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