TGA presentation given at the PDA Australia Chapter seminar, 18 September 2012
18 September 2012
**These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which they relate. These papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health and Ageing (of which the TGA is a division) advises that (a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation papers.**
- Presentation by: Karen Longstaff, Principal Microbiologist, Office of Laboratories and Scientific Services, TGA
- Presented at: PDA Australia Chapter, Ethylene Oxide and Gamma sterilisation: Trials and Tribulations seminar, 18 September 2012, Melbourne
- Summary of presentation: The presentation addressed the current direction of international standards for the development, validation and routine control of Ethylene oxide and radiation sterilization processes for health care products. It also highlighted common microbiological performance qualification omissions in applications for products sterilized by ethylene oxide or radiation.
Content last updated: Tuesday, 18 September 2012
Content last reviewed: Tuesday, 18 September 2012
Web page last updated: Monday, 3 December 2012
URL: http://www.tga.gov.au/newsroom/events-presentations-pdaa-120918.htm