SPMC's FAQs provide guidance for your technical challenges.

SPMC response to questions regarding non-traditional sterilization processes

Last Updated On May 2, 2014

The SPMC technical group received several questions during a PMP News webinar Sterilization: A Packaging Perspective in November 2013 on ozone and plasma sterilization related specifically to the efficacy of these sterilization methods. Since the SPMC group is focused on healthcare packaging, the intent of the webcast was to provide the audience with a general understanding of the impact different sterilization methods have on packaging materials. As a packaging industry group we do not offer a position on the efficacy of different sterilization methods. For that we recommend you reach out to sterilization companies for their expertise. We do however have the expertise to provide guidance on packaging considerations.

From a packaging perspective, both ozone and gas plasma require a porous web to allow the sterilization gas to enter and exit the sealed package. Since these sterilization processes are similar to ETO, the same types of packaging considerations are applicable from a porosity perspective. Material performance in these sterilization methods do vary. There are limits to the use of cellulosic-based material, for example, in plasma sterilization while this restriction does not apply in EtO.

For further information on sterilization practices and FDA approved methods refer to CDC and FDA websites. The links listed below can provide starting points for this guidance:

• http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_11sterilizingPractices.html
• http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm194429.htm
• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072783.htm