ABOUT MILLIPORESIGMA

  

The life science business of Merck KGaA, Darmstadt, Germany brings together the world-class products and services, innovative capabilities and exceptional talent of EMD Millipore and Sigma-Aldrich to create a global leader in the life science industry.

At MilliporeSigma, our mission is to help our customers improve human health and life worldwide. This commitment means providing leading life science products and services in ways that also help improve the communities and environment in which we all live.

We re-imagine a future in which:

  • Access to health and clean water is available to everyone around the world;
  • Life science products not only advance human health, but also help restore and preserve our world; and
  • Companies work in harmony with their communities to improve human lives.

We aren’t just re-imagining this future. We are working towards it every day. We invite you to learn more about our leadership commitment and our approach to corporate responsibility, as well as our goals and accomplishments for future-forward products, streamlined operations, and inspired people within and outside of our company.

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: 978-762-5100

APPLICATION NOTES

E-BOOKS

Q&A

PRODUCTS

  • Immerse yourself in a self-guided, virtual tour of an M Lab™ Collaboration Center!

  • The Milliflex® Rapid System 2.0 brings together membrane filtration and ATP bioluminescence to detect, image and quantify microcolonies of bacteria, molds and yeasts up to 4 times faster than compendial bioburden or sterility testing methods.

  • Pour them with confidence!

  • Processing large batch sizes in one run using single-use equipment is a challenge. The Mobius® TFF 80 system has been designed for large-scale tangential flow filtration, with flow rate capabilities up to 80 L/min and up to 20 m2 of membrane area installed.

  • 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 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.

  • 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.

  • 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.

  • 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.

  • Culture media selection is of utmost importance, as it directly impacts key elements of your quality control strategy, especially for environmental monitoring in cleanrooms and isolators in aseptic manufacturing. Explore a collection of expert guidance on environmental monitoring and culture media selection, study findings, and innovative solutions that can help you optimize your contamination control strategy. Further, gain insight into the impact of manufacturing guidelines and media features and specifications on environmental monitoring testing.

  • To effectively monitor product quality, it is critical to test for microbial contamination throughout the pharmaceutical manufacturing process. Sterility testing is a vital step to ensure products purporting to be sterile do not contain viable microorganisms prior to their distribution and administration to patients. Consequently, it is of utmost importance that the testing method employed for products, formulations, tissue materials, and medical devices is both accurate and reliable. Explore a collection of streamlined sterility testing solutions and expert guidance on sterility testing, quality control (QC), and data integrity. Optimize your sterility testing and QC procedures with world-leading tools and technologies that can help you ensure full traceability and regulatory compliance.

  • Filtration is a critical aspect of pharmaceutical manufacturing, as it helps to ensure the quality, safety, and purity of the final product. This comprehensive list of strategies to reduce bioburden, guidance on filtration selection, and expert insights on regulation, filtration, sampling, and quality control can help you optimize your contamination control strategy and ensure effective filtration in your production process. Explore high-performance specialty membranes and filtration devices relied upon by laboratories worldwide and across the academic, pharmaceutical, biotechnology, and industrial sectors.

  • Regulatory compliance and traceability are essential for biopharmaceutical companies to ensure the safety and quality of their products. The pharmaceutical industry is heavily regulated, and companies must adhere to a wide range of laws and regulations in order to remain compliant. Traceability is a crucial component of regulatory compliance, as it allows companies to track the history and movement of their products throughout the supply chain. Having a strong focus on traceability and compliance is key to operating a safe and efficient quality control (QC) lab. This comprehensive list of expert insights, strategies, tools, and techniques for achieving complete traceability and regulatory compliance can help you transform your QC lab.