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Issue 30: April 2017

Standards

IEST leads development of first ISO 14644 nanotechnology standard

David Ensor, Anne Marie Dixon, Roberta Burrows

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Abstract

IEST convenes ISO Technical Committee 209 Working Group 10 in the first cleanroom standard for air cleanliness by nanoscale particle concentration, ISO 14644-12. The 1999 issue of ISO 14644-1 included informative requirements for ultrafine particles, i.e. particles smaller than 0.1µm. During the revision of ISO 14644-1, ISO TC 209 decided that it would make more sense to remove the guidance on ultrafine particles and place it in a separate nanoscale particle standard, ISO 14644-12, and this is currently at the DIS stage. ISO 14644-12 will be a monitoring standard for use mainly in the "operational" state. Supporting information for this standard has come from the work of ISO/TC 229 Nanotechnologies. Nanoscale particles have different characteristics from sub-micron and macro particles which are mainly related to human activity and they are generated by nanotechnology processes. It is anticipated that the standard will be useful to process engineers seeking a standardized monitoring protocol in nanotechnology processes.

Keywords: Nanotechnology, ISO, TC 209, 14644, cleanroom, nanoparticle, ultrafine particle

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ISO 14644-1 revisions summary

Daniele Pandolfi

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Abstract

The recent revisions of ISO 14644-1 and -2 have introduced several changes regarding cleanroom classification and monitoring. This paper will highlight the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1.

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Cleanroom standards status update

John Neiger

Regulatory reflections

Cleanroom environmental monitoring systems, regulatory compliance and risk mitigation

Jason Kelly

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Abstract

This paper presents an overview of applying GMP and risk mitigation to the design and implementation of a real time monitoring system. A well designed and implemented monitoring system enables the end user to mitigate risk and to get the most out of it, based on the end users process and setting appropriate alerts and alarms and then following well designed and validated SOPs when an alert or alarm is generated. The integration of a monitoring system as a process tool to monitor cleanroom environmental conditions depends greatly on leveraging the experience of the monitoring system vendor and on understanding the monitoring system, design and validation lifecycle. Having the perfect plan, by producing a monitoring system user requirement specification (URS) developed on a risk based approach, is the optimal way to start such a project. Selecting a monitoring system vendor with such experience helps the process run more smoothly.

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Letter

Standardisation of dates

Tim Coles

News

Cleanroom Guangzhou Committee meets with local cleanroom enterprises

Contec adds new PROSAT wipe to its range of low endotoxin products

Great kick-off to 2017 for CHTS and BPS Crowthorne

Pharminox Isolation delivers a half-suit isolator for sterility testing

Helapet unveils new products for 2017

Golden start to 50th anniversary year for CRC

Cleanzone to present "Living in Space" showcase at Techtextil in Frankfurt in May

Events and Training Courses

Life-lines