Organization for Standardization (ISO) air cleanliness clas-sification of the compounding environment is a critical mea - sure that is affected by facility design. Primary Engineering …
<800> Hazardous Drugs—Handling in Healthcare Settings require the PEC and C-PEC to provide a unidirectional ISO Class 5 environment during the compounding of sterile preparations. 1,2 …
in Healthcare Settings, require that most sterile compounding be done within an ISO Class 5 primary engineering control (PEC) that is properly placed in a buffer area supported by an ante …
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to an ISO Class 5 PEC. l The USP Chapter <797> specifications in cleaning and disinfecting the sterile com-pounding areas, personnel training and competency evaluation of garbing, aseptic …
ISO Class 7 buffer room located within a cleanroom suite Alternatively, a pharmaceutical isolator (different type of engineering control than a CAI/CACI) can be placed in an ISO Class 8 …
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A PEC, commonly called a hood, is a type of engineering control. The room in which the hood is placed is called an SEC. 11.1-5 What does classified mean? Classified devices or rooms …
ISO Class 5 environment For use in a single patient for a single case/procedure/injection. Discard according to the time specified by the manufacturer for the opened vial or at the end of …
• If accessed in ISO 5 air quality or better, it may be assigned a BUD of 12 hours if stored according to manufacturer labeling for storage requirements. Does not apply to ampules (see …