ASTM D4775-94(1999)

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

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-Dec-1998
• ICS: 55.180.40 - Complete, filled transport packages
• Technical Committee: D10 - Packaging

Relations

• Replaced By: ASTM D4775-04 - Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
• Effective Date: 01-Apr-2004

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 – 94 (Reapproved 1999)
Standard Specification for
Identification and Configuration of Prefilled Syringes and
Delivery Systems for Drugs (Excluding Pharmacy Bulk
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
system.
1.1.2 The concentration, volume, and total amount of the
FIG. 1 Label on TUBEX Type Syringe
drug, and whether it is to be diluted prior to administration.
(“TUBEX” is a registered trademark of Wyeth Laboratories.)
2. Referenced Documents
4.2 Difficulties have also occurred in distinguishing be-
2.1 ASTM Standards:
tween syringes containing drugs ready for intravenous injec-
D 996 Terminology of Packaging and Distribution Environ-
tion and similar syringes containing solutions which must be
ments
diluted before use. An objective of this specification is to
D 4267 Specification for Labels for Small-Volume (Less
minimize the chance for such errors.
than 100 mL) Parenteral Drug Containers
5. Label Requirements
3. Terminology
5.1 Label copy shall comply with Specification D 4267 and
3.1 General definitions for packaging and distribution envi-
shall include the information required by regulation and by the
ronments are found in Terminology D 996.
manufacturer. In addition the requirements of the following
3.2 Definitions of Terms Specific to This Standard:
sections shall apply.
3.2.1 delivery system—as used in this specification,a
5.2 In syringes of the type shown in Fig. 1 and Fig. 2,
closed system consisting of a container of concentrated solu-
10-point or larger type is preferred for the drug name and the
tion or powder which facilitates the transfer of the contents into
amount of drug per millilitre, or total amount as appropriate.
a diluent prior to administration or use.
This type shall satisfy the test for legibility in 7.1, but at a
3.2.2 pharmacy bulk package—drug supplied in a stock
distance of 500 mm (19.7 in.). This information shall be legible
container to be held in the pharmacy and used for multiple
with minimal rotation of the immediate drug container.
dispensing.
5.3 In syringes of the type in Fig. 3, where the immediate
3.2.3 syringe—an instrument by means of which drugs in
drug container is fitted into the syringe barrel, the drug name,
solution or other liquids are injected into or withdrawn from
concentration, and total volume shall appear as close to the
any vessel or cavity.
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
at least equal to one ninth of the external circumference of the
4.1 Difficulties have occurred in the correct identification of
container up to a maximum of 10 mm.
syringes containing significantly different medications once
5.3.1 The opaque background of these two lines of text shall
they have been removed from their cartons. The objective of
not exceed one third of the circumference of the container .
this specification is to facilitate identification of the drug, its
There shall be good contrast between the type used for the drug
concentration, volume, and total amount.
name, concentration, and total volume, and either the drug
This specification is under the jurisdiction of ASTM Committee D-10 on
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer
Packages.
FIG. 2 Label on Tel-E-Ject Type Syringe
Current edition approved March 15, 1994. Published May 1994. Originally
published as D 4775 – 88. Last previ
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