ASTM_F_1327_-_05.pdf

Designation:F 1327 05Standard Terminology Relating toBarrier Materials for Medical Packaging1This standard is issued under the fixed designation F 1327;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 terminology contains related definitions and de-scriptions of terms used or likely to be used in medicalpackaging standards that involve barrier materials.The pur-pose of terminology is to promote clear understanding andinterpretation of the standards in which they are used.2.Referenced Document2.1 ASTM Standards:2F 17 Terminology Relating to Flexible Barrier MaterialsF 1980 Guide for Accelerated Aging of Sterile MedicalDevice Packages3.Terminology Definitionsaccelerated aginga technique to simulate the effects of timeon a package by subjecting the product/package system toelevated temperatures in a controlled environment represen-tative of controlled environment storage conditions.Theequivalent time is generally estimated by assuming thedegradation of packaging materials follows the kineticsdescribed by the Arrhenius reaction rate function,morediscussion of which is available in Guide F 1980.adhesive transfera condition occurring when an adhesive-coated material is peeled away from an opposing material towhich it has been sealed and shows visible evidence of theadhesive being left on the opposing material.This evidenceis in the form of an adhesive layer that remains with theopposing material,the adhesive having separated eitheradhesively from the coated web or cohesively within theadhesive itself.aseptic packaging See Terminology F 17.barrierSee Terminology F 17.barrier materialsspecialized porous or nonporous packag-ing materials that provide environmental protection to thepackage contents as well as protection to the environmentfrom the package contents:(1)gas,vapor,humidity,liquid,microbial,or light resistant materials that control or elimi-nate the amount of those environmental constituents thatpass into or out of a package;(2)a porous materialpreventing the passage of microorganisms that might con-taminate the contents of the package.biological evaluation test(biotest)See Terminology F 17.burst strengtha measure of the internal pressure necessaryto rupture a package or seal.channelany unimpaired pathway across the entire width ofthe intended seal.coextrusionSee Terminology F 17.delaminationSee Terminology F 17.dispersion coating See Terminology F 17.environmental challengingthe process of subjecting apackage to extremes of temperature,or humidity,or both,with the goal of determining sensitivities of the package toenvironmental stresses.In contrast to accelerated aging,environmental challenging often includes conditions,ortransitions,or both,of temperature and humidity that equalor exceed those that can be encountered in a package lifecycle.extrusion coating See Terminology F 17.flexibleSee Terminology F 17.fusion sealSee Terminology F 17.heat sealthe result of bonding surfaces by controlled appli-cation of heat,pressure,and dwell time.hermetically sealed aseptic containerSee Terminology F 17.laminateSee Terminology F 17.laminationSee Terminology F 17.leakany opening in a flexible package that is contrary tointention and either lets contents escape or permits sub-stances to enter.major package defect See Terminology F 17.microbial contamination See Terminology F 17.minor package defect See Terminology F 17.multilayered structure See Terminology F 17.package integritythe physical capability of a given packageto protect its contents with the desired level of protection1This terminology is under the jurisdiction ofASTM Committee F02 on FlexibleBarrier Materials and is the direct responsibility of Subcommittee F02.50 onPackage Design and Devlopment.Current edition approved April 1,2005.Published April 2005.Originallyapproved in 1991.Last previous edition approved in 1998 as F 1327 98.2For 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.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.over a defined period of service;for example,as a barrier tophysical,microbiological,or chemical challenges.peelable sealthe opening characteristic of forcibly separat-ing two package substrates,which have been joined togetherby a sealing process,without tearing the substrates.porous packaging materiala material used in medicalpackaging which is intended to provide an environmentaland biological barrier,while allowing sufficient air flow to beused in gaseous sterilization methods(for example,EtO,steam,gas plasma).retortableSee Terminolo