June 1, 2001
Originally Published MPMN June 2001 HOTLINE Nondestructive Method Improves Porous-Package Testing
Gas sensor is used to detect leaks
Technology for the nondestructive testing
A manufacturer of testing equipment recently acquired intellectual property that provides a unique method for detecting defects in porous packages. Mocon Inc. (Minneapolis, MN) purchased technology from True Technology Inc. (Boston, MA) for the nondestructive testing of packages made of DuPont Tyvek. The technology promises to provide an attractive alternative to current methods, which rely on destructive dye or pressure tests.
"Tyvek-containing packages breathe—how do you know if they are leaking?" asks Dane Anderson, chief financial officer at Mocon. The company's new test relies on tape placed over a porous Tyvek package. A tracer gas is introduced, and a sensor detects any leakage of the gas from within the package.
According to Anderson, the advantages of the new testing method for medical OEMs are twofold: "First, it's sensitive; the test gives a specific signal with defective packages," he says. This is in contrast with the visual inspection methods currently employed by device manufacturers. "Secondly, the test is nondestructive, so you are not losing package and product," he adds, explaining that this is particularly important for high-value products.
Mocon is a provider of testing systems and consulting services for the assessment of materials and processes. The company plans to incorporate its new technology into a new whole-package integrity testing device that will join its standard product line early next year. "This patented technology will enable us to introduce other instrumentation and services for testing the integrity of a variety of sterile medical packages," says the company's president and CEO, Robert Demorest. Mocon began by manufacturing permeation-testing equipment, but now also offers technology for leak-testing nonbreathable packages for drugs and medical devices.
Laser-Sintered Metal Prototyping Process Yields Durable Metal Parts Quickly
The process makes fully dense metal parts using stainless-steel alloy material
LSM prototypes are fully dense metal parts made directly from CAD data.
Laser-sintering of metal is one of the fastest ways to rapid prototype fully dense metal parts, prototypes, and tooling inserts for plastic injection molding. Rapid Prototype Company, Inc. (Auburn Hills, MI) uses LaserForm ST-100, a powdered metal material made with a stainless-steel alloy to produce complex, durable metal parts directly from CAD data. The metal material allows a better surface finish and a stronger model. Parts can be polished, textured, plated, and machined, and typical turnaround time is only four to seven days.
Laser-sintered metals offer two advantages. First, cavity and core tooling inserts can be created quickly and use production materials. "Most other short-run or bridge-tooling options can't run production materials, and the few that can don't get high part volume because the tooling quickly wears," says Rob McCarthy, Rapid Prototype Co. marketing manager. Laser-form molds have shot greater than 100,000 injection-molded plastic parts.
The other advantage of this process is that it can be used to create metal parts directly. "Previously, parts could be made in nylon materials, or in photo polymers, and used to evaluate form," says McCarthy. "But if the part is metal in production, a plastic one just doesn't have the same feel. Imagine a plastic fork versus a stainless-steel one." Designers want the feel of the real thing, he adds. "Previously this meant machining parts, investment casting, and sand casting, processes that take more time and that have constraints. With the sintering process, we can provide multiple iterations in less time," says McCarthy.
For more information, contact Rapid Prototype Company, Inc., 4141 N. Atlantic Blvd., Auburn Hills, MI 48326; ph: 248/391-6600; fax: 248/391-7462; URL: http://www.rapidprototypeco.com; email: [email protected]
Software Manages Manufacturing Changes
Streamlining the change process helps shorten time to market
Using Manufacturing Change Manager, anyone involved
Manufacturers can shorten product introductions and achieve faster time to market and volume production using Web-based Manufacturing Change Manager (MCM) from Ingenuus Inc. (Sunnyvale, CA). MCM is an automated solution that allows manufacturers to manage product and process change requests and orders in real time throughout the global supply chain. Using MCM, every kind of change request and change order is efficiently routed, reviewed, and approved.
"The rapid rate of technological change, combined with a demand for more powerful and customizable products, means that product lifecycles are often measured in months rather than years," says Dave Allenbaugh, vice president of sales. "These developments are forcing manufacturers to rethink and streamline their change process in order to remain competitive."
Since it integrates easily with any enterprise data system, MCM is suited to companies managing multisite engineering, manufacturing, sales, and distribution operations connected via the Internet.
MCM's Smart Expediter controls the flow of change by providing a virtual tracking agent that understands business relationships, monitors progress, and eliminates bottlenecks. The Smart Expediter pushes and tracks entire packages of information through the supply chain, including manufacturing and engineering orders, indentured bills of materials, drawings, specifications, procedures, and other essential documents. It tracks change of all types, including customer, supplier, purchasing, manufacturing, engineering, ISO, and variation change requests.
Medical Product Manufacturing News is always on the lookout for innovative products and services. If you are aware of any that have recently been or are about to be introduced, please call the Hotline editor, Karim Marouf, at 310/445-4267.
Copyright ©2001 Medical Product Manufacturing News
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