PRODUCT UPDATE
Molded Rubber & Plastic Corp.
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A contract moulder of implantable-grade biomaterials specializes in working with PEEK-Optima for medical applications that require contact with blood or tissue for more than 30 days. Molded Rubber & Plastic Corp. (Butler, WI, USA; www.mrpcorp.com) can process the material using injection moulding, extrusion, or compression moulding techniques. The material provides biocompatibility, stability, strength, and rigidity. It can also overmould PEEK with a sealing silicone. Class 10,000 cleanroom capabilities are available to customers in such markets as orthopaedics, cardiac rhythm management, and surgical instrumentation.
The company’s manufacturing facilities are equipped with small precision presses that produce accurate, repeatable moulded parts weighing less than 1 g for implantable electromechanical devices, catheters, and other applications. The firm uses CO2 lasers to fabricate parts with precise openings and to finish components for flash removal. This ensures no distortion, even when working with elastomers. The company formulates elastomer materials in its in-house lab to custom product requirements.
AdvanSource Biomaterials Corp.
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Using proprietary manufacturing techniques, AdvanSource Biomaterials Corp. (Wilmington, MA, USA; www.advbiomaterials.com) develops advanced polymer materials for medical devices. The materials are suited for use as structural engineering polymers or as coatings for a variety of material substrates. Designed to overcome a range of design and functional challenges, these materials are biocompatible, biodurable, antimicrobial, and possess controlled hydrophilicity.
The firm’s antimicrobial formulations feature an antimicrobial agent that is dispersed homogeneously throughout the material to prevent leaching as well as to provide long-lasting and consistent microbial resistance. Complementing the supplier’s ChronFlex and HydroMed polymer product families, these materials are offered as a means of combating foreign body–derived infections without healthcare deliverers needing to use antibiotic drugs with patients or device manufacturers having to employ secondary processing steps in production. They exhibit a high kill rate and yield a device that is not susceptible to bacterial growth. The products can be supplied as structural engineering polymers or as coatings for various substrates, and they are amenable to processing by conventional extrusion and injection moulding techniques.
The company provides full partnership and R&D support from concept initiation through full-scale manufacturing. The firm adheres to US FDA good manufacturing practices to continuously improve quality and productivity.
NuSil Technology
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A clear silicone tacky gel from NuSil Technology (Sophia Antipolis, France; www.nusil.com) is designed for casting and potting, and can be cured onto various substrates, including fabric backings. Suitable for use in transdermal, wound-care, and hypertropic and keloid scar-management applications, among others, the MED-6345 gel features temporary adhesive qualities that allow the product to gently adhere to the skin while enabling easy removal and reapplication. Its polysiloxane structure is permeable to gases, resulting in a soft, breathable, water-resistant cover.
The company’s materials are manufactured in ISO-certified facilities, and many of the silicone biomaterials are tested to USP Class VI requirements. In 1993, NuSil Technology was uniquely positioned to respond to the availability crisis of silicone materials for use in long-term implant applications in the medical device market. Well established in the medical silicone market and having firsthand knowledge of the products that were being discontinued, the firm responded to this situation by providing more than 25 replacement products that are clones of discontinued originals manufactured by other companies. Master files and test data compendia including physical, chemical, and biological testing are made available on all of the company’s medical products to ease regulatory approval.
Wacker Chemie AG
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Certified to ISO 9001:2000 and ISO 14001:2004, Wacker Chemie AG (Munich, Germany; www.wacker.com) offers silicone products for a variety of medical applications. Designed to protect wounds and promote healing, a line of silicones is suited for use in wound-care applications. In addition to its biocompatibility, purity, and performance characteristics, Silpuran liquid silicone rubber features good vapour permeability that yields breathable medical dressings. Silicone-based dressings can be removed without inflicting trauma on the wound and can prevent wounds from reopening, according to the silicone supplier. By preserving the skin’s elasticity and preventing tissue from drying out, the material can also enable beneficial treatment of scars. The silicone is compliant with USP Class VI standards and select ISO 10993 tests.
EuropTec AG
Suited for use in implantable medical devices, a material composed of PEEK and carbon fibre is 30 times stronger than unreinforced PEEK. The EuropRay material from EuropTec AG (Oftringen, Switzerland; www.europtec.com) consists of 45% PEEK by volume. The material offers high interply shear strength and is chemically resistant, biocompatible, and supports a large temperature range. The plastic, which can be used in MRI, CT, and other radiological imaging applications, is also x-ray translucent and can withstand thorough washing and sterilization.
Unlike woven fibre-reinforced composites, EuropRay features quasi-isotropic fibre alignment in the x and y axes, which results in a material with uniform properties in all directions. As a result, parts made with the material have high dimensional stability owing to the material’s uniform structure. In addition, the optical appearance of the material is uniform, giving it a finished appearance. The material weighs 80% less than steel. EuropRay has passed biocompatibility tests according to ISO 10993-1.
