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March 2006

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MEETING AGENDA

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IoPP MEDICAL DEVICE PACKAGING TECHNICAL COMMITTEE

In cooperation with HealthPack 2006 Conference

(www.healthpack.net)

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When:            Tuesday, March 14, 2006, 4:30PM
Location:        Crowne PlazaDallas Market Center

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1. Opening Remarks By Committee Co-chairs:
            Curt Larsen (DuPont)
            John Spitzley (Medtronic)

  • The meeting is called to order at approximately 5pm

 2. Anti-Trust Statement

  • Larsen summarizes the statement – no collusion nor price discussion etc.

 3. Approval of minutes from March 22, 2005 Meeting

  • Larsen and Spitzley agree that the minutes look good and then moves that we approve the meeting notes as is - Nick Fotis seconds – and the notes are approved as is.

4. Updates From Task Groups:

  1. Labeling Task Group – Dave Olson (Web Label)
    • Olson has an 8 slide presentation primarily an update of the e-labeling & the changes going on in Europe and a guidance document for med device labeling
    • The presentation is to be placed on the MDPTC website
    • Members of the committee include:
    • Mark Anderson – Boston Scientific
    • Ryan Cannon – American Medical Systems
    • Jan Gates – Guidant
    • Gerry Gunderson – QTS Packaging
    • Chelsea Harland – KJ International
    • Susan Ritter – Tyco Healthcare / Valleylab
    • Judy Salzer – Medtronic
    • Discussion during and after the presentation:
    • Gates: the committee is working to meet ASTM in the middle
    • Larsen: what will be the schedule for agreement?
    • Gates: Framework should be complete this spring and move ahead during the summer for prototype – get the performance criteria first, then data  
  2. Industry Standards And Regulatory Update – Hal Miller (Pace Solutions)
    • 2 Updates at this time
    • ISO document – 11607 – officially approved by ISO
      • CEN has not reported the results of their balloting
      • final editing – Mike Scholla – may be published late April – mid May
        • Spitzley – is the plan to go out for comment like the ISO document 0 or for general comment?
          • F02.10 Permeation – Mike Troedel
            • One component must be able to be folded back on itself – it will be considered flexible – such as a clamshell
          • Every member will be a member of each of the 5 subcommittee – if you don’t want to be a member of a particular subcommittee, please contact Tom OToole
      • Will the ASTM D10 committee have the same relationship with F2 as before?
      • Pat Nolan is the new committee chair for D10
    • TIR 22 – AAMI technical guidance document – revamped to accommodate the new 11607 – near to be released for comment, looking to be ready for comment on the end of April – next AAMI meeting in June – well on its way
    • Fotis – the plan is to send it out with the spreadsheet – need to propose per section – sterilization working group 7
    • A newsletter for ASTM F2 committee will announce that they have changed their name to “Flexible Barrier Packaging”.The newly reorganized committee have disbanded the 2 subcommittees and reformed them into 5 technical committees and an executive committee as follows:
    • F02.15 Chemical / Safety Properties – Bob Thornburg
    • F02.20 Physical Properties – Marie Tkacik
    • F02.40 Package Integrity – Nick Winters
    • F02.50 Package Design and Development – Dhuanne Dodrill
    • F02.90 Executive – Tom O’Toole
    • Who will belong in which subcommittee?
    • What is the definition of a flexible package?
  3. Update on MSU Package Integrity Project and Fund Raising Effort – Hal Miller is subbing for Laura Bix
    • The hole committee has 2 slides
    • They developed a new or different test method for sterility – methodology for medical device trays and they are waiting for peer review
    • The committee has a new spray cabinet that fits their needs a lot better – trial of the chamber is ongoing – holes have been drilled in trays for the last part of the project – they have looked at the morphology of the organisms they’ll use and all looks good
    • Going forward – there have been problems getting resources, especially money
      • If money is the problem then we should solicit money – get a list of names and companies – looking at the top management – supplier presidents etc.
      • If this becomes commercially funded, will this be the last time IoPP be excluded from updates?
      • Funding of the $140,000 - $5000/participant – deliverables are:
      • 1. Test method
      • 2. need higher number of samples 
      • 3. graduate student to perform the tests;
      • 4. experiment 2,
        • Miller - Not at this time – they have their own number – most products are liquid – this is different from airborne penetration through a particular hole
          • 70k for materials and direct costs – the rest to MSU – let’s do it the right way – this is typical university funding
          • Not likely, this is different; no tax advice from this group
          • Yes, there will be another proposal for Phase II
          • Come August, we’ll have a much better idea where we stand
          • The task group will be publishing in a peer reviewed journal – it will then be public record.People can get to know about this and if accepted, then it’s a question of how you use it.
          • Extra money will go toward the next phase
          • Larsen, Spitzley, Polkinghorne & Miller
          • The project is currently running out of MSU
    • The test method is to measure the effects of pressure differential on microbial ingress – rigid trays using porous and non-porous barriers with holes of 10 & 100 micron holes – will pressure differential have an effect on microbial ingress
    • The task group is trying to bracket the hole size through which bugs will pass – they are trying to zero in on the hole size for significant ingress
    • The task group will be getting proposal letters together for this university project
    • Larsen – we may not see the results of this project because the funding may become private and as such the ‘stockholder’ that is investing may wish to get something back for their investment
    • Active discussion with many participants including, Larsen, Spitzley, Miller, Scholla, etc.
    • IoPP cannot provide the funding – the task group will need to take it to the university level as a consortium – if this becomes a funding consortium
    • This is so important to the industry – need to get buy-in from regulatory bodies
    • It won’t do anyone any good if the information is held privately
    • A PhD thesis may not be able to be available for $$ - this will likely be published because how else can this be acceptable by regulatory bodies
    • Phase I – takeaways – will there be a pressure differential effect 10 vs. 100 micron?Once the bookends are established, the goal will be to define the size of the hole in which there is a significant risk.
    • What is the finite number?Hopefully it will be established this year but probably next year.There will be a big leap forward after Phase I
    • Bob Fiedler – Has the task group approached the food industry?
    • Fotis – have you seen the letter on breakdown on where the money is spent –
    • Gundersen – Can any of this money be considered charitable? – gifts in kind?
    • Scholla – describes typical funding schema for universities – direct and indirect costs – usually 50% to the project and 50% to the university
    • Miller – we have a list of 60 individuals & companies – if we get 28 – we’ll get the cash needed –
    • Carlson – Is this funding only for Phase I?
    • When will a PhD candidate will be identified for Phase II?
    • If there is no ingress at 100 microns – we’re in a good spot
    • Fotis – if this is successful, has the FDA been contacted?
    • Gates – if you get more than 28 $5000 contributors – will the companies be told? Andif smaller companies want to combine forces, then ok as well?
    • The letter that goes out will emphasize the cost of recalls because of pinholes.
    • Who is compiling the list?
    • Target is to be a high level packaging person with the ability to write a $5000 check
    • Heinz Wolf – is this a global effort?
    • Wolf - Will the results be published around the world??
    • Scholla – Results will be published in Applied Microbiology – thought to have worldwide readership
    • General request to the committee in attendance to join the funding of this project.

5. Report on IoPP Summit Conference. - Eric Carlson

  • A statement from the IoPP Summit Conference was read by Carlson.Brochures were made available to the committee.

6. Report on MDPTC membership report - Eric Carlson

  • Currently the MDPTC has 308 members
  • We will be remaining paperless – if you are not on the list – please see Carlson after the meeting or send an email to Carlson through the Committee website

7. MDPTC Website updates – Eric Carlson

  • Carlson discussed the size of the website and asked for input and recommendations to make the website better for the committee members such as a resource page on the website

8. Discussion on new and current officers/positions for the MDPTC & Organization.

  • Larsen addressed the membership to discuss what is needed to move the organization ahead
  • Getting people in for programs – other than meeting at venues like this (HealthPack) and PackExp in Chicago
  • Other meetings can be held if need be – task group chairs to mine the membership for additional task groups such as an education chair

            Proposal

            Chairperson(s) – John Spitzley & Curt Larsen

            Vice Chairperson – OPEN

            Secretary – Eric Carlson

            Treasurer – Karen Polkinghorne

            Webmaster – Eric Carlson

            Program Chair – OPEN –

                                Volunteered was G. Jordan Montgomery

            Task Group Committees Chair – OPEN –

                               Randy Troutman volunteered

      Education Chair - OPEN          

      Elected vs. Appointed by Executive Committee NONE

      Bylaws – See other IoPP Tech. Committees

 

9. New Business/Open Discussion
    none

 

10. Adjourn

 

adjourned at 603pm

 

 


 

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