Equipment News: Testing and inspection
Custom leak testing equipment
A company manufactures customized leak testing equipment for the medical device industry. A recent project involved designing a dual-nested leak tester that could meet stringent guidelines for leakage and porosity. The dual-nest design enables one housing to be tested while the other nest is manually loaded or unloaded. The customer's requirement for operator ease of use was met by slaving the Uson-based leak tester to an Allen Bradley PLC that handles all machine function sequencing. The company specializes in custom equipment for similar assembly and testing needs. Automation Tool Co., P.O. Box 2649, Cookeville, TN 38502.
A company offers two lines of video microscopes designed for video inspection in product manufacturing. The VM-40 and -60 Measurescopes use a newly designed video measuring head mounted on a microscope stand made of cast steel for excellent manual video inspection capability. Both models feature proprietary measuring optics that deliver sharp images over the entire field of view. Objectives ranging from 1 to 100x are available. Working envelopes range from 2 x 2 x 6 to 8 x 6 x 8 in. Users can custom configure systems from a selection of six stages and four stands. A linear scale built into the stands permits accurate measurement over the entire range of vertical motion. Both models feature an optical focus aid for accurate z-axis measurements. Nikon Inc., 1300 Walt Whitman Rd., Melville, NY 11747.
Digital bottle-cap torque tester
A digital torque tester measures the required application or removal torque of bottle caps for medical vials. Some of the other uses of the Model STB torque tester include measuring breakaway fastener, motor-stall, and valve-operating torque. A universal gripping mechanism accommodates a variety of round or irregularly shaped items. The tester also connects to the Model BGI digital torque indicator. The complete system features a 41/2-digit LCD with a multifunction set of annunciators, peak-torque memory in clockwise and counterclockwise directions, and selectable analog and digital filtering. Mark-10 Corp., 458 W. John St., Hicksville, NY 11801.
Optical measurement systems
Designed for fast, noncontact inspection of small, thin, delicate, or complex workpieces such as IC lead frame, PCB, or nonmetal components, a series of optical measurement systems feature drive speeds up to 8 in./sec (x- and y-axes) and 6 in./sec (z-axis). Acceleration is 3.2 ft/sec2. Quick Vision systems feature high-resolution CCD cameras with 380,000 pixels that produce a crisp magnified image on a CRT screen. An autofocus function provides high-accuracy height and depth measurement, and can be set for surface or edge focusing and specified according to surface texture. Four models of Quick Vision are available in different sizes with measuring ranges up to 24 (x-axis), 24 (y-axis), and 6 in. (z-axis). All have a resolution of 0.0002 in. Mitutoyo Measuring Systems, 965 Corporate Blvd., Aurora, IL 60504.
Video inspection system
The inspection of electronic, plastic, and metal parts used in medical device manufacturing is performed by a video inspection system. The SmartScope MVP system features a motorized zoom lens, manual or motorized x-y-z stages, substage and ring lights, software, and video edge detection. The x-y stage has manual fine adjustment controls, while the z stage has both coarse and fine adjustments. CNC software provides semiautomatic operation on manual systems and fully automatic operation on motorized systems. The units are available with measuring ranges of 8 x 6 x 6, 12 x 6 x 6, 18 x 18 x 6, or 24 x 18 x 6 in. Optical Gaging Products Inc., 850 Hudson Ave., Rochester, NY 14621.
Ten-year FDA benchtop durability test requirements for stents and vascular grafts can be met in just weeks using the Model 9010 stent/graft tester. The patented design features high-performance electrodynamic pump technology and a laser-based measurement system. The tester is suitable for generating fatigue data used for PMA submittals and for the development of new designs. Standard features include a PC-based servo control system with real-time graphic displays and integrated data acquisition. The unit accommodates vascular devices ranging from 3 to 40 mm. EnduraTEC Systems Corp., 7557 Market Place Dr., Eden Prairie, MN 55344.
A tensile tester has a measuring capacity up to 150 lb and a travel distance of 18 or 36 in. The LT-150 processes up to 500 samples per second with a speed accuracy of 0.2%, speed range from 0.002 to 40 in./min, and a displacement resolution of 0.001 in. The machine features simple menu-driven software and PC-based electronics. Suitable for testing lightweight materials such as medical disposables, tubing, adhesives, and film, the unit can be used for rapid determination of tensile strength, elongation at peak and break, maximum and average peel strength, static and kinetic friction, tensile energy, and compression measurements. Thwing-Albert Instrument Co., 10960 Dutton Rd., Philadelphia, PA 19154.
Tensile test system
A 0500-lb tensile, cycle, and compression test system is suitable for testing adhesives, fiber, composites, ceramics, and other materials for QA, QC, and product evaluation. The AccuTest/502 system is designed for ease of use, with smart buttons, LCD for menu selection and programming, and two test result data displays to consolidate test control, setup, and data operations in one console. The machine can input and store seven test setups and six report graphics setups. Test results can be reviewed immediately and then printed or stored for later recall and graphing. The unit supports multiple load cells and provides built-in safety features, including load cell overrange and clamp compression. Physical Testing Equipment Services Inc., P.O. Box 19108, Johnston, RI 02919.
Optical measurement systems
A company makes noncontact optical measurement systems that incorporate aspects of optical comparators, toolmaker's microscopes, and coordinate measuring machines. Available in either manual or automatic versions, the systems are designed for dimensional analysis and inspection of such medical parts as stents, catheters, tubing, valves, syringes, and pacemakers. They measure piece parts for first-article, process control, or final inspection. The OMIS II (pictured) and -III series can be customized for specific applications. Systems feature Windows-based software and on-screen graphics. RAM Optical Instrumentation, 1791 Deere Ave., Irvine, CA 92606.
Microprocessor-based leak tester
A microprocessor-based leak tester is equipped with touch screen programming and multiple testing programs for different parts. The Testra model tester features fast testing speed with high repeatability. It can perform leak tests, flow tests, vacuum tests, functional tests, and more. Testing applications include tubing, IV administration sets, blood sets, filters, catheters, dialyzers, instruments, and oxygenators. Uson, 5215 Hollister, Houston, TX 77040.
Automated package tester
An automated package tester measures burst and creep test pressures and displays real-time performance characteristics. The Model BT-1000 machine displays a plot of pressure versus time on a large, blue-on-white LCD display. It features a leak testing mode for nonporous package film and foil materials; the instrument tests such materials in seconds. Statistical analysis of the built-in data log provides immediate access to data in process or validation performance runs. Data can be interfaced with existing programs through the RS-232 port or in printed output. T.M. Electronics Inc., 330 Tacoma St., Worcester, MA 01605.
Image acquisition system
A CCD-based image sensor uses patented image acquisition technology to deliver repeatability and image stability for high-speed on-line vision and inspection applications. The SmartImage sensor can perform precision measurement, blob analysis, SPC data output, motion control guidance, and 2-D code reading. The system comes complete with hardware, software, illumination, cabling, and training. DVT Corp., 1670 Oakbrook Dr., Ste. 330, Norcross, GA 30093.
A multichannel catheter tester routes air to a catheter to test for outer-wall integrity, occlusion, and interlumen leaking. A luer connecting nest (LCN) ensures leaktight seals between the product and the Sprint-LC tester. The LCN, which uses spring-loaded holders riding on independent bearings, eliminates retraction force, provides easy maintenance, applies consistent force, and self-aligns. The tester features temperature-controlled pressure transducers in stainless-steel housings and micromachined mass-flow sensors for high speed, performance, and reliability. It can store 99 programs, and each program can be linked to any other program such that the user can conduct a variety of tests on the same product in one test sequence. Pressure ranges are from 1 to 500 psig, and flow ranges are from 1 sccm to 20 L/min. Available in 2, 3, or 4 channels, the Sprint-LC unit is suitable for medical device design engineers seeking test equipment that meets FDA and ISO calibration requirements. Industrial Data Systems, 2370 South 2700 West, Salt Lake City, UT 84119.