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Testing & Inspection: Wireless data logger

Originally Published MPMN June 2005

SPOTLIGHT

Testing & Inspection

Wireless data logger

A wireless data logger measures and monitors temperature from 32° to 300°F and pressure from 0.40 to 300 psi. The PicoVACQ PT has dimensions of 0.6 in. in diam and 1.4 in. in height, and can be placed inside a product or directly in sterilizers, pouches, bottles, or any other type of packaging. The unit can record up to four measurements per second and start recording either from a temperature threshold or a time. The device is suitable for obtaining reports of thermal validation or control, testing equipment, and verifying sterilizers. TMI USA, Dulles, VA www.tmigi.com



Laboratory services

A company’s services include more than 400 microbiological and analytical tests. Specialties include microbiology tests, sterilization validation, lot-release tests, biocompatibility tests, organism identification, and filter validation. Within a 62,000-sq-ft facility, 80 laboratories are maintained as well as a custom-built 3000-sq-ft sterility testing cleanroom suite. Nelson Laboratories, Salt Lake City, UT www.nelsonlabs.com


Chemical and microbiological analysis

Chemical and microbiological analytical services are offered by a company with a large laboratory capacity, extensive technical expertise and experience, and a multiple-shift staff. Services include drug substance and drug product stability testing, commercial product release testing, stability storage testing, plastic and glass container testing, and analytical method development and validation. Lancaster Laboratories, Lancaster, PA
www.lancasterlabs.com


Thermal imaging service

Hourly thermal imaging is available as part of a company’s yield improvement services. Thermal imaging is a noncontact method for measuring temperature. Many parts can be in one scene, even those in motion. More than 1 million temperature measurements can be taken each second at 0.1°C sensitivity. The technique is a fast way to find the root cause of defects in drying, bonding, lasing, dipping, molding, and other temperature-sensitive processes. The service requires no change to existing production protocols. Elastic Design LLC, San Bruno, CA www.elasticdesign.biz


Luer testing

Testing of luer products is performed according to ISO 594, EN 1707, and ISO 10555 standards. Physical tests include gauging, ease of assembly, unscrewing torque, overriding torque, air and liquid leakage, separation force, and stress cracking. Melab GmbH, Leonberg, Germany www.melab.de


Troubleshooting tool

A stand-alone troubleshooting tool is designed for control system testing and maintenance. Suitable for use in medical product manufacturing, the Crakker enables evaluation of programmable logic controllers, relay logic, and document control systems. The unit records timing, transitions, and status of up to 16 input and output points in real-time speeds, without altering or reprogramming a validated system. Logic Beach Inc., La Mesa, CA www.crakker.com


Performance and safety testing

A comprehensive range of performance and safety testing services are available. The company’s capabilities include chemical and physical testing to ensure biocompatibility and material characterization. Fast turnaround and complete confidentiality are ensured. Akron Rubber Development Laboratory Inc., Akron, OH www.ardl.com


Safety testing

A company tests finished devices, components, or raw materials to determine their safety. A customized master specification is offered in order to develop the most accurate test method for a product. Tests include bioburden analyses such as aerobic, anaerobic, and spore former assays. Cleanroom certifications are also available, as well EtO residual analysis to ensure monitoring compliance in accordance with many standards. On-site environmental monitoring determines the efficacy of air filtration systems and the impact on medical devices in the manufacturing process. Dynatec Scientific Laboratory, El Paso, TX www.dynatec-labs.com


Low-force dynamic test systems

A family of dynamic mechanical test systems features a 20-kHz servocontroller capable of single- or multiple-axis control and data acquisition for material, component, and device tests. The Dyna-Myte units expand the bandwidth of mechanical-properties testing beyond the firm’s 100Q and 100R tensile, tear, compression, and peel testers to include fatigue, cyclic, and dynamic-properties tests. Systems are configured from a wide range of dynamic actuators from 50 to 3000 N, with travel from 12 to 300 mm, and include load cells and strain sensors, LVDTs, and encoders to measure and control mechanical stress and strain at frequencies to 100 Hz. Test Resources Inc., Shakopee, MN www.testresources.com

Copyright ©2005 Medical Product Manufacturing News

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