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.

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An open box of Sartorius Microsart ATMP Sterile Release and its contents

Microsart® ATMP Sterile Release 

Rapidly detect total bacteria and fungi in cell cultures, cell culture-derived biologicals and ATMPs, based on qPCR.

Cyclus dPCR Bacteria Fungi Tool Box kit front view of the box opened with vials visible and angeled position of the cover

Cyclus® dPCR Tool Box Bacteria Fungi

Sensitive total bacteria and fungi testing for ATMPs or short shelf-life samples based on digital PCR.

An open box of Sartorius Microsart ATMP Sterile Release and its contents

Request a Free Trial 

Try our Rapid Sterility demo kit before you buy and experience the reliable, validated results you need. Contact us to request your free kit.

Top down view of an open box of Microsart ATMP Bacteria qPCR Detection Kit and its contents.

Microsart® ATMP Bacteria 

Rapid detection of bacteria in cell cultures, cell culture-derived biologicals and ATMPs, based on qPCR.

Top down image of a Microsart ATMP Fungi box open to display its contents.

Microsart® ATMP Fungi 

Rapid detection of fungi in cell cultures, cell culture-derived biologicals and ATMPs, based on qPCR.

Microsart® ATMP Extraction 

Extraction of total bacteria and fungi DNA prior to PCR.

Kit Selection Guide

Choose the Right Kit for Your Needs

 

ApplicationUse this Kit Product Details
Release testing cell-based therapeutics (ATMPs) such as autologous chondrocyte transplants or CAR-T cells.Cyclus® dPCR Tool Box Bacteria FungiShopNow
Microsart® ATMP Sterile Release Shop Now
Microsart® ATMP ExtractionShop Now
Microsart® ATMP FungiShop Now
Microsart® ATMP BacteriaShop Now
Detection of Bacteria and Fungi in R&D cell cultures .Cyclus® dPCR Tool Box Bacteria FungiShop Now
Microsart® RESEARCH Fungi Shop Now
Microsart® RESEARCH BacteriaShop Now

 

 

Rapid Sterility Testing Kits and Features

An open box of Sartorius Microsart ATMP Sterile Release and its contents

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.

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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 Bacteria Fungi Tool Box kit front view of the box opened with vials visible and angeled position of the cover

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.

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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 SamplesSuitable 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

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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).

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Rapid Sterility Testing Resources

Featured Sterility Testing Resources

Poster

Digital PCR Technology for Sterility Testing

One Sheet

Rapid Bacteria & Fungi Swab Test for Medical Devices

See how three ETO-sterilized medical swabs were identified to be suitable for contamination detection and are now free of bacterial DNA.

Rapid Solutions: Microsart®️ ATMP Bacteria, Fungi and Mycoplasma flyer cover
Flyer

Rapid Solutions: Microsart® ATMP Bacteria, Fungi and Mycoplasma

Application Note

Beta Test: Real-time PCR-based Presence/Absence Test

Explore detection of bacterial contamination in ATMPs with this real-time PCR-based test.

Microbial forms in vibrant colors and distinct shapes, highlighting the diversity of microscopic life
Application Note

Enhancing ATMP QC With Microsart® ATMP Sterile Release

A Comparison With Alternative Solutions

Application Note

PCR-Based Rapid Sterility Test and the Compendial Culture Method

We compared the microbial detection capability of the  Real-time PCR kits with the compendial sterility test

Poster

Detection of Nucleic Acid Traces

A PCR Kit Manufacturer Perspective

First Final Release Test of ATMPs Prior to Treatment Validation of a qPCR-Based Rapid Sterility Test
Poster

Rapid Sterility Testing for Cell Therapy Quality Control Poster

In this poster, a validation study was designed to evaluate bacterial and fungal detection capability.

First Final Release Test of ATMPs Prior to Treatment – Validation of a qPCR-Based Rapid Sterility Test webinar screenshot
Webinar

Webinar: First Final Release Test of ATMPs Prior to Treatment

Validation of a qPCR-Based Rapid Sterility Test

cell based therapies thumbnail

Digital Tool: Cell-Based Therapies - Be on the Safe Side

Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment

Rapid Sterility Product Documentation & Literature

Manual: Microsart® Validation Standard Mycoplasma 10CFU

PDF | 103.8 KB

Microsart® Validation Standard

PDF | 114.4 KB

Microsart® Calibration Reagent Bacteria

PDF | 233.1 KB

Manual: Microsart® Calibration Reagent for Fungi and Yeast Species

PDF | 216.9 KB
Manual

Cyclus® dPCR Tool Box Bacteria Fungi - Instructions for Use

PDF | 489.9 KB

Manual: Microsart® RESEARCH Fungi

PDF | 528.8 KB

Manual: Microsart® RESEARCH Bacteria

PDF | 397.2 KB

Microsart® ATMP Bacteria Patient

PDF | 1.0 MB

Manual: Microsart® ATMP Bacteria

PDF | 533.5 KB

Microsart®️ ATMP Fungi

PDF | 621.4 KB
Rapid Solutions: Microsart®️ ATMP Bacteria, Fungi and Mycoplasma flyer cover
Flyer

Rapid Solutions: Microsart®️ ATMP Bacteria, Fungi and Mycoplasma 

PDF | 759.1 KB
Flyer

Rapid Sterility Solutions: Microsart® ATMP Sterile Release

PDF | 932.6 KB

Microsart® ATMP Bacteria/Fungi/Sterile Release

PDF | 493.4 KB
Datasheet

Cyclus® dPCR Tool Box Bacteria Fungi - Primer and Probes Mix for Digital (Droplet) PCR Detection

PDF | 1.0 MB

Microsart® RESEARCH Bacteria

PDF | 629.4 KB

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