eugmp annex 1 2008 and particle counting pt2
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7/30/2019 Eugmp Annex 1 2008 and Particle Counting Pt2
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environment when there is uni-directional (laminar) airflow and non uni-directional (turbulent) airflow. Note the new terms for laminar and turbulent airflow.
Portable counter with direct mount isokinetic sample probe
Section 7
In operation classification may be demonstrated during normal operations, simulated operations or during media fills as worst-case simulation is required for this. EN ISO 14644-2 provides information ontesting to demonstrate continued compliance with the assigned cleanliness classifications.
EU GMP Annex 1 is describing cleanroom re-qualification in this section. ISO 14644-2 details proposedre-qualification frequencies for demonstrating continued cleanroom compliance.
There is a level of expectation that the Grade A zones should be re-qualified every 6 months, Grade Bevery 6 months at rest and annually in operation, Grade C and D zones annually. If an organizationdecides on an alternative approach, then this should be justified, the basis for such a justification could beon historical monitoring particle count data.
To be continued
Part 3, third and final application note in this series, will cover relevant sections from section 8 onwardsof EU GMP Annex 1. These sections contain detail on particle monitoring.
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