Accelerated and Real-Time Aging Services

Shelf-life validation of sterile barrier systems

ISO 11607 requires sterile medical device manufacturers to demonstrate the shelf life of their packaging system. Accelerated aging is used to simulate the effects of real-time aging by subjecting samples to elevated temperatures for specific periods of time, thereby generating data more quickly and allowing for shorter time to market.

In parallel with accelerated aging, the manufacturer must also conduct a real-time study in order to validate the data generated during the accelerated aging process.

Accelerated aging according to ASTM F1980

Accelerated aging techniques are defined on the basis that the chemical reactions involved in the deterioration of materials follow the Arrhenius reaction rate function. This function states that a 10°C temperature increase or decrease results in approximately two times increase or decrease in the rate of the aging process.

The level of relative humidity (RH), while not specified by the standard, should be included at realistic levels.

STERIS offers a range of accelerated aging chambers, which can accommodate both large pallets and single shipping units.

Stability Testing

STERIS also offers stability testing capabilities in accordance with ICH guidelines for pharmaceutical manufacturers.

Conditions include:

  • 5°C
  • 25°C, 60% RH
  • 30°C, 65% RH
  • 30°C, 75% RH
  • 40°C, 75% RH

Technical Support

Our technical support team also offers guidance toward:

  • Packaging evaluations and concept reviews
  • Risk assessment
  • Test planning and protocol development
  • Evaluating prior validations and gap analysis

Contact our team of experts to find out more about our Global Contract Sterilization, Testing and Validation Services.