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Important elements to consider when choosing a contract manufacturer for your packaging and sterilization needs are FDA certification and ISO 13485 and ISO 9001 compliance. These standards require an exceptional level of commitment on the part of a contract manufacturer, and therefore indicate...

...quot;ISO 11607 has done a good job of putting on paper what we and other people have been preaching for years: you have to measure and document your process . . . in essence, to validate it, " says Franks. "ISO 11607 lays out the sequence of things that you need to look at, and one of its...

...and diagnostic settings in which visibility of tissues, blood, and other fluids is required. Because biocompatibility is essential for any material used in direct or indirect contact with patients, polycarbonate grades are available that comply with biocompatibility testing standards such as ISO 10993-1...

...of powders, gels, high- and low-viscosity liquids, creams, and sterile products from 1 to 2,800 g. Products are packaged in a Class 100 cleanroom. Packaging products are designed specifically for safe shipping and handling of medical devices. The product line is based on an ISO 9001:2000 -certified. MPMN...

...but designers should also maintain ease of use for manufacturers and customers, incoming inspection, shipping, and ergonomics, " she told MD &M. (NewsTrends) There is More to Packaging than Just a Box (MDDI archive, Mar 05). Skip to : [Content] [Navigation]. Medical Device Link. The Online...

A company specializes in the production of close-tolerance, multiresin, multicolor, and two-shot overmolded parts and their assemblies. Also offering steel tool development and injection molding, the firm operates from facilities that are ISO 9002 certified. Process control equipment, vision camera...

Bandex S.A., located in San Luis, Argentina, manufactures disposable containers and plates from expanded polystyrene (EPS). The production line extrudes and thermoforms virgin polystyrene, recycled polystyrene, talc, and masterbatch color pellets. Bandex is the market leader in EPS packaging...

Tyvek medical packaging segment leader for DuPont Nonwovens (Wilmington, DE); and John Spitzley, associate fellow of packaging for Medtronic, Inc. (Minneapolis). Questions posed by MD &DI are in bold, with the participants' answers following. With the acceptance of international standards such as ISO...

containers for liquid ranging from 10 to 200 L. Products can be custom made and carry the CE mark. The firm is certified to ISO 9002. Stand 1319 Loctite European Group A global manufacturer of industrial adhesives and equipment offers a reference manual on adhesive, sealant, coating, and dispensing...

...solid-waste materials. Factoring in this consideration also contributes to the need to reduce the shelf container size. The Effect of ISO 11607. Both testing contractors and device manufacturers are reporting the sheet-separation phenomenon more frequently than in the past. Several factors seem...

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