INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Unlock higher yields and ensure regulatory success with a tailored process optimization program designed to eliminate contamination risks and stabilize biopharmaceutical workflows.

  • Discover a 21 CFR Part 11-compliant digital validation platform designed for conducting IQ & OQ on your microbial QC testing systems dedicated to bioburden testing, sterility testing, and air monitoring.

  • Mikart’s analytical services begin with accurate measurements of formulation characteristics and are informed by our dedicated team’s mastery of process — the precise changes that maximize your product’s performance and market adoption.

  • FMS/BioTrak/Portable/Remote/Environmental Sensors

  • Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.