Real-time Aging Testing

Real-time aging testing is performed by placing the test item on a shelf and allowing it to be exposed to normal storage conditions. The testing provides the best data to demonstrate that packaging performance is maintained over the shelf life specified by the manufacturer. It is recommended to perform real-time aging in parallel with accelerated aging in order to support and verify accelerated aging conclusions.

The common factors which will affect the shelf life include:

- Type and configuration of packaging materials

- Amount of times a package is handled before use

- Storage on open or closed shelves

- Storage area conditions

- Method of sealing

Standard for Real-time Aging Testing

ISO 11607-1

Our Real-time Aging Testing Service

With extensive expertise in consulting, package validations encompassing package and sterilization configurations, material qualification, and package development, as well as large storage space, STEMart provides real-time aging testing on products at specific intervals to provide accurate shelf life conclusions.

• Develop Real-time Aging Testing Protocol

  Depending on the characterization of the materials under investigation, our experts will develop comprehensive real-time aging protocol including sample size, storage conditions, test intervals and post-aging inspection parameters for evaluation of package performance.

• Conduct Post-aging Tests at Specific Intervals
  • Burst test

  Measure and quantify the strength of a medical device package seal by pressurizing a package until bursts.

  • Bubble leak test

  Determine defects or gross leaks in sterile medical device packaging.

  • Dye penetration test

  Observe any capillary movement of the dye in the bag through the sealed area.

  • Peel test

  Visually inspect the peeled seam to assess the homogeneity and defects or fraying of package.

  • Visual inspection

  Visually inspect if there is wrinkle, inhomogeneity or channel formation on the sealing seam of the empty packaging or in the presence of the packaged product.

  • Tensile test

  Provide information about material strength.

  • Yellowness index

  Describe the change in color of packaging from clear or white to yellow.

  • Impact resistance test

  Measure the ability of packaging to resist high-rate impact.

  • Flexure test

  Determine the flexural modulus or flexural strength of packaging.

• Establish Product Shelf Life
• Produce Final Report

Our Advantages

• Temperature mapped and validated environmental chambers
• Light chambers for assessing photosensitive materials
• cGMP retain program management

Our experienced experts will provide one-stop real-time aging testing service according to ISO 11607 to minimize time to market and help manufacturers ensure product safety in its end-use environment. If you have any additional questions about Real-time Aging Testing or would like to consult with the experts at STEMart, please feel free to contact us.