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November 2006

 

Meeting Minutes October 31, 2006

  1. Call to order – Curt Larsen and John Spitzley at 2:30PM.
    There were approximately 30 members in attendance.
  2. IoPP Antitrust Compliance Statement was posted for reading by the attendees.

  3. The minutes from the March 2006 were not available for review and approval. Please review them on the website and notify the recording secretary, Eric Carlson of any changes, If none are received in the next 45 days, they will stand approved as posted.

  4. Report on IoPP Summit Conference/Annual Meeting. - Eric Carlson
  • Packaging Summit Meeting - May, 2006
    • This year's College of Fellows inductees are:
      • LEON VENECH
      • CONNIE HARDY-JONES 
      • HENRY JOHNSON 
      • BOB FIEDLER
    • This year's Honorary Life Member inductees are:
    • JAMES HENRY
    • HOWARD MARTIN
    • Member of the Year:
      • CHRIS DEJARDIN
    • Chapters of the Year
      • Category I Large Chapter:
        • Chicago Chapter

        Category II Medium Chapter:

        • Tejas Chapter

        The Category III, Small Chapter:

        • Fox Valley Chapter

        Chapter Growth Award:

        • Michigan Chapter
    • Technical Committee (for the fifth year in a row) is:
    • The Chemical Packaging Committee
  1. Report on Membership & Website - Eric Carlson
  • Membership
    • Current membership = 305
    • IoPP new members that expressed interest in the MDPTC = 125
  • Website
    • Main Page with 45 sub pages
    • More complete info than all other Technical Committees
    • Soon to grow with addition of Education Subcommittee
    • Request for information that would be important to the membership
  1. Report on MDPTC new officers job descriptions – Curt Larsen
    The new appointees are putting together working groups; if any members are interested in joining any of these, please contact the individual chairs.

    Job descriptions – starting with the chair positions: Spitzley & Larsen – eventually the co-chairs will be retiring eventually
  • The chairs are considering having some elections – ready to move away from the infancy of the committee – we would like to have more formal meetings, elections and organization
  • Vice Chair – Glen Petrie: volunteer – will work on chapter of the year
  • Treasurer – Karen Polkinghorne
  • Recording & Membership Secretary / Webmaster – Eric Carlson
  • Task Group Chair: Randall Troutman, Oliver, pivotal position to manage and keep progress or sunset the task groups.
  • Program Chair – Jordan Montgomery, Medtronic: In charge of behind the scenes of getting programs at or away from these type meetings.
  • Education Co-chairs – Jen Neid - Tolas, Gerry Gunderson QTS, Nick Fotis-Cardinal Health

7. Update on MSU Package Integrity Project (PIP) and Fund Raising Effort – Hal Miller - Update provided in absentia by John Spitzley

  • The ‘Hole’ project was initiated here in the MDPTC
  • Dr. Laura Bix realized a big issue in the medical device community in which there is a need for a revised and more defensible package integrity testing as well as a determination of the sensitivity levels.
  • Currently, there is no data with regard to hole size or defect type that can cause a breach in sterility and thus a loss of integrity.Thus, industry cannot provide regulatory (FDA) etc. Data is not available to provide to quantify the hole size where the sterility of a package is compromised.Intuitively, we know that not all anomalies and defects will cause a loss of integrity.If, through testing, we could determine the size or type of this defect, the information would be extremely beneficial to the entire industry.This multi layered ongoing research is seeking to answer some of this very complex question.
  • Up until now, the hole project has been a two part study:
    • First Part of the study is the validation of the microbial test method – this is about half done. It will require additional funding from industry to complete approximately two more semesters of grad student research.
    • The second part is to determine the impact of a pressure differential with a non-porous barrier – currently two hole sizes are being evaluated: 10 micron to 100 micron on a rigid tray, film lid sample.
      • Jane Severin has completed her PhD and will present her results next Thursday November 2nd on the hole size and morphology / pressure differential part of the project.
      • If the testing demonstrates that the pressure differential has no effect, then there will be a substantial change in the tests required.Some have argued that large defects are the types of defects that are the only issue, others are looking at very small defects.
        • Currently funds raised are about $30,500
          • Several points were made by the members present
          • Karen Greene – is there a way to motivate the donations with a ROI? No answer was forth coming. It will be different for each organization and what role they play in the sterile package system.
    • Contributors will receive a complete update at MSU on Thursday, November 2nd.
    • Regulatory and trade organizations are very interested in this research.
    • Contact information: Laura Bix at MSU School of Packaging or Hal Miller with your contributions
  • Fundraising Status
  • Hal Miller has taken on the fundraising for this project – and this has allowed the project to move forward. 
  • Prior to this effort, the students had paid to support their own research.  As a result, the students tended to gravitate to funded research and the hole project would have gone dormant. The fundraising has been so important. 
  • Original estimate required to complete this 2 part project was $140,000
  • More donations urgently needed!!!
  • At the November 2nd meeting, there will be a discussion of how this information and data will be shared. 
  • Ultimately, the information will be published in a peer review  publication.  There may be a change to test methods or there may be a new ASTM standard written around this new information.  Implication for the industry are significant.    
  • This will take a lot of time and money and MSU needs more donations for this research to continue. Unfortunately the vast majority of companies in our industry tend wait in the wings and rely on big companies  to support this type of work and reap the benefits for free. This is being addressed by the research contributors and advisers; a system were those that contribute will benefit while those that do not contribute will not is seriously being considered. Folks, the original contributions ranged up to $5,000.00. If successful, the value to each company and the industry can be tremendous.
  • Spitzley – human inspection is most costly and this deals with the human factor. It is only a 60-80% reliable.
  • Spitzley – The work will yield an integrity test based on objective thresholds.
  • Larsen – Defects identified will be quantified and decisions such as rework or recall will be based on scientific evidence.
  • Greene – is worst case being considered?Spitzley indicated that yes, a lot of thought went onto determining the sample configuration.

8. Labeling Task Group Report – Proposed new test method for label adhesion.

  • No report

9. New Education Committee (EC) Initiative
Larsen presented a report prepared by Nick Fotis and Jen Neid.

  • The EC discussed the proposals from Jen and Nick on adding to our website the capabilities such as can we have an “Ask the Expert” feature.Can a form be programmed into the website – the short answer is yes and there an email link can be programmed in with the tools national provides to the membership.It is unclear whether the questions and answers will be or can be searchable
  • EC to discuss with Chris Barry from Landon-Farrey this opportunity.
    • EC had discussions with IoPP national to get the form programmed – they said ok.

10. Standards Update: JS

  • ASTM F2 had a meeting October 26-27, 2006 in Atlanta, GA
  • F2097 will be balloted soon and this will include all flexible packaging, not just medical packaging.Guidance document for doing things differently.This will be re-balloted in the next 6 months.Very important document.
  • F1980 –The accelerated aging guide is being rewritten and balloted to eliminate some confusion on the use of humidity and the use of aged packages for distribution testing.
  • D10 committee met prior to the F2 committee.A proposed revision to D4169 was on the table – this is a package design test performance evaluation guide. Test intensity Assurance Levels are in question and will be addressed with respect to the random vibration levels. Bob Fiedler added that the three Assurance Levels were confidence levels and described how AL1 was double AL2 and AL3 was half of AL2.However, because the vibration input uses a power function and it more than doubles the severity of the test with a simple mathematical doubling of the number.The question was how to change the test to more accurately correspond to what is actually seen in the field.Many people are testing to AL2. Spitzley also added that currently D4169 is a part of the CDRH recognized standards program, this is accept for use when meeting the US regulatory requirements.It is difficult to change your submissions based on changing the ASTM levels.The change in the test will be the better and easier way for the industry to keep their AL they use without having to justify a change in assurance level. AAMI TC198, WG7 –
    • Last April, a new revision for 11607 was published in two sections
      • Section 1: Requirements for materials, sterile barrier systems and packaging systems
      • Section 2: Validation requirements for forming, sealing and assembly processes
        • All the other EN868 vertical material specifications will be retained, but they are not mandatory or compulsory. These too are being revised to make them more performance based and eliminating rigid specification based requirements.
    • This is a truly harmonized document with EN868.EN868-1 is to be withdrawn April of 2007
  • AAMI TIR 22 Guidance for AAMI/ANSI/ISO 11607-1&-2:2006
  • The revision of the Technical Information Report (TIR) 22 has been balloted and will be discussed at the next meeting of AAMI TC198/WG7 in November. After that meeting, the final text document will be sent out for a final 30 day review & comment period   at which time, any editorial comments will be considered and the document will be published.
  • Larsen stated that this is a good document, better than previous issues.   It is a more chronological organized to reflect the order that a package is developed through production and sale. People in other countries have requested to look and review the document.  This has been well received globally.
  • The new 11607 documents can be ordered www.aami.org.
  • Remember that all ASTM documents can be purchased from ASTM International at www.astm.org.

11. Old business - none

12. New Business: co-chairs

  • HealthPack – New Orleans – March 8, 2007 after the first day’s program.Sponsors of the conference have been very cooperative. Larsen and Spitzley are co-program chairs. For additional information and registration for HealthPack 2007 Conference, go to www.healthpack.org.
  • Elections for the MDPTC – Larsen and Spitzley indicated they they have no intentions of being co-chairs for life.Between now and our next meeting, they will try get a nominating committee put together to address elections, what will be elected offices……committee chair(s)only or vice chair as well?The chairs will be looking to national and other committees to see how they address this aspect of their organizations.
  • Storage and conditioning testing and how that is different than accelerated aging is being considered by several gropups and individuals.What is done and what should be done?Hi temp hi humid and low/low.There is a lot of data about cold chain and long term storage.Better for the industry to have realistic data.A work item surfaced last weeks ASTM F02 Committee meeting in which Pat Nolan is heading up the task group to address this issue.Can they wrest the data away from private parties
    • This would result in a new ASTM document that would list typical environmental stresses exhibited in different areas and different times of the year.
    • Jan Gates has been involved with a cold chain Distribution conference. They also would like to developa guide for the device industry for conditioning and stressing when doing performance testing of packaging systems. Committee F02 is likely to get the most focus and will likely stay in F02. Attached at the end of these minutes is a copy of information provided by Jan Gates of Abbott and Ben Romero from Bristol Meyer / Squibb on additional activities in this area, please contact Jan for additional information.
    • There is some action to get data from UPS and FedEx – Larsen is tracking that information.Wish to get as much data from as many sources as possible.
    • Daphne Allen - Parenteral Drug Association is working on this and may be able to assist as well.
      • Larsen was not aware of this but feels that for the device industry, the work will probably fall within the ASTM F02 Committee because the greatest interest appears to reside there.

        Kevin O’Brien indicated that Brazil has a requirement to have each package be labeled for storage conditions.How will this effect the MDM?
        It was also pointed out that there is no correlation nor should there ever be between these environmental stresses and the conditions used to accelerated aging. Greene questioned should this be a TG effort to assist Gates and Romero?
      • The committee would welcome input from these efforts on the temperature study
  • Allen brought up the call for comment published in the Federal Register on a proposed system for a unique ID for medical devices?Labeling TG is not available – chair is aware of the input from the FDA – Dave Olson is TG chair.Position statement or comments?We are looking for some input from this task group.
  • The committee would welcome additional input from the membership and work from the labeling TG
  • Additional work on aging PSA, abrasion, documentation for aging verification for the labels.

13. Chairs call for comments, donations, suggestions??

14. Lewis Rothschild – Technical Committee Chairman from IoPP – there is a Technical Committee TG on sustainable packaging – first meeting January 25 Holland, Michigan – if this an area of interest – send a rep to the meeting.  An announcement about this will be on the IoPP website next week.

  • Note will be going to the chairman – Randall Troutman from Oliver & MDPTC Vice Chair has agreed to attend the meeting and report to the committee.

15. Be aware that all contact information for the individuals mentioned in these minutes are available thought the members only portion of the IoPP website. To make it easier for the secretary and   reduce the length of these minutes, the specific individual contact info was not spelled out in most cases.

16. The meeting was adjourned at 4:05pm


 

ANNOUNCEMENT

 

 

Name:    IQPC/ASTM Cold Chain Temperature Study Group

 

Study:     Temperatures during shipment of goods by single parcel post.

 

Objectives:       

  1. Develop non-proprietary data through a rigorous protocol that could be used for validation of controlled temperature shipping containers. 
  2. Test temperatures through shipping routes of multiple single parcel carriers
  3. Test temperatures to multiple sites in the United States, Europe, the Pacific Rim and elsewhere.

 

Interested in the study group?

 

For more information contact –

Jan Gates at Abbott Vascular

jgates@guidant.com or 951.914.4948

or

Benjamin Romero at Bristol-Myers Squibb

benjamin.romero@bms.com or 732.227.6391

 

 

History:

Round table discussions on regulatory issues for cold chain shipping were conducted during an IQPC Cold Chain Distribution Conference (September 26 & 27, 2006).  One topic that the discussions reveled was the lack of temperature information on shipping to various parts of the US and the world.   This lack of information made justifying that a controlled temperature profile was acceptable for use difficult for product shipping locations.  Each company agreed that developing the data was expensive and slow (typically a year’s worth of data is needed to capture seasonal extremes) and in-house resources could be limited.  This usually leads to over or under packaging a product to maintain the temperature correctly. 

 

The round table discussions lead to the idea that a task group should be developed for a non-proprietary white paper on temperature studies.  The Cold Chain Conference was initially started for pharmaceutical companies but temperature information is valuable for the medical devices and other industry groups requiring cold chain shipping temperature control. 

 

Costs:

Taking the challenge in an individual company would cost thousands of dollars.  This study group would like to request a $5,000 donation for a company to facilitate the study.   Once interest is determined and a draft protocol written, a meeting to discuss the next steps will be scheduled.

 

 

 

10/29/06

 

 

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