Gamma Irradiation Sterilization for Medical Packaging

2026/03/19 7:36 pm

According to the Association for the Advancement of Medical Instrumentation (AAMI) TIR17:2017, medical device packaging must support effective gamma irradiation sterilization while maintaining product safety and sterility throughout its lifecycle.

To meet these requirements, medical device packaging materials should:

• Allow sterilization: Enable sterilants to penetrate the package so all device surfaces are properly sterilized.
• Allow sterilant removal: Permit sterilants to exit the package to prevent harmful residues from remaining on the device.
• Maintain sterility over time: Preserve the integrity of the sterile barrier during storage, shipping, and throughout the product’s shelf life.

Key Medical Device Packaging Properties

Breathability
For gas sterilization processes, packaging must allow sterilant gases to enter and exit while still preventing microorganisms from penetrating the package. Proper breathability also helps balance pressure changes during sterilization and protects seal integrity.

Packaging Density
The way products are packaged—such as the number of items per pouch or cartons per pallet—can affect sterilization performance. Higher-density packaging may require longer sterilization or aeration times and can influence temperature and sterilant distribution.

Material Compatibility
Packaging materials must withstand sterilization processes without degrading or deforming. Some materials can become brittle or lose strength under certain sterilization conditions.

Polyethylene and Gamma Irradiation Sterilization

Our polyethylene bags and films deliver reliable, consistent performance in gamma irradiation sterilization environments.  Industry testing rates polyethylene as: 

• Good to Excellent for single-use sterilization (<50 kGy)
• Likely suitable for resterilization (<100 kGy)

These proven material characteristics make Great American Packaging’s polyethylene a trusted and dependable solution for a wide range of medical device packaging applications, where sterilization compatibility and material integrity are critical.

Backed by more than 60 years of expertise in polyethylene extrusion, printing, and converting, Great American Packaging delivers reliable, high-performance packaging solutions tailored specifically for medical device manufacturers. Our deep technical knowledge and manufacturing capabilities enable us to support critical sterilization processes while ensuring consistent quality, precision, and supply.