ASTM F3287-2017 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method《用质量萃取法进行包裹泄漏物无损检测的标准试验方法》.pdf
《ASTM F3287-2017 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method《用质量萃取法进行包裹泄漏物无损检测的标准试验方法》.pdf》由会员分享,可在线阅读,更多相关《ASTM F3287-2017 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method《用质量萃取法进行包裹泄漏物无损检测的标准试验方法》.pdf(12页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F3287 17Standard Test Method forNondestructive Detection of Leaks in Packages by MassExtraction Method1,2This standard is issued under the fixed designation F3287; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the ye
2、ar 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 method provides a nondestructive means to detectholes (leaks) in a variety of non-porous rigid and semi-rig
3、idpackages.1.2 This test method detects package leaks by measuring themass flow extracted from a package while the package isenclosed inside an evacuated test chamber. The test system isa closed system during the leakage measurement portion of thetest cycle. The closed system includes a vacuum reser
4、voir,Intelligent Molecular Flow Sensor (IMFS), and vacuum testchamber. Mass extracted from the test package into the vacuumtest chamber flows to the vacuum reservoir through the IMFSto equalize the system. Mass flow rate from the vacuumchamber to the vacuum reservoir is measured by the IMFS.Based on
5、 the conservation of mass law, mass flow into theclosed system is equal to the mass loss from the test package.The test system is capable of producing quantitative (variabledata) or quantitative (pass/fail) results depending on therequirements.1.2.1 Headspace gas leakage defects equivalent to a 1mdi
6、ameter glass micropipette (sharp edge defect) can be detectedat a 95% confidence level.1.2.2 Liquid leakage defects equivalent to a 1m diameterglass micropipette can be detected at a 95% confidence levelfor glass vials and LDPE bottles. Liquid leakage defectsequivalent to a 2m diameter glass micropi
7、pette can bedetected for glass syringes.1.3 UnitsThe values stated in SI units are to be regardedas standard. Pressure units are expressed as Pa, mbar, or Torr.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the use
8、r of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in
9、the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:3E177 Practice for Use of the Terms Precision and Bias inASTM Test Methods
10、E691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF17 Terminology Relating to Primary Barrier Packaging2.2 ISO Standard:4ISO/IEC 17025 General requirements for the competence oftesting and calibration laboratories3. Terminology3.1 For terminology related
11、 to flexible barrier packaging,see Terminology F17.3.2 Definitions of Terms Specific to This Standard:3.2.1 baseline flow measurement, nmeasured flow rate fora negative control test package. Measured flow is largelyattributed to characteristics of the package (material type,labels, etc.).3.2.2 blank
12、 master part, na piece of metal tooling withsimilar volume and shape as the actual test package. This isused to represent a leak free package.3.2.3 chamber base, nlower portion of a vacuum testchamber that is connected to the mass extraction test instru-ment. Chamber base commonly includes an o-ring
13、 to seal thechamber lid onto the base. The chamber base also contains a1This test method is under the jurisdiction ofASTM Committee F02 on PrimaryBarrier Packaging and is the direct responsibility of Subcommittee F02.40 onPackage Integrity.Current edition approved Nov. 1, 2017. Published November 20
14、17. DOI:10.1520/F3287-17.2Mass Extraction is covered by a patents (1, 2). If you are aware of analternative(s) to the patented item, please attach to your ballot return a descriptionof the alternatives. All suggestions will be considered by the committee. Ifalternatives are identified, the committee
15、 shall reconsider whether the patented itemis necessary. The committee, in making its decision, shall follow Regulation 15.3For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, re
16、fer to the standards Document Summary page onthe ASTM website.4Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United Stat
17、esThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Tra
18、de (TBT) Committee.1nest to contain the test package. Nest configuration is depen-dent on test package features.3.2.4 chamber lid, nupper portion of a vacuum testchamber. The chamber lid commonly conforms to the portionof the test package that extends above the chamber base.3.2.5 container closure i
19、ntegrity test (CCIT), na methodto determine if a package is sealed to a specified level.3.2.6 glass micropipette, na thin glass tube that includes aspecific diameter within 620% of specification at the tip of thecapillary tube. Micropipettes are independently qualified bysupplier. Flow paths of this
20、 nature are commonly designated assharp edge (SE) holes. This can be used to represent a hole ofa specific diameter when inserted into a package.3.2.7 gross leak (GL) check, npreliminary step in the leakdetection process where chamber pressure is measured beforethe chamber is fully evacuated. This s
21、tep is intended to detectmajor issues (e.g. missing cap, chamber lid not installed,missing part, etc.).3.2.8 intelligent molecular flow sensor (IMFS), nmassflow measurement sensor that is capable of operating in thetransitional and molecular flow regimes measuring mass flow,pressure (vacuum) and tem
22、perature (3). The IMFS is indepen-dently calibrated against traceable standards per the require-ments of ISO 17025.3.2.9 large leak check (LLC), npreliminary step in theleak detection process where the mass exiting the chamber ismeasured before the chamber is fully evacuated. This step isintended to
23、 detect leaks large enough to allow the test packageto be evacuated as the vacuum test chamber is evacuated inpreparation for the fine leak test. This step is also intended todetect liquid leakage or spillage early in the process tominimize system drying (moisture removal) requirements.Refer to sect
24、ion 10for additional details regarding the dryingprocess. The size of defect that would be detected in this teststep is largely dependent on target fine leak detection level.3.2.10 leak, na hole, void, or defect in the wall or matedcomponents of a package capable of passing aerosols (micro-organisms
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