ASTM D5022-95(2001)
(Specification)Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use
Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use
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.
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 5022 – 95 (Reapproved 2001)
Standard Specification 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 D 5022; 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 3.4.1 Flip-Off type cap—a plastic cap which must be
removed to expose the injection port in the elastomeric and
1.1 This specification deals with identification of small
metal vial closure.
volume containers of drugs intended to be diluted before
parenteral administration, as follows:
4. Requirements
1.1.1 Container shape,
4.1 Drugs in liquid form requiring dilution before parenteral
1.1.2 Labeling statements.
2 administration shall not be packaged in containers that re-
1.1.3 Vial closures and Flip-Off, type caps, and
semble a normal syringe. The design of such containers shall
1.1.4 Ampoule marking.
preclude direct intravenous line injection of the solution.
2. Referenced Documents 4.2 The labels on such containers (for example, vials and
3 ampoules) shall bear the words “Dilute Before Use”, or similar
2.1 ASTM Standards:
warning, in type with initial capitals at least 2.5 mm in vertical
D 996 Terminology of Packaging and Distribution Environ-
height (10 point or larger) in bold font in contrasting ink,
ments
whenever space permits, preferably with a box printed in red
D 4267 Specification for Labels for Small-Volume (100 mL
(such as Pantone 805 or Warm Red). When copy space is not
or Less) Parenteral Drug Containers
sufficient for 10 point type, the warning shall be at least equal
D 4775 Specification for Identification and Configuration of
in size to the name and strength designation of the drug.
Prefilled Syringes and Delivery Systems for Drugs (Ex-
4.3 AdditionalrequirementsspecificforPotassiumChloride
cluding Pharmacy Bulk Packages)
for Injection Concentrate as Mandated by the United States
2.2 Other Standards:
5
4
Pharmacopeia, are as follows:
Pantone Matching Systems Current Edition
4.3.1 Immediately following the name, the label for Potas-
3. Terminology sium Chloride for Injection Concentrate shall bear the boxed
warning as shown in Fig. 1.
3.1 General definitions for packaging and distribution envi-
4.3.2 Vials containing potassium Chloride for Injection
ronments are found in Terminology D 996.
Concentrate shall be provided with a black metal closure
3.2 ampoule—a hermetically sealed, small bulbous glass or
(overseal)withablackcap.Bothshallbearthewords“Mustbe
plastic vessel; opening is achieved by breaking the stem (also
diluted” in legible type, in a color that stands out from its
ampule or ampul).
background (see Fig. 2).
3.3 vial—a small, usually cylindrical, vessel capable of
4.3.3 Ampoules containing Potassium Chloride for Injec-
closure, such as for medications, perfumes, essences, and
tion Concentrate shall be identified by a black band or series of
samples.
black bands above the constriction (see Fig. 3).
3.4 Description of Term Specific to This Standard:
4.3.4 Such black meta
...
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