Cleanroom - GMP vs. Containment

ISPE - International Society for Pharmaceutical Engineering D/A/CH e.V. · Oliver Gottlieb

26/03/2025, 11:00 · Room 6 · DE

Cleanroom  - GMP vs. ContainmentConsiderations regarding Cleanroom and Containment - different requiremtns of GMP (e.g. Annex 1) vs Containment - air locks in over or under pressure ( sink or bubble) - pressure loss, respecive air loss in GMP rooms and air locks - air tightness vs particle tightness based on system builds - operator protection always supersedes GMP

Agenda

  • requiremtns of GMP
  • air locks
  • pressure loss, respecive air

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