QC/ Sterility Assurance - Microbiology Bioburden

Bioburden (MG005)

Test Options/Variations

MG005-01MTotal Fungi - Membrane Filtration
MG005-01PTotal Fungi - Standard Plate Count
MG005-11MTotal Aerobes - Membrane Filtration
MG005-11PTotal Aerobes - Total Plate Count
MG005-21MTotal Aerobes and Spores - Membrane Filtration
MG005-21PTotal Aerobes and Spores - Total Plate Count
MG005-31MTotal Aerobes and Anaerobes - Membrane Filtration
MG005-31PTotal Aerobes and Anaerobes - Total Plate Count
MG005-41MTotal Aerobes and Fungi - Membrane Filtration
MG005-41PTotal Aerobes and Fungi - Total Plate Count
MG005-51MTotal Aerobes, Spores, and Anaerobes - Membrane Filtration
MG005-51PTotal Aerobes, Spores, and Anaerobes - Total Plate Count
MG005-61MTotal Aerobes, Spores and Fungi - Membrane Filtration
MG005-61PTotal Aerobes, Spores and Fungi - Total Plate Count
MG005-71MTotal Aerobes, Anaerobes and Fungi - Membrane Filtration
MG005-71PTotal Aerobes, Anaerobes and Fungi - Total Plate Count
MG005-81MTotal Aerobes,Spores,Anaerobes & Fungi - Membrane Filtration
MG005-81PTotal Aerobes, Spores, Anaerobes and Fungi - Total Plate Count
MG005-91MColiforms - Membrane Filtration
MG005-91PColiforms - Total Plate Count
MG005-EXMTotal Aerobes: Extended Incubation - Membrane Filtration
MG005-EXPTotal Aerobes Extended Incubation - Total Plate Count

 

This test is selected for determining a quantitative estimation of the number of viable microorganisms associated with medical products, raw materials or tissue samples. Validation of the processing methods should be validated (see MG063 and MG121). Bioburden testing is typically conducted to help select a material for a device or to help establish a sterilization method.  We employ both membrane and plate methods.

Standards

  • ISO 11737-1
  • USP 1231
  • USP 61
  • 21 CFR 1271
  • ISO ISO/IEC 17025
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