Are microbial challenges required for medical device packaging validation?

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There is no universally accepted method of demonstrating microbial barrier properties, although there are efforts to address this that may eventually be incorporated into the standard. The part 1 standard section 5.2.2 indicates only that the microbial barrier requirement can be demonstrated by showing the material is impermeable. Annex C requires that impermeable materials for sterile barrier systems shall be tested for air permeance in accordance with ISO 5636-5. Other tests are noted in Annex B. In practice, demonstrating a sufficient microbial barrier is performed on the material itself by the raw material supplier and their test reports can be referenced in the MDM’s technical file.