SAFENSURE™ Sterility Rapid Detection Kit (qPCR)

产品概述（Product Overview）

To speed up in-process and lot-release sterility testing, the Sterility Rapid Detection Kit (based on NAT) is developed and validated to meet European Pharmacopeia Chapter 2.6.1 and USP General Chapter <71> requirements.​

Its key advantage is integrated detection: paired with the SAFENSURE™ Sterility Sample Preparation Kit (OPA-E102), it sensitively and reliably detects bacteria and fungi simultaneously in biological products, pharmaceuticals, and medical devices—no separate qPCR assays needed. This avoids split-sample handling and repeated operations, reducing error risks.​

Meeting strict sterility testing regulations (no detectable viable microorganisms), it replaces traditional 14-day culture-based methods. Even with dual detection, it delivers accurate results in just 3 hours, boosting product release efficiency and cutting testing time/labor costs.

产品特性（Features）

1. Broad Coverage: It covers microbial species, including those specified in major Pharmacopoeias (EP, USP, ChP).
2. Simultaneous Bacteria-Fungi Detection: It enables concurrent detection of bacteria and fungi without the need for separate qPCR assays, streamlining sterility testing workflows and reducing operational complexity.
3. Strong Specificity: It is developed with multiple primers and probes for bacteria and fungi, with no cross-reactivity to closely related non-bacterial and non-fungal strains.
4. High Sensitivity: Fully compliant with or superior to regulatory guidance of 100 CFU/mL.
5. Convenient Operation: Designed for single-well testing, with the kit containing essential components for easy use.
6. Comparable Results: Detection results from the kit are comparable to those from culture-based methods.
7. High-quality: This kit is manufactured in ISO 13485 standard facility.

应用说明（Application）

The kit is used for detection of bacteria or fungus contamination in cells and bioproduct media.

For use in quality control/manufacturing process only.

It is for research use only.

技术参数（Technical Specifications）

使用提示（Attention）

If your experimental workflow involves host cell DNA sample preparation, please use the recommended sample preparation kits listed in the table. This ensures that the buffers used during both sample preparation and residual DNA quantitation remain consistent, supporting reliable and accurate results.

组分（Materials Provided）

质量管理控制体系（QMS）

1. 质量管理体系（ISO, GMP）
2. 质量优势
3. 质控流程