Rapid Sterility Testing Kits for the Reliable, Validated Results You Need
Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment with Microsart® ATMP Sterile Release
- Detect bacterial and fungal contamination within 3 hours with a proven, real-time PCR method using our pioneering Microsart® ATMP Sterile Release Kit.
- Get the combined speed of Microsart® ATMP Bacteria and Microsart® ATMP Fungi in one kit.
- Ensure patient safety and reduce the need for prophylactic medication with antibiotics by releasing only contamination-free cell therapy products for use.
Shop Rapid Sterility Testing Kits
Kit Selection Guide
Choose the Right Kit for Your Needs
| Application | Use this Kit | Product Details |
|---|---|---|
| Release testing cell-based therapeutics (ATMPs) such as autologous chondrocyte transplants or CAR-T cells. | Cyclus® dPCR Tool Box Bacteria Fungi | ShopNow |
| Microsart® ATMP Sterile Release | Shop Now | |
| Microsart® ATMP Extraction | Shop Now | |
| Microsart® ATMP Fungi | Shop Now | |
| Microsart® ATMP Bacteria | Shop Now | |
| Detection of Bacteria and Fungi in R&D cell cultures . | Cyclus® dPCR Tool Box Bacteria Fungi | Shop Now |
| Microsart® RESEARCH Fungi | Shop Now | |
| Microsart® RESEARCH Bacteria | Shop Now |
Rapid Sterility Testing Kits and Features
Microsart® ATMP Sterile Release
Rapid Bacteria & Fungi Detection in 3 Hours
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). This packaging version includes all required reagents for the release testing of 10 patient samples in total. Individually packed DNA extractions and PCR reagents (per sample to test) avoid cross-contamination and ensure the highest convenience.
Why Choose Microsart® ATMP Sterile Release?
- Sterile ATMPs Before Treatment — ATMPs are tested using qPCR that detects a broad range of gram-positive and gram-negative bacterial and fungal contaminants, including dormant cell stages or species that go undetected in growth-based methods.
- Reliable Results in 3 Hours — Avoid lengthy 14-day cultivation protocols and save time. TaqMan® probes ensure the highest level of qPCR specificity. The duplex assay includes an in-built amplification control to rule out false negatives.
- The Only Non-infectious Validation Standards — Validation standards for required bacterial and fungal species in Microsart® Validation Standards are lyophilized, quantified and 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.
- Compliance with International Standards — 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.
- Reduce Pipetting Steps — 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.
- Use Your Existing Equipment — 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.
Cyclus® dPCR Tool Box Bacteria Fungi
Bring Your Rapid Sterility Testing to the Next Level
Cyclus® dPCR Tool Box Bacteria Fungi enables fast and sensitive detection of bacterial and fungal contaminations in cell cultures, biologicals, ATMPs, and other short shelf-life samples using digital (droplet) PCR technology. This ready-to-use primer probe kit is compatible with and approved for use with various digital PCR master mix chemistries and systems that can detect FAM™ and HEX™ (nanoplate- and droplet-based systems). It includes a Primer Probe mix for rapid and sensitive total bacteria and fungi detection, Internal Control DNA, Positive Control DNA, and PCR-grade water. When combined with a highly pure sample preparation and a dPCR device-specific master mix, it forms an assay for detecting bacterial or fungal contamination.
Why Choose Cyclus® dPCR Tool Box Bacteria Fungi
- Contaminant Versatility — Cyclus® dPCR Tool Box guarantees rapid detection of a broad range of bacterial and fungal contaminants, including all USP 71 relevant species, in cell-based products or other short-shelf life products.
- Fast Results — Achieve sensitive detection of bacterial and fungal contaminations in cell cultures, biologicals, and ATMPs, or other short shelf-life samples using digital (droplet) PCR technology, with results available in only a few hours.
- High Specificity — Utilizes highly specific TaqMan™ probes for precise detection.
- Combined Power — This ready-to-use kit includes highly pure reagents, a lyophilized primer-probe mix for bacteria and fungi detection, an internal PCR control, a positive control, and a negative control.
- Designed for use with Microsart® ATMP Extraction for sample preparation prior to amplification.
- Long-term Stability — Cyclus® dPCR Bacteria Fungi is stable at 2 to 8 °C for up to 18 months.
- More Samples — Suitable for rapid sterility testing of up to 10 samples.
Rapid Sterility Videos
Microsart® ATMP Sterile Release Kit: Rapid Results Before Treatment in Just 3 Hours
This video explains the challenges in ensuring the safety of treatments before they are given to patients, and how to get ATMP-QC results before treatment
Step by Step Tutorial for Microsart® ATMP Bacteria
Follow this Microsart® ATMP Bacteria kit tutorial to detect bacteria in cell cultures, cell culture-derived biologicals and ATMPs, based on real-time PCR (qPCR).
