Overview
EN ISO 8871-2:2020 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization" (ISO 8871-2:2020) specifies procedures for the identification and physicochemical characterization of elastomeric parts, including coated stoppers, used with parenteral drug containers and medical devices. The standard defines a suite of analytical and physical tests that determine typical material characteristics, verify coatings/surface treatments, and support agreements between manufacturers and users on product consistency and suitability for pharmaceutical applications.
Key Topics
- Scope & Purpose
- Identification and characterization methods for rubber-based elastomeric parts and coatings used in pharmaceutical containers and devices.
- Selection of an appropriate test set depending on elastomer type and application.
- Physical and chemical tests (standard includes methods and informative annexes):
- Hardness (durometer/Shore, ISO 48-4 reference)
- Density (ISO 2781 reference)
- Ash content (ISO 247-1 reference)
- Compression set
- Swelling behaviour (including in oils)
- Infrared spectroscopy (material identification and surface/ATR for coatings)
- Gas chromatography - fingerprinting and volatile components (incl. headspace GC)
- Thermogravimetric analysis (TGA) fingerprinting
- Residual moisture determination
- Extractables in aqueous autoclavates (see ISO 8871-1 linkage)
- Sample preparation, reagents and reporting
- Guidance on sample treatment, number of samples, and interpretation (including annex H for ATR interpretation).
Applications
Who uses EN ISO 8871-2:2020 and why:
- Pharmaceutical manufacturers - to qualify and validate elastomeric components that contact parenteral products.
- Medical device and component manufacturers - for incoming inspection, product development and supplier quality agreements.
- Quality control and analytical laboratories - for routine testing, batch release and change-control comparability.
- Regulatory affairs and procurement teams - to document material identity, consistency and suitability for regulatory submissions and supplier contracts.
Practical uses include material verification, supplier qualification, failure investigation, specification setting, and risk mitigation for extractables, leachables and compatibility.
Related Standards
- ISO 8871-1 - Extractables in aqueous autoclavates (related test for extractables).
- Referenced test standards: ISO 48-4 (hardness), ISO 247-1 (ash), ISO 2781 (density).
- EN ISO 8871 series - broader guidance for elastomeric components for parenteral use.
EN ISO 8871-2:2020 is essential for stakeholders requiring reliable, standardized methods to identify and characterize elastomeric parts and coatings intended for pharmaceutical and medical-device applications.