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SBS Paperboard and EtO Sterilization

Q.

Can I use Solid Bleached Sulphate (SBS) material to package a disposable product which will be subject to EtO sterilization? I am trying to determine whether SBS packaging will hold up to the EtO process and if there will be any latent failures I need to be concerned with.

A.

This SBS paperboard material is used for packaging in a variety of industries including food, consumer and medical device markets. The grades available are varied and the surface treatments – clay or poly coated, for example, can also vary making it difficult to state generically about its fitness for use. The SPMC recommends contacting the supplier of the SBS to provide the guidance for specific grade and material performance based on the details of your product, package design and EtO process. For industry guidance on the important material characteristics to consider for various different sterilization methods, reference the AAMI TIR22: Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006. For further information concerning materials the AAMI/ANSI TIR 17 2008: Compatibility of materials subject to sterilization will also provide assistance.

Last updated on 2010-07-27 19:18:35 UTC
Keywords: sterilization, EtO, SBS, solid bleached sulphate, paperboard, AAMI TIR17, AAMI TIR22

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