Microsart® Validation Standard Clostridium sporogenes
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.:
- SMB95-2008
- Availability:
- pcs
*Custom/bulk order quotes are provided within 24 hours of request.
Choose your Microsart® Rapid Sterility Testing
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).
Applications
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ApplicationBacteria Detection
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Application AreaRapid testing
Biological Information
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SpeciesClostridium sporogenes
Compliance Information
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Regulatory RequirementsFor EP 2.6.1 and 2.6.27 compliant validation
Components
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Additional Required Components
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qPCR cycler
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PCR reaction tubes
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Centrifuge for 1.5 mL PCR tubes
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Pipettes
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Extraction kit
- PCR kit
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qPCR cycler
Dimensions
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Filter DiameterN/A
General Specifications
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Culture MediaN/A
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Membrane Color | Grid ColorN/A
Materials of Construction
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Filter MaterialN/A
Physicochemical Information
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Pore SizeN/A
Product Information
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BrandMicrosart®
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Pack SizeN/A
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TypeReagents
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What you receive
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6 vials with 99 CFU lyophilized
- 2 vials negative control lyophilized
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6 vials with 99 CFU lyophilized
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