1、Designation: D2063/D2063M 10 (Reapproved 2012)Standard Test Methods forMeasurement of Torque Retention for Packages withContinuous Thread Closures Using Non-Automated(Manual) Torque Testing Equipment1This standard is issued under the fixed designation D2063/D2063M; the number immediately following t
2、he 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 These test methods eval
3、uate the torque retention ofcontinuous thread closures on containers, with matching fin-ishes, for predetermined environmental conditions over time.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
4、equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.NOTE 1The SI unit system is the recommended system.1.3 This standard does not purport to address all of thesafety concerns, if any, associa
5、ted 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-ments
6、D3198 Test Method forApplication and Removal Torque ofThreaded or Lug-Style ClosuresD3474 Practice for Calibration and Use of Torque MetersUsed in Packaging ApplicationsD4169 Practice for Performance Testing of Shipping Con-tainers and SystemsD4332 Practice for Conditioning Containers, Packages, orP
7、ackaging Components for TestingE41 Terminology Relating To ConditioningE171 Practice for Conditioning and Testing Flexible BarrierPackagingE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method3. Terminology3.1 Definitions:3.1.1 For definitions of general pa
8、ckaging and distributionterms, see Terminology D996.3.1.2 For definitions of application torque and removaltorque, see Test Method D3198.3.1.3 For Definitions regarding conditioning, see Terminol-ogy E41.3.2 Definitions of Terms Specific to This Standard:3.2.1 immediate removal torqueremoval torque
9、that ismeasured at a stated interval, from 1 to 5 min after closureapplication.3.2.2 torque retentiona comparison between removaltorque at the end of a test period and a predeterminedimmediate removal torque.4. Summary of Test Methods4.1 Test Method A: Static EvaluationAt predeterminedtime intervals
10、, the removal torques of representative samples ofa container/continuous thread closure system, previouslystored at various environmental conditions, are measured.4.2 Test Method B: Dynamic EvaluationPractice D4169 isused to develop a uniform system of evaluating the ability ofprimary packages, in t
11、he shipping units, to withstand thedistribution environment. At the end of predetermined distri-bution cycles, the removal torques of representative samples ofa container/continuous thread closure system are measured.5. Significance and Use5.1 This test method allows for the measurement of thetorque
12、 retention properties of container/continuous thread clo-sure systems of various designs, materials, and manufacture,and is suitable for packaging development and engineeringevaluation.1These test methods are under the jurisdiction of ASTM Committee D10 onPackaging and are the direct responsibility
13、of Subcommittee D10.32 on Consumer,Pharmaceutical, Medical, and Child Resistant Packaging.Current edition approved April 1, 2012. Published May 2012. Originallyapproved in 1991. Last previous edition approved in 2010 as D2063/D2063M 09(2010). DOI: 10.1520/D2063_D2063M-10R12.2For referenced ASTM stan
14、dards, 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,
15、PA 19428-2959, United States.5.2 This test method can be used for the evaluation ofcontainer/continuous thread closure systems under controlledconditions (where the application torque is known and theapplied downward force to the closure is zero).5.3 This test method measures torque retention proper
16、ties ofcontainer/continuous thread closure systems with the use of anon-automated, spring torque-meter (with either a dial indica-tor or a digital readout) or a torque wrench.6. Apparatus6.1 Non-automated Spring Torque Meter, with an appropri-ate scale that accurately measures within the expected to
17、rquerange for the particular container/continuous thread closuresystem to be evaluated.6.1.1 Torque meter, if used, will have a scale where theanticipated torque readings are not less than one-third of themaximum range of the scale for the container/continuousthread closure system to be evaluated. T
18、orque results will beavailable in a visual format.6.1.2 A torque wrench, if used, will have an appropriatedesign and capacity capable of providing a reading within theanticipated range for the container/continuous thread closuresystem to be evaluated. Torque results will be available in avisual form
19、at.7. Sampling and Test Specimens7.1 Measure no less than ten test specimens for each torquemeasurement point per test variable.7.2 Select previously unused continuous thread closures andcontainers as test specimens.8. Calibration8.1 Calibrate spring torque meters in accordance with theprocedures of
20、 Practice D3474.9. Conditioning and Preparation of Test Specimens9.1 Perform test specimen conditioning in accordance withSpecification E171 and Practice D4332.9.2 Fill all of the containers with the specified volume orweight of product, or other materials that yield similar weightand thermal charac
21、teristics. See Note 2 and Note 3.NOTE 2The total quantity of test specimens sampled will dependupon the method selected and the number of environmental storageconditions.NOTE 3Given the purpose of the evaluation, empty containers may beused as an option to filled containers.10. Procedure (See Note 5
22、)10.1 Test A: Static Evaluation:10.1.1 Select the minimum application torque for thecontainer/continuous thread system as recommended by theclosure manufacturer. (For example, the U.S. Pharmacopaeia,the Society for the Plastics Industry, the Glass ContainerManufacturers Institute, or other sources.)
23、10.1.2 Firmly position the container or closure in such amanner that the axis of rotation of the closure is concentricwith the center of the torque measuring device. See Note 4.NOTE 4It is recommended that one operator, and a single torqueinstrument be used to apply all closures in any one test to r
24、educe possibleoperator/instrument inconsistencies and variabilities.10.1.2.1 Exercise care in positioning the container or clo-sure to prevent distortion of either component.NOTE 5Under certain conditions of product-filling, storage and dis-tribution, it may be desirable to combine appropriate segme
25、nts of TestMethod A and Test Method B.10.1.3 Avoiding contact with the fixed component, grip themovable component (normally the continuous thread closure)and rotate it at a constant and uniform rate, in a tighteningdirection, to the predetermined application torque.10.1.4 Release the movable compone
26、nt (normally the con-tinuous thread closure) upon reaching the desired torque. SeeNote 6.10.1.5 Apply the balance of the closures or containers to thematching components as directed in 10.1.2, 10.1.3, and 10.1.4.10.1.6 Store the assembled test specimens as appropriate inaccordance with Specification
27、 E171 or Practice D4332.10.1.6.1 Maintain one group of test specimens as a controlby storing this group at ambient laboratory conditions. SeeNote 6.NOTE 6The application torque range is usually determined on thebasis of the desired removal torque range.10.1.6.2 Maintain, as appropriate, one or more
28、groups oftest specimens at constant temperatures different than ambientlaboratory conditions. If desired, cycling at various tempera-ture and relative humidity conditions may be performed.10.1.7 At the end of each predetermined time period,determine the removal torque for each test sample.10.1.7.1 D
29、etermine the removal torques either at ambientlaboratory conditions or at the alternative temperature andrelative humidity conditions.10.1.7.2 The following test intervals are recommended:immediate (between 1 and 5 minutes), 24 h, 48 h, 7 days, 14days, and 28 days. See Note 7.NOTE 7Sterilization cyc
30、les, if applied, using steam, ethylene oxide,gamma radiation, or other methods are known to affect certain plastics;these effects may influence removal torques.10.1.8 Determine the removal torque for each test specimenby firmly positioning either the container or the continuousthread closure in such
31、 a manner that the axis of rotation of theclosure is concentric with the center of the measuring device.10.1.8.1 Exercise care in positioning the container or con-tinuous thread closure to prevent distortion of either compo-nent.10.1.9 Avoiding contact with the fixed component, grip themovable compo
32、nent (normally the continuous thread closure),and rotate it uniformly, at a constant rate, in a looseningdirection until the continuous thread closure rotates freely.Note the maximum torque required to loosen the closure andrecord this value for the test specimen. See Note 8.NOTE 8It is recommended
33、that one operator, and a single torqueinstrument, be used to remove all closures in a given test to reducepossible operator/instrument inconsistencies and variabilities.10.1.10 Record the maximum torque required to loosen theclosure for each remaining specimen.D2063/D2063M 10 (2012)210.1.11 Remove t
34、he balance of the movable components(normally the continuous thread closures) as directed in 10.1.8and 10.1.9.10.2 Test Method B: Dynamic Evaluation:10.2.1 Follow the procedures of Practice D4169 for recom-mendations relevant to the number of test specimens, condi-tioning, and distribution cycles to
35、 be used to evaluate these testspecimens.10.2.2 Follow Section 8 on Calibration for test equipmentcalibration.10.2.3 Follow Section 10 on Procedure (Test Method A) forrecommendations concerning continuous thread closure appli-cation.10.2.4 Begin evaluation of a selected distribution cycle afterimmed
36、iate removal torque has been determined and before anyadditional long-term storage, if long-term storage is desired.(Testing may be determined following distribution cycling withremoval torques noted.)11. Report11.1 Report the following information:11.1.1 Identification of the test method used.11.1.
37、2 Identification of the continuous thread closure andcontainer manufacturer(s), the material(s) of construction ofthe closure (including any liner, liner coating, and additionalsealing components), and the container (including any coatingor annealing agents).11.1.3 Thread finish and other designatio
38、n(s) of the continu-ous thread closure and the container.11.1.4 Description of test specimen preparation.11.1.5 Description of storage conditions.11.1.6 Description of distribution cycles and handling con-ditions.11.1.7 Description of the test area environment.11.1.8 Number of test replicates.11.1.9
39、 Application torque range and mean value for eachtest condition variable.11.1.10 Removal torque range and mean value for each testcondition variable.11.1.11 Description of the torque instruments used.11.1.12 Evaluation of comparative results, if appropriate.11.1.13 Statement that testing was done in
40、 accordance withthis test method or a description of the difference(s) from thistest method.12. Precision and Bias312.1 Precision:12.1.1 The repeatability and reproducibility are in accor-dance with the definitions of these terms in Practice E691 (at95 % probability level). These values are based on
41、 an inter-laboratory study involving six laboratories each of whichmeasured removal torques of three different closures at therecommended six time intervals. (See Note 9.)12.1.2 Repeatability The difference between successiveremoval torque results, after 28 days of storage, obtained by thesame opera
42、tor with the same equipment unit under constantoperating conditions on test packages from a single lot com-plying with given specifications, within a laboratory, wasdetermined to be as follows (see Note 10):TestPackage 1TestPackage 2TestPackage 3Average 5.97(0.68)8.04(0.92)8.09(0.92)Repeatability 0.
43、74 1.06 1.91Standard deviation, Sr(within a laboratory)(0.08) (0.12) (0.22)95 % Limits 2.06 5.35 2.97NOTE 9See Research Report RR:D10-1005 for a complete descrip-tion of the interlaboratory/intralaboratory evaluation of this test method.NOTE 10Initial values are expressed in torque inch pounds-force
44、;values in parentheses are expressed in Newton-metres.12.1.3 Reproducibility The difference between successiveremoval torque results, after 28 days of storage, obtained bydifferent operators with different equipment units under con-stant operating conditions on test packages from a single lotcomplyi
45、ng with given specifications in different laboratories,was determined to be as follows (see Note 10):TestPackage 1TestPackage 2TestPackage 3Average 5.97(0.68)8.04(0.92)8.09(0.92)Reproducibility 1.992 2.932 2.605Standard deviation, SR(between laboratories)(0.23) (0.33) (0.29)95 % Limits 5.55 7.14 8.1
46、712.2 BiasSince there is no accepted reference componentsuitable for determining the bias for the procedure in this testmethod for measuring torque retention, no statement on bias isbeing made.13. Keywords13.1 continuous thread closure; removal torque; retention3Supporting data have been filed at AS
47、TM International Headquarters and maybe obtained by requesting Research Report RR:D10-1005.D2063/D2063M 10 (2012)3ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly adv
48、ised 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 subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either
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