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Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring

Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring

This webinar took place on 28 February 2017 and is available to watch now on-demand.

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ABOUT THIS WEBINAR

ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control. This webinar provides a review of the changes and how they affect your environment monitoring.

KEYNOTE SPEAKER

Daniele Pandolfi, Particle Measuring Systems regulations webinarDaniele Pandolfi, Global Product Line Manager, Aerosol, Life Sciences Division, Particle Measuring Systems

Daniele Pandolfi has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, building close customer relationships. He helps customers to solve their cGMP issues.

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19 responses to “Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring”

  1. ayugi says:

    i hope it will improve our environmental controls.

    Thanks

  2. ayugi says:

    i hope to get a copy in print.

    Thanks

  3. Elizabeth Bennett says:

    Thank you

  4. Zorica says:

    interesting webinar

  5. Dear Daniele Pandolfi,

    New published ISO 14644-2:2015 standard focused on Monitoring. Before 2015, ISO 14644-2:2000 (Withdrawn) had periodic test interval approach but now we have only

    “Periodic classification testing shall be undertaken annually in accordance with ISO 14644-1. This frequency can be extended based on risk assessment, the extent of the monitoring system.”

    so, we need to talk about new test interval approach for main tests and ancillary tests.

    We’re glad to see this kind of value-added webinars.

    Regards,

    Ahmet Kemal Babacan

    • Hi Ahemet

      I will discuss this during today’s webinar, providing some alternative guidelines to be followed in order to identify the best monitoring frequency (for example the WHO guidelines).

      Regards

      Daniele

  6. gracias por preparar estos webinars

  7. Clint Walker says:

    Hi.

    I’ve read the ISO standard, and scratching my head to see what the GMP / Regulatory bodies will do. Will they accept it verbatim?
    It also seems like an opportunity to reduce sample time in Grade A areas … if you’re not using 5um but a smaller particle size … lots of questions … looking forward to your seminar.

    • Hi Clint,

      Thank you for your interest in our Webinar!

      Unfortunately the GMP committee is working “underground” and is impossible to get any information about it.

      Our expectation is that GMP annex 1 will incorporate many new requirements available in the ISO14644-1/2, but we will need to wait a few months before getting the first proposal draft.

      Daniele

  8. Irwin says:

    Thanks for the opportunity. I look forward to meet you and all colleagues.

  9. Ignacio Catano says:

    Gracias por su webinar. Saludos

  10. Abdelkarim says:

    Thank you for your Webinar

  11. Claudio Alves says:

    Obrigado pela oportunidade de participar do webinar

  12. Dr. Raymond Jansen says:

    Hi,
    really looking forward to this webinar….
    Cheers,
    Raymond

  13. Luis says:

    Thank you for webinar

  14. eva troja says:

    Thank you for webinar

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