The SCANRDI® is an ultra-rapid alternative technology for detecting microbial contaminants in drug products. Designed to meet compendial testing standards, studies on Limit of Detection (LoD) and Equivalency have been performed with a focus on species listed by the Pharmacopeias microorganisms. 

Testing for mycoplasma contamination is a required release test for Cell & Gene Therapy (CGT) products as specified in the major pharmacopeias(1-3).

Environmental Monitoring (EM) is crucial to assure patient safety. The visual end point reading of petri dishes has been used for decades without a true performance assessment. Automatization technologies are more present and improve EM practices

Automated culture systems are widely used for rapid-real-time microbial contamination detection for pharmaceutical products including small molecule, bioproduction, and cell and gene therapy

This poster presents results from independent studies performed by 4 bioproduction companies using the BIOFIRE® Mycoplasma system that can detect >130 species of mycoplasma. The BIOFIRE® filmarray system condenses all the steps of a conventional PCR test into an enclosed pouch and provides sample to answer in less than one hour with as little as 2 minutes of hands-on time.

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).