Producing a range of disposable medical devices for use in infusion therapy, transfusion therapy, dialysis, gastroenterology, urology, anesthesia, and surgery, Angiplast Pvt. Ltd. manufactures products in FDA-compliant facilities certified to ISO 9001:2000 and ISO 13485:2003 standards. The company has made such products as needle-free infusion sets, urine meters, blood lines, and extension lines. Its capabilities include injection molding, radio-frequency welding, silk-screen printing, solvent bonding, tipping and punching, cleanroom assembly with jigs and fixtures produced in-house, device packaging, EtO sterilization, and in-house testing.
■ Angiplast Pvt. Ltd.
Manufacturing, assembly, and packaging services
Specializing in handling medical device components and assemblies, Precision Medical Products Inc. offers device manufacturing, assembly, and packaging services. The company is equipped with form-fill-seal and peelable-pouch packaging machines for high-volume projects and an Alloyd packaging machine to fulfill lower-volume requirements. Additionally, a band sealer is available for pouch sealing. All packaging operations are carried out in ISO Class 7 cleanrooms. To provide device OEMs with sterilization support, the outsourcing services company uses sterilization contractors that are validated and approved for processing medical devices.
■ Precision Medical Products Inc.
Implantable device manufacturing
A turnkey contract medical device manufacturer with design and assembly capabilities, VitalDyne Inc. offers core device manufacturing competencies that include laser cutting, welding, marking, ablation, and microhole drilling of polymers and alloys. It offers sensing and drug-delivery catheters, steerable biopsy sheaths, spinal implants, cardiology devices, and orthopedic products and accessories. In addition to offering product development services, the company provides sterile packaging for medical devices in an ISO Class 7 cleanroom according to ISO 11607-2:2006 standards.
■ VitalDyne Inc.
Converting, assembly, and packaging
Certified to ISO 13485 standards, Fabrico operates three Class 10,000 cleanrooms for converting and assembly. In addition to offering in-house material, adhesive, and electrical testing, the company can print packages and tamperproof and tamper-evident labels. It supplies hermetically sealed packaging; Tyvek, film, and foil pouches; custom trays; tray lids; and breathable packaging made from cohesive medical paper. The company has expertise in the use of medical packaging materials and has access to a variety of medical-grade substrates and adhesives. Its converting capabilities include precision die-cutting, laser and water-jet cutting, multilayer laminating, and slitting to tight tolerances.
Molded parts and assemblies
From partial component assembly to complete turnkey projects, GW Plastics Inc. offers full-service contract manufacturing services in FDA-registered and ISO 13485–certified facilities. Its capabilities include product design, in-house precision tooling, prototyping, part production, assembly, decorating, testing and validation, custom packaging, and order fulfillment. The company specializes in injection molding, liquid injection molding of silicone products, and scientific injection molding. It produces medical and surgical components, fully assembled medical and diagnostic devices, drug-delivery systems, and single-use consumables.
■ GW Plastics Inc.
For insights related to full-contract manufacturing services, check out our Q&A with Ben Bouchard, vice president, international business development, and managing director–China at GW Plastics Inc. (Bethel, VT).
Published in MPMN, November/December 2013, Volume 29, No. 6
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