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  • 1.  ASTM standards

    Posted 17-May-2022 22:16
    I have a few questions here...What happened if you develop a product and you dont have an ASTM standards to comply with for testing..  Do you develop your own ASTM, if yes How? Or do you just come with an internal test method in the lab to test on product.

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    Bedwuine Senatus
    QA/RA Director
    Springfield NJ
    United States
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  • 2.  RE: ASTM standards

    Posted 18-May-2022 02:20
    Hello Bedwuine,

    If there is not an available ASTM standard applicable to your product, then in most cases the development of testing methods would be a result of your design inputs, e.g. specifications for the product.  There may be situations where you can use similar ASTM standards as a starting point and there may also be expectations for testing as well, such as competitor or similar devices on the market already having performance requirements.  In my experience there were many times we had to develop our own internal test method for a product to ensure design outputs meets the design inputs.  Also depending on the test method this should be validated to ensure the test method is correct and more importantly the test method is providing the correct results.  The test method validation is sometimes not needed if the testing method is obvious, though should have rationale and justification around for how the company developed the internal test method.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: ASTM standards

    Posted 18-May-2022 06:29
    I agree with Richard, and would add that the engineering team at MED Institute has decades of experience in developing new test methods for novel technology. Please feel free to contact me directly if you would like more information. 

    Best regards,

    Ted


    Best regards,

    Ted



    Original Message


  • 4.  RE: ASTM standards

    Posted 19-May-2022 03:41
    Great advise, 

    Same goes for pharmaceuticals: "ASTM International's committee on the manufacture of pharmaceutical and biopharmaceutical products (E55) was created to address many facets of this expansive field. Formed in 2003, the group addresses issues related to "process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry." It works with drug and drug-equipment makers, government agencies, designers, professional societies, trade associations, financial organizations, and those in academia."

    Good luck,

    Dar

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    Darlene Rosario MBA, RAC
    Principle Consultant
    Ventura CA
    United States
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    Original Message


  • 5.  RE: ASTM standards

    This message was posted by a user wishing to remain anonymous
    Posted 18-May-2022 15:16
    This message was posted by a user wishing to remain anonymous

    I had a similar situation recently. We are developing a product and consulted with a NTRL who determined that the current standard did not completely our product. It was new and innovative. The standard was changed to encompass our product. The NTRL was UL and it was one of their standards, so we worked with them to get the standard updated.
    Original Message


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