1、Designation: D 7257 06Standard Test Method forAutomated Shelling Two-Piece Child-Resistant ClosuresThat Are Activated by Two Simultaneous DissimilarMotions1This standard is issued under the fixed designation D 7257; the number immediately following the designation indicates the year oforiginal adopt
2、ion or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers the measurement of the forcerequired to separate
3、 (or “shell”) the snap-fitted outer cap fromthe inner cap of Type IA, IB, or IC child-resistant closures. SeePractice D 3475.1.2 This test method is an alternative to Test MethodD 3481, a manual test procedure.1.3 This test method does not measure the force required toseparate parts of a child-resis
4、tant closure system that wereoriginally “screwed-on” instead of “snapped-on” (for example,pull a cap over or through continuous or multi-start threadswhen the cap was originally screwed on).1.4 The values stated in inch-pound (lbf) units are to beregarded as standard.1.5 This standard does not purpo
5、rt 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:2D 34
6、74 Practice for The Calibration and Use of TorqueMeters Used in Packaging ApplicationsD 3475 Classification of Child-Resistant PackagesD 3481 Test Method for Manual Shelling Two-Piece Child-Resistant Closures That Are Activated by Two Simulta-neous Dissimilar MotionsE 105 Practice for Probability Sa
7、mpling Of MaterialsE 122 Practice for Calculating Sample Size to Estimate,With a Specified Tolerable Error, the Average for aCharacteristic of a Lot or Process3. Terminology3.1 Definitions:3.1.1 shelling fixture or bracketa metal bracket that at-taches to a two-piece, child-resistant closure and pri
8、es an outercap from an inner cap. The bracket is shaped to simulate theprying action of a childs teeth. See Fig. 1.3.1.2 drive cablea non-extensible cable attached from theshelling fixture to a tensile strength measuring device toprovide the cap shelling force.3.1.3 lifting notchindentation on the s
9、helling fixture thatlifts the outer cap off the inner cap during the test. See detail Ain Fig. 1.4. Summary of Test Method4.1 This test method measures the force required to pry theouter cap off the inner cap using a fixture having a contact pointunder the tip of the skirt of the outer cap and lever
10、age beingplaced on that point and the top of the cap. This procedure isused where a pivotal prying force can be successfully used toseparate the components of the closure system, thereby dis-abling the child-resistant function.5. Significance and Use5.1 This test method of applying force may be used
11、 as astandard test to compare the characteristics of a given design ofcontainer/child-resistant closure system with a standard or tocompare the characteristics of container/child resistant closuresystems differing in construction.5.2 It may be used to simulate certain manipulations thatmay be expect
12、ed to occur in protocol testing (such as, pryingwith the teeth, or objects in the room, biting, and pulling withthe teeth).5.3 This test may be used to establish performance specifi-cations. Shelling force may vary with cap application torque,bottle design, and other factors. Consequently where prec
13、isecomparative results are desired, these factors must be carefullycontrolled.1This test method is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.31 on ChildResistant Packaging and Closure Systems.Current edition approved April 1, 2006.
14、Published May 2006.2For 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.1Copyright ASTM International, 100 Barr Ha
15、rbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.FIG. 1 Shelling BracketD72570626. Apparatus6.1 Testing MachineA testing machine of the constant-rate-of-crosshead-movement with vertical orientation type andcomprising essentially the following:6.1.1 Fixed MemberA fixed or esse
16、ntially stationary gripcapable of holding a suitable bottle finish for the cap to betested. The fixed grip should be the lower grip.6.1.2 Movable MemberA movable, top member carryinga second grip.6.1.3 GripA grip for holding the shelling bracket cablecan be either the fixed or self-aligning type.6.2
17、 Attachments, Fixtures, and so forth (see Fig. 1):6.2.1 Cap Holding Fixture, with one contact point under thetop of the outer cap skirt and the other point contacting the topof the cap. The distance between the two contact points shouldbe 34 mm or approximately 138 in. (in accordance with page 19of
18、the Krogman study) or to the farthest side of the cap if lessthan 34 mm.6.2.2 Non-extensible Cable, to be attached to the movablemember of the testing machine. The cable should be marked insuch a manner that the same length of cable will be attached tothe tensile tester and shelling bracket for all
19、samples beingtested.6.2.3 Bottle FixtureA standard GPI bottle finish, withcorresponding finish to the closure(s) being tested.7. Sampling, Test Specimens, and Test Units7.1 The number of samples will depend on the desiredpurpose for which the test is being conducted. However, for agiven set of sampl
20、es, sufficient measurements should be takenin accordance with established statistical sampling proceduresin order to obtain consistent results.7.1.1 Refer to Practices E 105 and E 122 for more specificinformation.7.2 Performance normally should be based on a test of notless than ten representative s
21、pecimens of a given type selectedat random.8. Conditioning8.1 Preconditioning is not necessary unless it is required tosimulate a particular storage environment.8.2 If special conditions are not required, components maybe stored for a minimum of 24 h at 23 6 2C (73.4 6 3.4F)and 50 6 5 % relative hum
22、idity.9. Procedure9.1 Apply all closures to be tested to the appropriatecontainer fixture at a specified and uniform torque.NOTE 1Specifying the application torque is necessary for test consis-tency as the physical relationship/interlocking between the inner and outerclosure can change at different
23、application torque levels. Torque metersshould be calibrated as referenced in Practice D 3474.9.2 Attach the shelling fixture drive cable to the movablemember of the tensile tester and raise the grip so that the fixtureis suspended freely. Zero the load sensor or note the weight ofthe fixture to sub
24、tract it from the shelling force measurementslater.9.3 The load cell of the tensile test should be directly abovethe cap on the container fixture.9.4 After the closure has been applied, attach the containerfixture to the fixed member of the tensile testing machine.9.5 Position the body of the shelli
25、ng fixture onto the closureso that the fixture is horizontal and lifting notch is under theouter cap.9.6 Set the tensile tester for a travel speed of 15 in./min (381mm/min) and start the tensile tester.9.7 Allow the tensile tester to run until the outer cap hasbeen pried from the inner cap, unless a
26、n alternative end pointis desired.NOTE 2Some closure systems lose their child resistance before theouter cap is completely removed from the inner cap. For this reason anappropriate test endpoint should be chosen for a given closure.9.8 The maximum force measured to reach the test endpoint shall be r
27、ecorded as the shelling force.10. Report10.1 The report shall include the following:10.1.1 Name, number and date of procedure used,10.1.2 Gross description of container/child-resistant closuresystem under test; its complete structural specifications; kind ofmaterial; size and style of closure and bo
28、ttle finish includingthread type; manufacturer and lot number; date of receipt orother identification of the specific batch being evaluated,10.1.3 Description of the exact test equipment and proce-dure that were used to obtain the test results, including thecontact point location of the shelling bra
29、cket (see 6.2.1),10.1.4 Table showing the maximum shelling force for eachtest, and10.1.5 Statement that the test was made in accordance withASTM Test Method D 7257. Any and all deviations from therecommended procedure should be noted.11. Precision and Bias11.1 PrecisionThe repeatability standard dev
30、iation hasbeen estimated for three packages based on testing conductedin one laboratory. One package had a within-laboratory stan-dard deviation of 0.3 lbf or 7.31 % of the average. A secondpackage had a standard deviation of 0.41 lbf, 8.36 % of theaverage shelling force. The standard deviation of a
31、 thirdpackage was 0.52 lbf, 25.8 % of the shelling force average.Other packages may have different repeatability values.11.2 BiasNo justifiable statement can be made on the biasof this test method since a true value cannot be established byan accepted referee method.12. Keywords12.1 shelling; two si
32、multaneous dissimilar motions; TypeIAchild-resistant closure; Type IB child-resistant closure; TypeIC child-resistant closureD7257063ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standar
33、d are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif
34、not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, whic
35、h you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).D7257064
