BS EN ISO 8871-2:2020 pdf free.Elastomeric parts for parenterals and for devices for pharmaceutical use Identification and characterization.
BS EN ISO 8871-2  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.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 一Determination of hardness- Part 4: Indentation hardness by durometer method (Shore hardness) ISO 247-1:2018, Rubber一Determination of ash – 一Part 1: Combustion method ISO 2781:2018, Rubber, vulcanized or thermoplastic一Determination of density ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use一Part 1: Extractables in aqueous autoclavates.layer of a different polymer completely or partly covering the elastomeric part to reduce migration, permeation and/or interactions of substances of rubber component to drug product and vice versa Note 1 to entry: The coating can be applied by different techniques, such as spraying, tumbling or vapour-depositing a liquid or vapour onto the rubber component or laminating a film onto the elastomeric surface during the moulding process.Note 2 to entry: The presence of the coating can be verified by using the test method described in Annex H.Note 1 to entry: Certain lubrication coatings can also be used to eliminate the need for silicone oil in the container closure system and/or enhancing other functionalities, such as gliding force, break loose force or removal force.Note 2 to entry: The coating can be applied by different techniques, such as spraying, tumbling or vapour-
depositing a liquid or vapour onto the rubber component or laminating a film onto the elastomeric surface.BS EN ISO 8871-2 pdf download.