Billerica, Massachusetts, June 28, 2016 — MilliporeSigma today has expanded its industry-leading Emprove® risk assessment program to include a selection of products for filtration and single-use processing. The program provides documentation and regulatory information on materials used in the manufacture of drug products. This information enhances transparency, facilitates manufacturers’ risk assessment workflows and supplier qualification.
“As the regulatory landscape continues to evolve, rapid and easy access to risk assessment information is even more critical,” said Udit Batra, Member, Executive Board, Merck KGaA, Darmstadt, Germany and CEO, MilliporeSigma. “The expansion of our Emprove® program helps ensure our customers are using only the highest quality products for their manufacturing processes.”
The Emprove® program now includes Millipore Express® filters, Pureflex® and Pureflex® Plus bags, Viresolve® Pro filtration devices and Durapore® filters. The program gives customers instant access to online regulatory and technical information on a wide range of products. That information includes details on extractables, residual solvents and elemental impurities for these products. In addition, customers will find labelling information, shelf-life data and procedures, sterilization procedures, packaging testing, audit report summaries and management processes for suppliers.
Using the Emprove® program, manufacturers can download dossiers on material qualification, quality management and operational excellence in one centralized location. In the past, manufacturers had to contact multiple parties for the data. MilliporeSigma’s data also saves manufacturers time and money associated with their own testing.
The original Emprove® program included more than 400 raw materials and active pharmaceutical ingredients used in manufacturing drug products such as excipients, process chemicals and active pharmaceutical ingredients. The newly expanded program provides industry-leading support to customers by anticipating regulatory needs and delivering confidence that reduces risk throughout the manufacturing process.
About the Life Science Business of Merck KGaA, Darmstadt, Germany
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. Udit Batra is the global chief executive officer of MilliporeSigma.
Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $130 billion global life science industry.
Merck KGaA of Darmstadt, Germany is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials – and generated sales of € 12.85 billion in 2015. Around 50,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges.
Merck KGaA, Darmstadt, Germany is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck KGaA, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.