PDA Letter Article

Isolator Surfaces and Contamination Risks to Personnel

by Richard Denk, SKAN AG, Andreas Flueckinger, MD, Roche, Hirokazu Kisaka, Takeda, Reinhold Maeck, PhD, Boehringer Ingelheim, Lars Restetzki, PhD, Roche, Andreas Schreiner, PhD, Novartis, Rico Schulze, Landesdirektion Sachsen

GMP Cleaning Requirements for Nonproduct Contact Surfaces

Operator Equiped with air samplers

When it comes to protection of cleanroom personnel and product, the possibility for contamination both within and outside an isolator exists.