ASTM F2227-2002(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method《CO2示踪气体法对不密封的及空的医用包装盘泄漏性进.pdf

《ASTM F2227-2002(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method《CO2示踪气体法对不密封的及空的医用包装盘泄漏性进.pdf》由会员分享，可在线阅读，更多相关《ASTM F2227-2002(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method《CO2示踪气体法对不密封的及空的医用包装盘泄漏性进.pdf（4页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: F 2227 02 (Reapproved 2007)Standard Test Method forNon-Destructive Detection of Leaks in Non-sealed andEmpty Medical Packaging Trays by CO2Tracer Gas Method1This standard is issued under the fixed designation F 2227; the number immediately following the designation indicates the year of

2、original 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 non-destructive test method detects pinhole leaksin t

3、rays, 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

4、 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

5、Standards:2D 996 Terminology of Packaging and Distribution Environ-mentsF 1327 Terminology Relating to Barrier Materials for Medi-cal Packaging3. Terminology3.1 General Term DefinitionsFor definitions used in thistest method, see Terminologies D 996 and F 1327, Sections 3.3.2 Definitions of Terms Sp

6、ecific 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/

7、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

8、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-destructiv

9、e 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 current imple-mentation, may not be fast enough to work on a productionpackaging line, but is well suite

10、d for statistical testing as wellas 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 trans

11、mission 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 Appara

12、tus7.1 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 of ASTM Committee F02 on FlexibleBarrier Packagi

13、ng and is the direct responsibility of Subcommittee F02.40 onPackage Integrity.Current edition approved April 1, 2007. Published May 2007. Originallyapproved in 2002. Last previous edition approved in 2002 as F 2227 02.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact A

14、STM 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.8. Reagents and Materials8.

15、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-tig

16、ht 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 isrecomme

17、nded that the spent carbon dioxide be naturally ventedaway from the test area and that adequate ventilation beprovided.10. Calibration and Standardization10.1 Before any measurements are made, the apparatusmust be calibrated. The calibration procedure is used foroverall system checkout, as well as t

18、o establish an initialreference profile for simulated pinhole leaks, and to determinetest limits for each different tray geometry to be tested using aspecific test fixture. The calibration procedure is performed toestablish the sensitivity setting of the instrumentation. It isexpected that the calib

19、ration procedures be carried out fre-quently; typically, at least one or more times a day, preferablyat the beginning of every shift.10.2 Refer to the instrument manufacturers operating in-structions regarding preparation of Calibration Standards, Con-ditioning of Calibration Trays and Instrument Ca

20、libration usedin establishing baseline settings.11. Procedure11.1 Verify that sufficient CO2trace gas is available for thetests. Monitor the trace gas supply and functionality of the gasdelivery system.11.2 Select and implement the properly sized test fixture forthe trays to be tested. Verify that t

21、he instrument and associatedtest fixture have been calibrated for the trays to be tested. Thetest fixture is too large when the instrument is unable to detecta calibrated control pinhole leak.11.3 Adjust the instrument baseline settings determined incalibration.11.4 Place the tray to be tested into

22、the test fixture makingcertain that the tray is centered in the fixture and that goodsealing contact is made between the tray flange and the fixtureincorporated sealing.NOTE 1The sealing membrane needs to be clean in order to developa good seal with the sealing flange of the tray. Laboratory conditi

23、ons maycause dust or debris to be collected on the sealing membrane. Theseconditions thus will warrant frequent inspection and cleaning of thesealing membrane with a lint-free cloth soaked with a solvent recom-mended by the manufacturer of the equipment.11.5 Close the top cover of the test fixture.1

24、1.6 Start the test.11.7 Note the pass or fail indicator and record results. Setaside any “failed/defective” trays for further evaluation. Fur-ther evaluation should include re-testing of the tray.11.8 Select another tray and repeat the testing process.12. Report12.1 The report shall include the foll

25、owing:12.1.1 A statement indicating that the tests were performedin accordance with ASTM Standard F 2227, except wherenoted.FIG. 1 Schematic of Test Fixture and Test TrayF 2227 02 (2007)212.1.2 The serial numbers, calibration values and mostrecent calibration dates for all calibration standards used

26、.12.1.3 Record the date, time, location, and identification ofthe apparatus and the operator.12.1.4 Record the tray type, size, material, product, andtraceable identification numbers.12.1.5 Record the leak rate reject set point as programmedinto the apparatus.12.1.6 Record the number of trays tested

27、, and the number offailed trays.12.1.7 Record the failed trays to be rejected by identifyingeither individual serial numbers or lot numbers.12.1.8 Record the disposition of good trays as well as failedtrays.12.1.9 Copies of any software-generated data sheets, orreports produced during the testing.13

28、. Precision and Bias13.1 PrecisionA round robin study was conducted in2002, which included three laboratories. Trays with andwithout pinhole leaks were tested for leaks. The equipmentused in this interlaboratory study was the Pac Guard Model 500available from MOCON.13.1.1 Two different tray sizes we

29、re tested. The large PETEtrays had the approximate outside dimensions of 129 mm wideby 167 mm long by 20 mm high (5.1 by 6.6 by 0.8 in.) with aninternal volume of 208 mL. The small PETE trays had theapproximate outside dimensions of 69 mm wide by 139 mmlong by 18 mm high (2.7 by 5.5 by 0.7 in.) with

30、 an internalvolume of 80.7 mL.13.1.2 Three sample trays for each of two sizes (six trays)had a 50 m (0.002 in.) calibrated pinhole (leak), and sixsimilar trays had a plugged pinhole (no leak).13.1.3 Each sample material was tested at three laboratories,using the same instrumentation. Each tray was t

31、ested at the twopossible orientations allowed by the instrument. Two otheroperators subsequently repeated the tests at different times. Agrand total of 216 tests were performed, 108 on materials withleaks and 108 on materials without leaks.13.2 Tables 1-3 represent a summary of all test data.13.2.1

32、The results show that none of the 108 tests oncalibrated leaks failed to detect the leak, that is, there were zerofalse negatives. There were also no false positives.13.2.2 Aside from laboratory conditions, it can be arguedthat the instrument tests were independent, and that the numberof defects fol

33、lows a binomial distribution with probability p oftesting error. An estimate of p is the error rate, and aconservative confidence interval for p can be determined. Thetables list the upper bound of a 95 % confidence interval for thetrue error rate.13.2.3 Tray size had no effect on the test results.1

34、3.3 BiasThe bias for this test method has not beendetermined because there is no known standard referenceavailable.14. Keywords14.1 carbon dioxide (CO2) leak testing; flexible packaging;infrared CO2sensor; medical package integrity test; non-destructive testing; package integrity monitoring; pass/fa

35、ilcriteria; permeable packaging; pinhole leaks; porous packag-ing; sealing membrane performance; sterile integrity tests;trace gas leak testing; trays pass/fail levelsANNEX(Mandatory Information)A1. LEAK TEST THEORYA1.1 Placing the unlidded tray in a test fixture to which theinfrared sensor is conne

36、cted initiates the test method. Thismethod does not locate the leak, but instead provides ameasurement of total leakage. The response of the instrumentto any leakage is a non-linear function of the leak (hole) size.The sensitivity of this method is a function of trace gasconcentration in the tray. I

37、t is recommended that the trace gasdelivery flow be adjusted to a rate that equals at least two ormore tray volume exchanges per test cycle time, thus yieldingclose to 90 to 100 % trace gas concentration levels within thetray.A1.2 In this test procedure, pinhole leaks or cracks in traysare detected.

38、 As shown in Fig. 1, the tray is placed in a testTABLE 1 Percent Incorrect by MaterialMaterialTestDeterminationsIncorrectAnalysisPercent (%)Incorrect95 % UpperBoundTray 216 0 0.0 1.7TABLE 2 Percent Incorrect by LaboratoryLabTestDeterminationsIncorrectAnalysisPercent (%)Incorrect95 % UpperBound172 0

39、0. 5.027372 0 0. 5.0TABLE 3 Percent Incorrect by Defect TypeDefect TypeTestDeterminationsIncorrectAnalysisPercent (%)Incorrect95 % UpperBoundPlugged pinhole 108 0 0.0 3.450 m pinhole 108 0 0.0 3.4F 2227 02 (2007)3fixture such that a good, vacuum tight contact is made betweenthe tray flange and assoc

40、iated fixture sealing (sealing mem-brane). CO2trace gas is then introduced into the sealed cavityof the tray.A1.3 Upon initiation of the test cycle, the tray is flushedwith CO2trace gas at a predetermined flow rate. The internaltray pressure of CO2is generally set between 0.25 and 0.75 kPa(0.0363 to

41、 0.1088 psi or 1 to 3 in. of water H2O column).During this flushing/soaking cycle, room air is drawn throughthe test fixture at a low vacuum of approximately 0.0249 kPa(0.00361 psi or 0.1 in. of H2O column) and channeled past theinfrared detection sensor. Near the end of the flushing/soakingcycle, a

42、 solenoid valve is energized causing the room air drawnflow to be cut off, thus producing an ambient pressure withinthe capture volume of the test fixture. If the tray has a pinholeor crack then some carbon dioxide will leak out of the tray andaccumulate in the capture volume of the test fixture.A1.

43、4 At the end of the test period, the solenoid valve revertsback to its initial (open) position. This permits room air toagain flow to the test fixture chamber. A pump then flushes theroom air through the capture volume, which in turn picks upany CO2that may have escaped out of the tray and pulls itt

44、hrough the infrared sensing chamber. If the carbon dioxideconcentration in the capture volume is significantly higher thanthat of the room air, the carbon dioxide alarm will be activated.In order to reduce potential false positive signal responses fromthe instrumentation, it is recommended that the

45、ambient carbondioxide levels not fluctuate since varying levels of carbondioxide may affect the sensitivity of the system. Thus, it ishighly recommended that the exhausted CO2be naturallyvented, through appropriate piping, away from the test area.ASTM International takes no position respecting the v

46、alidity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is s

47、ubject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headq

48、uarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This stan

49、dard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).F 2227 02 (2007)4