Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring
Supported by:
28 February 2017
Supported by:
28 February 2017
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, 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.
Supported by Particle Measuring Systems
Particle Measuring Systems (PMS) sets the standard for contamination monitoring. With more than 60 patents, they create the technology that enables you to make fact-based decisions, improve process yield and comply with changing regulatory requirements. They understand the challenges their customers face and keep up with your changing needs by actively participating in industry, trade and technology groups. With more than 420 employees, they have over 35 distributors and local sales and services in more than 70 countries.
Find out more: http://www.pmeasuring.com
Related topics
Cleanrooms, Environmental Monitoring, Good Manufacturing Practice (GMP)
Really looking forward to get insights of the topic by great speaker on via webinar..
thanks
i hope it will improve our environmental controls.
Thanks
i hope to get a copy in print.
Thanks
Thank you
interesting webinar
Thank you for your interest in our Webinar!
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 Before 2015, ISO 14644-2:2000 (Withdrawn) had periodic test interval approach but now we have only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
gracias por preparar estos webinars
Thank you for your interest in our Webinar!
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
Thanks for the opportunity. I look forward to meet you and all colleagues.
Gracias por su webinar. Saludos
Thank you for your Webinar
Obrigado pela oportunidade de participar do webinar
Hi,
really looking forward to this webinar….
Cheers,
Raymond
Thank you for webinar
Thank you for webinar
Thanks