IoPP MEDICAL DEVICE PACKAGING TECHNICAL COMMITTEE
March 23, 2005, 4:30PM
Location: Hilton Palacio del Rio, San Antonio, TX
1. Opening Remarks By Committee Co-chairs Curt Larsen (DuPont) & John Spitzley (Medtronic):
The meeting was called to order at 4:05 by John Spitzley with brief opening remarks of welcome and how the MDPTC tries to hold the committee meetings at significant events such as HealthPack, PackExpo and ASTM meetings. Curt Larsen officially opened the meeting indicating that the last meeting was held in Chicago at the 2004 PackExpo last November. Curt welcomed members and non-members – and encouraged those who are not members of IoPP to consider joining and once you are a member of IoPP to then ask to be a part of this group
2. Anti-trust Statement
The antitrust statement was not read in full; the co-chairs advised the audience not to discuss any private or confidential information relating to pricing, etc; all private information is to remain private.
3. Updates From Task Groups:
A. Sterile Packaging Integrity Task Group – Jane Severin (MSU) Preliminary work and research funding
- Dr. Sara Risch (Director – School of Packaging, Michigan State) was began with some opening remarks (as follows) and introduced Jane Severin
- Background – this program has been trying to determine a validated method to determine the how large a ‘hole’ constitutes a breach in a sterile barrier
- The existing project and personnel are proposing two additional follow on studies to be done
- The primary study is looking at worse case scenario, then look at realistic conditions
- Once the method is secure, two more studies have been proposed
- Jane Severin is introduced as a PhD student, however, she has been involved in industry for many years
- Jane Severin presented her findings (The presentation is on the website). A selection of the question/answers are presented herein:
- Question – Did you count CFU?
- Answer: yes – not presented here for simplification of results
- Question – is the barrier material is porous?
- Answer: Yes ; different degrees of porosity is not considered
- Comment: Experiment 3 will be nonporous
- Comment - Studies are available with regard to particulates through a porous membrane
- Reply: Those studies are known but not currently being used
- Suggestion – make sure that pressure changes are noted when using different temps and conditions
- Reply: Found a chamber that can control pressure
- Question - What about high temp exposure? Africa etc
- Answer: Not on the table right now
- Question – When treated with aerosol and then moved from aerosol chamber to incubate – will you clean the outside?
- Question – What is the plan … exposure followed by incubation?
- Answer: Exposure for 30 min followed by incubation
- Spitzley -This project is at a juncture – we’ve been doing it on the cheap through this committee; Spitzley proposes that a task force be established to formulate a plan for funding, message, etc. We feel that most problems of loss of integrity is catastrophic, but this is without data. Do we have volunteers to establish a task force?
- Larsen – formation of a task force to acquire funding, with Michigan St. to be involved and continue their current work. Not just the Medtronic and Cardinals will benefit.
- Risch – thank you for the in kind contributions.Materials etc have come from school of packaging and time from grad students; A quick review of some of the numbers from MSU for this project:
- Study is easily $150k
- Cost of just drilling the holes is $100k - the rest is 50-60k
- Need to go to individual company for funding or this group needs to step up to the plate
- Spitzley – this is lots of money, but with a valuable method, cost to each company would allow for less costly testing.The best way to do this is a small effective task force unless other suggestions or a big donor?
- Karen Polkinghorne, DuPont Medical Packaging, volunteered to be chairman of the task force
- Hal Miller – how long would this work take?
- Risch – Ron Iwaszkiewicz & Jane Severin (MSU PhD candidates) would like to be done by the end of the year
- If Iwaszkiewicz & Severin could be full time students, this would be faster
- Severin has project #3 has a target by end of 2006
- Hal Miller– Is experiment 1 part of someone’s graduate work?
- Risch – Iwaszkiewicz & Jane Severin’s work
- Mike Scholla – Recommendation that this be published for peer review and industry critique for merit and comment
- Answer: Dr. Bix would probably be willing to publish
- Polkinghorne should have some connections for publication
- Risch – Is there consensus to publish? Scholla says no reason not to
- Larsen – Polkinghorne needs to get people to work on the task force; Risch is willing to work on the committee to get it going
- Larsen – Funding will be the most critical to timelines
- Money to get the program started is not available at MSU
- Resident companies may have the ability to get this hole drilling work done; in house or suppliers and vendors; capabilities are out there
- Scholla – what is the viability of getting a grant proposal to FDA or somewhere else? Homeland security?
- Risch – submission minimum is 6 months for an answer, should have started 2 years ago
- Grant proposals should be started for the next 2 projects – Dr. Bix is working on this
- Larsen & Spitzley call for others for the task force: Randy Troutman, Tom Roberts, Rich Bell, Mike Scholla formally volunteered
- This task force could continue work for other activities
- Publishing the paper will assist the task force
- Karen Greene: Professional fund raiser may be effective – can they do it pro-bono.If the needs can be clearly identified.
- AAMI or others to fund? – probably not unless they could publish the standard
- Question – Are there protocols written for projects #2 and #3
- Process for drilling the holes – eximer laser; verification is more expensive than this method
- Larsen indicated that this task force effort needs to move faster than the next MDPTC meeting
- This is an example of the cooperative work between MSU and industry
B. Labeling Task Group – Dave Olson (Web Label)
Dave Olson begins his presentation at 5:03 (Presentation is on the website)
- Comment – A test protocol or guide similar to the one that Nick Fotis did for documentation may be of help for the TIR for AAMI
- Put a task group together to publish something (Hal)
- Maybe a framework, but the companies are very inconsistent
- CL indicated he wrote one that he’ll forward to DO
- Question (Greene) – What peel strength number is required?
- Answer: Whatever you set up for a pass/fail criteria – adhesion may be the only requirement
- Percentage of flagging, tunneling, lift off, corner lift
- Comment - Bob FiedlerASTM has information
- Pressure Sensitive Tape Council has standards
- TLMI has standards
- Pick one or all or the best
C. Industry Standards And Regulatory Update – Hal Miller (Pace Solutions)
Hal Miller begins his update at 5:21
- Nothing new since our last MDPTC meeting in November because ASTM and AAMI have not met
- Julie Clifford from D10 is trying to merge F2 and D10 into one organization with a task group to assess
- First proposal is F2 become division 4 of D10
- Second proposal – reorganization of D10
- More coming from a meeting in October of the two groups in Reno, NV
- CEN will OK the ISO 11607-1 and -2
- TIR22 will be a ‘cookbook’ to follow the requirements of ISO 11607
4. MDPTC Officers
Larsen: The co-chairs want to get rid of their jobs. They were appointed and they have been happy to do the work, but now both will be looking for more support. Need new blood infusion into the committee. If you’re interested in working at this level, they would like help. There will be a proposal for new people and positions, treasurer, programs, etc. This is all with the understanding that the new folks will take over eventually.
5. New Business/Open Discussion
New business: 5:30
Any new business? Something to do, or not do?
Question from Randy Troutman: Is someone working on a standardized spec for “Data Sheets”?
Answer: Yes. This work by Nick Fotis and the Data Sheet Task Group is finished and on the website in the Task Group Links.
6. Adjourn – at 5:32