MILLIPORESIGMA

The life science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has 19,000 employees and 72 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery, improving quality of life for patients, fostering the success of customers and helping to meet global challenges. With a mission to streamline and improve the efficiency of analytical processes and methods, the organization has extensive expertise in developing advanced laboratory water solutions, sample filtration, smart chemicals, consumables, instrumentation, microbial testing and overarching digital connectivity for research, industrial, pharmaceutical, and medical applications.

For your pharmaceutical analysis and QC, whether you are working on small or large molecules, you can trust our portfolio and expertise to ensure quality and reliability throughout the entire product characterization, method development, manufacturing and quality control process.

ARTICLES AND WHITE PAPERS

CONTACT INFORMATION

MilliporeSigma

400 Summit Drive

Burlington, MA 01803

UNITED STATES

Phone: 1-800-645-5476

APPLICATION NOTES

E-BOOKS

  • Discover the risks and sunken costs of sticking with traditional inventory management practices. Additionally, learn how motion waste in the laboratory material lifecycle takes a toll on productivity.

  • In this eBook scientific experts discuss newer, faster, and more efficacious strategies for peptide mapping and analysis of biotherapeutic products.

  • This practical guide on all aspects of High-performance liquid chromatography (HPLC) method development will help you making it through the maze of HPLC options.

  • Bioburden control is an integral component of every biologics production process. Determining the appropriate bioburden control strategy can be challenging given the many different technologies available for today’s biologics manufacturers. In this eBook, we provide information to highlight the differing objectives for bioburden control by unit operation and discuss the parameters that guide filter selection and optimization. In addition, we focus on industry trends toward intensified processing and increased implementation of single-use systems, and how they are changing expectations for sterile filtration and bioburden control.

Q&A

PRODUCTS

  • As the only major supplier worldwide, we offer all three media to test for Mycoplasma according to EP 2.6.7 and USP 63 as both broth and agar plates. These ready-to-use Friis, Frey, and Hayflick culture media help to make the cumbersome compendial procedures of testing cell cultures, raw materials, intermediates, and final products for mycoplasmas easier.

  • 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 systemwhen 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.

  • Bioburden testing and microbial limit testing, are a quality control test to determine 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.

  • Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs testing in the course of pharmaceutical quality control. Test methods being used are the rabbit pyrogen test (RPT), the bacterial endotoxin test (or LAL test), and the monocyte activation test (MAT).

  • 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.