DIN EN 15384-1-2017 Packaging - Test method to determine the porosity of the internal coating of flexible aluminium tubes - Part 1 Sodium chloride test German version EN 15384-1 20.pdf

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1、April 2017 English price group 7No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 55.120!%dN“2654398www.din.deDIN EN

2、15384-1Packaging Test method to determine the porosity of the internal coating of flexible aluminium tubes Part 1: Sodium chloride test;English version EN 153841:2017,English translation of DIN EN 15384-1:2017-04Packmittel Prfverfahren zur Bestimmung der Porositt der Innenbeschichtung von Aluminiumt

3、uben Teil 1: NatriumchloridVerfahren;Englische Fassung EN 153841:2017,Englische bersetzung von DIN EN 15384-1:2017-04Emballage Mthode dessai pour dterminer la porosit du revtement intrieur des tubes souples en aluminium Partie 1: Mthode au chlorure de sodium;Version anglaise EN 153841:2017,Traductio

4、n anglaise de DIN EN 15384-1:2017-04Together with DIN EN 153842:201704,supersedesDIN EN 15384:200801www.beuth.deDocument comprises 10 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.03.17DIN EN 15384-1:2017-04 2 A comma is used

5、 as the decimal marker. National foreword This document (EN 15384-1:2017) has been prepared by Technical Committee CEN/TC 261 “Packaging” (Secretariat: AFNOR, France). The responsible German body involved in its preparation was DIN-Normenausschuss Verpackungswesen (DIN Standards Committee Packaging)

6、, Working Committee NA 115-02-08 AA “Tubes”. Amendments This standard differs from DIN EN 15384:2008-01 as follows: a) DIN EN 15384 has been subdivided into two parts, i. e. separate parts have been prepared for the sodium chloride test and for the copper sulphate test; b) the standard has been edit

7、orially revised. Previous editions DIN 55436-3: 1983-10, 1992-12 DIN EN 15384: 2008-01 EUROPEAN 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 al

8、uminium tubes - Part 1: Sodium chloride test Emballage - Mthode dessai 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: Natri

9、umchlorid-Verfahren This European Standard was approved by CEN on 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 an

10、d bibliographical references concerning such national standards may 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

11、responsibility of a CEN member into its own language and notified 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 Yugosla

12、v Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, 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 EU

13、ROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC 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 EEN 15384-1:2017 (E) 2 Contents Page European

14、Foreword . 3 1 Scope 4 2 Principle . 4 3 Apparatus 4 4 Procedure 6 5 Tolerances . 7 6 Test Report 7 Bibliography . 8 DIN EN 15384-1:2017-04 EN 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 whi

15、ch 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 shall be withdrawn at the latest by July 2017. Attention is drawn to the possibil

16、ity 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 CEN-CENELEC Internal Regulations, the national standards organisations of the

17、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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlan

18、ds, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 15384-1:2017-04 EN 15384 -1:2017 (E) 4 1 Scope This European Standard is applicable for internally coated cylindrical and conical aluminium tubes, mainly used for the

19、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 sodium chloride method to detect the electrolyte conductivity as one criterion for the q

20、uality of the internal coating. NOTE 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 uncoated areas, nor any hint on possible reactions between th

21、e 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 of course results of enhanced stability studies. 2 Pri

22、nciple 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 nozzle, the second electrode is dipped into the solut

23、ion. 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 schematic diagram of the test equipment is given in Figure 1.

24、 DIN EN 15384-1:2017-04 EN 15384 -1:2017 (E) 5 Key 1 electrode (positive pole) 2 aluminium tube 3 insulating spacer 4 movable electrode (negative pole) 5 electrolyte 6 electrode holder 7 processor unit Figure 1 Test device DIN EN 15384-1:2017-04 EN 15384 -1:2017 (E) 6 4 Procedure All parameters havi

25、ng a significant influence on the test results for sodium chloride methods 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

26、,5 at 100 mA Electrodes - polarity - material - diameter dipping electrode 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 stain

27、less steel 6 mm 0,3 mm for all tube sizes Electrolyte Sodium chloride solution (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 ide

28、ntifiers for chemical compounds, polymers, biological sequences, mixtures 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

29、 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 touches the tube shoulder, avoiding any contact between the tube wall / tube shoulder and the dipping electrode.

30、 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 measuring interval. The electrolyte can be used for testing 10 tubes. Measurements on one tube are repeatab

31、le. DIN EN 15384-1:2017-04 EN 15384-1:2017 (E) 7 5 Tolerances The tolerances 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 requi

32、red. In addition, for some specific internal coatings but also depending on the 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

33、 the sodium chloride method Tube diameter mm Maximum electrolyte conductivity 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 giv

34、e different results. In this case, comparative measurements and 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

35、 the test report shall contain the following information: a) reference 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 t

36、he apparatus and the selected test parameters, e) type of internal 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 thi

37、s standard, k) date, place and name of the inspector. DIN EN 15384-1:2017-04 EN 15384 -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 inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection DIN EN 15384-1:2017-04