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.
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
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.
Copyright ©2002
Medical Product Manufacturing News
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.
