Sterility Testing Profiles

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Sterility Testing for Cell Lines, Cell Culture Media, and other Biological Material

Test name and components

Sample type requirements

Biologics Sterility Profile: Direct Inoculation Protocol
• Direct inoculation on a battery of eight media, incubated
for a period of 10 days
• Identification of Microbial Contaminants by MALDI-TOF
Mass Spectrometry

1-1.5 mL tissue culture media and
cellular material (if present)

Biologics Sterility Profile and Anaerobic Culture

1-1.5 mL tissue culture media and
cellular material (if present)

Biologics Sterility Profile and Mycoplasma spp. PCR Assay 1-1.5 mL tissue culture media and
cellular material (if present)