Microsart® Validation Standard Aspergillus brasiliensis
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.:
- SMB95-2038
- 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 fungal 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 fungal cells as well as a high GC:CFU-ratio.
Applications
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ApplicationFungal Detection
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Application AreaRapid testing
Biological Information
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SpeciesAspergillus brasiliensis
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® 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.
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® 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.
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)
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.
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.
Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^6 genome copies of a specific fungal species per vial.
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.
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.
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