Regulatory Open Forum

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  • 1.  Plastic Micro and Macro Particles

    This message was posted by a user wishing to remain anonymous
    Posted 30-Sep-2021 16:54
    This message was posted by a user wishing to remain anonymous

    Hi, As I am very much concern about the plastic particles which are generated in the dental aligner manufacturing facility can someone suggest me how we can prevent ourselves from the inhalation of plastic particles beside using mask what are the other possible measures we can take to control it and to keep the plastic microparticles and macroparticles in check.
    please suggest.

    Thanks


  • 2.  RE: Plastic Micro and Macro Particles

    Posted 18-Oct-2021 13:29
    If I am interpreting this correctly, you are worried about the health of employees, not patients. If that's correct, that's an important issue, but it's not for FDA. In the US, OSHA regulates inhalation risks in the workplace. It's not my expertise, but I found this and I hope it helps you.

    PPE: https://www.osha.gov/personal-protective-equipment

    Respiratory protection: https://www.osha.gov/respiratory-protection

    I hope that helps!

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    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.

    Maryland
    United States
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  • 3.  RE: Plastic Micro and Macro Particles

    Posted 20-Oct-2021 08:24
    Dear Andrea,

    Thankyou so much for the information.

    Regards

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    Shivani Chawda
    Quality Assurance Executive
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