ASTM_D_5022_-_95_2001.pdf

Designation:D 5022 95(Reapproved 2001)Standard Specification forIdentification of Vials and Ampoules ContainingConcentrated Solutions of Drugs to be Diluted Before Use1This standard is issued under the fixed designation D 5022;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification deals with identification of smallvolume containers of drugs intended to be diluted beforeparenteral administration,as follows:1.1.1 Container shape,1.1.2 Labeling statements.1.1.3 Vial closures and Flip-Off,2type caps,and1.1.4 Ampoule marking.2.Referenced Documents2.1 ASTM Standards:D 996 Terminology of Packaging and Distribution Environ-ments3D 4267 Specification for Labels for Small Volume(Lessthan 100 mL)Parenteral Drug Containers3D 4775 Specification for Identification and Configuration ofPrefilled Syringes and Delivery Systems for Drugs(Ex-cluding Pharmacy Bulk Packages)32.2Other Standards:Pantone Matching Systems Current Edition43.Terminology3.1 General definitions for packaging and distribution envi-ronments are found in Terminology D 996.3.2 ampoulea hermetically sealed,small bulbous glass orplastic vessel;opening is achieved by breaking the stem(alsoampule or ampul).3.3 viala small,usually cylindrical,vessel capable ofclosure,such as for medications,perfumes,essences,andsamples.3.4 Description of Term Specific to This Standard:3.4.1 Flip-Off type capa plastic cap which must beremoved to expose the injection port in the elastomeric andmetal vial closure.4.Requirements4.1 Drugs in liquid form requiring dilution before parenteraladministration shall not be packaged in containers that re-semble a normal syringe.The design of such containers shallpreclude direct intravenous line injection of the solution.4.2 The labels on such containers(for example,vials andampoules)shall bear the words“Dilute Before Use”,or similarwarning,in type with initial capitals at least 2.5 mm in verticalheight(10 point or larger)in bold font in contrasting ink,whenever space permits,preferably with a box printed in red(such as Pantone 805 or Warm Red).When copy space is notsufficient for 10 point type,the warning shall be at least equalin size to the name and strength designation of the drug.4.3 Additional requirements specific for Potassium Chloridefor Injection Concentrate as Mandated by the United StatesPharmacopeia,5are as follows:4.3.1 Immediately following the name,the label for Potas-sium Chloride for Injection Concentrate shall bear the boxedwarning as shown in Fig.1.4.3.2 Vials containing potassium Chloride for InjectionConcentrate shall be provided with a black metal closure(overseal)with a black cap.Both shall bear the words“Must bediluted”in legible type,in a color that stands out from itsbackground(see Fig.2).4.3.3 Ampoules containing Potassium Chloride for Injec-tion Concentrate shall be identified by a black band or series ofblack bands above the constriction(see Fig.3).4.3.4 Such black metal closures and black Flip-Off typecaps and use of a black band or series of bands above theconstricture on an ampul shall only be used for PotassiumChloride for Injection Concentrate.5.Significance and Use5.1 Accidents continue to occur due to the users inability toeasily identify vials and ampoules containing concentratedsolutions of drugs which must be diluted before parenteraladministration.The objective of this specification is to facili-tate easy identification of such vials and ampoules.6.Legibility Test6.1 The copy for the proprietary name or established name1This specification is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on ConsumerPackages.Current edition approved Sept.10,1995.Published March 1996.Originallypublished as D 5022 89.Last previous edition D 5022 89.2“Flip-Off”is a registered trademark of the West Company.3Annual Book of ASTM Standards,Vol 15.09.4Available from Pantone Inc.,55 Knickerbocker Rd.,Moonachie,NJ 07074.5USP 23/NF18 1995,pp.1254,1651,Available from USPC,Inc,OrderProcessing Dept.,12601 Twinbrook Parkway,Rockville,MD 20852.1Copyright ASTM,100 Barr Harbor Drive,West Conshohocken,PA 19428-2959,United States.of the drug,and the amount of the drug per unit,total volumeand warning statement,shall be legible in a light of 215 lux(20fc)at a distance of 500 mm(19.7 in.)by a person with 20/30unaided or corrected vision.7.Keywords7.1 ampoules;drugs;label;vialsThe American Society for Testing and Materials takes no position respecting the validity of any patent rights asserted in connectionwith any item mentioned in this standard.Users of this standard are expressly advised that determination of the validity of any suchpatent rights,and the risk of infringement of such rights,are entirely their ow