Westpak, Inc., established in 1986, is a leading independent testing laboratory with facilities in San Jose and San Diego, California. Westpak’s laboratories are accredited to ISO/IEC 17025 by the American Association of Laboratory Accreditation (A2LA) for a wide variety of test procedures. Westpak is also ISO 14001 and 9001 Registered. Westpak specializes in product, reliability, distribution, packaging and related custom testing services for solar, technology, medical device, pharmaceutical and other industries. Westpak’s philosophy is "Integrity is the priceless ingredient in testing."
What is Medical Device Testing?
Medical Device Package Validation incorporates package performance testing, accelerated aging, material evaluation, and sterile integrity testing, following the guidelines of ISO 11607. Westpak provides product validation services for both first articles and production devices.
Available Medical Device Testing Services:
Medical Device Product Evaluation Services
Tensile Strength Testing, Compression/Bend Testing, Assembly Strength Testing, Shock, Vibration Testing, and Material Evaluation.
For more information on Medical Device Testing click here to download a PDF.
http://www.westpak.com/pdf/medical-device-testing.pdf
Customized Test Protocols
Depending on your needs we can assist in protocol development or provide a company specific document with a detailed test plan. Consult our experienced staff when you need answers about testing.
Package Performance Testing
Package performance testing simulates environmental hazards within a controlled laboratory environment. By performing these tests inside a laboratory, the inputs have a high degree of repeatability that yields accurate results with a high level of confidence. Environmental hazards include temperature, humidity, altitude, random vibration, impacts, compression, and others.
Sterile Package Integrity
Sterile Package Integrity testing can be conducted using several methods, such as Bubble Emission and Dye Penetration.These tests easily ascertain failures due to material fatigue or channel leaks within the seal of pouches or trays.
Seal Strength Testing
Peel and Burst Testing measure the strength of heat seals within flexible barrier and thermoform packaging materials. These tests are used to validate the heat-sealing process and to determine if the seals of postproduction package systems are within acceptable limits.
Accelerated Aging Studies
Accelerated Aging studies establish product shelf-life data in order to get products to market. Aging studies require verification from real-time storage testing. Call Westpak for assistance with identifying the correct duration, temperature, and humidity levels.
Altitude Testing
Many products can be sensitive to the reduced atmospheric pressure experienced at high altitudes. An altitude test identifies product sensitivity prior to shipment.