Supplement to MFHPB-01
October 2001
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SUPPLEMENT TO THE METHOD MFHPB-01
HEALTH PRODUCTS AND FOOD BRANCH
OTTAWA
The following information is offered as a supplement to the method MFHPB-01, dated March 2001, and should be used with this method. The purpose of this supplement is to provide additional information (such as source(s) of materials, critical steps, confirmation steps, or helpful hints etc.).
1) Laminar air flow cabinet or biological safety cabinet, located in a clean environment
Carry out all microbiological analyses under a laminar flow cabinet or biological safety cabinet, located in a clean environment. The minimum requirements for a clean environment is a laboratory (or a portion of the laboratory) containing no open windows and designed so that there are no direct drafts across the work area.
The particle count of the laminar flow should not exceed a total of 100 particles of size 0.5 micron or greater per cubic foot, (Class 100, U.S. Federal Standard 209B). A Class 10,000 clean room is acceptable under the provisions detailed in section 8.1.3. A class 100,000 clean room has also proved to be satisfactory providing additional quality assurance measures as detailed in section 8.1.3 are taken.
9.1 Association of Official Analytical Chemists (AOAC). 1995. Chapter 21. Bacteriological Analytical Manual, Arlington, Virginia, USA..
9.2 Association of Official Analytical Chemists (AOAC). 1995, Supplement March 1997. Official