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  • 1.  How to differentiate and set requirements for adhesive peel in Sterile Barrier Systems?

    This message was posted by a user wishing to remain anonymous
    Posted 12-10-2024 09:29 AM
    This message was posted by a user wishing to remain anonymous

    We're currently discussing the quality of medical device sterile barrier systems, which consist of a rigid tray (e.g., PETG) and coated Tyvek. While the specific combination is intended for cohesive peel, we occasionally encounter areas of what appear to be an adhesive peel or an incomplete sealing. In the specific case the defect appears in the middle of the seal area, why a dye leak test doesn't add information.

    I'm looking for advice on:

    • Differentiating between adhesive peel and actual defects: What are the key indicators to look for?
    • Setting requirements for adhesive peel: What standards or guidelines should we follow to ensure the integrity and reliability of the seal? It seems that it is difficult to avoid discontinuous seals completely for this kind of sterile barrier system, but we would like to specify how much/little is acceptable. Which data do we need to support the decision?
    • Common issues: What are the typical problems associated with discontinuities in the seals, and how can they be mitigated?

    Any insights or shared experiences would be greatly appreciated!



  • 2.  RE: How to differentiate and set requirements for adhesive peel in Sterile Barrier Systems?

    Posted 12-11-2024 05:08 PM

    I can assist with this and get answers to your questions but prefer to do so offline and know who I am dealing with.  Feel free to reach out to me offline at Mark Leuenberger, Profound Development Group, (513) 379-1241, mark@profounddevelopmentgroup.com .



    ------------------------------
    Mark Leuenberger
    President / Principal Consultant
    Profound Development Group, LLC
    Loveland OH
    (513) 379-1241
    ------------------------------

    Original Message


  • 3.  RE: How to differentiate and set requirements for adhesive peel in Sterile Barrier Systems?

    Posted 12-11-2024 05:27 PM
    Sent from my iPhone
    Ben Miyares
    Packaging Management Institute


    Original Message


  • 4.  RE: How to differentiate and set requirements for adhesive peel in Sterile Barrier Systems?

    Posted 12-20-2024 11:46 AM

     

    Ref:  "Common issues: What are the typical problems associated with discontinuities in the seals, and how can they be mitigated?"

     

     

    There are several potential causes of an incomplete seal in the midst of the seal flange area. I am not sure if you mean along a section of the seal flange or actually a spot in the middle of the track surrounded by otherwise good adhesion. 

     

    1. Obviously check the sealing platen for a surface "ding" caused by metal spring pin wear from a different geometry seal tool previously in use on the sealer.  The wear spot is now landing directly on the seal tool nest you are using.  Your seal platen damage may look like hail damage on a car hood. Yikes.
    2. Surface cleanliness has been a sporadic issue in some cases so don't overlook that. Ex. release agents contamination.
    3. The underside of your seal flange meets the adjacent vertical sections of the tray.  There is always a small radius at this point. Sometimes the radius is not what was originally called out on the tray drawing.  This is insignificant except where the edge of the sealing gasket is making contact into this radius before the flange surface makes contact with the face of the gasket.  This creates a high pressure section along this intersection at the radius while the flange face sees less contact/pressure.  Some people dial back their sealer recipe to mitigate the high pressure along this intersection to the detriment of the main seal face.  Real solution is to have a gasket edge that does not ride up into the intersection radius.
    4. More common is the situation where the corners of the tray are over sealing and a certain section of the flange seal elsewhere is deficient. This has to do with the resulting tray material thickness of the flange after thermoforming.  You can always bet the corner material measures the thickest and the mid-point of the longest flange will measure the thinnest. But how much deviation is there? An added factor is a deep draw feature nearest a flange may also cause a thinning of the flange material nearest that deep draw.  This is the nature of thermoforming and is not a tray defect given that it measures consistent tray to tray.   Some tray designs can perform well without impacting seal performance while some more extreme tray designs outside certain variances in flange material thickness need special attention by the seal tool nest designer.

     

    The discussion of root causes is a bit more detailed than what can fit in this channel of discussion but contact us if you want to discuss details and examples. Contact us if you want to dig into your questions.

     

     

     

     

    Visit us at MD&M West.  Anaheim, CA.  Feb 4-6, 2025

     

    https://www.xpressreg.net/register/IMEW0225/start.asp?sc=INVITE975228

     

     

    Best regards,

     

    John A. Abraham

    Atlas Vac Machine, LLC

    9150 Reading Rd.

    Cincinnati, OH  45215

    513-407-3513 (O)

    513-386-7064 (fax)

     

    https://atlasvac.com/

     




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