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References for Material Stability in Sterilization

Q.

The radiation stability of a number of materials commonly used in sterile packaging of medical and pharmaceutical products was discussed during the webinar. Where can I find this information for other materials, such as PVDF and polycarbonate?

A.

A number of reference documents were highlighted during that webinar that bear mentioning again.

  • AAMI TIR17:2008 – Compatibility of materials subject to sterilization
  • AAMI TIR22:2007 – Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices
  • International Atomic Energy Agency: Guidelines for industrial sterilization of disposable medical products (Co-60 gamma irradiation), TEC DOC-539, Vienna IAEA 1990.
  • Trends in Radiation Sterilization of Healthcare Products, Pub-1313. Vienna IAEA 2008.

These documents, and others, provide helpful guidance related to the effect of sterilization on materials, as part of a fuller discussion of sterilization processes and considerations. According to these references, polycarbonate is considered to be radiation-stable, owing to the aromatic nature of the chemical structure (contain conjugated planar ring systems with delocalised pi electron clouds). Some grades may undergo discoloration, although significant strides have been made by resin and additive producers to minimize, mitigate, or eliminate this effect. Fluoropolymers, like PTFE and PCTFE, are known to be unstable to radiation sterilization. Other fluoropolymers (such as PVDF) are more stable to radiation sterilization, although, as always, product validation and verification are expected over the intended shelf-life.

Last updated on 2014-05-01 19:05:40 UTC
Keywords: AAMI, material stability, references, radiation stable

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