1、BS EN 15384-1:2017Packaging Test method to determine the porosity of the internal coating of flexible aluminium tubesPart 1: Sodium chloride testBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 15384-1:2017 BRITISH STANDARDNational forewordThis British Standard
2、is the UK implementation of EN 15384-1:2017. The UK participation in its preparation was entrusted by Technical Committee PKW/0, Packaging, to Subcommittee PKW/0/-/10,A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purpor
3、t to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 91013 5 ICS 55.120 Compliance with a British Standard cannot confer immunity from legal obligations
4、.This British Standard was published under the authority 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February 2017.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dPackaging - Plastics.which is withdrawn.Together with BS EN 15384-2:2017, it supersedes BS EN 15384:20
5、07BS EN 15384-1:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15384-1 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 1: Sodium chloride test Emballage - Mthode des
6、sai pour dterminer la porosit du revtement intrieur des tubes souples en aluminium - Partie 1 : Mthode au chlorure de sodiumPackmittel - Prfverfahren zur Bestimmung der Porositt der Innenbeschichtung von Aluminiumtuben - Teil 1: Natriumchlorid-Verfahren This European Standard was approved by CEN on
7、21 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 ma
8、y be 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
9、to 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
10、, Ireland, 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
11、Management 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 15384-1:2017 EBS EN 15384-1:2017EN 15384-1:2017 (E) 2 Contents Page European Foreword . 3 1 Scope 4 2 Principle . 4 3 Apparat
12、us 4 4 Procedure 6 5 Tolerances . 7 6 Test Report 7 Bibliography . 8 BS EN 15384-1:2017EN 15384-1:2017 (E) 3 European foreword This document (EN 15384-1:2017) has been prepared by Technical Committee CEN/TC 261 “Packaging”, the secretariat of which is held by AFNOR. This European Standard shall be g
13、iven 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 shall be withdrawn at the latest by July 2017. Attention is drawn to the possibility that some of the elements of this document may be
14、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 CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this Europe
15、an Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovaki
16、a, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 15384-1:2017EN 15384-1:2017 (E) 4 1 Scope This European Standard is applicable for internally coated cylindrical and conical aluminium tubes, mainly used for the packing of pharmaceutical, cosmetic, hygiene, food or other
17、household products. The internal coating is used as a barrier and should avoid any contact between aluminium and the product. This standard defines the sodium chloride method to detect the electrolyte conductivity as one criterion for the quality of the internal coating. NOTE The electrolyte conduct
18、ivity 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 uncoated areas, nor any hint on possible reactions between the aluminium tube and the product. The electrolyte conductivi
19、ty 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 of course results of enhanced stability studies. 2 Principle The electrolyte conductivity of internally coated alu
20、minium 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 nozzle, the second electrode is dipped into the solution. A defined voltage is applied for a fixed time. The indu
21、ced 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 schematic diagram of the test equipment is given in Figure 1. BS EN 15384-1:2017EN 15384-1:2017 (E) 5 Key 1 electrode (po
22、sitive pole) 2 aluminium tube 3 insulating spacer 4 movable electrode (negative pole) 5 electrolyte 6 electrode holder 7 processor unit Figure 1 Test device BS EN 15384-1:2017EN 15384-1:2017 (E) 6 4 Procedure All parameters having a significant influence on the test results for sodium chloride metho
23、ds are listed in Table 1. Table 1 Test conditions for the sodium chloride method Parameter Sodium chloride method Temperature 23 2 C Voltage and measuring interval internal resistance 6 300 mV DC 4,0 s voltmeter 20 k/V ammeter 2,5 at 100 mA Electrodes - polarity - material - diameter dipping electro
24、de is the negative pole dipping electrode stainless steel (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 tube shoulder) adapter electrode stainless steel 6 mm 0,3 mm for all tube sizes Electrolyte Sodium chloride so
25、lution (10,2 0,01) g Sodium chloride p.a. NaCl, CAS a7647145 Dissolve the NaCl in deionized water and make up to (1 000 2) ml with deionized water. aCAS is Chemical Abstracts Service CAS registry numbers are unique numerical identifiers for chemical compounds, polymers, biological sequences, mixture
26、s and alloys. Depending on the method and the kind of apparatus (different apparatus are available) specific adjustments and 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 i
27、s an electric circuit between the tube and electrode. Insert the dipping electrode centrally into the tube until it touches 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
28、 the electrode. Start the measurement application of voltage immediately. Read the result in mA on the display after the measuring interval. The electrolyte can be used for testing 10 tubes. Measurements on one tube are repeatable. BS EN 15384-1:2017EN 15384-1:2017 (E) 7 5 Tolerances The tolerances
29、given in this standard are based on long-term experiences and are valid only for membrane tubes. 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 t
30、he product, different tolerance limits may be required. Any deviations from this standard shall be agreed mutually between both parties. Tolerances for the sodium chloride method are given in Table 2: Table 2 Tolerances for the sodium chloride method Tube diameter mm Maximum electrolyte conductivity
31、 mA Cylindrical tubes Conical tubes Mean value Single value Mean value Single value 20 10 25 15 30 20 30 15 30 20 40 30 40 20 40 25 50 40 45 25 50 30 60 45 50 35 80 - - NOTE 1 Test apparatus from different suppliers may give different results. In this case, comparative measurements and correlations
32、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) reference to thi
33、s 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 internal coating, f
34、) 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 15384-1:2017EN 15
35、384-1:2017 (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 procedures for inspect
36、ion 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 incorporated
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