Segregated compounding area definition
Segregated compounding area means a designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSP’s with 12-hour or less BUD. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of CSP’s and shall be void of activities and materials that are extraneous to sterile compounding.
Segregated compounding area means a designated space, either a demarcated area or room, which is restricted to preparing low-risk preparations with 12-hour or less beyond-use date. A segregated compounding area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for the compounding of sterile preparations and shall be void of activities and materials that are extraneous to sterile compounding.
Segregated compounding area means a designated, unclassified space, area, or room that contains a primary engineering control.
More Definitions of Segregated compounding area
Segregated compounding area means a designated, demarcated area or room that is restricted to compounding low-risk sterile preparations, which shall contain a primary engineering control providing unidirectional airflow that maintains an ISO class five environment and shall be void of all activities and materials extraneous to the sterile compounding process.
Segregated compounding area means a designated room or area within a room that is restricted to preparing non-hazardous, low-risk level CSPs with 12-hour or less BUD. Such rooms shall contain a device that provides unidirectional airflow of ISO Class 5 air quality and shall be void of activities and materials that are extraneous to sterile compounding.
Segregated compounding area means a designated, unclassified space, area, or room that contains a primary engineer- ing control.
Segregated compounding area means a designated space, either a demarcated area or room, which is restricted to preparing Low-Risk Level compounded sterile preparations with twelve (12) hour or less BUD. The area must contain a device that provides Unidirectional Flow of ISO Class 5 air quality and shall be void of activities and materials that are extraneous to sterile compounding.
Segregated compounding area means a designated space, either a demarcated area or room, that is restricted to preparing sterile-to-sterile compounded sterile products with a 12- hour or less beyond use date. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of compounded sterile products and shall be void of activities and materials that are extraneous to sterile compounding.