1、Designation: D2063/D2063M 10Standard 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 the designation ind
2、icates 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 evaluate the torque re
3、tention 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 equivalents; there
4、fore, 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, associated with its use.
5、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-mentsD3198 Test Method
6、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, orPackaging Component
7、s for TestingE41 Terminology Relating To ConditioningE171 Specification for Atmospheres for Conditioning andTesting Flexible Barrier MaterialsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method3. Terminology3.1 Definitions:3.1.1 For definitions of general
8、 packaging 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 torq
9、ue 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 interv
10、als, 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, i
11、n the 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 thetor
12、que 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 responsibili
13、ty of Subcommittee D10.32 on Consumer,Pharmaceutical and Medical Packaging.Current edition approved April 1, 2010. Published April 2010. Originallyapproved in 1991. Last previous edition approved in 2009 as D2063/D2063M 09.DOI: 10.1520/D2063_D2063M-10.2For referenced ASTM standards, visit the ASTM w
14、ebsite, 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 S
15、tates.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 properties ofcontainer/contin
16、uous 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 torquerange for the parti
17、cular 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. Torque results will beav
18、ailable 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 format.7. Sampling and Test
19、 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 Practice D3474.9. Cond
20、itioning 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 characteristics. See Note 2 a
21、nd 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)10.1 Test A: Static Ev
22、aluation: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.)10.1.2 Firmly position
23、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 reduce possibleoperator/
24、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 segments of TestMethod A and
25、 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 component (normally the con-ti
26、nuous 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 E171 or Practice D4332
27、.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 groups oftest specimens
28、 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 Determine the removal to
29、rques 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 cycles, if applied, using
30、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 a manner that the axis
31、 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 component (normally the cont
32、inuous 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 that one operator, and
33、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 10210.1.11 Remove the balance of the movable comp
34、onents(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 be used to evaluate these tes
35、tspecimens.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 afterimmediate removal torque has been d
36、etermined 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.11.1.2 Identification of the contin
37、uous 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 designation(s) of the continu-ous thread
38、 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 Application torque range and
39、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 accordance withthis test meth
40、od 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 an inter-laboratory study inv
41、olving 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 operator with the same equipment un
42、it 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 0.74 1.06 1.91Standard deviation
43、, 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;values in parentheses are exp
44、ressed 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 lotcomplying with given specifications i
45、n 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 8.1712.2 BiasSince there is no ac
46、cepted 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 ASTM International Headquarters
47、and maybe obtained by requesting Research Report RR:D10-1005.D2063/D2063M 103ASTM 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 advised that determination of the validi
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