Microsart® Validation Standard Staphylococcus aureus
Microsart® Validation Standard are used for validating robustness and sensitivity of NAT-based detection methods, to be used for contamination control of cell cultures, cell culture media components and cell culture derived biologicals like cell autologous transplants and ATMPs.
Item no.: SMB95-2010
Microsart® Validation Standards are not infectious and therefore safe in use. They are titrated to 99 CFU/ml, the sensitivity limit for sterility tests according to European Pharmacopoeia (EP) 2.6.1 Sterility. The bacteria strains used for the manufacture of Microsart® Validation Standard are low passage reference strains cultivated in suitable culture broth. The cultures are harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead bacteria and plated on Agar medium for quantification based on Colony-forming Units (CFU).
Regulatory RequirementsFor EP 2.6.1 and 2.6.27 compliant validation
Additional Required Components
PCR reaction tubes
Centrifuge for 1.5 ml PCR tubes
- PCR kit
- qPCR cycler
What you receive
6 vials with 99 CFU lyophilized
- 2 vials negative control lyophilized
- 6 vials with 99 CFU lyophilized