Hi,
Existing Plenum HEPA filters are replace with Terminal HEPA filters in all clean room facility.
both HEPA size and function is similar but due this change the area will be effected. So area qualification is proposed.
as pr above details is this change considered as MAJOR change or MINOR change?
What does your quality standards require? Fit-for-fit and function-for-function maybe minor change; however, IQ, OQ, & PQ with Design Specification update may be required.
If you modify the existing system than system go through the change control system.
After initiating change control (Now onwards write as CCN) system modify but impact is major due to is modify the controlled area which highly impact on product. Some key points are below:
Why you need? Need strong justification
Layout
How long is done
Re - qualification required (CFM, velocity, PAO, DP, Area recovery, NVPC etc…)
Temperature mapping of controlled area
Modification layout existing vs proposed
After clear all above things than is near to close
Thanks
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