1、Designation: D 2063/D 2063M 09Standard Test Methods forMeasurement of Torque Retention for Packages withContinuous Thread Closures1This standard is issued under the fixed designation D 2063/D 2063M; the number immediately following the designation indicates theyear of original adoption or, in the ca
2、se 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 retention ofcontinuous thread closures on container
3、s, 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; therefore, eachsystem shall be used independently of t
4、he 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. It is theresponsibility of the user of this stand
5、ard 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:2D 996 Terminology of Packaging and Distribution Environ-mentsD 3198 Test Method for Application and Removal Torqueof Threaded o
6、r Lug-Style ClosuresD 3474 Practice for Calibration and Use of Torque MetersUsed in Packaging ApplicationsD 4169 Practice for Performance Testing of Shipping Con-tainers and SystemsD 4332 Practice for Conditioning Containers, Packages, orPackaging Components for TestingE41 Terminology Relating To Co
7、nditioningE 171 Specification for Atmospheres for Conditioning andTesting Flexible Barrier MaterialsE 691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Method3. Terminology3.1 Definitions:3.1.1 For definitions of general packaging and distributionterms, see Ter
8、minology D 996.3.1.2 For definitions of application torque and removaltorque, see Test Method D 3198.3.1.3 For Definitions regarding conditioning, see Terminol-ogy E41.3.2 Definitions of Terms Specific to This Standard:3.2.1 immediate removal torqueremoval torque that ismeasured at a stated interval
9、, 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, the removal torques of representat
10、ive samples ofa container/continuous thread closure system, previouslystored at various environmental conditions, are measured.4.2 Test Method B: Dynamic EvaluationPractice D 4169is used to develop a uniform system of evaluating the ability ofprimary packages, in the shipping units, to withstand the
11、distribution 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 retention properties of container/
12、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 of Subcommittee D10.32 on Consumer,
13、Pharmaceutical and Medical Packaging.Current edition approved Oct. 1, 2009. Published October 2009. Originallyapproved in 1991. Last previous edition approved in 2002 as D 2063 91(2002).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceas
14、tm.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.5.2 This test method can be used for the evaluation ofcontai
15、ner/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/continuous thread closure systems with the use of anon-automated, spring
16、 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 particular container/continuous thread closuresystem to be evaluated.6.
17、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 beavailable in a visual format.6.1.2 A torque wrench, if used, will ha
18、ve 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 Specimens7.1 Measure no less than ten test specimens for each tor
19、quemeasurement point per test variable. See Note 2.7.2 Select previously unused continuous thread closures andcontainers as test specimens.8. Calibration8.1 Calibrate spring torque meters in accordance with theprocedures of Practice D 3474.9. Conditioning and Preparation of Test Specimens9.1 Perform
20、 test specimen conditioning in accordance withSpecification E 171 and Practice D 4332.9.2 Fill all of the containers with the specified volume orweight of product, or other materials that yield similar weightand thermal characteristics. See Note 3.NOTE 2The total quantity of test specimens sampled w
21、ill 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 4)10.1 Test A: Static Evaluation:10.1.1 Select the minimum application torque for thec
22、ontainer/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 the container or closure in such amanner that the axis of rota
23、tion of the closure is concentricwith the center of the torque measuring device. See Note 5.10.1.2.1 Exercise care in positioning the container or clo-sure to prevent distortion of either component.NOTE 4Under certain conditions of product-filling, storage and dis-tribution, it may be desirable to c
24、ombine appropriate segments of TestMethod A and Test Method B.NOTE 5It is recommended that one operator, and a single torqueinstrument be used to apply all closures in any one test to reduce possibleoperator/instrument inconsistencies and variabilities.10.1.3 Avoiding contact with the fixed componen
25、t, 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-tinuous thread closure) upon reaching the desired torque. SeeNot
26、e 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 E 171 or Practice D 4332.10.1.6.1 Maintain one group of test specimens as a controlb
27、y storing this group at ambient laboratory conditions.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 at constant temperatures different than ambientlaboratory conditions.
28、If desired, cycling at various tempera-ture and relative humidity conditions may be performed. SeeNote 7.10.1.7 At the end of each predetermined time period,determine the removal torque for each test sample.10.1.7.1 Determine the removal torques either at ambientlaboratory conditions or at the alter
29、native 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.NOTE 7Sterilization cycles, if applied, using steam, ethylene oxide,gamma radiation, or other methods are known to aff
30、ect 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 of rotation of theclosure is concentric with the center of the measurin
31、g device.See Note 8.10.1.8.1 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 continuous thread closure),and rotate it uniformly, at a constant
32、 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.NOTE 8It is recommended that one operator, and a single torqueinstrument, be used to remove all closures in a given test
33、 to reducepossible operator/instrument inconsistencies and variabilities.10.1.10 Record the maximum torque required to loosen theclosure for each remaining specimen.D 2063/D 2063M 09210.1.11 Remove the balance of the movable components(normally the continuous thread closures) as directed in 10.1.8an
34、d 10.1.9.10.2 Test Method B: Dynamic Evaluation:10.2.1 Follow the procedures of Practice D 4169 for recom-mendations relevant to the number of test specimens, condi-tioning, and distribution cycles to be used to evaluate these testspecimens.10.2.2 Follow Section 8 on Calibration for test equipmentca
35、libration.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 determined and before anyadditional long-term storage, if long-term sto
36、rage 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 continuous thread closure andcontainer manufacturer(s), the material(s) of c
37、onstruction 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 closure and the container.11.1.4 Description of test specimen prepara
38、tion.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 mean value for eachtest condition variable.11.1.10 Removal torque rang
39、e 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 method or a description of the difference(s) from thistest method.12. Prec
40、ision and Bias312.1 Precision:12.1.1 The repeatability and reproducibility are in accor-dance with the definitions of these terms in Practice E 691 (at95 % probability level). These values are based on an inter-laboratory study involving six laboratories each of whichmeasured removal torques of thre
41、e 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 unit under constantoperating conditions on test packages from a single
42、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, Sr(within a laboratory)(0.08) (0.12) (0.22)95 % Limits 2.06 5.35 2.
43、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 expressed in Newton-metres.12.1.3 Reproducibility The difference between
44、 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 in different laboratories,was determined to be as follows (see Note 10
45、):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 accepted reference componentsuitable for determining the bias for the p
46、rocedure 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 and maybe obtained by requesting Research Report RR: D10-1005.D 2063/
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