Rapid Sterility: total bacteria and fungi detection in only 3 hours

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Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment with the Microsart® ATMP Sterile Release kit

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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Rapid bacteria and fungi detection in only 3 hours with Microsart® ATMP Sterile Release

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:

  • Microsart® ATMP Bacteria
  • Microsart® ATMP Fungi
  • Microsart® ATMP Sterile Release (combined kit)


2. For detection of Bacteria and Fungi in R&D cell cultures:

  • Microsart® RESEARCH Bacteria  
  • Microsart® RESEARCH Fungi  



Step by Step Tutorial for Microsart® ATMP Bacteria

DNA-free pipetting of PCR.

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Poster — Next Generation Cellular Therapeutic Technologies: Rapid Detection of Bacterial Contamination

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Digital Tool: Cell-Based Therapies – Be on the Safe Side Get QC Results for Advanced Therapy Medicinal Products (ATMPs) Before Treatment

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Resources

Microsart® ATMP Bacteria — Rapid detection of total bacteria in ATMPs prior treatment

PDF | 103.7 KB

Microsart® RESEARCH Bacteria

PDF | 309.3 KB

Microsart® ATMP Bacteria

PDF | 1.4 MB

Microsart®️ ATMP Extraction

PDF | 1.1 MB

Microsart®️ ATMP Sterile Release

PDF | 932.6 KB

Microsart® Calibration Reagent

PDF | 650.8 KB

Microsart® RESEARCH Bacteria

PDF | 1.1 MB

Microsart®️ Validation Standard Bacteria and Fungi

PDF | 441.7 KB

Microsart®️ RESEARCH Fungi

PDF | 825.6 KB

Microsart®️ ATMP Fungi

PDF | 950.2 KB

Microsart®️ Calibration Reagent Fungi

PDF | 576.1 KB

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