Medical Device Packaging Testing | Eagle Flexible Packaging

Medical Device Packaging Testing

When a medical device arrives at its final destination, medical professionals are often eager to put it to good use on behalf of their patients. While the packaging that a medical device was shipped in is usually quickly discarded, it is important to take note of the critical role that these specialized products play in the process of delivering vital equipment to the healthcare industry.

Because medical device packaging is so important in the effort to safeguard sensitive equipment, packaging manufacturers must continually put their products through a series of stringent medical device packaging testing to ensure quality.

Medical Device Packaging Materials

Medical device packaging is made from many different types of materials, including:

  • Plastic
  • Adhesives & Coatings
  • Paper
  • Aluminum
  • Inks
  • Tyvek®

All of these production sources must meet stringent quality and performance guidelines before being used in the manufacturing process.

Medical Device Packaging Testing Processes

Packaging Integrity Testing

In order for medical device packaging to function as it should, the industry has developed a number of critical tests to ensure consistent product quality. Here are some of the most widely used testing methods.

Bubble Leak Testing

This process requires the tester to visually look for bubbles while a sterile barrier system is put under pressure and submerged under water.

Burst Testing

Burst testing involves the pressurization of a packaging product until it bursts. This testing method will reveal packaging pressure limits, as well as a visual confirmation of where a seal failure occurred.

Dye Penetration Testing

This form of testing injects dye into a sealed, non-porous packaging product in order to monitor if any capillary movement of dye takes place. A visual inspection can determine any defects.

Tensile Testing

Tensile testing evaluates the durability of seals within flexible barrier materials. This test can help determine both the consistency of the seal, as well as the packaging product’s opening force.

Abrasion & Rub Testing

This test is designed to determine the resistance of printed surfaces against scuffing or rubbing. Evaluating this data can help packaging products hold up more effectively during shipment and storage.

Microbial Barrier Testing

It is critically important that medical devices remain sterile before being used. Microbial barrier testing evaluates a packaging’s ability to block bacteria from reaching a medical device.


Maintaining the sterility and integrity of medical devices is a top priority. The medical device packaging industry is dedicated to continually improving the manufacturing process to ensure that specialized equipment remains safe to use for healthcare workers and patients.

Eagle Flexible Packaging is proud of the reputation we have earned in the industry for taking the time to get to know our customers’ unique business needs, so we can create tailor fit packaging solutions for each one. Contact us today to learn more about why so many medical device manufacturers have chosen us to be their trusted partner.