Medical Device And Package Testing Area Expansion

SAN JOSE (August 29, 2012) – Test-O-Pac Industries Inc. has recently invested $200,000 towards the expansion of their medical device and package testing capabilities by adding a 3000 sq. ft area  dedicated to a class 1000 clean room. To support their current customers and our growing demand in medical device and package testing, Test-O-Pac has dedicated a fully equipped room for a variety of tests including:  Accelerated Aging and Real Time Aging Tests (ASTM F 1980), Tensile Strength Testing (ASTM F88/F88M), Gross Leak Test, Dye Penetration (ASTM F 1929), and other test methods to verify the integrity of the sterile barrier in medical device and package testing.

The Accelerated Aging Test of sterile medical device packages allows one to determine an expiration date and shelf life of packaged medical devices. The effects due to the passage of time, environmental factors affecting the sterile integrity of packages, and the physical properties of component packaging materials are all determined. Real Time Aging tests are also performed to confirm the Accelerated Aging Test results.

A reliable way of determining how different processes can affect the performance of your final product is Tensile Strength Testing. The Tensile Strength Test is a test method that measures the strength of seals in flexible barrier materials. Seal strength is a quantitative measure used in the process of validation, process control, and capability. It is relevant to opening force, packaging integrity and the packaging processes’ ability to produce consistent seals.

Other tests that verify seal strength include the Bubble Test (ASTM F 2096), the Dye Penetration Test, and the Burst Test (ASTM F2054). The Internal Pressurization Test method, alternately known as the Bubble Test, provides a practical way to examine packaged medical devices for gross leaks, which may determine the product to be non-sterile. The Dye Penetration Test is used to detect seal leaks in porous medical packages. This procedure is only applicable to individual leaks in a package seal. The Burst Test uses internal air pressurization within restraining plates to quickly evaluate package seal strength during the manufacturing process. This method provides an indicator of the burst strength of a package, which is important to the package manufacturer and end user in ensuring adequate package integrity.

Test-O-Pac Industries, Inc. is an environmental and package testing laboratory that offers the entire spectrum of value added testing services to a wide range of clients since 1977. Managed essentially as an independent testing laboratory, their goal is to "Serve our customers by providing the climatic, dynamic and mechanical stimuli necessary to exercise their products, be it components, modules or entire systems." Due to the ever changing requirements of customers, their focus has shifted towards medical device and package testing, which is why their expansion was made. The Engineers pride themselves in their ability to respond to the variety of customer needs. To find out more, please visit www.testopac.com.

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