Particle Counting, Cleanroom Classification and Particle Monitoring
Cleanroom classification is a fundamental qualification activity for pharmaceutical cleanrooms. It is the activity that demonstrates that your cleanrooms will achieve their designated Grade and associated particle limits specification under maximum occupancy and activity (it underpins maximum room occupancy). Leading on from this, it is essential that total non-viable monitoring is performed meaningfully to demonstrate continued performance of the cleanroom during routine operations.
This course covers: how particle counters work and how to avoid under and over-sampling of larger particles (e.g. use of correctly sized and orientated isokinetic probes); setting up the classification exercise and incorporating ISO-14644 / EU Annex 1 / FDA Aseptic Processing Guide requirements (including the implications of the latest draft Annex 1); and effective particle monitoring (probe positioning by risk assessment). It does not cover microbial monitoring.
A worked classification example will be included. The course is aimed at individuals involved directly or indirectly in carrying out classification and particle monitoring. Target disciplines include validation, quality assurance, production (supervisors and management) and engineering.
Presenter: Mike James
Tuesday, 11th August 2020
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9:00 - 11:00 (London/Dublin)
10:00 - 12:00 (Amsterdam/Berlin)
Duration 2 hours
£200 per delegate
NOTE: Course fees will be subject to a 20% UK VAT charge if your billing/invoice address is in the UK and/or delegates are UK based