Downgauging is a concern for other companies as well. Thus, Sealed Air's Latitude ML29C forming film enables medical device manufacturers to downgauge from other films by as much as 30%, Berendt comments. As a result, one of the company's customers has moved from a 10-mil EVA/Ionomer/EVA film to a 7-mil Latitude film to package a procedural kit that includes a syringe and other light consumables for the U.S. market. Because the film is thinner than competing films with equivalent or better mechanical properties, more material can be wound on 50-lb rolls, according to Berendt. Thus, the amount of downtime required for roll changeovers has been reduced, leaving more time for production.
Manufacturing and cleanroom device assembly servicesA full-service contract manufacturer offers injection molding, radio-frequency welding, silk-screen printing, solvent bonding and leak testing, and tipping and punching services. Operating an ISO 9001:2000- and ISO 13485:2003-certified production facility, Angiplast Pvt. Ltd. also performs physicochemical, sterility, pyrogen, and toxicity testing in an in-house laboratory to applicable USP and ISO standards. Additional capabilities include EtO sterilization. Most of the company's medical devices carry the CE mark. The supplier develops production processes, manufactures custom products to specification in short runs and mass-production volumes, and packages medical devices in pouches or kits.Angiplast Pvt. Ltd.AHMADABAD, INDIAContract manufacturing of finished productsA full-service supplier of comprehensive engineering, manufacturing, and assembly solutions, ISO 13485-certified and FDA-registered Inteprod LLC partners with medical device makers to develop and produce electromechanical devices, diagnostic systems, and disposables. Its service range comprises transfer to manufacturing, quality assurance and compliance, materials sourcing, production planning, manufacturing control, and finished-product assembly. The company's multidisciplinary technical staff provides long-term sustaining engineering to identify, support, and implement design changes, engineering upgrades, and product and process quality and cost improvements. Fully integrated manufacturing solutions entail product safety elements, product and process verification, design for manufacturing, design for cost reduction, and process control documentation.Inteprod LLCEAGLEVILLE, PAElectronic manufacturing servicesSuntron Corp. provides integrated, full-contract electronic manufacturing services and embedded computing systems. The company's capabilities include box build of Class I to Class III devices, PCB assembly, and large-scale system integration. In addition to ultrasound and endoscopy systems, cancer monitoring and diagnostic systems, neurostimulation devices, electrosurgical devices, orthopedic surgical devices, and other safety-critical products, the service provider produces patient monitoring and connectivity systems and hospital asset tracking systems. Class 10,000 and Class 100,000 cleanroom installations enable the FDA-registered and ISO 13485-certified company to produce critical assemblies that meet medical device industry standards.
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