ASTM_D_5022_-_07.pdf

Designation:D502207StandardSpecification forIdentification of Vials and Ampoules ContainingConcentrated Solutions of Drugs to be Diluted Before Use1This standard is issued under the fixed designation D5022;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()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:3D996 Terminology of Packaging and Distribution Environ-mentsD4267 Specification for Labels for Small-Volume(100 mLor Less)Parenteral Drug ContainersD4775 Specification for Identification and Configuration ofPrefilled Syringes and Delivery Systems for Drugs(Ex-cluding Pharmacy Bulk Packages)D7298 Test Method for Measurement of Comparative Leg-ibility by Means of Polarizing Filter Instrumentation2.2 Other Standards:Pantone Matching Systems Current Edition43.Terminology3.1 General definitions for packaging and distribution envi-ronments are found in Terminology D996.3.2 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 Terms Specific to This Standard:3.4.1 Flip-Off type capa plastic cap which must be re-moved to expose the injection port in the elastomeric and metalvial 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.1This specification is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical,Medical,and Child Resistant Packaging.Current edition approved Oct.1,2007.Published October 2007.Originallyapproved in 1989.Last previous edition approved in 2001 as D5022 95(2001).DOI:10.1520/D5022-07.2“Flip-Off”is a registered trademark of the West Pharmaceutical Services,101Gordon Dr.,Lionville,PA 19341.3For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.4Available from Pantone Inc.,World Headquarters,590 Commerce Blvd.,Carlstadt,NJ 070723098.5USP 23/NF18 1995,pp.1254,1651,Available from USPC,Inc,OrderProcessing Dept.,12601 Twinbrook Parkway,Rockville,MD 20852.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesNOTICE:This standard has either been superseded and replaced by a new version or withdrawn.Contact ASTM International(www.astm.org)for the latest information15.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 Copy legibility of the proprietary