Quality Control Products Get Their Own Pavilion at MD&M East

Originally Published MPMN July/August 2002

INDUSTRY NEWS

Quality Control Products Get Their Own Pavilion at MD&M East

Quality control and testing and inspection products are used in virtually every phase of medical device manufacturing, from R&D to finished product and package testing. Last month, at MD&M East 2002 (New York City), manufacturers offering a full array of these critical testing and inspection products and services were featured in their own Quality Pavilion.

Suppliers exhibited optical and laser inspection equipment, materials-testing equipment, quality assurance testing equipment and services, product reliability technology, surface-measurement products, data-acquisition and -collection devices, and validation and ISO certification software, among other products.

Following is a wrap-up of some notable products and services introduced at the show.

Benchtop Tester

The SmartScope Quest 250 from Optical Gaging Products Inc. is a multisensor measurement system offering high accuracy.

A system is designed to test the tensile, compression, and flexural properties of medical devices and materials. The 3300-series instrument from Instron (Canton, MA; www.instron.com) includes a load frame with integrated control electronics, a load cell, surface-mount circuitry, and Series IX materials-testing software. A high-torque motor with closed- loop position control enables the system to constantly measure the test force being applied, ensuring complete accuracy and repeatability.

Column covers are fitted with T-slots to allow compatibility with various accessories, such as grips, fixtures, extensometers, and chambers. Safety features include ball-screw covers for long machine life and operator protection. The benchtop tester is available in a choice of colors.

Real-Time X-Rays A desktop, real-time x-ray inspection system provides sufficient resolution and sensitivity to enable device manufacturers to detect subtle failures during production. The conveyorized MXRA system from Glenbrook Technologies (Randolph, NJ; www.glenbrooktech.com) is suitable for inspecting low-density products and materials such as catheters, injection-molded plastics, and silicones.

The company's camera technology can produce x-ray images using anode voltages as low as 15 kV to reveal voids in plastic moldings that would not be apparent using conventional real-time x-ray techniques. The high-sensitivity images are of high resolution, revealing defects as small as 0.001 in.

The system is currently being used by medical device manufacturers for 100% inspection of sealed products such as surgical staples, molded catheters, pacemakers, temperature sensors, and other inaccessible devices.

The MXRA system can be upgraded with image processors, video micrometers, andprinters.

Video Measurements

An x-ray image taken with the MXRA system. The small image provides a close-up view of a defect in a molded catheter.

A benchtop, multisensor dimensional system offers high-accuracy video measurements with a continuously adjustable zoom lens. The SmartScope Quest 250 from Optical Gaging Products Inc. (Rochester, NY; www.ogpnet.com) integrates data from video, touch probe, and laser sensors to completely characterize a part. The touch probe is used to acquire data from areas not accessible by the optics and supports a variety of standard probe heads and styli.

"While the video and touch probe are ideal for dimensional measurements on a macro scale, the laser allows for surface profiling and scanning at a micro level," says Eric Gesner, the company's corporate product manager.

All sensors are calibrated to a common reference frame, and can be used interchangeably with the same measurement program. Parts that previously needed to be measured in separate setups on different machines can be measured completely on the SmartScopeQuest.

Document Management System Has New Capabilities

Software now offers complete change management and document control functionality within the 3-D, computer-aided design (CAD) process while enabling compliance with GMPs and FDA requirements. Document Control Systems (Salt Lake City; www.mastercontrol.com) has adapted its MasterControl 3D for SolidWorks to provide full revision control and audit trail tracking for every 3-D design component that meets and exceeds FDA's 21 CFR, Part 11 regulations for electronic signatures and recordkeeping.

The software is validation-ready with prewritten validation test plans for performing installation qualifications and operational qualifications. The company also offers on-site validation support for performance qualification to allow complete validation and 21 CFR, Part 11 compliance.

The software can manage any document, regardless of the application in which it was created, including word processing, spreadsheets, graphics, audio, video, and CAD. It provides the means to control the three main components created and manipulated during the 3-D CAD process: parts, drawings, and assemblies.

"This software is the only product currently available that will allow medical device companies to be Part 11 compliant for every aspect of their business related to documentation, especially with departments that are approving 3-D CAD drawings," says Brad Wright, the firm's president and CEO.

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