ASTM_F_2227_-_13.pdf

Designation:F222713Standard Test Method forNon-Destructive Detection of Leaks in Non-sealed andEmpty Packaging Trays by CO2Tracer Gas Method1This standard is issued under the fixed designation F2227;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 non-destructive test method detects pinhole leaksin trays,as small as 50 m(0.002 in.)in diameter,orequivalently sized cracks,subject to trace gas concentration inthe tray,tray design and manufacturing tolerances.1.2 The values stated in SI units are to be regarded asstandard units.Values in parentheses are for information only.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D996 Terminology of Packaging and Distribution Environ-mentsF1327 Terminology Relating to Barrier Materials for Medi-cal Packaging(Withdrawn 2007)33.Terminology3.1 General Term DefinitionsFor definitions used in thistest method,see Terminologies D996 and F1327,Sections 3.3.2 Definitions of Terms Specific to This Standard:3.2.1 trace gasa compound selected solely for use toidentify leakage flow.4.Summary of Test Method4.1 This test method utilizes CO2sensing techniques in thedetection of a CO2trace gas to quantify leaks in medicalpackaging trays.The test method provides a qualitative(accept/reject)inspection method to evaluate trays for pinholesand cracks.Further information on the“Leak Test Theory”may be found in Annex A1.5.Significance and Use5.1 Harmful biological or particulate contaminants mayenter the package through imperfections such as pinholes orcracks in trays.5.2 After initial instrument set-up and calibration,the op-erations of individual tests and test results do not need operatorinterpretation.5.3 Leak test results that exceed the permissible thresholdsetting are indicated by audible or visual signal responses,orboth,or by other means.5.4 This non-destructive test method may be performed ineither laboratory or production environments and may beundertaken on either a 100%or a statistical sampling basis.This test method,in single instrument use and currentimplementation,may not be fast enough to work on a produc-tion packaging line,but is well suited for statistical testing aswell as package developmental design work.6.Apparatus6.1 Non-destructive Trace Gas Leak Detection ApparatusThe apparatus test fixture consists of three major elements andis shown in Fig.1.6.2 Sealing MembraneThe purpose of the membrane is toseal off the tracer gas transmission out of the top of the opentray.6.3 Control TraysCalibrated pinholes,or leaks,con-structed in control trays for instrument calibration as well as fortest procedure verification.6.4 Test FixtureApparatus,which must be designed toensure detection of a calibrated leak.7.Preparation of Apparatus7.1 The test apparatus is to be started,warmed-up,and madeready according to the manufacturers specifications.Theinstrument must be operated in an environment as described inthe instruments user manual.1This test method is under the jurisdiction ofASTM Committee F02 on FlexibleBarrier Packaging and is the direct responsibility of Subcommittee F02.40 onPackage Integrity.Current edition approved Aug.1,2013.Published September 2013.Originallyapproved in 2002.Last previous edition approved in 2007 as F2227 02(2007).DOI:10.1520/F2227-13.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 8.Reagents and Materials8.1 CO2Trace Gas Cylinder and RegulatorA cylinder of“Commercial”or“Bone Dry”grade carbon dioxide with aminimum of 206.84-kPa(30-psi)pressure is required forcalibration and testing.8.2 Sealing MembraneThe sealing membrane must ex-hibit the correct pliability and tackiness in order to form agas-tight bond without leaving a residue on the tray-sealingsurface after removal from the test fixture.9.Hazards9.1 As the test fixture is closed,it may present pinch-pointhazards.9.2 CO2,although inert and non-toxic,can cause danger ofsuffocation if it is allowed to displace oxygen.Thus it isrecommended that the spent carbon dioxide be naturally ventedaway from the test area and that adequate ventilation beprovided.10.Calibration and Standardization10.1 Before any measur