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ASTM D4775-04

(Specification)

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

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

ABSTRACT
This specification covers the identification of: drug contained in the prefilled syringe or delivery sysetm and the concentration, volume, and total amount of the drug, and whether it is to be diluted prior to administration. The label copy shall comply with the specified requirements. Delivery systems shall not resemble a normal syringe and shall be unsuitable for direct intravenous line injection. The copy for the proprietary name or established name of the drug shall be legible in accordance with the legibility test.
SCOPE
1.1 This specification covers the identification of:
1.1.1 The drug contained in the prefilled syringe or delivery system.
1.1.2 The concentration, volume, and total amount of the drug, and whether it is to be diluted prior to administration.

General Information

Status
Historical
Publication Date
31-Mar-2004
ICS
55.180.40 - Complete, filled transport packages
Technical Committee
D10 - Packaging
Current Stage
Ref Project

Relations

Replaces
ASTM D4775-94(1999) - Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
Effective Date
01-Apr-2004
Replaced By
ASTM D4775/D4775M-09 - Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
Effective Date
01-Oct-2009

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ASTM D4775-04 - Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)ASTM D4775-04 - Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
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ASTM D4775-04 - Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: D 4775 – 04
Standard Specification for
Identification and Configuration of Prefilled Syringes and
Delivery Systems for Drugs (Excluding Pharmacy Bulk
1
Packages)
This standard is issued under the fixed designation D 4775; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This specification covers the identification of:
1.1.1 The drug contained in the prefilled syringe or delivery
FIG. 1 Label on Syringe Type Shown
system.
1.1.2 The concentration, volume, and total amount of the
drug, and whether it is to be diluted prior to administration.
they have been removed from their cartons. The objective of
this specification is to facilitate identification of the drug, its
2. Referenced Documents
concentration, volume, and total amount.
2
2.1 ASTM Standards:
4.2 Difficulties have also occurred in distinguishing be-
D 996 Terminology of Packaging and Distribution Environ-
tween syringes containing drugs ready for intravenous injec-
ments
tion and similar syringes containing solutions which must be
D 4267 Specification for Labels for Small-Volume (Less
diluted before use. An objective of this specification is to
than 100 mL) Parenteral Drug Containers
minimize the chance for such errors.
3. Terminology
5. Label Requirements
3.1 General definitions for packaging and distribution envi-
5.1 Label copy shall comply with Specification D 4267 and
ronments are found in Terminology D 996.
shall include the information required by regulation and by the
3.2 Definitions of Terms Specific to This Standard:
manufacturer. In addition the requirements of the following
3.2.1 delivery system—as used in this specification,a
sections shall apply.
closed system consisting of a container of concentrated solu-
5.2 In syringes of the type shown in Fig. 1, 10-point or
tionorpowderwhichfacilitatesthetransferofthecontentsinto
larger type is preferred for the drug name and the amount of
a diluent prior to administration or use.
drug per millilitre, or total amount as appropriate. This type
3.2.2 pharmacy bulk package—drug supplied in a stock
shallsatisfythetestforlegibilityin7.1,butatadistanceof500
container to be held in the pharmacy and used for multiple
mm (19.7 in.). This information shall be legible with minimal
dispensing.
rotation of the immediate drug container.
3.2.3 syringe—an instrument by means of which drugs in
5.3 In syringes of the type in Fig. 2, where the immediate
solution or other liquids are injected into or withdrawn from
drug container is fitted into the syringe barrel, the drug name,
any vessel or cavity.
concentration, and total volume shall appear as close to the
extreme right hand end of the drug container—that is, the
4. Significance and Use
opposite end to the needle—as possible, in bold type, in height
4.1 Difficulties have occurred in the correct identification of
at least equal to one ninth of the external circumference of the
syringes containing significantly different medications once
container up to a maximum of 10 mm.
5.3.1 Theopaquebackgroundofthesetwolinesoftextshall
1
This specification is under the jurisdiction of ASTM Committee D10 on
not exceed one third of the circumference of the container.
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer
Thereshallbegoodcontrastbetweenthetypeusedforthedrug
Packages.
name, concentration, and total volume, and either the drug
Current edition approved April 1, 2004. Published May 2004. Originally
approved in 1988. Last previous edition approved in 1994 as D 4775 – 94 (1999).
container or an added opaque label background sufficient to
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
conform with Section 7.The name of the drug on the container
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
shall be legible through the barrel during preparation and use
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. sufficient to conform with Section 7.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
D4775–04
a delivery system designed to facilitate the addition of the
powder to the container of parenteral solution. If supplied as a
concentrated solution, the immediate container shall not allow
the use of a standard syringe to transfer the concentrated
FIG. 2 Label on Syringe Type Shown
solution to a container of parenteral solution.
6.2 The drug container shall be labelled “Dilute Before
Use” or other appropriate warning,
...

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