ASTM D4775/D4775M-09
(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.
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.
General Information
Relations
Buy Standard
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
StandardSpecification 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 D10 on
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer,
5.3 In syringes of the type in Fig. 2, where the immediate
Pharmaceutical and Medical Packaging.
drug container is fitted into the syringe barrel, the drug name,
Current edition approved Oct. 1, 2009. Published October 2009. Originally
concentration, and total volume shall appear as close to the
approved in 1988. Last previous edition approved in 2004 as D4775 – 04. DOI:
10.1520/D4775_D4775M-09.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
D4775/D4775M−09
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
FIG. 2 Label on Syringe Type Shown Use” or other appropriate warning, in at least 10-point bold
type in dark ink, whenever space permits, preferably within a
red fluorescent box, such as Pantone 805 (see Fig. 3).
5.3.1 T
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:D4775–04 Designation: D 4775/D 4775M – 09
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/D 4775M; 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
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.
2. Referenced Documents
2
2.1 ASTM Standards:
D 996 Terminology of Packaging and Distribution Environments
D 4267 Specification for Labels for Small-Volume (Less than 100 mL) Parenteral Drug Containers Specification for Labels for
Small-Volume (100 mL or Less) Parenteral Drug Containers
D 7298 Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation
3. Terminology
3.1 General definitions for packaging and distribution environments are found in Terminology D 996.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 delivery system—as used in this specification, a closed system consisting of a container of concentrated solution or
powder which facilitates the transfer of the contents into a diluent prior to administration or use.
3.2.2 pharmacy bulk package—drug supplied in a stock container to be held in the pharmacy and used for multiple dispensing.
3.2.3 syringe—an instrument by means of which drugs in solution or other liquids are injected into or withdrawn from any
vessel or cavity.
4. Significance and Use
4.1 Difficulties have occurred in the correct identification of syringes containing significantly different medications once they
have been removed from their cartons.The objective of this specification is to facilitate identification of the drug, its concentration,
volume, and total amount.
4.2 Difficulties have also occurred in distinguishing between syringes containing drugs ready for intravenous injection and
similar syringes containing solutions which must be diluted before use.An objective of this specification is to minimize the chance
for such errors.
5. Label Requirements
5.1 Label copy shall comply with Specification D 4267 and shall include the information required by regulation and by the
manufacturer. In addition, the requirements of the following sections shall apply.
5.2 In syringes of the type shown in Fig. 1, 10-point or larger type is preferred for the drug name and the amount of drug per
1
This specification is under the jurisdiction of ASTM Committee D10 on Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer Packages .
Current edition approved April 1, 2004. Published May 2004. Originally approved in 1988. Last previous edition approved in 1994 as D4775–94 (1999).on Consumer,
Pharmaceutical and Medical Packaging.
Current edition approved Oct. 1, 2009. Published October 2009. Originally approved in 1988. Last previous edition approved in 2004 as D 4775 – 04.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
D 4775/D 4775M – 09
FIG. 1 Label on Syringe Type Shown
millilitre, or total amount as appropriate. This type shall satisfy the test for legibility in 7.1, but at a distance of 500 mm (19.7
in.).[19.7 in.]. This information shall be legible with minimal rotation of the immediate drug container.
5.3 In syringes of the type in Fig. 2, where the immediate drug container is fitted into the syringe barrel, the drug name,
concentration, and total volume shall a
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.