Rapid, reliable sterility testing

Traditional sterility tests can take up to 14 days - far too long for life-saving drugs and cutting-edge cell and gene therapies, many of which cannot be tested using standard membrane filtration methods. Even minimal contamination is unacceptable, making fast, sensitive, and reliable sterility testing essential.

Alpha Laboratories now offers RiboNAT™ by FUJIFILM Wako, a rapid sterility solution designed for speed and accuracy. Using Nucleic Acid Amplification (NAT) technology and targeting ribosomal RNA (rRNA) via RT-rPCR, RiboNAT delivers precise results in just 7 hours. By focusing on rRNA - which is more abundant in microorganisms than genomic DNA - the test achieves high sensitivity (9 CFU/mL) while detecting a broad range of bacteria and fungi. It also reduces false positives from dead cells and residual DNA, thanks to a nucleic acid inactivator and DNase.

With RiboNAT, laboratories can reliably screen samples in a single day, supporting faster validation and safer delivery of drugs with limited shelf life. The easy-to-use workflow integrates smoothly into existing sterility QC processes, providing a crucial control point without adding complexity.

For labs ready to accelerate sterility testing and streamline their workflow, RiboNAT™ offers a faster, safer, and more consistent solution.

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