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 is less particle-generating than nonsterile, and compounders sanitize after preparing each batch of CSPs. There is greater risk of cross-contamination from particle-generation for nonsterile compounding.

  • Additional USP chapters incorporated by reference into USP Chapter 795 shall also be followed.[ARC 2194C, IAB 10/14/15, effective 11/18/15] 657—20.4(124,126,155A) Sterile compounding.

  • Sterile compounding facilities must be designed, outfitted, and maintained properly to minimize the risk of contamination of CSPs. The required air quality must be achieved and maintained through PECs and secondary engineering controls (SECs).

  • Sterile compounding facilities must be designed to minimize the risk of airborne contamination of the area in which sterile compounding occurs.

  • New Rule Yes No Revised Filing 9/8/2019 4729:7-2-02 Sterile compounding exemptions.New Rule Yes No Revised Filing 9/8/2019 4729:7-2-03 Drugs compounded in a pharmacy.

  • Sterile compounding facilities must develop and implement written procedures for microbiological air and surface monitoring (see 17.

  • Additional USP chapters incorporated by reference into USP Chapter 795 shall also be followed.[ARC 2194C, IAB 10/14/15, effective 11/18/15]657—20.4(124,126,155A) Sterile compounding.

  • Sterile compounding differs from nonsterile compounding (see PharmaceuticalCompounding—Nonsterile Preparations 795 and Good Compounding Practices 1075 ) primarily by requiring a test for sterility.

  • Wine lists are effectively bought, and retailers will only deal exclusively with particular vineyards.

  • Sterile compounding shall be performed by qualified pharmacy personnel in a supporting SCC while one SCC is compromised.


More Definitions of Sterile compounding

Sterile compounding means compounding of biologics, diagnostics, drugs, nutrients, and
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Sterile compounding means compounding of biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797, must be sterile when administered to patients prepared using aseptic techniques.
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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, 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 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

  • 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.

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

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

  • Licensed Product means any pharmaceutical product that contains a Licensed Compound, either alone or with one or more other pharmaceutical ingredients, and including all formulations, line extensions and modes of administration thereof.

  • 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 reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

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

  • 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.

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.