INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Performing endotoxin testing? Trust your data with a Monocyte Activation Test that mimics the human immune reaction and detects both endotoxins and non-endotoxin pyrogens.

  • Sterility testing is a requirement to confirm that pharmaceutical products purporting to be sterile do not contain viable microorganisms before being released and administered to patients. So, it is vital that the method used for testing medical devices, pharmaceutical products, formulations, tissue materials, and other products is both reliable and accurate.

  • 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.

  • Three media, Friis, Frey, and Hayflick, are used to detect different ranges of mycoplasmas. MilliporeSigma offers all three as ready-to-use, with longer shelf-life broth and plates for compendial testing.

  • The Integra uses the same proven three spinning roller sealing head design as the standard PW Westcapper®. Now, a servo driven actuator will bring the sealing head to the vial and utilize a load cell to accurately provide proper sealing pressure. This functionality provides a quality seal despite variations in vial height.