INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Quality control is a critical component for ensuring safety, efficacy, and consistency in the development and production of biologics. This comprehensive list of strategies, techniques, workflows, and best-in-class products for developing biopharmaceuticals can help you navigate the complexities of biologics and simplify the manufacturing process. Improve your quality control procedures and optimize your biologics production process with tools and expertise relied upon by researchers worldwide.

  • To monitor product quality effectively, it’s critical to test for microbial contamination throughout manufacturing. Discover an easy-to-use, non-destructive, fluorescent staining-based system for faster microbial detection.

  • Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.

  • Combination Powder and Fume Hood with HEPA filtration and house exhaust connection designed to process liquid and powder substances. Fume Hood designed to house stir plate and analytical balance. It features cup sink; air, water, and gas fittings; and alarm for monitoring and maintaining recommended face velocity of 75 LFPM. Fume and Powder Hoods separated by sliding door to eliminate cross-contamination during processing. Powder Hood uses front airfoils and rear plenums to maintain laminar airflow across the work surface, which is vented through a HEPA filtration system to house exhaust.

  • 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.