Description
BIOFIRE® Mycoplasma (BIOFIRE® SPOTFIRE® System) is a fully automated, closed-system platform designed to enable rapid, in-house mycoplasma detection for biopharmaceutical manufacturing environments. It delivers results in less than one hour, requiring only two minutes of hands-on time, without the need for specialized molecular expertise.
The system consists of two simple components: the SPOTFIRE® instrument and a single-use, self-contained reagent pouch. Automated extraction, amplification, and detection are integrated within a single instrument, reducing manual intervention and simplifying traditionally complex molecular workflows. The system detects more than 130 strains of mycoplasma and mollicutes.
Its compact, stackable design supports up to four modules, allowing manufacturers to scale testing capacity without expanding laboratory space. Built-in barcode scanning, electronic signatures (21 CFR Part 11 enabled), customizable user access, and bidirectional LIMS connectivity support traceability, data integrity, and regulatory compliance.