ASTM D4775/D4775M-09(2014)
(Specification)Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages) (Withdrawn 2022)
Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages) (Withdrawn 2022)
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.
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
Note 1: The values in SI units are the recommended values.
WITHDRAWN RATIONALE
This specification covers the identification of the drug contained in the prefilled syringe or delivery system and the concentration, volume, and total amount of the drug, and whether it is to be diluted prior to administration.
Formerly under the jurisdiction of Committee F02 on Flexible Barrier Packaging, this specification was withdrawn in August 2022 because of limited use by industry.
General Information
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:D4775/D4775M −09 (Reapproved 2014)
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 D4775/D4775M; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope tionorpowderwhichfacilitatesthetransferofthecontentsinto
a diluent prior to administration or use.
1.1 This specification covers the identification of:
3.2.2 pharmacy bulk package—drug supplied in a stock
1.1.1 The drug contained in the prefilled syringe or delivery
system. container to be held in the pharmacy and used for multiple
dispensing.
1.1.2 The concentration, volume, and total amount of the
drug, and whether it is to be diluted prior to administration.
3.2.3 syringe—an instrument by means of which drugs in
solution or other liquids are injected into or withdrawn from
1.2 The values stated in either SI units or inch-pound units
any vessel or cavity.
are to be regarded separately as standard. The values stated in
each system may not be exact equivalents; therefore, each
4. Significance and Use
system shall be used independently of the other. Combining
values from the two systems may result in non-conformance
4.1 Difficulties have occurred in the correct identification of
with the standard.
syringes containing significantly different medications once
they have been removed from their cartons. The objective of
NOTE 1—The values in SI units are the recommended values.
this specification is to facilitate identification of the drug, its
concentration, volume, and total amount.
2. Referenced Documents
2
2.1 ASTM Standards: 4.2 Difficulties have also occurred in distinguishing be-
tween syringes containing drugs ready for intravenous injec-
D996 Terminology of Packaging and Distribution Environ-
ments tion and similar syringes containing solutions which must be
diluted before use. An objective of this specification is to
D4267 Specification for Labels for Small-Volume (100 mL
or Less) Parenteral Drug Containers minimize the chance for such errors.
D7298 Test Method for Measurement of Comparative Leg-
ibility by Means of Polarizing Filter Instrumentation 5. Label Requirements
5.1 Label copy shall comply with Specification D4267 and
3. Terminology
shall include the information required by regulation and by the
3.1 General definitions for packaging and distribution envi- manufacturer. In addition, the requirements of the following
ronments are found in Terminology D996. sections shall apply.
3.2 Definitions of Terms Specific to This Standard: 5.2 In syringes of the type shown in Fig. 1, 10-point or
3.2.1 delivery system—as used in this specification,a
larger type is preferred for the drug name and the amount of
closed system consisting of a container of concentrated solu- drug per millilitre, or total amount as appropriate. This type
shallsatisfythetestforlegibilityin7.1,butatadistanceof500
mm [19.7 in.]. This information shall be legible with minimal
rotation of the immediate drug container.
1
This specification is under the jurisdiction of ASTM Committee F02 on
Flexible Barrier Packaging and is the direct responsibility of Subcommittee F02.50
5.3 In syringes of the type in Fig. 2, where the immediate
on Package Design and Development.
drug container is fitted into the syringe barrel, the drug name,
Current edition approved Oct. 1, 2014. Published November 2014. Originally
concentration, and total volume shall appear as close to the
approved in 1988. Last previous edition approved in 2009 as D4775/D4775M – 09.
DOI: 10.1520/D4775_D4775M-09R14.
extreme right hand end of the drug container—that is, the
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
opposite end to the needle—as possible, in bold type, in height
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
at least equal to one ninth of the external circumference of the
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. container up to a maximum of 10 mm.
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D4775/D4775M−09 (2014)
FIG. 1 Label on Syringe Type Shown
FIG. 3 Label on Delivery System with Spike
6.2 The drug container shall be labelled “Dilute Before
Use” or other appropriate warning, in at least 10-point bold
FIG. 2 Label on Syringe Type Shown
type in dark ink, whenever space permits, preferably within a
red fluorescent box, suc
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