SOBRAFO Farmácia Oncológica Practice Questions - Título De Especialista Em Farmácia Oncológica (SOBRAFO CFF) Exam

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Under ANVISA RDC nº 220/2004 (Regulamento Técnico de Serviços de Terapia Antineoplásica), read together with the sterile-compounding requirements of RDC nº 67/2007 Anexo IV, which international cleanroom ISO classification applies to the inner work zone of the Biological Safety Cabinet (primary engineering control) and to the surrounding cleanroom preparation area (secondary engineering control), respectively?

ISO Class 5 (Grade A) inside the Biological Safety Cabinet and ISO Class 7 (Grade B/C) for the surrounding preparation cleanroom. ISO Class 7 inside the Biological Safety Cabinet and ISO Class 8 for the surrounding preparation cleanroom. ISO Class 4 inside the Biological Safety Cabinet and ISO Class 5 for the surrounding preparation cleanroom. ISO Class 8 inside the Biological Safety Cabinet and unclassified controlled air for the surrounding preparation cleanroom.

Correct Answer:

ISO Class 5 (Grade A) inside the Biological Safety Cabinet and ISO Class 7 (Grade B/C) for the surrounding preparation cleanroom.

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