Merck

Merck - Complete solutions for medical device R&D, scale-up, production and QC

For innovators and manufacturers of contact lenses, dental materials, medical sealants/adhesives, medical devices and medical materials suppliers needing to accelerate product development across multiple global sites while maintaining efficiency, flexibility, and compliance in a changing regulatory environment, Merck scientists and engineers continue to develop the most trusted products and services covering R&D an manufacturing processes with Milli-Q® best-in-class laboratory water, reliable, consistent application-relevant SigmaAldrich® lab and production materials, standard-setting Millipore® solutions for preparation, separation, filtration and biomonitoring, and high-precision Supelco® analytical reagents, columns and standards.

Medical device manufacturers partner with us to source quality raw materials, obtain supply chain security, and to leverage a wide range of services to accelerate product development. We can supply a comprehensive solution of application-relevant materials for R&D, scale-up, production and QC through our global distribution network. Our flexible bulk and customization options offer convenience and increased efficiency; while our quality systems and regulatory expertise offer peace of mind from a partner that understands the increasingly complex regulatory environment.

Our core capabilities include:

- High quality raw materials for your device manufacturing
- Broad range of chemical custom manufacturing capabilities
- Flexible bulk and custom packaging options
- Extensive QC offerings for both analytical and microbiological testing
- Quality assurance program and services to mitigate risk

Learn more about our solutions for medical device production: www.sigmaAldrich.com/Medical-Device

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Products & services

Specialty materials for dental applications

Dental applications require high-quality materials that are biocompatible, wear-resistant and durable. Restorative dental materials must withstand the adverse conditions of the oral environment. The selection of monomers, initiators, crosslinkers, ionomers and additives impacts longevity, mechanical characteristics and ultimately the performance of the end product. Besides monomers and other polymerization agents, inorganic materials offer biocompatibility and chemical inertness for dental applications ranging from crowns, caps and cements to additives, elastomers and restorative materials. Adjustment of inorganic constituents allows for tuning of optical and mechanical properties. We offer a large selection of well-characterized, high purity monomers, inorganics and starting materials for a wide range of dental applications.

Custom and bulk services

Dental manufacturers can accelerate commercialization by leveraging our bulk and custom services.

Specialty monomers for ophthalmic applications

From Research to Commercial Scale Manufacturing Innovative high quality raw materials are essential for providing effective and comfortable intraocular and contact lenses. We offer a selection of monomers for ophthalmic R&D and commercial applications, as well as manufacturing capabilities to customize or produce monomers to customer's specifications, reducing your total cost of product development and manufacturing process.

Make the move to the monocyte activation test for pyrogens

The Monocyte Activation Test (MAT) can detect both endotoxin and non-endotoxin pyrogens by utilizing a reproducible cell line, coupled with an ELISA readout. In contrast to the Rabbit Pyrogen Test, this alternative method, assay produces sensitive results based on the human immune reaction.. With our Mono-Mac-6 cell-line, or cryopreserved blood-based MAT kits, we provide a robust, reliable and standardized method for pyrogen detection.

Bioburden testing equipment and reagents

When it comes to bioburden testing, false results can waste valuable time. We can help you to streamline and simplify your entire microbial limit test workflow from filtration and microbiological culturing through to detection.

Air and surface environmental monitoring instruments and reagents

A single source of solutions for a wide range of needs to enable efficient and cost-effective environmental monitoring of ambient air and surfaces in your controlled areas, we offer products that are reliable, flexible, convenient, fast, and easy to handle. All instruments are fully compliant with regulations and industry standards. We provide data and expertise to support your in-house validation activities, minimizing the burden of complying with the USP and other complex regulatory guidelines and standards.

Sterility testing reagents and supplies for medical devices

Sterility testing is a crucial required step in the product release of many medical devices. For more than 40 years, MilliporeSigma has set the industry benchmark for closed membrane filtration with Steritest™, a closed system that allows samples to be withdrawn aseptically from any container type without being exposed to the surrounding environment. The Steritest™ system includes a wide range of rigorously tested membrane filters, adapters, accessories, sterile media, and rinse fluids, all of which meet USP, EP, and JP requirements.

QC and analytical testing solutions for medical device

When it comes to analysis by HPLC, UHPLC, or LCMS in the medical device industry, we know only the utmost reliability will do. That's why every product across our comprehensive analytical portfolio is meticulously tested against the tightest specifications to ensure the highest industry standards and compliance with applicable regulations.

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Merck - Complete solutions for medical device R&D, scale-up, production and QC