EN 13628-2:2002

Packaging - Flexible packaging material - Determination of residual solvents by static headspace gas chromatography - Part 2: Industrial methods

This part 2 should be read in conjunction with prEN (261190) part 1 and describes rapid methods as commonly used in quality control for example for monitoring the level of residual solvents used in the production of flexible packaging by static headspace chromatography. The procedure described in this part involves one single injection of the headspace which implies an incomplete extraction of the solvent. The values obtained may be lower than the absolute content which should be determined according to Part 1. During the analysis there may be interferences from possible products of thermal decomposition.

Verpackung - Flexible Packstoffe - Bestimmung der Restlösemittel durch statische Dampfraumanalyse mittels Gaschromatographie - Teil 2: Industrielle Verfahren

Dieser Teil der Europäischen Norm beschreibt Schnellverfahren, die üblicherweise in der Qualitätskontrolle angewendet werden, um Restgehalte von bei der Produktion von flexiblen Packmaterialien verwendeten Lösemitteln mittels gaschromatographischer Dampfraumanalyse zu überwachen. Das in diesem Teil beschriebene Verfahren beinhaltet eine Einfachinjektion des Dampfraumes, die eine unvollständige Extraktion des Lösemittels zur Folge hat. Die so erhaltenen Werte können geringer sein als der Absolutwert, der entsprechend Teil 1 bestimmt werden sollte. Reste von thermischen Zersetzungsprodukten werden von dieser Norm nicht erfasst.
Dieses Verfahren ist für flexible Packstoffe anwendbar, die aus ein- oder mehrschichtigen Kunststofffolien, Papier oder Karton, Metallfolien oder deren Verbundmaterialien bestehen.
Dieses Verfahren ist für Restlösemittelgehalte kleiner als 0,5 mg/m2 nicht anwendbar.

Emballage - Matériaux d'emballages souples - Détermination des solvants résiduels par chromatographie en phase gazeuse et espace de tête statique - Partie 2: Méthodes industrielles

La présente partie (partie 2), qu'il convient de consulter conjointement au prEN(261 WI 190) partie 1, décrit les méthodes rapides couramment utilisées pour le contrôle de la qualité, par exemple pour surveiller le niveau de solvants rési duels utilisés dans la fabrication d'emballages souples par chromatographie en phase gazeuse et espace de tête statique. Le mode opératoire décrit dans cette partie consiste en une injection unique de l'espace de tête impliquant une extraction incomplète du solvant. Les valeurs obtenues peuvent être inférieures au contenu absolu qu'il convient de déterminer selon la partie 1.

Embalaža – Prožni embalažni materiali – Določevanje ostanka topil s statičnim vzorčevalnikom iz plinske faze (headspace) za plinsko kromatografijo – 2. del: Industrijska metoda

General Information

• Status: Published
• Publication Date: 15-Oct-2002
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: CEN/TC 261 - Packaging
• Drafting Committee: CEN/TC 261/SC 5/WG 26 - Packages made from flexible materials (e.g. flexible plastics, plastic laminates, paper/board laminated, metal foil laminates, textiles)
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 11-Sep-2024
• Completion Date: 14-Apr-2025
• Directive: 80/232/EEC - Ranges of nominal quantities and nominal capacities permitted for certain pre-packaged products
• Directive: 87/356/EEC - Ranges of nominal quantities and nominal capacities permitted for certain pre-packged products (Dir. 80/232/EEC amendment)
• Ref Project: SIST EN 13628-2:2003 - Packaging - Flexible packaging material - Determination of residual solvents by static headspace gas chromatography - Part 2: Industrial methods

Overview

EN 13628-2:2002 - Packaging: Flexible packaging material - Determination of residual solvents by static headspace gas chromatography - Part 2: Industrial methods (CEN) specifies rapid, industrial procedures for monitoring residual solvents in flexible packaging using static headspace gas chromatography (HS-GC). Designed for routine quality control, this part complements EN 13628-1 (absolute methods) and describes single‑injection headspace techniques commonly used on production lines and QC laboratories.

Key topics and requirements

• Scope and materials: Applies to mono‑ or multilayer plastic films, paper/board, foil or combinations; not intended for solvent amounts < 0.5 mg/m² or for thermal decomposition residues.
• Method principle: Place specimen in a hermetically sealed vial, incubate to transfer volatile solvent into the headspace, withdraw an aliquot and analyze by GC (typically FID).
• Single headspace extraction: One injection only - a rapid industrial approach that can give lower values than absolute multi‑extraction methods in Part 1.
• Incubation: Conditions must be controlled and reported; recommended example is 110 °C for 20 min (temperature ±2 °C, time ±0.5 min) to ensure repeatability.
• Specimen sizing: Area-to-vial volume ratios typically between 3:1 and 5:1 (cm² : ml); use matched templates and rapid handling to avoid solvent loss.
• Calibration and quantification: External or internal standards may be used; equations for converting GC peak areas to mg/m² are specified.
• Apparatus and consumables: Sealed vials with inert septa (PTFE-lined), crimp tools, analytical balance, headspace sampler or heated syringe, and appropriate GC columns/carry gases.
• Sampling and quality procedures: Sampling per ISO 2859‑1 / ISO 2859‑2; accuracy and precision guidance referenced to ISO 5725‑2.
• Limitations: Single injection implies incomplete extraction; interferences from thermal decomposition products can occur and should not be interpreted as target solvents.

Applications and users

• Who uses it: Packaging converters, film/foil manufacturers, production QC labs, analytical chemists, and compliance officers in food, pharma or consumer packaging sectors.
• Practical uses:
  • Routine in‑line or batch quality control for residual solvent monitoring.
  • Rapid screening to verify production processes and solvent removal steps.
  • Supplier acceptance testing and process troubleshooting.
• Why use it: Fast, reproducible HS‑GC industrial method suitable for high throughput QC where speed is prioritized over absolute solvent mass determination.

Related standards

• EN 13628‑1 (Part 1: Absolute methods) - for definitive quantification.
• ISO 2859‑1 and ISO 2859‑2 - sampling procedures.
• ISO 5725‑2 - method precision and reproducibility guidance.

Keywords: EN 13628-2:2002, residual solvents, static headspace gas chromatography, HS-GC, flexible packaging, industrial methods, quality control, headspace sampler, GC-FID.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verpackung - Flexible Packstoffe - Bestimmung der Restlösemittel durch statische Dampfraumanalyse mittels Gaschromatographie - Teil 2: Industrielle VerfahrenEmballage - Matériaux d'emballages souples - Détermination des solvants résiduels par chromatographie en phase gazeuse et espace de tete statique - Partie 2: Méthodes industriellesPackaging - Flexible packaging material - Determination of residual solvents by static headspace gas chromatography - Part 2: Industrial methods55.040SDNLUDQMHPackaging materials and accessoriesICS:Ta slovenski standard je istoveten z:EN 13628-2:2002SIST EN 13628-2:2003en01-julij-2003SIST EN 13628-2:2003SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13628-2October 2002ICS 55.040English versionPackaging - Flexible packaging material - Determination ofresidual solvents by static headspace gas chromatography -Part 2: Industrial methodsEmballage - Matériaux d'emballages souples -Détermination des solvants résiduels par chromatographieen phase gazeuse et espace de tête statique - Partie 2:Méthodes industriellesVerpackung - Flexible Packstoffe - Bestimmung derRestlösemittel durch statische Dampfraumanalyse mittelsGaschromatographie - Teil 2: Industrielle VerfahrenThis European Standard was approved by CEN on 26 August 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13628-2:2002 ESIST EN 13628-2:2003
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