Closure integrity tester
The ME3 vacuum-based instrument, which uses mass-extraction technology developed by the manufacturer ATC Inc., can perform high-speed container-closure integrity testing for in-line medical device packaging applications. The device has a high-speed evacuation circuit for process testing in applications requiring short test times and also includes an automated vacuum test circuit designed for ultratight leak testing. The equipment tests for both large-scale and fine leaks, displaying pressure and flow rates in real time. Used in conjunction with the manufacturer’s 21 CFR Part 11–compliant Windows-based software program for leak-test data acquisition, the instrument provides a complete testing system. The system’s software includes a protected database and an analysis and monitoring platform that tracks user actions within the software and also features account administration, audit trails, file validation, and time-stamped records export capability.
Infrared band-pass filters
Advanced infrared (IR) narrow-band-pass optical filters from Deposition Sciences Inc. are suitable for use in medical device testing, measurement, and inspection in production environments. The filters offer high spectral performance, with accurate centerwavelength placement to offset temperature shifts. They also provide good temperature stability, which makes them applicable for such spectroscopic procedures as sophisticated gas sensing. Their IR spectral range enables users to detect a particular gas and identify the concentration levels of gases such as CO2, CH4, HOx, and others. The absorption of IR radiation at wavelengths between 2.0 and 20.0 μm provides a definitive signature of the bending, stretching, or twisting of the atomic bonds in a particular gas molecule. These optical filters allow discretization of the spectra through a gas sample at multiple detection wavelengths, both inside and outside the absorption band of interest.
Deposition Sciences Inc.
SANTA ROSA, CA
Leak-testing flexibility is built into the Med75 Combo instruments for medical device leak and flow testing from InterTech Development Co. These leak testers perform a range of functions: leak and flow testing for medical products, pressure-decay and mass-flow leak detection in combination, and leak and flow testing for catheters. Several options, including as many as four independent channels, allow users to conduct the tests that best suit the application. The several test circuits operate independently, with individual pressure regulators, valves, and calibration ports. A touch screen control panel, dual USB ports, Ethernet connectivity, and embedded Web pages all facilitate data management. The leak detectors can be employed as stand-alone instruments, or they can be interfaced with a PC or an external programmable logic controller, through which setup is automatic.
InterTech Development Co.
Heart valve durability tester
The Model MDS heart valve tester tests a single valve rather than a batch by means of a piston pump driven by an uncommutated, motion-controlled, flexure-guided solenoid actuator. Available from Blockwise Engineering LLC for testing the durability of prosthetic heart valves, the machine enables users to set up regulationcompliant tests in much less time than traditional valve-testing equipment allows. It does not incorporate sliding or rolling seals or bearings and is therefore designed for infinite fatigue life. Setup time is minimal because the design brings all setup parameters into an autotuning computer touch screen control, where calculated pressure statistics with regulatory significance are displayed in real time. A special system widens the pressure spike upon valve closure, resulting in minimum stress on the valve while still meeting test standards.
Blockwise Engineering LLC
Delivering a clear, bright image, the Micro borescope from Lenox Instrument Co. performs close-range inspection of coronary stents; tubes; micromolded, machined, and cast parts; and electronic and mechanical assemblies. The instrument is particularly helpful in applications in which access is limited and the insertion point measures only a few millimeters in diameter. The borescope features a focusing eyepiece and a fiber-optic bundle that provides good resolution. Its rugged design and durable construction enable it to tolerate tip deflections and moderate bending. Offered in flexible and semirigid models, the scope is available in diameters as small as 0.02 in. and in standard lengths from 4 in. to 50 ft. Other lengths and custom configurations can also be supplied. All models are fully video and digital adaptable, allowing users to view and record real-time or still images. Compatible color-video systems and light sources are available from the supplier.
Lenox Instrument Co.
Tabletop universal testers
The EZ Test EZ-X series of compact tabletop test systems has been designed by Shimadzu Scientific Instruments to provide high levels of test force measurement precision, control precision, and test speed. The universal testers can be configured into 29 models that are designed to meet small-capacity testing requirements for the medical device industry. They offer ±0.5% accuracy over a range of 1/500 of load capacity to full capacity and allow data sampling at speeds up to 1000 measurements per second. A high-speed, long-stroke model features a 3000- mm/min return speed that minimizes the wait between tests. To extend the range of possible test applications, the manufacturer offers a selection of specialized jigs for sample preparation and evaluation of device properties. This series of test units can inspect such items as syringes, adhesive bandages, and packages for physical characteristics and other performance criteria.
Shimadzu Scientific Instruments
The IK-HR2D high-definition camera from Toshiba Imaging Systems Div. can be used to add full-motion, live video output to microscopes employed for inspecting circuit boards, assembling devices, and performing other inspection, testing, and measurement tasks in which real-time, high-resolution, high-quality color imaging is critical. Besides being in high resolution, the images captured exhibit good contrast and clarity. Supporting ergonomic and efficiency objectives, the one-piece, compact CMOS high-definition camera measuring 1.73 × 1.73 × 3.17 in. offers live-image data capture at speeds up to 60 frames per second and includes both DVI-D and USB outputs. User-selectable video output formats include 1080p/720p at 60 fps and 1080i at 30 fps. Video frames can be output at up to 10 fps via the built-in USB port for convenient transfer of live images to a computer without the use of a frame grabber.
Toshiba Imaging Systems Div.