Sterile compounding definition

Sterile compounding means the aseptic processing in a clean air environment of any pharmaceutical preparations that are required to be sterile when they are administered into patient body cavities, central nervous and vascular systems, eyes, and joints, and when used as baths for live organs and tissues, including by not limited to injections (e.g., colloidal dispersions, emulsions, solutions, and suspensions), aqueous bronchial and nasal inhalations, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.
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Sterile compounding means any manipulation of a sterile or non-sterile product intended to produce a sterile final product.
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Sterile compounding means compounding of biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797 Standards, are prepared using aseptic techniques.
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Examples of Sterile compounding in a sentence

  • Sterile compounding shall be performed in a separate area in compliance with ARTICLE XXVIII of these regulations.

  • Sterile compounding shall be performed with a laminar flow hood or other appropriate environmental control device capable of maintaining, during normal activity, at least Class 100 conditions in the work area where sterile compounding is performed.

  • Sterile compounding shall not continue when repeated above action level results occur in primary engine controls or ISO 7 or lower rooms.

  • Sterile compounding areas and critical areas must be structurally isolated from other areas designated to avoid unnecessary traffic and airflow disturbances, separate from nonsterile compounding areas, and restricted to qualified compounding personnel.

  • Sterile compounding in anticipation of future prescription drug or medication orders must be based upon a history of receiving valid prescriptions issued within an established pharmacist/patient/prescriber relationship, provided that in the pharmacist's professional judgment the quantity prepared is stable for the anticipated shelf time.

  • Sterile compounding must be performed in a separate area in compliance with Section 40‑43‑88.

  • Sterile compounding areas and critical areas must be structurally isolated from other areas designated to avoid unnecessary traffic and airflow disturbances according to USP chapter 797, separate from nonsterile compounding areas, and restricted to qualified compounding personnel.

  • Sterile compounding shall be performed within a laminar flow hood or other appropriate environmental control device capable of maintaining, during normal activity, at least Class 100 conditions in the work area where sterile compounding is performed.

  • Sterile compounding differs from nonsterile compounding primarily by requiring the maintenance of sterility when preparations are compounded exclusively with sterile ingredients and components and by requiring the achievement of sterility when preparations are compounded with nonsterile ingredients and components.

  • Sterile compounding Student Resources and Support Services Financial Aid/ScholarshipsThe Financial Aid Office at WVC is available to assist students in finding and applying for all types of financial assistance, including grants, work study opportunities, veteran benefits, scholarships, and student loans.


More Definitions of Sterile compounding

Sterile compounding means compounding of biologics, diagnostics, drugs, nutrients, and
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Sterile compounding means the aseptic processing in a clean air environment of any pharmaceutical including, but not limited to, the following preparations that are required to be sterile when they are administered to patients: baths and soaks for live organs and tissues, into patient body cavities, central nervous and vascular systems, eyes, and joints, and when used as baths for live organs and tissues, including by not limited to injections (e.g., colloidal dispersions, emulsions, solutions, and suspensions), aqueous bronchial and nasal inhalations, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.ITEM 3. Amend rule 657—13.11(155A) as follows: 657—13.11(155A) Low-risk preparations and low-risk preparations with 12-hour or less beyond-use date. 13.11(1) Conditions defined—low-risk preparations. Preparations compounded under all of the followingconditions are at a low risk of contamination.
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Related to Sterile compounding

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

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • 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:

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Licensed Compound means [***].

  • 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.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • 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)).

  • 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.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • SONIA Compounded IndexStart means, with respect to an Interest Accrual Period, the SONIA Compounded Index determined in relation to the day falling the Relevant Number of London Banking Days prior to the first day of such Interest Accrual Period; and

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • 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.

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

  • SONIA Compounded IndexEnd means the SONIA Compounded Index Value on the date falling “p” London Business Days prior to (i) in respect of an Interest Accrual Period, the Interest Payment Date for such Interest Accrual Period, or (ii) if the Notes become due and payable prior to the end of an Interest Accrual Period, the date on which the Notes become so due and payable; and

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • API means the American Petroleum Institute.

  • 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.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.