Medical Device Link.

Originally Published EMDM March/April 2003

Product Update

Suppliers innovate to meet the evolving needs of device OEMs

Manufacturers shopping for testing equipment have a familiar mantra. They want products that are affordable and flexible, and that don’t require a graduate degree to operate. The good news is that suppliers often can meet these customer demands.

The declining cost of computer hardware and electronics has had a trickle-down effect on many testing devices. Even highly sophisticated instruments that used to be limited to multinationals with deep pockets are beginning to find a home on the shop floors of small and midsized companies. Tumbling costs, it should be noted, have not affected the capability of instruments to perform ever-more-exacting tasks. And many suppliers are gearing their efforts to the development of easy-to-use products that combine multiple functions in a portable system.

Test-A-Pack Systems (Orchard Park, NY, USA) has developed a unit that performs a suite of leak and seal-strength tests on packaging. A Windows-based user interface and other features make the device so easy to use that an inexperienced operator can have it up and running in 10 minutes, according to the firm.

Flexibility is a key feature of benchtop pH, conductivity, and ion meters designed by Mettler Toledo Inc. (Greifensee, Switzerland). Expansion units can be added to the modular devices as a company’s needs evolve. Built-in self-diagnostics simplify troubleshooting.

Instron (Canton, MA, USA) recently introduced a substantially redesigned line of testers that measure tension, compression, texture, and flexure. The In-Spec 2200 II series, available in benchtop and handheld models, features an integrated PDA that interfaces with a laptop computer. Hundreds of stored calculations can be accessed.

These and several other products are described in this section. If your sourcing activities require a broader range of options, go to our on-line European Suppliers Directory at www.devicelink.com. More than 200 companies can be searched based on a range of product and service categories.

Niom Laboratory

A laboratory holds an ISO 17025 accreditation for the testing of Class IIa medical devices used in dentistry. Niom Laboratory (Haslum, Norway) performs mechanical and chemical testing of alloy materials for fixed and removable dental prosthetics, resin-based filling materials, and light-cured and water-based cements. The laboratory offers accredited test methods for cytotoxicity and can conduct in vitro tests for mucosal irritation. Test results can be used in product development as preclinical documentation and for batch control. 

Clinical testing of dental materials is conducted according to international standards and regulations. Assignments typically include design of the test protocol, collaboration with public and private clinics that carry out the clinical procedures, evaluation of results, and drawing up preliminary and final reports. 

Mettler Toledo Inc.

Benchtop pH, conductivity, and ion meters are designed to deliver accurate and reliable results in a variety of laboratory settings. SevenMulti and SevenEasy meters from Mettler Toledo Inc. (Greifensee, Switzerland) include a robust electrode support arm that can stand alone or connect to the meter in two positions. The arm can be rotated 360º, while the holder will stay horizontal at all heights. The advanced SevenMulti meter features an innovative modular design. Expansion units include pH, conductivity, ion, mV, ORP, and ISFET. Other features include high and low alarms, data logging, a screen saver to maximize display lifetime, and RS-232 interface for data transfer to a printer or computer. “The SevenMulti meters have built-in self-diagnostics that simplify troubleshooting, and the advanced series can be upgraded to dual-channel units with durable plug-in expansion units,” says market manager Rhonda Hicks. “The flexibility of the modules will allow the meters to grow with a company’s changing needs.”

Mettler Toledo has also launched two new mass comparators that deliver mass weight measurements in laboratory environments. Mass comparators or comparator balances determine the mass of weights or samples to a very high degree of accuracy. According to the company, the AX206 and the AX2005 are the first manual mass comparators on the global market capable of determining the mass of an object of up to 200 g with a 1-µg resolution and the mass of a 2-kg object with a 10-µg resolution.

This new technology offers simple touch screen operation as well as measurement accuracy. “With state-of-the-art technology and easy touch screen operation, these comparators can be configured with great precision to suit the personal needs of each individual tester,” explains Charlie Francis, laboratory business area market manager for the supplier. 

Test-A-Pack Systems

A package-testing system can perform a complete range of leak and seal-strength testing from a single setup. The 2800-series unit from Test-A-Pack Systems (Orchard Park, NY, USA) integrates mass- flow, pressure decay, burst, creep, and creep-to-burst tests in a single system to detect channel or pinhole defects and show compliance with relevant standards. The tester communicates with a standard PC via a Windows-based user interface to simplify setup, testing, and data recording. The software is menu driven and prompts the operator through setup and testing. 

“A new unit can be up and running within 10 minutes of opening the box,” says Ken Haas, product line manager for Test-A-Pack Systems. “It takes only minutes for a new user to learn the system and reliably run test after test. Changing package types is just a matter of pushing a few buttons.” The 2800- series tester is designed for compatibility with international power standards and is CE compliant. 

Bacharach Europe Ltd.

A manufacturer of infrared gas-detection equipment has developed two portable instruments that simplify the measurement of medical gases. The Medigas FP99 from Bacharach Europe Ltd. (Leamington Spa, Warks, UK) is a lightweight, battery-operated analyzer that complies with ISO 7396 and HTM 2022 requirements. This handheld instrument is easy to operate, featuring user-friendly screen prompts and data storage with ID coding and a time-and-date-stamp function. An internal pump performs purging and ambient-air testing. The unit has storage capacity for other measured parameters such as dew point, particulars, vacuum, and pressure, and it incorporates nitrous oxide, oxygen, and carbon dioxide measurement capabilities. 

The Medigas PM 3010 is a handheld infrared instrument that monitors occupational exposure to anaesthetic gases. Compact and lightweight, it measures levels of nitrous dioxide in the range of 0–1000 ppm with a resolution of 5 ppm. Readings can be displayed in real time or as an 8-hour time-weighted average. Data can be stored manually or automatically depending on user requirements. 

ASM Automation Sensorik Messtechnik GmbH

A bench-type leak tester is targeted for embedded test lines. The 3156 Leak Current HiTester from ASM Automation Sensorik Messtechnic GmbH (Moosinning, Germany) is equipped with a terminal board and breaker on the front panel, allowing test equipment to be easily connected to it even when the tester is rack mounted. The 3156 can be easily adapted for automated testing. It can also store and recall up to 30 sets of test conditions. 

The unit features a matrix touch panel display and an automated test mode that can automatically switch the device status and power supply polarity while conducting tests. The unit can store test results for up to 100 devices and allows direct access to all data, which can be easily downloaded to a PC or printed using an optional printer. 

QuadTech Inc.

A safety tester is capable of performing all the electrical safety tests routinely required in the production of electronic medical products. Available from QuadTech Inc. (Maynard, MA, USA), the Guardian 6100 can perform up to nine critical electrical safety tests in sequence. It enables the stringent safety testing required of medical products to be performed quickly and easily. 

The unit is easily programmed from the front- panel keypad or remotely via an IEEE-488 or optional RS-232 interface. The unit’s internal memory can store up to 99 test setups, of up to 99 steps each. Its “pause” feature allows testing to be temporarily halted if other operations need to be performed during a test sequence. Test results are indicated on the front-panel display. The 6100 also offers password-protected front-panel lockout to prevent an operator from inadvertently altering test conditions.

Nelson Laboratories Inc. 

An isolator unit for product sterility testing protects test articles from contamination and false positives by eliminating direct contact between the analyst and the test sample. Supplied by Nelson Laboratories Inc. (Salt Lake City, UT, USA), the unit is suitable for small medical devices and pharmaceutical products, especially prefilled syringes and aseptically filled products. 

The stainless-steel isolator uses a Steris VHP 1000 biodecontamination system. Each product must meet a qualification test to validate the ability of the exterior barrier to keep the VHP sterilant from penetrating the interior test article. Following successful validation, products can be tested for sterility in the isolator using either closed membrane filtration or direct transfer methods. The decontamination system allows rapid sterilization at a low temperature. 

Nelson Laboratories is US FDA registered and certified to ISO 9001:2000 and ISO 17025. It offers more than 400 microbiological and analytical test services including microbiology, sterilization validation, package tests, and routine lot release tests. 

Nebraska Center for Excellence in Electronics

An independent nonprofit testing and training organization offers its services to customers in the United States, Europe, and Asia. The Nebraska Center for Excellence in Electronics (NCEE; Lincoln, NE, USA) assists companies in getting precompliance and compliance tests done quickly. NCEE has a fully automated 10-m semianechoic EMC chamber and more than 15,000 sq ft of lab space. Capabilities include CE and US FCC compliance consulting, as well as testing for product safety, vibration, temperature, shock, and humidity. 

Instron

A provider of testing equipment has introduced a redesigned series of portable testers. The In-Spec 2200 II testers from Instron (Canton, MA, USA) are available in handheld and benchtop versions and are suitable for a variety of testing applications including tension, compression, texture, and flexure. They can be transported to various sites to perform spot testing and can identify manufacturing defects quickly. 

Featuring a linear drive system and precision force measurement, the versatile portable testers are specially designed for quality assurance and product development applications. To ensure the highest level of accuracy and repeatability, they are equipped with a unique internal drive system that eliminates operator and loading technique variability. 

The testers feature an integrated colour PDA to input control parameters and display results. The instruments can also be interfaced with a laptop to add hundreds of stored calculations and real-time graphics. 

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