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Melting PLA print when outside in sun

Discussion in 'Off Topic' started by Eric Viglotti, Aug 13, 2017.

  1. Geof

    Geof Volunteer Moderator
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    these are large brackets :D no thin parts Thinking if its that strong (since the material must be FDA approved by the vendor) this may just work out.
     
  2. WheresWaldo

    WheresWaldo Volunteer ( ͠° ͟ʖ ͡°)
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    @Geof are you using Stainless Steel nozzles? Doesn't the FDA require the entire process use approved materials and tools?
     
  3. Geof

    Geof Volunteer Moderator
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    Negative. The client requires the material used to be FDA approved. I do no work that requires FDA inspection or guidelines. Have no issues meeting a clients demands but refuse to deal with that huge debacle lol
     
  4. WheresWaldo

    WheresWaldo Volunteer ( ͠° ͟ʖ ͡°)
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    Okay, I will try to understand the stuff you wrote. So no SS nozzles. That's all I got! ;)
     
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  5. Geof

    Geof Volunteer Moderator
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    side note: when I talked to a rep about doing FDA approved stuff they informed me they technically dont consider 3D Printing to be (ever as far as their concerned) safe enough to be approved. Cant clean it.
     
  6. Geof

    Geof Volunteer Moderator
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    LOL Yes no SS nozzles
     
  7. daniel871

    daniel871 Well-Known Member

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    Well, the thing to do there would be to heat treat the part, then run it through a dishwasher with the Sanitize cycle and document doing it. :p
     
  8. OutsourcedGuru

    OutsourcedGuru Active Member

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    I work at a biopharma company which makes medical devices. To be honest, the FDA is way behind the curve on everything. The word "brass" doesn't appear in any of the draft documents I've read. Clueless. At best, they're focusing on filament selection/sourcing.

    Guys, all the big mixers at work have to be stainless steel. We got our once-every-five-or-so year audit last month from the FDA, for what it's worth.

    Anyone who claims that the FDA approved their filament is a liar, in my humble opinion (ask to see the letter). One could suggest that a filament is FDA-compliant... (for what purpose?) You wouldn't believe how "silo'd" the FDA is with respect to compliance channels and approval processes. As of mid-last year, their guidance is only in draft now and has nothing to do with food.

    What will eventually happen is that many people will die and then the FDA will swoop in and make drastic changes. Act in such a way that you can claim that you used GMP (good manufacturing practice) as you understood it at the time.
     
    #28 OutsourcedGuru, Sep 13, 2017
    Last edited: Sep 13, 2017
  9. Geof

    Geof Volunteer Moderator
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    Their concern from what they told me isn't the brass as the amounts that would come off are well within the "allowed" amount. The issue is the fact that with their testing a uncoated 3D Printed part CAN NOT come clean of bacteria regardless of how its cleaned (not necessarily true but I get it). They arnt saying you cant do it, just the part has to be thrown away when contaminated with food particles.

    This is why I stay away from the whole mess. lol. Client wants it fine, FDA approved material ran through a standard set up. Anything past that is on you.
     
  10. OutsourcedGuru

    OutsourcedGuru Active Member

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    Honestly, any client that wants a food-safe part should be taunted at (see Monty Python and the French castle scene). Brass includes lead in many cases and even though it's unlikely to cause harm, I would think in terms of lawyers who can do harm. An investment in hotend/block/nozzle combination with zero bronze would be my own safety margin when dealing with such a client and I'd charge them $2,000 for the inconvenience.

    "Yes, I can print a food-safe part but there will be some startup charges to consider..."

    The bacteria concern is real. And yet, we purchase and use a variety of plastic in our lives which contain that same health risk. A polyurethane coating might help. You might suggest that meat and eggs contain harmful bacteria which are well-known in the food industry and wouldn't be good candidates for this application. ABS would be out of the question.

    Read about UFPs. The suggestion to wash the part is a good one (warm water + anti-bacterial soap).

    A stainless steel hot end is good, not bad, for this.

    The longer the plastic is exposed to food, the bigger the concern. Some applications aren't really smart.
     
  11. daniel871

    daniel871 Well-Known Member

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    Well, you could always print in PETG and then heat polish the surfaces until they were smooth, but you'd have to be pretty artistic/steady-handed with a torch to do that properly.

    Then the same "Hand wash with soap and water only, do not put in dishwasher or expose to temperatures above (glass transition temperature of PETG)" warnings would have to be included with all of the printed parts.
     
  12. Geof

    Geof Volunteer Moderator
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    Not worth the headache :D
     
  13. jwmueller

    jwmueller Active Member

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    Mine warped in the oven, but I know oven results vary not to mention it could be in the infill pattern itself causing the warp while trying the heat treat. I am going to play around as you all have me curious.

    The reason for my post - Essentium PLA has a glass transition temp of 55-60C (I have emailed them to ask on how they like the part to be heat treated and if the water method is good)

    I am going to run one in the Raptor, Proto-Pasta, and Essentium. My report will be slow as the print time is 10+ hours. ;) I would not mind finding a good PLA to use, as that would reduce my overall print time. Some of my parts are 8" x 4" x ~1", some are larger but they are all flat bottom designs. I have thought about making them a two-part design, and utilizing the Palette+ to add rubber feet directly into the print. What I have seen is my filament usage is almost double to just add text into the print...
     
  14. jwmueller

    jwmueller Active Member

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    I read a report that said basically this, it even went into the details of why autoclaving the extruder parts would not fully sanitize the system. It was a fun read, but I have no clue how I even found it. Just one of those days when you stumble on a report while looking for something else. Eastman white paper maybe.
     
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  15. OutsourcedGuru

    OutsourcedGuru Active Member

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    For example:

    NIH paper on 3D printing surgical instruments
    The "fun" here is that you'd have to design a test suite and contract a company to perform those tests. You'd probably be expected to create a Certificate of Manufacture and a Certificate of Analysis.

    You should see the fun was involved in trying to create those plastic transportation crash barriers for highway use.

    It's never worth it.
     

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