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Merck Expands Industry-Leading Emprove<sup>®</sup> Program to Include Filtration and Single-Use Products

Merck KGaA, Darmstadt, Germany

Emprove® risk assessment program provides easy access to information on materials used for drug product manufacturing

27 Jun 2016
Alex Waite
Editorial Assistant

Product news

Merck, a leading science and technology company, 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 of the Merck Executive Board and CEO, Life Science. "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. Merck'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.

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EMPROVE® exp Portfolio

Merck

EMPROVE® exp for use as excipient As drug approval procedures grow stricter, regulatory requirements are becoming more demanding for excipients. Our high-quality EMPROVE® exp raw materials for use as excipients not only comply with relevant regulations, but also come with detailed documentation, facilitating lower costs of qualification, so you can get to market faster. EMPROVE® exp dossiers comprise information on the manufacturer and manufacturing process. They provide specifications in accordance with the requirements of a variety of pharmacopoeias, as well as details on impurities, stability data and a certificate of analysis (CoA). This way, we help reduce your workload and accelerate your qualification processes.EMPROVE® exp Portfolio Features: Complete Dossier (Basic, Analytical, Stability-Dossier) - Update every 12 month - CDA necessary - Charged Basic Dossier - Available online - Free of charge Analytical Dossier (Basic Dossier+Analytical Method) - CDA necessary - Charged Stability Dossier (Basic Dossier+Stability Method) - CDA necessary- Charged

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Sample PreparationSample preparation can improve the quality and speed of separation techniques. Products to assist sample preparation include filtration equipment, evaporators, membranes and sieves.FiltrationFiltration and microfiltration are used to separate solids, particulates or large molecules from fluids (liquid or gases) in order to purify the filtrate. Explore a range of filter formats, including filter paper, plates and membranes for your separation needs. While larger particulates may be separated by gravity filtration, smaller particulates may require additional force for timely separation. Microfiltration equipment includes vacuum filters, as well as positive pressure, crossflow and centrifugal filtration devices. Find the best filtration products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.Compound AnalysisCompound analysis is used to discover specific compounds that could be promising candidates for pharmaceutical use. This potential is identified when compounds have the desired effect, such as interaction with a target protein, during high throughput screening.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. UltrafiltrationLaboratory SafetyLaboratory safety is essential to the effective operation of all laboratories and is required to minimize the risk of harm during experiments. Guidelines, regulations, and equipment should be available in all laboratories to ensure that the working environment is safe and secure.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.Solvent MonitoringManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.Elemental AnalysisElemental analysis involves determining the elemental composition of a sample, often used in environmental, pharmaceutical, and material sciences. Techniques like ICP-MS, X-ray fluorescence, and atomic absorption spectroscopy allow precise quantification of elements such as metals and nonmetals in complex matrices. Browse our peer-reviewed product directory to find the best elemental analysis tools, compare products, check reviews, and get pricing directly from manufacturers.

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