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Rapid Sterility: Total Bacteria and Fungi Detection in Only 3 Hours
Detect bacterial and fungal contamination within 3 hours using the proven real-time PCR method in our Microsart® ATMP Sterile Release Kit, a combination of Microsart® ATMP Bacteria and of Microsart® ATMP Fungi. To ensure patient safety and reduce the need for prophylactic medication with antibiotics, make sure to release only contamination free cell therapy products for use.
Microsart® ATMP Sterile Release Kit: A pioneering test no one else can offer.
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ATMPs are tested using qPCR that detects a broad range of gram-positive and gram-negative bacterial and fungal contaminants.
Avoid lengthy 14-day cultivation protocols and save time. TaqMan® probes ensure the highest level of qPCR specificity. No need to perform uncertain melting curve analysis.
Validation standards for required bacterial and fungal species in Microsart® ATMP Sterile Release are lyophilized to render them non-infectious. We provide step-by-step, matrix-specific validation guidance from Sartorius qPCR experts. Avoid the risk of cross-contamination with individually packaged, sample-specific vials.
Microsart® ATMP Sterile Release kits were developed in close cooperation with authorities, and are validated according to EP 5.1.6 and USP <1223> for sensitivity, specificity, and robustness.
This test is not a replacement for the classic sterility test according to USP<71> or EP 2.6.1.
The ready-to-use master mix has the DNA for internal control already included. Avoid false-negative results and minimize the number of reactions you need to run.
Microsart® ATMP Sterile Release Kits can be used with any qPCR cycler able to detect the fluorescent dyes FAM® and ROX®. Our clear, color-coded reagents guide the user through the short and simple protocol. Lyophilized reagents ensure consistent quality without the need for freezer storage.
Available Kit Options:
1. For testing cell-based theraputics (ATMPs) such as autologous chondrocyte transplants or CART-T cells:
2. For detection of Bacteria and Fungi in R&D cell cultures:
DNA-free pipetting of PCR
DNA-free pipetting of PCR.
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Contamination Under Control for Reproducible Amplification
A PCR Kit Manufacturer Perspective
In this poster, a validation study was designed to evaluate bacterial and fungal detection capability.
Validation of a qPCR-Based Rapid Sterility Test
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