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Inspection and Testing Systems Offer Custom Capabilities and Heightened Sensitivity

Originally Published MPMN January/February 2002

EQUIPMENT NEWS: Testing and Inspection Equipment

Inspection and Testing Systems Offer Custom Capabilities and Heightened Sensitivity

Systems are suitable for devices, materials, and packaging

To achieve the level of precision necessary in the manufacture of medical devices, OEMs employ inspection and testing machines to detect flaws in their products and weed out defective ones. These machines have become more essential and more technologically advanced as safety and quality requirements have become more stringent. Following is a sampling of some recent developments in inspection and testing equipment, including a vision system that offers high-end features at a reduced cost, a custom-designed inspection system with a reagent dispenser, and a material tester with an enhanced electronics package.


Machine vision system provides scalability, versatility

A stand-alone system is designed to simplify machine vision procedures on the factory floor. Visionscape Express, from RVSI Acuity CiMatrix, is suitable for inspection, assembly verification, gauging, and automatic identification applications. It supports two cameras in its standard configuration and can expand to four-camera operation. A variety of cameras and integrated imagers can be interfaced to combine cameras, lenses, and lighting in a single system. A frame grabber and a vision accelerator, both with an analog interface, and a vision accelerator with a digital camera interface are some of the optional accessories available. All configurations feature I/O capabilities including dedicated triggers and strobe outputs for available channels. Ten opto-isolated digital I/O ports are wired directly to terminals on the back of the system. For expanded capabilities, an optional external opto-isolated I/O board provides 24 digital I/O points and 8 analog outputs. A custom vision ASIC is designed to accelerate low-level vision algorithms for enhanced throughput. "Visionscape Express offers the power, flexibility, and scalability of a high-end system," says machine vision product manager Greg Hallerman. "It can adapt to demanding applications as inspection requirements grow."


Vision inspection systems are highly customizable

Omron Electronics' F160 integrates two cameras into a microprocessor-based system to reduce inspection time.

A machine vision sensor system combines dual cameras and high-speed processing to deliver faster capture and image processing speeds than traditional systems. Provided by Omron Electronics LLC, the system has two cameras with eight user-selectable shutter speeds and an interactive lighting interface. A variable box measurement for area and defect inspection ensures that the F160 system uses optimal measurement regions. The regions can be set to change automatically when performing inspections for objects of varying sizes, such as surface-mount components. Flash-RAM memory cards allow expansion of memory capacity to handle multiple product lines. The system's high-speed setting allows 5000-item-per-minute inspection. Character recognition software enables the F160 to recognize many types of characters, adapt to fluctuations in character shape and size, and discriminate between similar characters. Customization features include a selection of compact camera options, operating menus, and symbol and text colors.

Kuntz's Membrane Striation machine combines a vision inspection system with a reagent dispenser.

While the F160 has many customization options, the Membrane Striation machine from Kuntz Mfg. Co., Inc., is a completely custom-made vision inspection system. Designed for use with rapid diagnostic test kits, this system also features a reagent dispenser and is capable of inspecting and reject marking up to 100 lines, which are dispensed simultaneously and continually at a rate of approximately 20 ft/min. It is a reel-to-reel system that offers integrated drying as well as in-line inspection of line presence, quality, line-to-line distance, and positioning on the membrane. The system can also inspect lamination placement and assemblies. An internal camera takes overlapping shots of the moving web; these images are instantaneously compared with predefined inspection tools and, if not satisfactory, are marked downstream. "Integrating vision inspection with automated systems helps guarantee that no bad parts are allowed to continue through the manufacturing process," says sales and marketing manager Anita Jul Brown. "Vision inspection features are suitable for any type of medical dispensing application in which parts need to be held within critical reference points."

The nonspray dispense method creates crisp lines that can be placed closely together. A built-in light meter measures light degradation, allowing the camera to compensate for basic light deviations. Preferred methods of reject marking used with medical devices, including disposable felt pen marking, laser marking, and ink-jet marking, can be employed on the system. On web machines, speeds of 25 m/min can be achieved, and speeds of 800 parts per minute are reached on assembly machines. The type of reagents used depends on the type of diagnostic test that is being created.


Testers suitable for a variety of biomaterials, polymers, and gels

Mach-1 material testers from Biosyntech Canada offer different models for a range of testing requirements.

Designed to test the mechanical and electrical properties of a variety of materials, a line of testers provides micromechanical evaluation and in vitro simulations. The Mach-1 systems from Biosyntech Canada Inc. can test biomaterials and biological tissues, pharmaceuticals, and a range of polymers and gels including adhesives, elastomers, films, foams, hydrogels, latex, pastes, and sponges. The A Class systems provide precision measurement, force, and displacement control for small and soft samples, and can perform tension, compression, dynamic, static, and creep testing. Class V systems are versatile, upgradable, and designed for multiaxis testing including compression, tension, shear, and torsion testing. E Class systems offer low force and static testing in compression. Intended for testing in controlled environmental applications, the Mach-1 systems are suitable for long-term living specimen studies of gels, cell cultures, and tissues. Contract testing services are also available.


Upgraded electronics package boosts performance of material testing platform

Material testing systems with an upgraded electronics package from Instron Corp. enable accurate data capture of events that happen quickly, such as the insertion of a needle.

A system suited for testing metals, biomaterials, microelectronics, adhesives, and composites incorporates an enhanced electronics package that permits accelerated performance and accurate data capture in applications with rapidly changing loads. The 5800-series material testers were introduced by Instron Corp. at the recent Medical Design & Manufacturing (MD&M) Exposition in Minneapolis.

"The system has a 5-kHz data acquisition rate and expanded bandwidth compared with previous systems," notes product manager Jim Ritchey. "It allows you to capture data on events that happen extremely quickly, such as the insertion of a needle, or where there are rapid changes in load, as in peel-tear tests." Ritchey also cites the system's open architecture as a key benefit. "We have a broad array of software available, but it doesn't cover every conceivable test. The open architecture enables the user to perform nonstandard applications," he explains.

The 5800-series load frames are available in floor, table, and single-column configurations; optional material testing accessories include extensometry devices, high-temperature furnaces, environmental chambers, load cells, grips, and fixtures. Optional applications software includes the Merlin suite for static and cyclic tests and the FastTrack suite for fracture toughness and simulation procedures. The system's versatility and adaptability to changing requirements give it an edge in the marketplace, according to Ritchey.


Leak detectors capable of finding microscopic defects

A custom-manufactured leak-detection system is tested, calibrated, and certified in an FDA-registered design lab. The IntelliScan MT-160 from I.C. Technologies Inc. can locate and display microscopic pinholes, pores, cracks, and fissures in deep-drawn foil, lidding foil, PVC, and other nontransparent lid and base materials. Each defect's relative position is displayed in real time on the front panel. The system features a noncontact design that allows full-speed scanning of whole surfaces at industry-level resolutions. It can find defects as small as 10 µm at speeds of more than 100 in./sec. Several outputs allow quick reaction to and rejection of the package or material. The triple-microprocessor design incorporates a 48-point internal self-monitoring circuitry and microprocessor program. Capable of inspecting different types of packaging including filled sealed pouches, cups, trays, and bottles, a leak tester with easy-to-change tooling can handle a variety of materials. Supplied by Packaging Technologies & Inspection LLC, the 225 machine is a turnkey system offering simplified inspection. Suitable for flexible and rigid containers and packages, it performs nondestructive testing at sensitivities down to <25 µm. An operator interface touch screen is used for data collection. A self-teach feature reduces setup and operator training time by automatically setting the reject, pressure, and testing criteria from the initial test samples, with minimal input by the operator. Reject values are fine-tuned and automatically adjusted. The testing procedure involves enclosing the product in a customized cavity, monitoring fill time and absolute vacuum, measuring the differential vacuum change, and comparing the results to learned reject criteria. A vacuum decay testing system has microcomponents that offer increased sensitivity.


Leak testers feature ISO 9000-certified parts

A series of leak testers, which are suitable for elastic or rigid devices, allows easy programming of operating conditions. The P-Test series testers from Tecnoideal s.r.l. have resolutions of 1 mmHg or 1 mm H20, depending on the model. Components used in the systems are either approved by a notified body or supplied by an ISO 9000-certified firm. The P-Test series is intended for air pressure decay leak testing of medical devices such as blood lines, infusion and transfusion sets, bags, filters, oxygenators, heat exchangers, reservoirs, stopcocks, and related products. The hardware has been redesigned to prevent damage caused by short circuits or power surges. Flash EPROM programming improves project management and offers a variety of programming options. A pneumatic circuit is designed to withstand hundreds of thousands of test cycles. The testers can be used on production lines as well as in quality assurance and R&D departments.

Katherine Sweeny

Copyright ©2002 Medical Product Manufacturing News

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