Rapid and accurate mycoplasma testing is essential to help prevent possible contamination and ensure the safety and efficacy of your pharmaceuticals. The current mycoplasma testing methods available are complicated, time-consuming, and require highly trained personnel. BIOFIRE® Mycoplasma, bioMérieux’s automated mycoplasma testing solution, provides rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release.
The system consists of the single use “molecular lab in a pouch” disposable and the new BIOFIRE® SPOTFIRE® for Pharmaceutical Industry instrument. Continue reading to discover the benefits of this newly upgraded, simple, small, and smart system and learn how it can minimize the risk of human error while reducing the costs of non-quality and outsourced testing.
Simple
BIOFIRE® SPOTFIRE® for the Pharmaceutical Industry has a simple workflow that allows virtually anyone to test for mycoplasma contamination, lowering training requirements and eliminating the need for PCR skills.
- The fully automated system provides a streamlined workflow and easy-to-interpret results.
- Rapid testing is made easy with only 3 steps.
- Receive mycoplasma testing results in less than 1 hour with only 2 minutes of hands-on time.
Small
BIOFIRE® SPOTFIRE® for the Pharmaceutical Industry has a small footprint, enabling testing to be performed near the production line instead of requiring a specialized lab.
- Its compact size makes in-house mycoplasma testing possible.
- The SPOTFIRE® instrument performs extraction, amplification, and detection in a single machine.
- Stack up to four modules for more throughput in the same footprint.
Smart
BIOFIRE® SPOTFIRE® for the Pharmaceutical Industry is a smart solution, providing accurate results, robust cybersecurity, and helping to ensure regulatory compliance.
- The system detects more than 130 strains of mycoplasma and mollicutes.
- Effortless data integrity is achieved through full traceability with electronic signatures, automated data backup, and customizable access privileges.
- The SPOTFIRE® instrument features 21 CFR Part 11 enabled software.
Receive Expert Support
- Our experts are here to support you at every step of the integration process.
- We offer validation services designed to help meet regulatory requirements – from documentation to comprehensive on-site support.
You can receive mycoplasma testing results in <1 hour with BIOFIRE® SPOTFIRE® for the Pharmaceutical Industry Discover How
