Global Medical Packaging Standards Update

Transcription

1 Global Medical Packaging Standards Update Brief update on ISO and and ISO the Guidance document for and Jackie Daly Johnson, Co Chair of AAMI TC198/WG 7 Packaging US Delegate to ISO TC198 Working Group 7 Packaging Standards Specialist, FPA, Sterilization Packaging Manufacturers Council President, Beacon Converters, Inc March 12-14, 2013 Marriott Louisville, KY

2 Documents of Interest Coming Soon ISO Guidance for ISO and -2

3 with and Comments from December 2011 ballot were fully resolved at meeting of the ISO Technical Committee 198, Packaging Working Group 7 (ISO/TC 198/WG 7) in Paris, France in April Document moved to ISO for processing, the DIS (Draft International Standard ballot) starts March14, 2013 and ends August 14, 2013.

4 with Definitions for closure integrity, microbial barrier, and seal integrity were refreshed- They were a bit open ended property which ensures that it prevents the ingress of microorganisms, Added- demonstrated under test conditions which consider sterilization process, handling, distribution, transport and storage.

5 with Table B.1 Test methods and their status Attribute/ Characteristics Reference Title of reference Test method has statement of precision and/or bias, repeatability and reproducibility Test method only has statement of precision and/or bias Guidance, Standard Practice Accelerated aging ASTM F1980: 2007 Standard Guide for Accelerated Aging NA NA YES *Sample Test Method Annex was reorganized by attribute/characteristic under consideration, type of reference (test method, practice, guidance document).

6 with Revisions of What do these revisions mean to the user? Will they create more work? Good news- no more work. The proposed revisions of and 2 do not add any new requirements, just improve wording and organization of documents.

7 with Guidance Documents for and -2 AAMI TIR22 stands as guidance for and -2, within the regulatory framework of the United States. A new document, ISO 16775, will provide international guidance for use of and -2. In comparison to TIR22, ISO16775 has a greatly expanded section on healthcare facility use of ISO

8 Highlights of ISO16775 Main Document provides guidance on meeting requirements of and -2 Annexes Provide Education Opportunities Format similar to TIR 22- main document is streamlined Scope Terms and Definitions Guidance for Healthcare Facilities Guidance for Industry. Annexes provide expanded narrative- there are 19 Annexes, numbering over 100 pages in total.

9 with Guidance Document ISO Comments on ISO draft were solicited in January 2011, these comments were resolved in meetings in Montreal in March 2011 and Washington DC in June Revised ISO draft was sent out in fall 2011 for comment,. All international comments were resolved at ISO TC198 meeting in Paris, France in April 2012.

10 with Guidance Document ISO AAMI packaging working group submitted US comments for both ballots as well as prior working drafts. ISO working group members agreed at Paris meeting that since drafts had been balloted, commented, resolved multiple times the late 2012 final vote ballot comments should be editorial in nature.

11 with Guidance Documents for and -2 Final vote on ISO16775 closes in March US Packaging Committee ballot closed in Feb, over 95% of members voted affirmatively, with limited comments. The US vote will be affirmative, with limited comments.

12 AAMI ISO TC198 Working Group 7 Participation AAMI packaging Working Group meets in conjunction with AAMI TC198 meetings, generally in spring and fall of each year. To facilitate participation in resolving ballot comments we utilized teleconferences throughout 2011 and Currently we are anticipating a slight breather period while refreshed and are published- once published we will start the process of collecting comments for next revision or work item proposals on the documents. So join AAMI and join in!

13 Thank you for your participation.