Cleanroom Compliance
One final item to discuss is the periodic tasks for demonstrating continued compliance of a cleanroom with ISO 14644 standards. These tasks include the following:
- HEPA filter leak testing: every 6 months for ISO Class 5 and lower classifications, every 12 months for classifications >ISO 5
- Particle classification: every 6 months for ISO 5 and lower, every 12 months for >ISO 5
- Airflow volume or airflow velocity: every 12 months
- Air pressure difference: every 12 months.
Because of the routine particle counts in operational conditions, verification of the classification of a cleanroom is usually performed under “at rest” conditions. Retrospective review of in operation particle counts may be used to demonstrate compliance under “in operation” conditions. Review and trending of viable and non-viable particle counts should be part of a quality system for any aseptic processing facility.
Air pressure difference can also be satisfied by review and trending of routine monitoring results—most building monitoring systems have the capability of trending differential pressures. With “in operation” particle counts and differential pressures satisfied by routine data, periodic recertification activities are limited to HEPA filter leak testing, “at rest” particle counts, and airflow volume or airflow velocity.
Resources & Articles
CLIN ® "Resources" page is for individuals/companies seeking information on cleanrooms and controlled environments. Find Cleanroom News, Discussion Forums, Cleanroom Cleaning Recommendations, Cleanroom Terminology, Cleanroom Directory, and more.
Content Disclaimer
Information are contributed by/from different websites and all credit goes to its respective owners/writers/websites/companies and etc, and while we endeavour to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the website for any purpose. Any reliance you place on such information is therefore strictly at your own risk.
In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of this website.
Through this website you are able to link to other websites which are not under the control of respective owners/writers/websites/companies and etc. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.
Every effort is made to keep the website up and running smoothly. However, CLIN ® takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.
