ASTM D4267-2007(2015) Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers《小体积 (100 mL或者更少) 注射药物容器标签的标准规格》.pdf

1、Designation: D4267 07 (Reapproved 2015)Standard Specification forLabels for Small-Volume (100 mL or Less) Parenteral DrugContainers1This standard is issued under the fixed designation D4267; the number immediately following the designation indicates the year oforiginal adoption or, in the case of re

2、vision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the orientation, the size of typeused, and the contrast of the copy with

3、 the label background onimmediate drug containers having a volume of 100 mL or less.1.2 The values stated in SI units are to be regarded as thestandard. The values given in parentheses are for informationonly.2. Referenced Documents2.1 ASTM Standards:2D7298 Test Method for Measurement of Comparative

4、 Leg-ibility by Means of Polarizing Filter Instrumentation3. Terminology3.1 Definitions:3.1.1 established namethe designated name or officialname (commonly referred to as generic name).3.1.2 immediate containerthat which is in direct contactwith the article at all times.33.1.3 labela display of writ

5、ten, printed, or graphic matterupon the immediate container of any article.43.1.4 labelingall labels and other written, printed, orgraphic matter (1) upon any article or any of its containers orwrappers, or (2) accompanying such article53.1.5 proprietary namemanufacturers trade or brandname.4. Label

6、 Requirements4.1 Contents of LabelThe label shall consist of the fol-lowing:4.1.1 Proprietary name of drug (optional).4.1.2 Established name of drug (required). Printing theactive moiety of the established name in accordance with 6.1shall suffice, example, GENTAMICIN Sulfate Inj).4.1.3 Amount of dru

7、g per unit (for example, milligrams permillilitre (mg per mL) or quantity of drug per container asappropriate).4.1.4 For liquids, the total volume of the contents shall bemarked in a legible manner.4.1.5 Other information as required by regulation and themanufacturer.4.2 GeneralManufacturers are enc

8、ouraged to use accept-able abbreviations (for example, HCl for hydrochloride) andminimize the use or size of other copy (for example, brand of,USP solution, injection) or unrequired punctuation (such asmg. versus mg) where label space is critical.5. Significance and Use5.1 Medication errors by users

9、 sometimes occur due todifficulty in reading or understanding drug container labels.The objective of this specification is to facilitate correct drugproduct identification. It does not absolve the user from theduty to read the label and correctly identify the drug productprior to use.6. Type Size Re

10、quirements6.1 The type size of the print used for the proprietary nameor established name of the drug and the numerals indicating theamount of drug per unit shall be as large as possible.6.1.1 On containers larger than 2 mL, the vertical height ofcapitals and numerals used for these items should be

11、at least2.5-mm (10-point or larger) type.6.1.2 On containers of 2 mL or less, the vertical height ofcapitals and numerals for these items should be at least 1.5-mm(6-point or larger) type.1This specification is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility

12、 of Subcommittee D10.32 on Consumer,Pharmaceutical, Medical, and Child Resistant Packaging.Current edition approved Oct. 1, 2015. Published October 2015. Originallyapproved in 1983. Last previous edition approved in 2007 as D4267 07. DOI:10.1520/D4267-07R15.2For referenced ASTM standards, visit the

13、ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3United States Pharmacopeia, U.S. Pharmaceutical Convention, Inc. (USPC),Order Processing Dept., 12601

14、Twinbrook Parkway, Rockville, MD, 20852, USP23/NF 18, 1995, p. 10.4Federal Food, Drug, and Cosmetic Act, Section 201(k); and USP 23/NF 18,1995, p. 11. Available from U.S. Government Printing Office, Washington, DC20402.5Federal Food, Drug, and Cosmetic Act, Section 201(m); and USP 23/NF 18,1995, p.

15、11.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States16.2 LegibilityIn all cases the type used for these itemsshall be bold enough to satisfy the legibility test (see 9.1).7. Orientation Requirements7.1 The copy required for proprietary

16、name, or establishedname of drug, and amount of drug per unit (4.1.1, 4.1.2, and4.1.3) shall be printed parallel to the long axis of the container.The left-hand margin of the copy shall start from the base endof the container so that it can be read while the top is held inthe right hand (see Fig. 1)

17、. In prefilled syringes, the copy shallstart flush with, and read from, the needle end (see Fig. 2).7.2 Alternatively, if the proprietary name and establishedname of drug, and amount of drug per unit (4.1.1, 4.1.2, and4.1.3) can be printed within 180 around the circumference ofthe container, the cop

18、y may be printed at right angles (perpen-dicular) to the long axis of the container (see Fig. 3).8. Legibility Requirements8.1 ContrastTo enhance legibility, manufacturers shallprovide contrast between the type used for the proprietaryname and established name of drug, and amount of drug perunit (4.

19、1.1, 4.1.2, and 4.1.3) and either the immediate drugcontainer or an added opaque label background sufficient tomeet 9.1. An opaque label background that does not preventinspection of contents is preferred when feasible. Use of pastelshades such as pink, green, brown, or gray for copy, and otherof th

20、ese shades for background, shall be avoided.8.2 Patient Care FacilitiesPatient care facilities shallprovide enhanced lighting and a black-and-white contrastbackground card in areas where drug product labels must beread.9. Legibility Test9.1 The copy for the proprietary name or established nameof dru

21、g, and amount of drug per unit (4.1.1 or 4.1.2 and 4.1.3)shall be determined to be legible utilizing the preferred methodfor determining legibility as specified in Test Method D7298.9.2 The alternative method for determining legibility of thecopy for proprietary name or established name of drug, and

22、amount of drug per unit (4.1.1 or 4.1.2 and 4.1.3) shall beconducted by placing the substrate containing the copy in alight of 215 lx (lux) (20-fc (foot candles) at a distance of 500mm (19.7 in.) and having a person with 20/30 unaided orcorrected vision attempt to read this copy. A contrastingbackgr

23、ound may be used.10. Keywords10.1 container; contrast; label; label content; legibility;legibility test; parenteral drug; type sizeFIG. 1 Copy Printed Parallel to Long Axis of ContainerFIG. 2 Copy Printed From Needle End of SyringeFIG. 3 Copy Printed at Right Angles to Long Axis of ContainerD4267 07

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