International Performance Standards for Class III BSC

The last blog addressed industry accepted standards for performance testing of Class III Biosafety Cabinet in the US. This blog focuses on other Internationally accepted standards. These standards contain some areas of overlap with US standards and in other areas provide supplemental information.

British/European Standard BE EN 12469:2000/EN 12469:2000, 2000 (1) :
Class III BSC has a completely enclosed workspace and manometer to show pressure drop (manometer range of -500 Pa to + 500 Pa), (500Pa =2”wg)
Supply air single HEPA, exhaust air double HEPA filtered. Each exhaust filter must be able to be independently tested

Leak tightness: /= to 0.7 m/s with one glove removed, (0.7 m/s =138 ft/min)

Public Health Agency Canada, 2004, (2):
PHAC Laboratory Biosafety Manual 3rd Edition 2004: Document Submission Requirements for the Recertification Performance and Verification Testing of Containment Level (CL) 4 Laboratories in Accordance with the Laboratory Biosafety Guidelines, 2004, Public Health Agency of Canada (and where applicable, Containment Standards for Veterinary Facilities, 1996, Canadian Food Inspection Agency)

Class III BSC to be tested in accordance with:
BS EN 12469:2000: Biotechnology- Performance criteria for microbiological safety cabinets (2000); British Standards Institute

Laboratory Safety Monograph: A Supplement to NIH Guidelines for Recombinant DNA Research (1979); National Cancer Institute Office of Research Safety and the Special Committee of Safety and Health Experts.
Acceptance criteria: measured leakage from any point in the cabinet shall not exceed a leak rate of 10 X 10-7 cc/sec at 750 Pa (750 Pa=3″ wg).

Provide the calibration certificates for the equipment used for the verification.
The final blog in this series will describe ‘best practices’ in field testing (annual on-site recertification) the Class III BSC. As there is no NSF 49 Standard or other regulation that addresses annual retesting, the next blog will consider all of US and International Standards and provide a recommendation for a comprehensive test procedure based on the various standards.

References:
Biotechnology- Performance criteria for microbiological safety cabinets; BS EN 12469:2000/EN 12469:2000, 2000, Dandy Booksellers Ltd.
Laboratory Biosafety Guidelines, 3rd Edition, 2004, Public Health Agency, Canada

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