Fachapotheker In FPH Spital Practice Questions - Fachapotheker In FPH In Spitalpharmazie Pharmacien Ne Spécialiste FPH En Pharmacie Hospitalière Exam

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A hospital pharmacist is designing the layout for a new cleanroom suite intended for the central preparation of cytotoxic intravenous infusions in accordance with EU GMP / PIC/S Annex 1. Which configuration of airflow and pressure cascade is mandatory for the cytotoxic preparation area?

Grade A horizontal laminar airflow cabinet located in a Grade B background room maintained under positive pressure relative to surrounding corridors Grade A Class II Type A2 or Type B2 Biological Safety Cabinet (or negative pressure isolator) with 100% external air exhaust, located in a Grade B room under negative pressure relative to the adjacent airlocks Grade A open workbench situated in a Grade C cleanroom maintained under positive pressure with 100% air recirculation through HEPA filters Grade B turbulent airflow room without local containment enclosures, operating under equal atmospheric pressure relative to surrounding anterooms

Correct Answer:

Grade A Class II Type A2 or Type B2 Biological Safety Cabinet (or negative pressure isolator) with 100% external air exhaust, located in a Grade B room under negative pressure relative to the adjacent airlocks

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