Medical Device Package Certification Testing

Medical Device Package Integrity Testing

Throughout distribution, a package can experience high amounts of humidity or extremely high temperatures. These conditions may warp or collapse a package when conditions are not ideal. Keystone Compliance has experience with cold chain packaging and can perform conditioning tests to see how well a package will function under certain environments.

Keystone provides comprehensive reports shortly after the completion of the testing. Additionally, our proven process helps avoid product launch delays. When packages do not meet the requirements, we assist with finding solutions.

Request a quote to learn why we are one of the fastest-growing package test labs in the country. Have a question about medical device integrity testing? Contact us and we will determine the best course of action.

Summary of Package Testing For Medical Devices

In addition to the EMC and environmental testing that Medical Devices must undergo, they should also be tested for transportation safety. These medical devices are often expensive and fragile. It is imperative that they reach their destination safely. In many cases, the medical devices are sterile.

With tests designed specifically for sterilization and general transportation safety, Keystone can help ensure devices reach their destination to provide the lifesaving purposes for which they were designed.

For medical devices, package validation testing is outlined in ISO 11607. The test consists of seal integrity (seal strength), material integrity (bubble leak), distribution testing, and package aging.

Why is Medical Device Package Testing Important?

From manufacturer to end-user hospital, doctor’s office, patient, etc.- a medical device will undergo stress throughout the distribution process. Package testing will test the ability of a package to withstand the predictable stresses that it will encounter throughout distribution.

Often, medical device packaging is designed to maintain sterility. Breach of sterility can result in returns, replacement costs, and loss of customer trust.

In some cases, medical devices may require a packaging system that will maintain its integrity when exposed to extreme environmental conditions.

Fortunately, Keystone can help prevent the loss of package integrity by simulating the predictable stresses. The simulated stresses mimic some of the things that can be expected such as temperature changes and rough handling.

Common Medical Device Package Testing Types

Accelerated Aging

Like real-time aging, accelerated aging is used to demonstrate the integrity and sterility of packaged products stored over time. However, environmental conditions are expedited at a much faster rate.

For more information on accelerated aging testing, please visit the links below:

Bubble Leak / Dye Penetration

The purpose of dye penetration package compliance testing is to detect gross leaks in packaging.

Regarding sterilization of the medical device, one of the most common test standards is ASTM F2096. ASTM F2096 is also known as the Bubble Test. This test measures the material integrity of the package. It is performed by submerging the package under water and increasing the internal pressure of the package.

Cold Chain

Cold chain performance testing is used to measure the effects of temperature and humidity on packages. ISTA 7D shipping tests can be used for the development of temperature-controlled transport packages made of any material. IEC 60601 applies to medical equipment in the home healthcare system

For more information on cold chain package testing, please follow the link below:

Seal Strength

Seal strength testing evaluates the strength of seals in flexible barrier materials. This type of testing pertains to opening force and package integrity. Not only does seal integrity testing cover the strength of seals but it evaluates the manufacturer’s packaging process. Lastly, flexible barrier testing also evaluates a manufacturer’s ability to produce consistent seals.

ASTM F88 measures the force required to separate a test strip of material containing the seal.

Sterile Barrier

The sterile barrier system shelf life is defined as the amount of real-time that a sterile barrier system can be expected to remain in storage under ambient conditions. When designing packaging for medical devices, storage conditions, expiry date, and intended use are important in identifying the compliance of sterile barrier systems.

ASTM F1980 evaluates accelerated aging protocols to determine the effects due to the passage of time on the sterile integrity of the sterile barrier system.

Expert Medical Device Package Test Lab

Companies partner with Keystone Compliance for package testing because of our high-quality work. We take pride in being a full-service testing laboratory that delivers accurate testing and reports in a timely fashion. Our customers appreciate the transparency and experience that we bring to every test.

The standards listed below are most commonly used for medical devices to ensure safety and sterilization throughout the distribution process. If you are looking for specific testing, please do not hesitate to contact us or request a quote