The revised USP Chapter <797> became effective on June 1, 2008. The principles set forth in USP<797> provide minimum practice and quality standards for compounded sterile preparations of drugs and nutrients based on current scientific information and best sterile compounding practices. Achieving and maintaining sterility and overall freedom from contamination of a CSP is dependant on several factors, one of which is the environmental conditions under which the process is performed. Northern Air Flow can help develop an environmental monitoring program pursuant to <797> guidelines. This can prove invaluable in rectifying potential performance problems.
Northern Air Flow services include;
Cleanroom Certification
- Airflow testing: Turbulent or unidirectional airflow.
- Airflow smoke pattern test: Unidirectional airflow clean zones.
- Room pressurization and air changes per hour calculations.
- HEPA filter leak test.
- Particle count survey.
- Environmental viable air testing.
Laminar Air Flow Workstation Certification
- Test procedures per CETA CAG-003-2006
Biological Safety Cabinet Certification
- Test procedures per NSF/ANSI 49-2004
- NSF accredited certifier on staff.
- Particle count to confirm ISO class 5 environment.
Compounding Aseptic Isolator Certification
- Test procedure per CETA CAG-002-2006
Although the task of compliance with the requirements of USP<797> may appear overwhelming, complicated and unattainable, quality can be established with a methodical and organized approach.
