First-Air according to Annex 1

STZ EURO · Benjamin Pfändler, Michael Kuhn

DE

First-Air according to Annex 1In pharmaceutical production, it is crucial that critical processes take place under the protection of clean (ideally particle- and germ-free) and low-turbulence air. This reduces the risk of germs or particles entering the product and causing contamination. Annex 1 of the EU GMP Guideline also places a strong emphasis on the first-air principle and its verification through flow visualization (smoke study). But what exactly does this mean, and how can the first-air principle be adhered to? We'll show you using practical examples!

Agenda

  • First AIr Protection
  • Protection of critical zones
  • Sources of contamination
  • Verification of First Air
  • Flow Barriers

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