Environmental testing

Our environmental stress testing is equipped with a full range of climatic and dynamic capabilities.

Environmental test chambers such as temperature-humidity, temperature-humidity-altitude, thermal cycling, salt spray/fog, high and low pressure are available.

Accelerated Aging of Sterile Barrier Systems for Medical Devices (ASTM F1980)

accelerated aging - storage of samples at an elevated temperature in order to simulate real time aging in a reduced amount of time.

The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.

ISO 11607-1:2006, clause 6, states that "the packaging system shall provide physical protection and maintain integrity of the sterile barrier system. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Stability testing shall maintain sterility to the point of use or until the expiry date. Stability testing shall demonstrate  that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available."

Depending on the device, aging test time varies. 1 year aging for a typical part takes about 40 days for the product stored at a test temperature of +55°C. We recommend to get the "Aging Testing" done in the beginning stages, to determine effects of temperature on product and packaging. 

Conditioning Containers, Packages, or Packaging Components for Testing (ASTM D4332)

Significance and Use:

Many materials from which containers and packages are made, especially cellulosic materials, undergo changes in physical properties as the temperature and the relative humidity (RH) to which they are exposed are varied. Therefore, the package should be placed and kept in a specified atmosphere for a length of time such that subsequent measurements of physical properties will be meaningful and reproducible.