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Qdossier Qsauri
"C"

closed isolator systems
Guideline or reference source
FDASDP Sterile drug products produced by asceptic processing - CGMP
Definition
exclude external contamination from the isolator’s interior by accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of openings to the surrounding environment. Closed systems remain sealed throughout operations.
Broader Term
isolator
Related Term
open isolator systems
 

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