medical device packaging and sterilization

Medical device packaging and sterilization

Protecting your medical device

Packaging is critical to physically protect medical devices from the hazards of transportation and storage. We package single-use instruments and disposable medical devices in both flexible and rigid packaging configurations.

Sterile medical devices intended to be used straight out of the package must also be protected against contamination. Our sterile packaging conforms to ISO-11607-1:2019, Packaging for Terminally Sterilized Medical Devices.

Leveraging our relationships with industry leaders in sterilization, we manage medical device sterilization processes from validation to product release.

Packaging validation

We have experience with the all applicable packaging validation requirements to ensure packaging integrity, seal strength, shelf life, and robustness for transportation and distribution.


NextPhase manages the requirements for a broad list of sterilization methods for the product that is designed and manufactured in our facilities.

  • Ethylene Oxide “Gas” Sterilization
  • Steam Sterilization
  • Flash Sterilization
  • Low-Temperature Sterilization Technologies
  • Gamma Sterilization
  • E-Beam Sterilization
  • Hydrogen Peroxide Gas Plasma
  • Peracetic Acid Sterilization

Our Mansfield facility offers steam sterilization and testing. Manufacturing engineers test all new medical devices to ensure that the recommended sterilization methods used for each device meet all applicable standards:

  • ISO
  • FDA
  • ANSI
  • AAMI

Our steam sterilization operations are compliant with ISO 17665 requirements for the development, validation, and routine control of a moist heat sterilization process for medical devices.

Package and product labeling
  • IFU printing
  • On demand labeling
  • UDI barcode labeling

Our packaging validation

  • ASTM F1929 - Dye migration or penetration
  • ASTM F2096 - Bubble leak
  • ASTM F1886 - Visual inspection
  • ASTM F88 - Tensile testing for rigid packaging systems
  • ASTM F2054 - Burst testing for flexible packaging systems
  • ASTM F1980 - Accelerated aging, and shelf life studies
  • ASTM D4169 & ISTA 1,2,3 series - Distribution and transit testing
  • ISTA 2A & 2B
  • ISTA 3A & 3B

Have a question about how to package/sterilize your product?