INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.

  • Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.

  • 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.

  • This intuitive and reliable HPLC system supports First Time Quality (FTQ) by reducing the risk of common errors and improving the accuracy of analytical measurements.

  • The CCI Test Vessel provides a simple means of preparing samples for container closure integrity testing (CCIT) using the highly-sensitive and non-destructive laser-based headspace analysis technology. When combined with a LIGHTHOUSE FMS Headspace Gas Analyzer, the CCI Test Vessel offers a robust solution for container integrity tests on a wide range of container types and packaging conditions.