ASTM_D_3968_-_97_2007.pdf

Designation:D396897(Reapproved 2007)Standard Test Method forMonitoring of Rotational Torque of Type IIIA Child-ResistantClosures1This standard is issued under the fixed designation D3968;the number immediately following the designation 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 This test method covers the measurement of rotationaltorques of Type IIIA child-resistant closures as a means ofmonitoring normal functioning of the child-resistant package.1.2 This test method is not intended to supplant preexistingclosure or package specifications or preexisting incomingmaterial test procedures.1.3 This standard does not purport to address the safetyconcerns,if any,associated with its use.It is the responsibilityof the user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D3474 Practice for Calibration and Use of Torque MetersUsed in Packaging ApplicationsD3475 Classification of Child-Resistant PackagesE105 Practice for Probability Sampling of MaterialsE122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or Process3.Terminology3.1 Definitions:3.1.1 rotational torquethe moment of force or system offorces tending to cause rotation of a Type IIIA closure on thefinish of its container.3.2 Definitions of Terms Specific to This Standard:3.2.1 Type III child-resistant closure3a reclosable snapclosure requiring an alignment of two points on closure andcontainer followed by a pushing off of the closure top or lip toremove the closure(taken from Classification D3475).4.Summary of Test Method4.1 Representative samples of packages with Type IIIAchild-resistant closures are evaluated for closure rotationaltorques by using an appropriate torque meter.5.Significance and Use5.1 The application of this test method provides a means forevaluating one of the variables affecting the ability of theclosure-container system to function as specified.5.2 Variability in rotational torque measurements is prob-ably due to the use of the torque meter to measure relativelysmall torque values,differences in critical package dimensions,and the aging of components.6.Apparatus6.1 Torque Meter Select a torque meter with a scalehaving the smallest range that will span the torque rangeexpected to be measured(for example,use a 0 to 10-lbfin.torque meter for readings under 10 lbfin.,not a 0 to 25 lbfin.torque meter).NOTE1Adigital or automated torque instrument,if used,will have anappropriate design and scale capacity for the container/closure system tobe evaluated.Torque results will be available in either electronic displayor print out formats.7.Sampling,Test Specimens,and Test Units7.1 Sampling of package specimens for this test methodshall be in accordance with statistically valid procedures.Referto Practices E105 and E122 for more specific information.7.2 Use package specimens whose component containersand closures are within their respective specifications.7.3 Use package specimens with a known number of closureapplications.7.4 Use a sufficient number of package specimens for thedesired statistical correlation.1This test method is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical,Medical,and Child Resistant Packaging.Current edition approved Oct.1,2007.Published November 2007.Originallyapproved in 1980.Last previous edition approved in 2002 as D3968 97(2002).DOI:10.1520/D3968-97R07.2For 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.3Examples are the Bristol-Myers,Brockway(Celluplastics),Calmar,PlasticResearch,and Stull Closures.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 8.Calibration8.1 Calibrate the torque meter in accordance with PracticeD3474.NOTE2Follow calibration procedure of manufacturer if a digital orautomated torque instrument is to be used.9.Conditioning9.1 Conduct the testing of assembled packages at standardconditions of 23 6 2C(73.4 6 3.4F)and 50 6 5%relativehumidity after their conditioning under these same standards orother specified temperature and relative humidity combina-tions.9.2 The atmosphere conditions in Table 1 may be used whenspecial conditioning is appropriate.Other atmosphere condi-tions may be used as appropriate.10.Procedure10.1 Select sample packages to be tested.10.2 Condition the sample packages,if desired.10.3 Measure rotational torques of test closures used on thesample packages