RAPID TESTING BY ANYONE, ANYWHERE, ANYTIME
RESULTS IN LESS THAN AN HOUR
BIOFIRE® Mycoplasma is a fully automated system that provides simple, accurate, rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release. We offer validation services designed to meet regulatory requirements—from documentation to comprehensive on-site support.
- BIOFIRE MYCOPLASMA
There's a better way to do mycoplasma testing — you no longer have to send out your testing, wait 28 days for the compendial method, or rely on a molecular biologist with specialized training. BIOFIRE® Mycoplasma allows nearly anyone to test for mycoplasma anywhere in the facility at any time, with results in under an hour!
- Two minutes of hands-on time
- Fully automated
- Go from sample to result in less than 60 minutes
- Test raw materials, in process samples, and final products
- Detects more than 120 strains of mycoplasma and mollicutes
- 21 CFR part 11 compliant
- FDA CBER Type V Master File Available
- Methold validation guidance
- Compendial method comparability report
- Installation, operation, and performance qualification support
- Feasability Service
The BIOFIRE® mycoplasma system consists of just two simple components—the FILMARRAY® instrument and the single-use “molecular lab in a pouch” disposable. With these two items, you have everything you need for fast, accurate mycoplasma testing.
BIOFIRE® MYCOPLASMA is a revolutionary approach to mycoplasma testing that brings value to biopharmaceutical manufacturing.
The current rapid methods available are complicated, requiring highly trained personnel and lengthy turnaround times. The BIOFIRE® Mycoplasma solution provides results in less than an hour, is fully automated, and requires only 2 minutes of hands-on-time.
Thanks to its ease-of-use and small footprint, BIOFIRE® Mycoplasma enables at-line testing near sample collection sites, by personnel non-specialized in mycoplasma detection or molecular techniques.
Safeguard your bioproduction procedures, minimize the impact of costs associated with a possible contamination in the factory, and gain valuable time in releasing batches with BIOFIRE® Mycoplasma.
- Cell Banks
- In-Process Controls
- Culture Media
- Release Tests At The Harvest