The 14-day turnaround time of current compendial sterility testing is plainly insufficient for a wide range of crucial, life-saving drugs and therapies, including an increasing number of novel cell and gene therapies which are incompatible with membrane filtration. As even slight contamination is unacceptable for parenteral treatments, this necessitates sterility tests that are not only faster than traditional methods, but as sensitive and accurate.
With an ever-increasing demand for faster sterility testing solutions, Alpha Laboratories is pleased to introduce the new RiboNAT™ rapid sterility test by FUJIFILM Wako. This test has been designed with rapid results in mind. It uses the Nucleic Acid Amplification (NAT) method, targeting ribosomal RNA (rRNA) and using RT-rPCR to deliver accurate results in just 7 hours. This test method boasts numerous benefits compared to other sterility tests – ribosomal RNA is present in higher relative quantities in microorganisms than genomic DNA, offering higher sensitivity (9 CFU/mL) while still detecting a broad range of bacteria and fungi. RiboNAT also significantly reduces false positives from dead microorganisms and residual DNA by inactivating and degrading DNA using nucleic acid inactivator and DNase.
The ability of RiboNAT to reliably and accurately detect a wide assortment of microbes in less than a day makes it an invaluable tool for validating and delivering drugs and therapies with short shelf lives, without having to administer at risk. This also seamlessly adds a crucial control point for sterility quality control into your workflow, with a simple and easy-to-learn testing process.
Embrace a faster future for sterility testing
