SIST EN 15384-1:2017

Packaging - Test method to determine the porosity of the internal coating of flexible aluminium tubes - Part 1: Sodium chloride test

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 household products.
The internal coating is used as a barrier and should avoid any contact between aluminium and the product. This European Standard defines the sodium chloride method to detect the electrolyte conductivity as one criterion for the quality 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 the aluminium tube and the product. The electrolyte conductivity is never 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.

Packmittel - Prüfverfahren zur Bestimmung der Porosität der Innenbeschichtung von Aluminiumtuben - Teil 1: Natriumchlorid-Verfahren

Diese Europäische Norm gilt für innenbeschichtete zylindrische und konische Aluminiumtuben, die überwiegend für die Verpackung von Produkten der Pharmazie, der Kosmetik, der Hygiene sowie von Lebensmitteln oder anderen Haushaltsprodukten verwendet werden.
Die Innenbeschichtung dient als Sperrschicht und sollte jeden Kontakt zwischen Aluminium und dem Produkt verhindern. Diese Norm legt das Natriumchlorid-Verfahren zur Bestimmung der elektrolytischen Leitfähigkeit als ein Kennzeichen der Qualität der Innenbeschichtung fest.
ANMERKUNG   Die elektrolytische Leitfähigkeit der Innenbeschichtung ist nur ein Kennzeichen zur Beurteilung der Qualität einer Innenbeschichtung. Sie gibt weder Informationen über Anzahl oder Größe von Poren oder unbeschichteten Flächen noch Hinweise auf mögliche Reaktionen zwischen Aluminiumtube und Produkt an.
Die elektrolytische Leitfähigkeit sollte nie als einziges Kennzeichen zur Qualitätsbeurteilung einer Innenbeschichtung angesehen werden, sondern immer gemeinsam mit anderen Kennwerten, wie z. B. Schichtdicke, Aceton  und/oder Ammoniakbeständigkeit und selbstverständlich Ergebnissen erweiterter Stabilitätsstudien.

Emballage - Méthode d'essai pour déterminer la porosité du revêtement intérieur des tubes souples en aluminium - Partie 1 : Essai au chlorure de sodium

La présente Norme européenne est applicable aux tubes cylindriques et coniques en aluminium à revêtement intérieur, principalement utilisés pour emballer des produits pharmaceutiques, cosmétiques, alimentaires, des produits d’hygiène et autres produits de première nécessité.
Le revêtement intérieur a pour fonction d’empêcher tout contact entre l’aluminium et le produit. La présente norme définit la méthode au chlorure de sodium pour détecter la conductivité de l’électrolyte, qui est un critère de qualité du revêtement intérieur.
NOTE   La conductivité de l’électrolyte du revêtement intérieur n’est qu’un critère d’évaluation de la qualité d’un revêtement intérieur. Elle ne donne aucune information sur la quantité ou la taille d’éventuels pores ou zones non revêtues, ni sur les possibles réactions entre le tube d’aluminium et le produit.
Il convient de ne jamais utiliser la conductivité de l’électrolyte comme seul critère d’évaluation de la qualité du revêtement intérieur mais de toujours l’associer à d’autres paramètres, comme l’épaisseur du film, la résistance à l’acétone et/ou à l’ammoniaque, et, bien sûr, aux résultats des études de stabilité détaillées.

Embalaža - Preskusna metoda za ugotavljanje poroznosti notranjih prevlek prožnih aluminijastih tub - 1. del: Preskus z natrijevim kloridom

Ta evropski standard se uporablja za cilindrične in stožčaste aluminijaste tube z notranjo prevleko, namenjene predvsem pakiranju farmacevtskih, kozmetičnih, higienskih, prehrambenih ali drugih gospodinjskih proizvodov.
Notranja prevleka se uporablja kot pregrada in preprečuje stik med aluminijem in proizvodom. Ta evropski standard določa metodo z natrijevim kloridom za zaznavanje elektrolitske prevodnosti kot eno merilo za kakovost notranje prevleke.
OPOMBA: Elektrolitska prevodnost notranje prevleke je samo eno merilo za oceno kakovosti notranje prevleke. Ne podaja nobenih informacij o količini ali velikosti morebitnih por ali območij brez prevleke ter nobenih namigov o mogočih reakcijah med aluminijasto tubo in proizvodom. Elektrolitska prevodnost se nikoli ne uporablja kot edino merilo za oceno kakovosti notranje prevleke, ampak se vedno uporablja z drugimi parametri, npr. debelino premaza, odpornostjo na aceton in/ali amoniak, in rezultati študij večje stabilnosti.

General Information

• Status: Published
• Public Enquiry End Date: 30-Nov-2015
• Publication Date: 08-Aug-2017
• ICS: 55.120 - Cans. Tins. Tubes
• ICS: 77.150.10 - Aluminium products
• Technical Committee: EPO - Packaging - sales and grouped
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 31-Jul-2017
• Due Date: 05-Oct-2017
• Completion Date: 09-Aug-2017
• Ref Project: EN 15384-1:2017 - Packaging - Test method to determine the porosity of the internal coating of flexible aluminium tubes - Part 1: Sodium chloride test

Relations

• Replaces: SIST EN 15384:2008 - Packaging - Flexible aluminium tubes - Test method to determine the porosity of the internal coating
• Effective Date: 01-Sep-2017

Overview

EN 15384-1:2017 (CEN) defines a standardized sodium chloride method to detect electrolyte conductivity through the internal coating of flexible aluminium tubes. The standard applies to cylindrical and conical internally coated aluminium tubes used for pharmaceutical, cosmetic, hygiene, food and household products. The test provides a reproducible indicator for coating integrity and is intended as one criterion within a wider quality control program.

Key points:

• The method measures electrolyte conductivity as an indicator of porosity or thin spots in the internal coating.
• Electrolyte conductivity is only one quality criterion and must be used together with other assessments such as film thickness, chemical resistance and stability studies.

Key Topics

Principle

The coated tube is filled with a defined sodium chloride electrolyte and measured with an enamel conductometer. One electrode contacts the nozzle or adapter; a movable dipping electrode is inserted into the electrolyte. A defined DC voltage is applied for a fixed interval and the induced current (mA) indicates the electrolyte conductivity of the coating.

Apparatus and reagents

• Enamel conductometer with processor unit
• Movable dipping electrode (stainless steel) with insulating spacer to avoid shoulder contact
• Adapter electrode (stainless steel, nominal 6 mm diameter)
• Electrolyte: sodium chloride solution prepared by dissolving (10.2 ± 0.01) g NaCl in deionized water and making up to (1 000 ± 2) ml
• Controlled laboratory conditions (reference temperature is 23 ± 2 °C)

Procedure (summary)

• Mount the tube in the adapter so an electrical circuit is ensured between tube and adapter electrode.
• Insert the dipping electrode centrally until it touches the tube shoulder, avoiding wall contact.
• Fill the tube with electrolyte up to 10 mm from the open end after inserting the electrode.
• Apply the specified DC voltage and read current after the defined measuring interval. The electrolyte may be reused for a limited number of tests (standard notes up to 10 tubes).

Tolerances and interpretation

Tolerances for maximum allowable electrolyte conductivity depend on tube diameter and geometry; larger diameters typically allow higher current limits. The standard provides tables of maximum mA values and cautions that special tube designs or treatments (sterilization, coning, cannulae) may require adjusted limits or correlations between equipment from different suppliers.

Applications

• Routine quality control of internal coatings for aluminium tubes used in pharmaceutical, cosmetic, food and household product packaging
• Incoming inspection of tube batches and verification after manufacturing steps or surface treatments
• Comparative testing during coating development and process qualification

Related Standards

EN 15384-1:2017 references and complements other packaging standards, including:

• EN 12374 - Flexible tubes terminology
• EN 13046 / EN 13047 - Dimensions and tolerances for cylindrical and conical metallic tubes
• ISO 2859-1 - Sampling procedures for inspection by attributes

Notes

The standard emphasizes that electrolyte conductivity is not a direct measure of pore size or quantity nor an assessment of chemical reactivity; it must be used alongside film thickness, solvent resistance tests and stability studies. The test report should document method reference, batch identification, apparatus and parameters used, test results, number of tested tubes, defects, acceptance decision and inspector details.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Embalaža - Preskusna metoda za ugotavljanje poroznosti notranjih prevlek prožnih aluminijastih tub - 1. del: Preskus z natrijevim kloridomPackmittel - Prüfverfahren zur Bestimmung der Porosität der Innenbeschichtung von Aluminiumtuben - Teil 1: Natriumchlorid-VerfahrenEmballage - Méthode d'essai pour déterminer la porosité du revêtement intérieur des tubes souples en aluminium - Partie 1 : Essai au chlorure de sodiumPackaging - Test method to determine the porosity of the internal coating of flexible aluminium tubes - Part 1: Sodium chloride test77.150.10Aluminijski izdelkiAluminium products55.120Cans. Tins. TubesICS:Ta slovenski standard je istoveten z:EN 15384-1:2017SIST EN 15384-1:2017en,fr,de01-september-2017SIST EN 15384-1:2017SLOVENSKI
STANDARDSIST EN 15384:20081DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15384-1
January
t r s y ICS
w wä s t r Supersedes EN
s w u z vã t r r yEnglish Version
Packaging æ Test method to determine the porosity of the internal coating of flexible aluminium tubes æ Part
sã Sodium chloride test Emballage æ Méthode d 5essai pour déterminer la porosité du revêtement intérieur des tubes souples en aluminium æ Partie
s ã Méthode au chlorure de sodium Packmittel æ Prüfverfahren zur Bestimmung der Porosität der Innenbeschichtung von Aluminiumtuben æ Teil
sã NatriumchloridæVerfahren This European Standard was approved by CEN on
t s November
t r s xä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
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t r s y CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s w u z væ sã t r s y ESIST EN 15384-1:2017
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