INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.

  • Advantech Sonic Sifter Powder Weighing and Transfer Enclosure designed to provide personnel protection during compacting and coating operations involving Highly Potent Active Pharmaceutical Ingredients (HPAPI).

  • 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.

  • Waters is providing a pathway for easier access to our latest innovative technologies with our FlexUP Technology Renewal Program.

  • 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.