ASTM_D_3472_-_97_2007.pdf

Designation:D347297(Reapproved 2007)Standard Test Method forReverse-Ratchet Torque of Type IA Child-ResistantClosures1This standard is issued under the fixed designation D3472;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 the torquedeveloped when Type IA child-resistant closures are rotated inthe counter-clockwise direction.Type IA closures are reclos-able continuous threaded closures that use a random push downwhile turning;no orientation of the push down force isnecessary.1.2 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 limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D3198 Test Method for Application and Removal Torque ofThreaded or Lug-Style ClosuresD3474 Practice for Calibration and Use of Torque MetersUsed in Packaging ApplicationsD3475 Classification of Child-Resistant PackagesD3810 Test Method for Minimum Application Torque ofType IA Child-Resistant ClosuresE105 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 Definition(see Classification D3475).3.1.1 Type IA child-resistant closurea two-piece continu-ous thread closure requiring a random push down whileturning;no orientation of the push down force is necessary.4.Summary of Test Method4.1 Representative specimens of child-resistant threadedclosures are applied to an appropriate container.A torque-measuring device is used to measure the amount of torquedeveloped when the closure is rotated in the counter-clockwisedirection without any vertical force applied.This is reverse-ratchet torque.5.Significance and Use5.1 These torque measurements are of value because thereverse-ratchet torque is a torque applied to the closure in theremoval direction of the closure.For Type IA closures,it isessential that this torque be significantly lower than somedefined level at which the closure might unscrew.5.2 This test may be used to establish performance specifi-cation for this attribute.6.Apparatus6.1 Torque Tester,(See Note 1.)The model used is deter-mined by the anticipated range of torques to be measured.Reverse-ratchet torques usually fall below 10 lbfin.(1.1 Nm).An appropriate torque tester range from 0 to 25 lbfin.(0 to 2.8Nm)or 0 to 10 lbfin.(0 to 1.1 Nm)is suggested.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 printout format.7.Sampling7.1 The number of samples will depend on the purpose forwhich this test is being run.For a given set of samples,sufficient measurements should be taken in accordance withestablished statistical sampling procedures.7.2 Refer to Practices E105 and E122 for more specificinformation on statistically valid procedures.8.Test Specimens8.1 Unused threaded closures complete with liner,if appli-cable,and containers with the proper corresponding finishshould be used.1This test method is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical and Medical Packaging.Current edition approved Oct.1,2007.Published October 2007.Originallyapproved in 1976.Last previous edition approved in 2002 as D3472 97(2002).DOI:10.1520/D3472-97R07.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 8.2 If appropriate care is taken to avoid build-up of lubricantor coating from liner facings,the same container may be usedfor multiple tests in a series.8.3 If repeated removal and reapplication is being studied asa variable,a separate container should be used for each closure,and the same closure-container combinations used for theduration of the test.9.Calibration9.1 Calibrate the torque meter in accordance with PracticeD3474.NOTE2Follow calibration procedure of manufacturer if a digital orautomated torque instrument is to be used.10.Conditioning10.1 Closure application and removal-torque measurementsmay be influenced by test circumstances such as time,tem-perature,and humidity conditioning of the closures prior totesting,as well as temperature and humidity at the ti