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On Demand

ISO EN 17141 & ISO 14968 Overview

A new standard for Pharmaceutical Cleanrooms – ISO/EN 17141 – Cleanrooms and associated controlled environments – Biocontamination control, was approved in August 2020 and brought into effect in April 2021.

This webinar looks at the requirements of the new standard for Microbiological monitoring and control and how it harmonizes with ISO 14698 parts 1 & 2.

We review the instrumentation validation needs to meet both standards and discuss what aspects are different between the two.

Webinar Presented By:
Mark Hallworth
Global Pharma and Sr. GMP Advisor, Life Sciences Division

Mark Hallworth is the Life Sciences Global Manager and Senior GMP Advisor at Particle Measuring Systems. Over Mark’s long career in contamination control, he has managed the design, installation, and validation of over 200 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE, and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark has written over 100 technical papers on environmental monitoring and contributed to several books specific to this field. Most recently, Mark was a member of the international ISO 14644-21 technical committee responsible for reviewing and revising the standard. He was awarded the IEST James Mildon award for “significant contributions to the advancement and increase of knowledge in the field of contamination control”.

Giulia Artalli
Global Product Line Manager, Microbiology & Sterility

Giulia Artalli is experienced in pharmaceutical microbiology and is currently Global Product Line Manager at Particle Measuring Systems. She started her career in research, before moving to work for companies such as Becton Dickinson and Diversey with a specific focus on the Life Science market. Giulia has extensive professional experience over 20+ years supporting pharmaceutical companies in the application of regulatory requirements, with a specific focus on microbiological contamination control. In her current role, she is focused on microbial environmental monitoring and supporting customers in the correct application in compliance with regulatory specifications.