ASTM_D_4775_-_D_4775M_-_09_2014.pdf

Designation:D4775/D4775M09(Reapproved 2014)Standard Specification forIdentification and Configuration of Prefilled Syringes andDelivery Systems for Drugs(Excluding Pharmacy BulkPackages)1This standard is issued under the fixed designation D4775/D4775M;the number immediately following the designation indicates theyear of original adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of lastreapproval.A superscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers the identification of:1.1.1 The drug contained in the prefilled syringe or deliverysystem.1.1.2 The concentration,volume,and total amount of thedrug,and whether it is to be diluted prior to administration.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard.The values stated ineach system may not be exact equivalents;therefore,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in non-conformancewith the standard.NOTE1The values in SI units are the recommended values.2.Referenced Documents2.1 ASTM Standards:2D996 Terminology of Packaging and Distribution Environ-mentsD4267 Specification for Labels for Small-Volume(100 mLor Less)Parenteral Drug ContainersD7298 Test Method for Measurement of Comparative Leg-ibility by Means of Polarizing Filter Instrumentation3.Terminology3.1 General definitions for packaging and distribution envi-ronments are found in Terminology D996.3.2 Definitions of Terms Specific to This Standard:3.2.1delivery systemas used in this specification,aclosed system consisting of a container of concentrated solu-tion or powder which facilitates the transfer of the contents intoa diluent prior to administration or use.3.2.2 pharmacy bulk packagedrug supplied in a stockcontainer to be held in the pharmacy and used for multipledispensing.3.2.3 syringean instrument by means of which drugs insolution or other liquids are injected into or withdrawn fromany vessel or cavity.4.Significance and Use4.1 Difficulties have occurred in the correct identification ofsyringes containing significantly different medications oncethey have been removed from their cartons.The objective ofthis specification is to facilitate identification of the drug,itsconcentration,volume,and total amount.4.2 Difficulties have also occurred in distinguishing be-tween syringes containing drugs ready for intravenous injec-tion and similar syringes containing solutions which must bediluted before use.An objective of this specification is tominimize the chance for such errors.5.Label Requirements5.1 Label copy shall comply with Specification D4267 andshall include the information required by regulation and by themanufacturer.In addition,the requirements of the followingsections shall apply.5.2 In syringes of the type shown in Fig.1,10-point orlarger type is preferred for the drug name and the amount ofdrug per millilitre,or total amount as appropriate.This typeshall satisfy the test for legibility in 7.1,but at a distance of 500mm 19.7 in.This information shall be legible with minimalrotation of the immediate drug container.5.3 In syringes of the type in Fig.2,where the immediatedrug container is fitted into the syringe barrel,the drug name,concentration,and total volume shall appear as close to theextreme right hand end of the drug containerthat is,theopposite end to the needleas possible,in bold type,in heightat least equal to one ninth of the external circumference of thecontainer up to a maximum of 10 mm.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.1,2014.Published November 2014.Originallyapproved in 1988.Last previous edition approved in 2009 as D4775/D4775M 09.DOI:10.1520/D4775_D4775M-09R14.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.3.1 The opaque background of these two lines of text shallnot exceed one third of the circumference of the container.There shall be good contrast between the type used for the drugname,concentration,and total volume,and either the drugcontainer or an added opaque label background sufficient toconform with Section 7.The name of the drug on the containershall be legible through the barrel during preparation and usesufficient to conform with Section 7.5.4 Distinctive labels or other means of distinguishingsyringes and containers filled with medications which can onlybe given safely by specific routes(such as anti-cancer drugs)shall be employed.5.5 Syringes a