ASTM D5022-95

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.

General Information

• Status: Historical
• Publication Date: 14-Sep-1995
• Technical Committee: D10 - Packaging

Relations

• Replaced By: ASTM D5022-95(2001) - Standard Specification for Identification of Vials and Ampoules Containing Concentrated Solutions of Drugs to be Diluted Before Use
• Effective Date: 15-Sep-1995

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.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