ASTM D7860-2014 1507 Standard Test Methods for Measurement of Torque Retention for Child Resistant and Non-Child Resistant Packages with Continuous Thread Closures Using Automated .pdf

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1、Designation: D7860 14Standard Test Methods forMeasurement of Torque Retention for Child Resistant andNon-Child Resistant Packages with Continuous ThreadClosures Using Automated Torque Testing Equipment1This standard is issued under the fixed designation D7860; the number immediately following the de

2、signation indicates the year oforiginal adoption or, in the case of revision, the year 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 These test methods evaluate

3、the torque retention ofcontinuous thread closures on containers with matchingfinishes, for predetermined environmental conditions overtime. Methods are defined for both Type I, style “A” pushdown and turn Type II2child resistant and non child resistanttype closures.1.2 The values stated in either SI

4、 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 the other. Combiningvalues from the two systems may result in non-conformancewith the standard.NOTE 1The SI unit sys

5、tem 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 standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitation

6、s prior to use.2. Referenced Documents2.1 ASTM Standards:3D996 Terminology of Packaging and Distribution Environ-mentsD3198 Test Method for Application and Removal Torque ofThreaded or Lug-Style ClosuresD3474 Practice for Calibration and Use of Torque MetersUsed in Packaging ApplicationsD3475 Classi

7、fication of Child-Resistant PackagesD4169 Practice for Performance Testing of Shipping Con-tainers and SystemsD4332 Practice for Conditioning Containers, Packages, orPackaging Components for TestingD7386 Practice for Performance Testing of Packages forSingle Parcel Delivery SystemsE691 Practice for

8、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 Terminology D996.3.1.2 For definitions of application torque and removaltorque, see Test Method D3198.3.1.3 For Definition

9、s regarding conditioning, see Terminol-ogy E41.3.2 Definitions of Terms Specific to This Standard:3.2.1 dry torquedry torque is defined as applying torque inthe absence of lubricant (i.e. product from the container orfilling operation) on the threads.3.2.2 immediate removal torqueremoval torque that

10、 ismeasured at a stated interval, from 1 to 5 min after closureapplication.3.2.3 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, th

11、e removal torques of representative samples ofa container/continuous thread closure system, previouslystored at various environmental conditions, are measured.4.2 Test Method B: Dynamic EvaluationPractices D4169and D7386 are used to develop a uniform system of evaluatingthe ability of primary packag

12、es, in the shipping units, towithstand the distribution environment. At the end of prede-termined distribution cycles, the removal torques of represen-tative samples of a container/continuous thread closure systemare measured.1These test methods are under the jurisdiction of ASTM Committee D10 onPac

13、kaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical, Medical, and Child Resistant Packaging.Current edition approved Oct. 1, 2014. Published November 2014. DOI:10.1520/D7860-14.2For classification of child resistant styles, see ASTM D3475 Standard Classi-ficatio

14、n of Child-Resistant Closures.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, refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International, 1

15、00 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15. Significance and Use5.1 This test method allows for the measurement of thetorque retention properties of container/continuous thread clo-sure systems of various designs, materials, and manufacture,and is suitable f

16、or package development and engineeringevaluation.5.2 Each test method can be used for the evaluation of nonchild resistant container/continuous thread closure systemsunder controlled conditions such as when the applicationtorque is known and the applied downward force to the closureis zero or for Ty

17、pe I, style “A” push down and turn childresistant container/continuous thread closure systems undercontrolled conditions such as when the application torque andthe applied downward force to the closure is known.5.3 This test method measures torque retention properties ofcontainer/continuous thread c

18、losure systems with the use of anautomated transducer based torque meter operating at a knownrotational velocity (rpm) or known torque ramp.5.4 This test method is intended for measurement of drytorque only.6. Apparatus6.1 Automated Transducer Based Torque Meter, with aprogrammable, fixed velocity o

19、r fixed torque ramp rate rota-tional torque head and digital output that accurately measureswithin the expected torque range for the particular container/continuous thread closure system to be evaluated. (See Note Xfor source(s) of equipment.)6.2 Torque Calibration Verification Device (Calibrated“St

20、andard”), is a magnetic type device that produces arepeatable breakaway torque within the expected torque rangefor the particular container/continuous thread closure system tobe evaluated. (A calibrated “standard” is a separate devicecalibrated to a known set torque value and used for verifyingthe m

21、easuring meter between calibration periods.)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.7.3 Select a single cap and container mold

22、cavity numbercombination for testing if possible. A single combination willreduce the variability between samples.7.4 For torque measurement and analysis of a productionline system, sample size should be determined based upon thequantity of mold cavities used to produce the containers andclosures us

23、ed in production.8. Calibration8.1 Calibrate transducer based torque meters to a traceableindustry recognized traceable standard (e.g. NIST) in accor-dance with the manufacturers procedures.8.2 Verify dynamic calibration of the transducer basedtorque meter by measuring both the application and remov

24、altorque of a calibrated force meter with a torque calibrationverification device (calibrated “standard”) five times beforetesting begins. Record results.9. Conditioning and Preparation of Test Specimens9.1 Perform test specimen conditioning in accordance withSpecification E171 and Practice D4332.9.

25、2 Fill all of the containers with the specified volume orweight of product, or other materials that yield similar weightand thermal characteristics. See Notes 2 and 3.NOTE 2The total quantity of test specimens sampled will depend uponthe method selected and the number of environmental storage condit

26、ions.NOTE 3Given the purpose of the evaluation, empty containers may beused as an option to filled containers for static testing.10. Procedure (see Note 4)10.1 Test A: Static Evaluation Non-Child Resistant Clo-sures:10.1.1 Select the minimum application torque for thecontainer/continuous thread syst

27、em as recommended by theclosure manufacturer. (For example, the U.S. Pharmacopoeia,the Society for the Plastics Industry, the Glass ContainerManufacturers Institute, or other sources.)NOTE 4Under certain conditions of product-filling, storage anddistribution, it may be desirable to combine appropria

28、te segments of TestMethod A and Test Method B.10.1.2 Set up torque meter for application torque operationbased on manufacturers procedures.10.1.3 Place a suitable closure onto the container.10.1.4 For actuated container clamping type concentric withmeasuring device, place the container into the mach

29、ine. Formanual style container clamping type, place the container intothe machines container holding device in such a manner thatthe axis of rotation of the closure is concentric with the centerof the measuring device.10.1.5 For positive actuated chuck style, start cycle andtighten the closure to th

30、e pre-determined application torque.For manual chuck style, affix the automated machines rotatingmeasuring device to the closure and tighten the closure to thepre-determined application torque. Record both the pre-determined applied torque and the torque rate or rotation rate ofthe torque measuring

31、head.10.1.6 Verify that the machine stopped applying torque atthe pre-determined application value. See Note 5.10.1.7 Apply the balance of the closures or containers to thematching components as directed in 10.1.3, 10.1.4, and 10.1.5.10.1.8 Store the assembled test specimens as appropriate inaccorda

32、nce with Specification E171 or Practice D4332.10.1.8.1 Maintain one group of test specimens as a controlby storing this group at ambient laboratory conditions. SeeNote 5.NOTE 5The application torque range is usually determined on thebasis of the desired removal torque range.10.1.8.2 Maintain, as app

33、ropriate, one or more groups oftest specimens at constant temperatures different than ambientlaboratory conditions. If desired, cycling at various tempera-ture and relative humidity conditions may be performed.D7860 14210.1.9 At the end of each predetermined time period,determine the removal torque

34、for each test sample at ambientlaboratory conditions or at the alternative temperature andrelative humidity conditions.10.1.9.1 The following test intervals are recommended:immediate (between 1 and 5 minutes), 24 h, 48 h, 7 days, 14days, and 28 days. See Note 6.NOTE 6Sterilization cycles, if applied

35、, using steam, ethylene oxide,gamma radiation, or other methods are known to affect certain plastics;these effects may influence removal torques.10.1.10 Set-up machine for removal torque operation basedon manufacturers procedures.10.1.11 Determine the removal torque for each test speci-men; for actu

36、ated container clamping type concentric withmeasuring device, place the container into the machine. Formanual style container clamping type, place the container inthe machines container holding device in such a manner thatthe axis of rotation of the closure is concentric with the centerof the measur

37、ing device.10.1.12 For positive actuated chuck style, activate machineto remove and measure the cap removal torque from thecontainer. For manual chuck style, affix the measuring deviceto the container closure and while avoiding contact with thefixed component, activate the machine to remove and meas

38、urethe cap removal torque from the container. Note the maximumtorque required to loosen the closure, the rotation speed ortorque rate of the rotating torque measurement device and thedwell time and record these values for the test specimen. SeeNote 7.NOTE 7It is recommended that the same automated t

39、orque instrumentbe used to remove all closures in a given test to reduce possible instrumentinconsistencies and their associated variables.10.1.13 Record the maximum torque required to loosen theclosure and the dwell time for each remaining specimen.10.1.14 Remove the balance of the movable componen

40、ts(normally the continuous thread closures) as directed in10.1.11 and 10.1.12.10.2 Test A1: Static Evaluation -Child Resistant Closures:10.2.1 Select the minimum application torque for thecontainer/continuous thread system as recommended by theclosure manufacturer. (For example, the U.S. Pharmacopoe

41、ia,the Society for the Plastics Industry, the Glass ContainerManufacturers Institute, or other sources.)NOTE 8Under certain conditions of product-filling, storage anddistribution, it may be desirable to combine appropriate segments of TestMethod A and Test Method B.10.2.2 Set up torque meter for app

42、lication torque operationbased on manufacturers procedures.10.2.3 Place a suitable closure onto the container.10.2.4 For actuated container clamping type concentric withmeasuring device, place the container into the machine. Formanual style container clamping type, place the container intothe machin

43、es container holding device in such a manner thatthe axis of rotation of the closure is concentric with the centerof the measuring device.10.2.5 Rotate the bottle and cap until the caps CR outerlocking lugs mesh with the inner lugs that allow the cap to betightened or removed. Activate the CR lockin

44、g mechanismwith sufficient vertical force to prevent slipping of the lugs.Record the vertical downward force.10.2.6 For positive actuated chuck style, start cycle andtighten the closure to the pre-determined application torque.For manual chuck style, affix the automated machines rotatingmeasuring de

45、vice to the closure and tighten the closure to thepre-determined application torque. Record both the pre-determined applied torque and the torque rate or rotation rate ofthe torque measuring head.10.2.7 Verify that the machine stopped applying torque atthe pre-determined application value. See Note

46、6.10.2.8 Apply the balance of the closures or containers to thematching components as directed in 10.1.3, 10.1.4, and 10.1.5.10.2.9 Store the assembled test specimens as appropriate inaccordance with Specification E171 or Practice D4332.10.2.9.1 Maintain one group of test specimens as a controlby st

47、oring this group at ambient laboratory conditions. SeeNote 9.NOTE 9The application torque range is usually determined on thebasis of the desired removal torque range.10.2.9.2 Maintain, as appropriate, one or more groups oftest specimens at constant temperatures different than ambientlaboratory condi

48、tions. If desired, cycling at various tempera-ture and relative humidity conditions may be performed.10.2.10 At the end of each predetermined time period,determine the removal torque for each test sample at ambientlaboratory conditions or at the alternative temperature andrelative humidity condition

49、s.10.2.10.1 The following test intervals are recommended:immediate (between 1 and 5 minutes), 24 h, 48 h, 7 days, 14days, and 28 days. See Note 10.NOTE 10Sterilization cycles, if applied, using steam, ethylene oxide,gamma radiation, or other methods are known to affect certain plastics;these effects may influence removal torques.10.2.11 Set-up machine for removal torque operation basedon manufacturers procedures.10.2.12 Determine the removal torque for each test speci-men; for actuated container clamping type concentric withmeasuring device, place the container i