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 been supporting thousands of Medical Device customers to 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. If you need a protocol to outline testing, our Engineering Services team is happy to help. Testing will follow the general guidelines of ISO 11607; many tests are outlined below.

To get a medical device to market, 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.  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.

Accelerated Aging

Accelerated Aging

Accelerated Aging - oftentimes referred to as Accelerated Shelf Life Testing - is commonly used in the medical device industry to accelerate the effects of time on a Sterile Barrier System to establish Shelf Life parameters. The Accelerated Aging process is based on the relationship of temperature and material reaction rate.
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Real Time Aging

Real Time Aging

Real Time Aging - oftentimes referred to as Shelf Life Testing - is exactly what the name implies. This testing is conducted at ambient conditions in actual real time in order to analyze the conditions of packages and/or products and the effects that time has on them. Real Time Aging studies can be performed to confirm the results of Accelerated Aging on test samples.
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Burst Testing

Burst Testing

The Burst Test internally pressurizes a package until the package "bursts" open in response to pressurization. This allows the test to have a higher probability of detecting the weakest area of the seal and provide a measurement of the pressure required to "burst" open the package.
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Seal Strength

Seal Strength

Peel/Tensile Testing is the process used to measure the force to pull apart two bonded surfaces. It is often used in the medical device industry to measure and quantify the strength of seals on medical pouched products as well as other sealed flexible packages. The purpose of the package strength testing procedures is baseline both pouch vendor and customer seals and later repeated to screen for undesirable changes negatively affecting the Sterile Barrier Systems (SBS) ability to maintain stability and the packaging system's ability to adequately protect the product. Note also that these are both quantitative tests.

The strength tests consist of the seal peel test according to ASTM F88 / F88M, and the burst test conducted according to ASTM F1140 / F1140M or ASTM F2054 / F2054M. Both are attempting to measure the strength and consistency of the seals on a pouch or tray containing a medical device, but have very different approaches. For the peel test, a 1 inch width section of the seal is pulled apart and the force of the seal strength is measured and plotted. In the burst test, the primary package is inflated with air pressure at a constant rate until the package fails or bursts. The fundamental purpose of both approaches is to prove the SBS hasn’t changed after sterilization, transit and storage.

Typical Procedures/Protocols

ASTM F88
ASTM F1140
ASTM F2054

Typical Sample Size

Typical sample sizes range from 30 to 60 samples.

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Gross Leak Detection / Bubble Test

Gross Leak Detection / Bubble Test

This test is conducted by submerging a lightly pressurized package under water to visually inspect for streams of bubbles that identify a leak or defect in both porous and non-porous packaging systems.
Read more about Gross Leak Detection / Bubble Test

Gross Leak Detection, or Bubble testing, is a widely used qualitative method of determining defects or gross leaks in sterile medical device packaging. This is the most common method used to determine the ability of a package to maintain a sterile barrier since it tests the entire Sterile Barrier System and not only the seal.

Dye Penetration Testing

Dye Penetration Testing

Dye Penetration Testing is an effective and widely used method of locating defects in pouch and tray seals. The test process places enough dye penetration solution into a package to create a 5mm deep well of dye along the seal’s inner edge. Defects and leaks in the seal area are observed by the test operator. Read more about Dye Penetration

Detecting leaks and defects in a Sterile Barrier System or primary package of a terminally sterilized medical device package can be challenging. When properly applied (within the guidelines of ISO 11607) leaks observed indicate a defect greater than 50 microns and would fail the criteria for a sterile barrier. This test is also useful as a second opinion or verification to leaks observed during Gross Leak Detection testing. Folds can often create a concentration of bubbles which may have been falsely determined as a failure.

Typical Procedures/Protocols
ASTM F1929

More Information
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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.

Many materials from which containers and packages are made, especially cellulosic materials, undergo changes in physical properties as the temperature and the relative humidity (RH) to which they are exposed are varied. Most plastic components change strength in direct proportion to changes in temperature.

Exposure is conducted via a dedicated environmental chamber designed to maintain tight controls over both temperature and humidity as well as the rates at which these quantities are changed. The test levels chosen and rates of change between these levels are documented in the customer’s protocol and encompass what might be encountered during the actual distribution cycle.

Typical Procedures/Protocols
ASTM D4332
IEC 60068-2
ISTA Series (all)
ISO 2233
MIL STD 810G

WESTPAK Capabilities

(65) Temperature and Humidity Chambers
(1) Thermal Shock Chamber
(4) Temperature and Altitude Chambers

Typical Sample Size

Typical sample sizes range from 30 to 60 samples.