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.
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, 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.

More Definitions of Segregated compounding area

Segregated compounding area means a designated, unclassified space, area, or room that contains a primary engineering control.
Segregated compounding area means a designated, unclassified space, area, or room that contains a primary engineer- ing control.
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 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.

Related to Segregated compounding area

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Bearing components means the bearing element, retainer, inner race, or outer race.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Exempt compound means the same as defined in Rule 2.

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • Recycled product means a product containing recovered material, or post-consumer recovered material, or both.

  • Landing area means that part of a movement area intended for the landing or take-off of aircraft;

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

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

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

  • Blood component means that part of blood separated by physical or mechanical means.

  • Accrual Components As specified in the Preliminary Statement.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Manufacturing Site means a location where a manufacturing

  • Nondesignated country end product means any end product that is not a U.S.-made end product or a designated country end product.

  • 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.

  • DRS/Profile means the system for the uncertificated registration of ownership of securities pursuant to which ownership of ADSs is maintained on the books of the Depositary without the issuance of a physical certificate and transfer instructions may be given to allow for the automated transfer of ownership between the books of DTC and the Depositary. Ownership of ADSs held in DRS/Profile is evidenced by periodic statements issued by the Depositary to the Holders entitled thereto.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

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  • 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;

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