SAFENSURE™ Sterility Rapid Detection Kit (qPCR)

组分（Materials Provided）

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.

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.

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.

存储（Storage）

Unopened kit should be stored at -15℃ to -30℃ upon receiving.

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