that USP <797> compliance is as simple in practice as it is in principle. Our technicians are trained in the guidelines of USP <797> and Controlled Environment Testing Association (CETA) CAG-003-2006, “Certification Guide for Compounding Facilities”. All of this means that you can rely on us to not only reach your compliance standards, but exceed them. To that end you will find, outlined below, some basic guidelines involved in the implementation and maintenance of USP <797>.
Sterile compounding must be performed inside an ISO Class 5 primary engineering controlled (PEC) environment, such as a laminar airflow workbench, biological safety cabinet, or isolator. Biological safety cabinets are certified by a NSF accredited technician. NSF International (NSF/ANSI 49) defines the test methods and acceptance criteria for field certification of all Class II biological safety cabinets. We can assist you in assuring that your PEC meets USP<797> certification standards every six months.
One of the variables in achieving and maintaining sterility and overall freedom from contamination of a CSP is dependent on the environmental conditions under which the process is performed. Northern Air Flow can help develop an appropriate environmental sampling plan which should include viable air samples, viable surface samples and nonviable airborne particle counts. Viable air testing is completed using USP <797> recommended method of volumetric impaction. Evaluation of viable samples will identify microorganisms to the genus level. All testing will be performed using current, state-of-the–art equipment.
Every sterile compounding facility has unique characteristics and a plan will be devised to fit your specific needs. Testing may include HEPA filter integrity test, airflow testing, airflow smoke pattern test, room pressurization and air changes per hour calculations.