Microsart® Validation Standard Bacillus subtilis
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.:
- SMB95-2005
- 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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SpeciesBacillus subtilis
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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Detection MethodPCR
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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
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.
Microsart® ATMP Bacteria kit is designed for the direct detection of bacteria in cellcultures, cell culture derived biologicals and ATMPs (e.g. autologous transplants),based on real-time PCR (qPCR).
Microsart® ATMP Sterile Release is designed to rapidly detect total bacteria and fungi in cell cultures, cell culture-derived biologicals, and ATMPs. The technology is based on real-time polymerase chain reaction (PCR).
Top Features of Microsart® ATMP Sterile Release
- Rapid detection of critical bacterial and fungal contaminants within three hours
- Designed for contamination control of ATMPs or short shelf-life applications
- The PCR kit is validated according to EP 5.1.6, EP 2.6.27, USP 1223
Popular Applications
- Lab research
- Quality control (QC)
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