What Goes Into Medical Device Package Integrity Testing?

Medical Device Package Integrity Testing

Medical device package integrity testing involves critical evaluations to ensure the safety and sterility of packaged products. These tests focus on seal integrity and the packaging’s ability to protect medical devices. Key aspects include assessing the strength and resilience of the packaging.

In these tests, various aspects of the packaging are scrutinized, including its ability to withstand pressure, resist tears, and prevent leaks. This is especially vital for flexible packages, which must maintain seal integrity despite their pliability.

This blog will guide you through the essentials of medical device package integrity testing. You’ll learn more about what it is, the compliance standards involved, and how to conduct package validation tests.


What is Medical Device Package Integrity Testing?

Medical device package integrity testing is a process that checks if a device’s packaging protects its contents from contamination and damage. The main purpose of these tests is to protect patient safety.

Secure packaging prevents health risks associated with contaminated or damaged devices. It may also increase the device’s shelf life depending on the nature of its material.

Organizations like the U.S. Food and Drug Administration (FDA) and international standards like ISO 11607 set package integrity testing standards.

FDA requirements for package integrity testing include testing for durability during transport and storage, ensuring the sterility barrier system is effective, and verifying that all medical packaging is non-toxic and non-reactive with the device.

ISO 11607 package integrity testing is divided into 2 parts.

  • ISO 11607-1 focuses on the requirements for the development and validation of packaging for terminally sterilized medical devices. It includes criteria for materials, design, and manufacturing processes.
  • ISO 11607-2 deals with the validation requirements for forming, sealing, and assembly processes of the packaging. It requires manufacturers to establish and maintain documented procedures for these processes.


How to Conduct Medical Device Package Testing

The method of conducting medical device package testing varies based on the type of test being performed. Different tests have unique procedures and purposes tailored to assess various aspects of the packaging integrity. You likely will need to perform more than one test for your device’s package.

Here are the different types of package testing processes and their purposes.


Test Purpose
Visual Inspection To check for defects visually, like tears or holes
Dye Penetration To detect leaks by observing dye penetration
Bubble Emission To identify leaks by observing bubble formation
Vacuum Decay To detect leaks through changes in vacuum level
Pressure Decay To identify leaks by measuring pressure changes
Burst Testing To test the strength of seals under pressure
Seal Strength Testing (Peel Test) To measure the force needed to break a package seal
Whole Package Integrity Testing To assess the integrity of the entire package


Since these tests have different goals,, your team will need to use a different test method to meet each goal. Here are the steps to follow for each process.


Visual Inspection

Prepare a well-lit area and use magnifying tools if necessary to ensure a thorough inspection. The equipment should allow detailed examination of the entire package.Then, examine the entire surface of the package, focusing on seal edges, corners, and areas prone to stress. Look for any physical defects like tears, holes, or irregularities in the seal.


Dye Penetration

Mix a contrasting dye solution, ensuring it’s compatible with the package material and visible against it. However, the dye should not chemically react to the package material. Apply the dye along the seal edges and wait for the recommended time. Then, inspect the package for dye penetration that may indicate seal breaches.


Bubble Emission

Fully submerge the package in a water-filled tank of controlled temperature. Ensure the package is visible and the water level is appropriate. Inject air into the package while it is submerged. Watch for bubbles escaping from the package. If present, they indicate the presence of leaks.


Learn More About The Tests You Need to Do


Vacuum Decay

Place the package in a vacuum decay test chamber. Ensure the chamber is properly sealed and the package is positioned correctly. Create a vacuum inside the chamber and monitor for any changes in vacuum level over time. A drop in vacuum indicates potential leaks.


Pressure Decay

Put the package in a pressure decay chamber, ensuring a proper seal and stable positioning. Apply pressure inside the chamber and monitor for pressure drops, which can reveal leaks in the packaging.


Burst Testing

Gradually increase the internal pressure of the package using controlled equipment. Ensure the pressure increase rate is consistent. Observe the point at which the package seal bursts. Record the pressure at this point, as it indicates the seal’s strength. You may have to place a warning label indicating this pressure point.


Seal Strength Testing (Peel Test)

Set up a peel test machine with the correct specifications for the package material and seal type. Attach the package to the peel test machine. Peel the seal at a consistent rate and measure the force required to break the seal.


Whole Package Integrity Testing

Whole package integrity testing evaluates the overall strength and resilience of the entire packaging system. This includes assessing the packaging’s ability to withstand environmental conditions like humidity, temperature fluctuations, and physical impacts during handling and transportation.

Whole package integrity testing must verify the packaging’s performance under conditions that mimic its journey from manufacture to end-use.This will ensure that the package can reliably protect the medical device throughout its lifecycle.


Need Expert Assistance With Your Medical Device Packaging Tests?

Like medical device testing itself, medical device package testing can be a very delicate process. Ensuring that your packaging meets compliance requirements and maintains the device’s integrity prior to use cannot be performed lightly.

Vantage MedTech’s medical device testing services extend to your device’s packaging. Our team will help you ensure that your packages follow compliance and withstand transportation. We have extensive experience helping manufacturers prepare their devices for international sale, so you can count on us to consider international shipping in our seal integrity tests.

Reach out to us today to get started.

Need help with your medical device?

Let Vantage MedTech show how to bring your idea from concept to prototype to FDA/CE approval with a free custom project analysis.