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BIOFIRE® Mycoplasma

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.

Product Details

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!

Features

  • 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
BIOFIRE® Mycoplasma and Man

Support

  • FDA CBER Type V Master File Available
  • Methold validation guidance
  • Compendial method comparability report
  • Installation, operation, and performance qualification support
  • Feasability Service

Test Components

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.

Applications

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

Brochure - BIOFIRE® Mycoplasma

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PHARMA_BROCHURE_BIOFIRE_MYCOPLASMA_A4_05_23_9314118_Pages.pdf
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