1、BS EN 15384-2:2017Packaging Test method to determine the porosity of the internal coating of flexible aluminium tubesPart 2: Copper sulphate testBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 15384-2:2017 BRITISH STANDARDNational forewordThis British Standard
2、is the UK implementation of EN 15384-2:2017. .The UK participation in its preparation was entrusted by Technical A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contrac
3、t. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 91014 2 ICS 55.120 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authori
4、ty of the Standards Policy and Strategy Committee on 28 February 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dCommittee PKW/0, Packaging, to Subcommittee PKW/0/-/10,Packaging - Plastics.which is withdrawn.Together with BS EN 15384-1:2017, it supersedes BS EN 15384:2
5、007BS EN 15384-2:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15384-2 January 2017 ICS 55.120 Supersedes EN 15384:2007English Version Packaging - Test method to determine the porosity of the internal coating of flexible aluminium tubes - Part 2: Copper sulphate test Emballage - Mthode de
6、ssai pour dterminer la porosit du revtement intrieur des tubes souples en aluminium - Partie 2 : Essai au sulfate de cuivre Packmittel - Prfverfahren zur Bestimmung der Porositt der Innenbeschichtung von Aluminiumtuben - Teil 2: Kupfersulfatverfahren This European Standard was approved by CEN on 14
7、November 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may b
8、e obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to
9、the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, I
10、reland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Man
11、agement Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15384-2:2017 EBS EN 15384-2:2017EN 15384-2:2017 (E) 2 Contents Page EUROPEAN FOREWORD 3 1 SCOPE . 4 2 PRINCIPLE . 4 3 APPARATUS
12、4 FIGURE 1 TEST DEVICE 5 4 PROCEDURE 5 TABLE 1 TEST CONDITIONS FOR THE COPPER SULPHATE METHOD . 6 5 TOLERANCES . 7 TABLE 2 TOLERANCES FOR THE COPPER SULPHATE METHOD . 7 6 TEST REPORT 7 BIBLIOGRAPHY 8 BS EN 15384-2:2017EN 15384-2:2017 (E) 3 European foreword This document (EN 15384-2:2017) has been p
13、repared by Technical Committee CEN/TC 261 “Packaging”, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by July 2017, and conflicting national standards shal
14、l be withdrawn at the latest by July 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 15384:2007. According to the C
15、EN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hung
16、ary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 15384-2:2017EN 15384-2:2017 (E) 4 1 Scope This European Standard is applicable for internal
17、ly coated cylindrical aluminium tubes, mainly used for the packing of pharmaceutical, cosmetic, hygiene, food or other household products. The internal coating is used as a barrier and should avoid any contact between aluminium and the product. This standard defines the copper sulphate method to det
18、ect the electrolyte conductivity as one criterion for the quality of the internal coating. The electrolyte conductivity of the internal coating is only one criterion for evaluation of the quality of an internal coating. It does not give any information on the quantity or size of any pores or uncoate
19、d areas, nor any hint on possible reactions between the aluminium tube and the product. The electrolyte conductivity should never be used as the sole criterion for quality evaluation of the internal coating, but always with other parameters e.g. film thickness, acetone and/or ammonia resistance and
20、of course results of enhanced stability studies. 2 Principle The electrolyte conductivity of internally coated aluminium tubes is tested by an enamel conductometer. The aluminium tubes are filled with an electrolyte solution up to a fixed level at its open end. One electrode is connected to the tube
21、 nozzle, the second electrode is dipped into the solution. A defined voltage is applied for a fixed time. The induced current is a measure for the quality (pores and/or film thickness) of the internal coating. 3 Apparatus 3.1 Enamel conductometer 3.2 Moveable electrode 3.3 Electrolyte NOTE A schemat
22、ic diagram of the test equipment is given in Figure 1. BS EN 15384-2:2017EN 15384-2:2017 (E) 5 Key 1 electrode (negative pole) 2 aluminium tube 3 insulating spacer 4 movable electrode (positive pole) 5 electrolyte 6 electrode holder 7 processor unit Figure 1 Test device 4 Procedure All parameters ha
23、ving a significant influence on the test results for the copper sulphate method are listed in Table 1. BS EN 15384-2:2017EN 15384-2:2017 (E) 6 Table 1 Test conditions for the copper sulphate method Parameter Copper sulphate method Temperature 23 2 C Voltage and measuring interval internal resistance
24、 4 500 mV DC 2,5 s voltmeter 20 k/V ammeter 2,5 at 100 mA Electrodes - polarity - material - diameter dipping electrode is the positive pole dipping electrode copper (a round insulating spacer of 5 2 mm has to be mounted on the bottom of the electrode to avoid direct contact between electrode and tu
25、be shoulder) adapter electrode stainless steel 5 mm 0,3 mm for tube diameter 19 mm 10 mm 0,5 mm for tube diameter 19 mm Electrolyte Copper sulphate solution (10,0 0,01) g Copper sulphate Pentahydrate p.a. CuSO45H2O CASa)(7758998) (5,00 0,01)ml Acetic acid, 100 %, p.a., HAcb)CASa)(64197) (0,05 0,01)
26、g/l wetting agent CASa)68425445 Dissolve the CuSO45H2O in deionized water, add the HAc and wetting agent and make up to (1 000 2) ml with deionized water. The electrolyte conductivity of the finished solution shall be (4,75 0,25) mS. aCAS is Chemical Abstracts Service CAS registry numbers are unique
27、 numerical identifiers for chemical compounds, polymers, biological sequences, mixtures and alloys. bHAc is the most common abbreviation for acetic acid in the context of acid-base reactions. Depending on the method and the kind of apparatus (different apparatus are available) specific adjustments a
28、nd calibrations may be necessary and should be done as described in the user manuals prior to use. To take a measurement put the tube into the adapter electrode, ensuring there is an electric circuit between the tube and electrode. Insert the dipping electrode centrally into the tube until it touche
29、s the tube shoulder, avoiding any contact between the tube wall / tube shoulder and the dipping electrode. Fill the tube with electrolyte up to 10 mm from the end after inserting the electrode. Start the measurement application of voltage immediately. Read the result in mA on the display after the m
30、easuring interval. The electrolyte can be used for testing 10 tubes. The test on one tube is not repeatable for the copper sulphate method. BS EN 15384-2:2017EN 15384-2:2017 (E) 7 5 Tolerances The tolerances given in this standard are based on long-term experiences and are valid only for membrane tu
31、bes. For tubes with special conification angles and nozzles, e.g. without membrane or cannula, higher tolerance limits may be required. In addition, for some specific internal coatings but also depending on the product, different tolerance limits may be required. Any deviations from this standard sh
32、all be agreed mutually between both parties. Tolerances for the copper sulphate method are given in Table 2: Table 2 Tolerances for the copper sulphate method Tube diameter mm Mean Value mA Single Value mA 28 25 80 28 45 35 80 45 50 45 80 Due to several variables which can affect the result (e.g. co
33、rrosion, surface of copper electrode) the accuracy of the methods may vary by several mA. For making well-founded conclusions a representative number of tubes should always be tested. NOTE 1 Test apparatus from different suppliers may give different results. In this case comparative measurements and
34、 correlations factors may be required. NOTE 2 The tolerances given in Table 2 are only valid for standard tubes and not for tubes with additional treatment such as sterilization. 6 Test report Unless otherwise agreed between both parties the test report shall contain the following information: a) re
35、ference to this standard and if necessary a specification for the method of sampling and acceptance of the batch, b) complete identification of the batch and of the tubes checked, c) description of the samples, d) registering number of the apparatus and the selected test parameters, e) type of inter
36、nal coating, f) test results, g) number of tested tubes, h) number of defects, i) if applicable the decision for acceptance or rejection, j) all factors, that may have had an influence on the test results and which are not covered by this standard, k) date, place and name of the inspector. BS EN 153
37、84-2:2017EN 15384-2:2017 (E) 8 Bibliography 1 EN 12374, Packaging - Flexible tubes - Terminology 2 EN 13046, Packaging - Flexible cylindrical metallic tubes - Dimensions and tolerances 3 EN 13047, Packaging - Flexible conical metallic tubes - Dimensions and tolerances 4 ISO 2859-1, Sampling procedur
38、es for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection This page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and services.BSI is
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