ASTM D5022 - 07

    Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use

    Active Standard ASTM D5022 | Developed by Subcommittee: D10.32

    Book of Standards Volume: 15.10


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    ASTM D5022

    Abstract

    This specification deals with identification of small volume containers of drugs intended to be diluted before parenteral administration such as container shape, labeling statements, vial closures and ampoule marking. Drugs in liquid form requiring dilution before parenteral administration shall not be packaged in containers that resemble a normal syringe. The design of such containers shall preclude direct intravenous line injection of the solution. The labels on each container shall bear the words dilute before use. Such black metal closures and black flip-off type caps and use of a black band or series of bands above the contracture on an ampoule shall only be used for Potassium Chloride for Injection Concentrate. With this, identification of such vials and ampoules shall be easy.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    1. Scope

    1.1 This specification deals with identification of small volume containers of drugs intended to be diluted before parenteral administration, as follows:

    1.1.1 Container shape,

    1.1.2 Labeling statements.

    1.1.3 Vial closures and Flip-Off, type caps, and

    1.1.4 Ampoule marking.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D996 Terminology of Packaging and Distribution Environments

    D4267 Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers

    D4775 Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)

    D7298 Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation


    ICS Code

    ICS Number Code 11.120.10 (Medicaments)

    UNSPSC Code

    UNSPSC Code


    DOI: 10.1520/D5022-07

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