Specifies the general procedure for determining bioburden levels and organism characterization in raw materials, subassemblies and final assemblies.Some characterization methods incorporate Milliflex 100 system and Leica Quebec Darkfield Colony Counter, as well as gas flame and agar plating techniques.Includes attached data collection form, “Bioburden Test Report.”Adheres to USP 23:71, “Sterility Test, Membrane Filtration,” and APHA, “Standard Methods for the Examination of Water and Wastewater.”
- Edition:
- 1
- Published:
- 10/01/2004
- Number of Pages:
- 7
- File Size:
- 1 file , 130 KB
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