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ASTM D5022-07

(Specification)

Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use (Withdrawn 2014)

Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use (Withdrawn 2014)

ABSTRACT
This specification deals with identification of small volume containers of drugs intended to be diluted before parenteral administration such as container shape, labeling statements, vial closures and ampoule marking. Drugs in liquid form requiring dilution before parenteral administration shall not be packaged in containers that resemble a normal syringe. The design of such containers shall preclude direct intravenous line injection of the solution. The labels on each container shall bear the words “dilute before use“. Such black metal closures and black flip-off type caps and use of a black band or series of bands above the contracture on an ampoule shall only be used for Potassium Chloride for Injection Concentrate. With this, identification of such vials and ampoules shall be easy.
SCOPE
1.1 This specification deals with identification of small volume containers of drugs intended to be diluted before parenteral administration, as follows:
1.1.1 Container shape,
1.1.2 Labeling statements.
1.1.3 Vial closures and Flip-Off, type caps, and
1.1.4 Ampoule marking.
WITHDRAWN RATIONALE
This specification dealt with identification of small volume containers of drugs intended to be diluted before parenteral administration.
Formerly under the jurisdiction of Committee D10 on Packaging, this specification was withdrawn in May 2014. This standard is being withdrawn without replacement due to its limited use by industry.

General Information

Status
Withdrawn
Publication Date
30-Sep-2007
Withdrawal Date
27-May-2014
ICS
11.120.10 - Medicaments
Technical Committee
D10 - Packaging
Current Stage
Ref Project

Relations

Replaces
ASTM D5022-95(2001) - Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use
Effective Date
01-Oct-2007

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ASTM D5022-07 - Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use (Withdrawn 2014)ASTM D5022-07 - Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use (Withdrawn 2014)
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ASTM D5022-07 - Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use (Withdrawn 2014)
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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:D5022 −07
StandardSpecification for
Identification of Vials and Ampoules Containing
1
Concentrated Solutions of Drugs to be Diluted Before Use
This standard is issued under the fixed designation D5022; 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 3.3 vial—a small, usually cylindrical, vessel capable of
closure, such as for medications, perfumes, essences, and
1.1 This specification deals with identification of small
samples.
volume containers of drugs intended to be diluted before
parenteral administration, as follows: 3.4 Description of Terms Specific to This Standard:
1.1.1 Container shape, 3.4.1 Flip-Off type cap—a plastic cap which must be re-
1.1.2 Labeling statements. movedtoexposetheinjectionportintheelastomeric and metal
2
1.1.3 Vial closures and Flip-Off, type caps, and vial closure.
1.1.4 Ampoule marking.
4. Requirements
2. Referenced Documents
4.1 Drugs in liquid form requiring dilution before parenteral
3
administration shall not be packaged in containers that re-
2.1 ASTM Standards:
semble a normal syringe. The design of such containers shall
D996 Terminology of Packaging and Distribution Environ-
preclude direct intravenous line injection of the solution.
ments
D4267 Specification for Labels for Small-Volume (100 mL
4.2 The labels on such containers (for example, vials and
or Less) Parenteral Drug Containers
ampoules) shall bear the words “Dilute Before Use”, or similar
D4775 Specification for Identification and Configuration of
warning, in type with initial capitals at least 2.5 mm in vertical
Prefilled Syringes and Delivery Systems for Drugs (Ex-
height (10 point or larger) in bold font in contrasting ink,
cluding Pharmacy Bulk Packages)
whenever space permits, preferably with a box printed in red
D7298 Test Method for Measurement of Comparative Leg-
(such as Pantone 805 or Warm Red). When copy space is not
ibility by Means of Polarizing Filter Instrumentation
sufficient for 10 point type, the warning shall be at least equal
2.2 Other Standards: in size to the name and strength designation of the drug.
4
Pantone Matching Systems Current Edition
4.3 Additional requirements specific for Potassium Chloride
for Injection Concentrate as Mandated by the United States
3. Terminology
5
Pharmacopeia, are as follows:
3.1 General definitions for packaging and distribution envi-
4.3.1 Immediately following the name, the label for Potas-
ronments are found in Terminology D996.
sium Chloride for Injection Concentrate shall bear the boxed
3.2 ampoule—a hermetically sealed, small bulbous glass or warning as shown in Fig. 1.
4.3.2 Vials containing potassium Chloride for Injection
plastic vessel; opening is achieved by breaking the stem (also
ampule or ampul). Concentrate shall be provided with a black metal closure
(overseal)withablackcap.Bothshallbearthewords“Mustbe
diluted” in legible type, in a color that stands out from its
1
This specification is under the jurisdiction of ASTM Committee D10 on
background (see Fig. 2).
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer,
4.3.3 Ampoules containing Potassium Chloride for Injec-
Pharmaceutical, Medical, and Child Resistant Packaging.
tion Concentrate shall be identified by a black band or series of
Current edition approved Oct. 1, 2007. Published October 2007. Originally
approved in 1989. Last previous edition approved in 2001 as D5022 – 95 (2001).
black bands above the constriction (see Fig. 3).
DOI: 10.1520/D5022-07.
4.3.4 Such black metal closures and black Flip-Off type
2
“Flip-Off” is a registered trademark of the West Pharmaceutical Services, 101
caps and use of a black band or series of bands above the
Gordon Dr., Lionville, PA 19341.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or constricture on an ampul shall only be used for Potassium
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Chloride for Injection Concentrate.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
4
5
Available from Pantone Inc., World Headquarters, 590 Commerce Blvd., USP 23/NF18 1995, pp. 1254, 1651, Available from USPC, Inc, Order
Carlstadt, NJ 07072–3098. Processing Dept., 12601 Twinbrook Parkway, Rockville, MD 20852.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
D5022−07
FIG. 1 Boxed Warning
FIG. 2 Vial Showing Black Flip-Off Type Cap and Black Closure
for Potassium Chloride for Injection Concentrate
FI
...

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