Segregated compounding area definition

Segregated compounding area means a designated space, demarcated area or room, that is restricted to preparing low-risk level CSPs with a BUD of 12 hours or less. Such area shall contain a device that provides an ISO Class 5 air quality and shall be void of activities and materials that are extraneous to sterile compounding.
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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.
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Segregated compounding area means a designated, unclassified space, area, or room that contains a primary engineering control.
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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.
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Segregated compounding area means a designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSP’s with twelve (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.
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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.
Sample 1Sample 2
Segregated compounding area means a designated, unclassified space, area, or room that contains a primary engineer- ing control.
Sample 1
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.
Sample 1
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.
Sample 1

Related to Segregated compounding area

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Compound means the taking of two or more ingredients and fabricating them into a single

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Removed Components means components of the Project or portions thereof which the Company or any Sponsor Affiliate in its sole discretion, elects to remove from the Project pursuant to Section 4.04 hereof or as a result of any Condemnation Event.

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;

  • Semi-annual (2/Year) sampling frequency means the sampling shall be done during the months of June and December, unless specifically identified otherwise.