INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Airborne ultrasound is a referenced technology in the new USP <1207> Chapter Guidance as a deterministic test method for seal quality testing, is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality integrity testing.

  • Partner with a trusted, globally proven CDMO whose world-class, rapidly scalable facilities and unwavering commitment to quality help accelerate patient access to life-saving biologics.

  • Maintain a Grade-A environment for sterile fill-finish with a dual-pressure aseptic isolator. Accelerate campaign turnarounds using integrated vaporized hydrogen peroxide.

  • Explore the latest in contaminant detection technology with this pharmaceutical metal detector for tablets and capsules. Ensure the highest quality products with its failsafe rejection system and more.

  • 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.