Medical Device

Medical device package validation incorporates package performance testing, accelerated aging and sterile integrity testing following the guidelines of ISO 11607. The repeatable testing available in a controlled laboratory lends to a high degree of confidence in patient safety.

Westpak has partnered with Medical Device customers to help get their products to market for over 30 years; we understand the steps needed to get there. We begin by collaborating with you on the product and package specifics, distribution environment, end-user, and any specific challenges.

A medical device manufacturer must follow the guidelines laid out in ISO 11607-1 and -2. Whether your company has a predetermined protocol, or you need one written, Westpak is here to help. We can assist in protocol development or provide a company-specific document containing a detailed, customized test plan.

Distribution Testing

Distribution Testing

Distribution Testing is the practice of conducting tests that simulate the distribution environment in a laboratory. Laboratory testing provides a controlled and repeatable setting whereby the ability of products and shipping units to withstand the distribution environment can be determined. Read more about Distribution Testing

Temperature and Humidity Testing

Temperature and Humidity Testing

Environmental Conditioning is a process of subjecting a test specimen to various temperature and humidity conditions in order to determine the effect of these conditions on the test specimen. Conducting conditioning in a chamber allows for tight controls over the inputs. Environmental conditioning subjects package systems to temperature and humidity conditions expected in the distribution environment. Conditioning is commonly conducted prior to distribution package performance testing. Read more about Temperature and Humidity Testing

Accelerated Aging

Accelerated Aging

Accelerated Aging - oftentimes referred to as Accelerated Shelf Life Testing - is a simulation technique that generates data quickly. It can be useful when actual product lifespan data is unavailable. A new product can be released to market based upon submission of successful Accelerated Aging results of its product/package to the regulatory body. Simulation is achieved by varying temperature; increased temperature results in an increased reaction rate.
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Real Time Aging

Real Time Aging

Real-Time Aging - frequently referred to as Shelf-Life Testing - is just what the name implies. Testing is performed at ambient conditions to provide the best data available to determine Shelf Life and the effects of aging on test samples. For medical device products, Real-Time Aging studies are performed to confirm the results of Accelerated Aging.
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Gross Leak Detection / Bubble Test

Gross Leak Detection / Bubble Test

To conduct a Gross Leak or Bubble Test, the test operator submerges a slightly pressurized package underwater and watches for bubble streams indicating a failure. Fails can include pinholes, substrate holes or channels in the package seal. The industry-standard test can be used for both porous and non-porous packages.
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Seal Strength / Peel Test

Seal Strength / Peel Test

Seal Strength testing, also known as the Peel Test, measures the ability of a package seal to resist separation. This packaging test is performed on carefully prepared samples by use of a universal testing machine in tensile operation, and specialized tooling. Read more about Seal Strength / Peel Test

Dye Penetration Testing

Dye Penetration Testing

A Die Penetration test is used to evaluate the integrity of the package by looking for channel leaks in the seal. To conduct the test, a trained operator injects a small amount of penetrating dye solution into the package, followed by rotating it, allowing the dye to flow along the edge seal. The operator has just a few seconds to make observations. Read more about Dye Penetration Testing

Burst Testing

Burst Testing

The Burst Test's purpose is to determine the pressure at which the package seal ruptures. It is performed by slowly injecting air into the package until the package bursts open, hopefully along the seal.
Read more about Burst Testing