Laminar-airflow equipment certification: what the pharmacist needs to know.

The basic information pharmacy practitioners need to determine the suitability and applicability of laminar-airflow equipment test standards and procedures is presented. The operative guideline for any laminar-flow clean bench (LFCB) certification is the cleanroom and work station requirements for controlled environments as defined by the federal government under Federal Standard 209b (FS 209b). FS 209b outlines the tests, test procedures, and acceptable performance ranges for all LFCB equipment. National Sanitation Foundation Standard Number 49 (NSF 49) is used in the certification of biological-safety cabinets (BSCs). NSF 49 covers those aspects of safety, maintenance, performance, and testing that are unique BSCs. To monitor certification properly, practitioners should be familiar with these standards and the air-velocity profile, high-efficiency particulate air filter performance, noise output, light, and electrical test procedures. A review of the requisite knowledge, experience, and reputation of certifying agents is presented, along with an outline of all the necessary procedures, equipment, and documentation to be used in the process. A thorough test report should be issued upon unit certification. As pharmacy practitioners are responsible for all other aspects of quality assurance, they should also be capable of auditing these certifications to ensure the aseptic quality of products compounded in the laminar-airflow environment.