BS EN ISO 8871‑2:2020 pdf – Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization.
1 Scope This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 48‑4, Rubber, vulcanized or thermoplastic — Determination of hardness — Part 4: Indentation hardness by durometer method (Shore hardness) ISO 247‑1:2018, Rubber — Determination of ash — Part 1: Combustion method ISO 2781:2018, Rubber, vulcanized or thermoplastic — Determination of density ISO 8871‑1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates 3? Terms? and? definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https://www.iso.org/obp — IEC Electropedia: available at http://www.electropedia.org/
4.4 Ash The inorganic residue after combustion shall be determined as described in ISO 247‑1:2018, 4.1, method A. 4.5 Infrared spectrum 4.5.1 Material One method to create a fingerprint of a rubber material is to record an infrared (IR) spectrum. The two common methods for obtaining an IR spectrum of a rubber material are pyrolysis IR and surface IR/ATR (attenuated total reflectance)‑technique. The pyrolysis IR can be obtained as described in Annex A. Alternatively, an aliquot of the pyrolysate can be brought on an ATR crystal of an FTIR‑spectrometer as described in Annex H. The surface IR/ATR can be obtained as described in Annex H. The spectra should be compared with a spectrum obtained by the same IR method on a reference sample of the material. In practice, pyrolysis IR requires a time‑consuming sample preparation. In addition, it needs the cautious handling of hazardous vapours and oils. In contrast to this, the surface IR/ATR offers the possibility to obtain a fingerprint from an elastomeric part with minimum or no sample preparation. 4.5.2 Coating The presence of a coating (barrier and lubrication coating) can be verified by comparing FTIR spectra of the surface and of the core material of the product (see Annex H). For measuring the coating, the samples do not need to be cut. 4.6 Compression set The compression set indicates the degree of permanent deformation remaining after compression at a constant deformation and defined temperature for a defined time. The compression set can be determined in accordance with Annex B.
4.7 Swelling Elastomeric materials are subject to varying degrees of swelling when exposed to organic solvents. The degree of volume and/or mass increase is primarily influenced by the type of elastomer. Swelling requires special care when the rubber components are in contact with emulsions or oily vehicles. The relevant procedure is specified in Annex C. 4.8? Development? of? a? fingerprint? by? gas? chromatography The elastomeric materials under examination are extracted in a solvent which does not dissolve but might swell the rubber. The extract is injected into a gas chromatograph. The chromatogram obtained exhibits a typical profile and can be used as a fingerprint for identification purposes. Furthermore, GC‑coupling techniques, for example gas chromatography – mass spectrometry (GC‑MS), may provide additional information about the composition of the extract. The relevant procedure is specified in Annex D.