Overview
ISO 8871-2:2020 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - sets out identification and characterization procedures for elastomeric parts (including coated stoppers) used with parenteral drug containers and medical devices. The standard defines a suite of physical and chemical test methods that produce fingerprints and quantitative characteristics for elastomeric materials and surface coatings. These test results support product specification, supplier-user agreements, and ongoing batch consistency verification.
Key Topics
- Scope and purpose
- Applicable to elastomeric parts and coated stoppers for pharmaceutical use.
- Provides test methods to determine typical material characteristics and coatings.
- Core test methods
- Hardness (Shore) - per ISO 48-4.
- Density - per ISO 2781 method A.
- Ash content - per ISO 247-1 combustion method.
- Infrared (IR) spectroscopy - pyrolysis IR and surface IR/ATR for material fingerprints and coating verification (Annex A and H).
- Compression set - permanent deformation after compression (Annex B).
- Swelling - behavior in organic solvents and oils (Annex C).
- Gas chromatography (GC) - development of material fingerprints and detection of volatile substances (Annex D and E), including GC–MS coupling for compositional insight.
- Thermogravimetric analysis (TGA) - thermal fingerprinting (Annex G).
- Residual moisture and extractables in aqueous autoclavates (see ISO 8871-1 reference).
- Sample preparation and test selection
- Guidance on sample treatment and the number of samples required.
- Tests selected depending on elastomer type and intended application.
- Coating identification
- Methods to verify barrier or lubrication coatings and surface treatments (ATR, comparative FTIR).
Applications
- Manufacturers of elastomeric closures and coated stoppers - establishing material identity, controlling formulation consistency, and validating coatings.
- Pharmaceutical companies and contract manufacturers - qualifying container closure components, supporting container-closure integrity and compatibility assessments.
- Quality control and analytical laboratories - routine characterization, lot release testing, and troubleshooting (e.g., detect volatile extractables).
- Regulatory and supplier agreements - using standardized fingerprints and metrics as the basis for technical specifications and supply contracts.
Related standards
- ISO 8871-1 - Extractables in aqueous autoclavates (related extractables testing).
- ISO 48-4 - Hardness (Shore) for rubber.
- ISO 2781 - Density determination for rubber.
- ISO 247-1 - Determination of ash in rubber.
ISO 8871-2:2020 is essential where reliable identification, coating verification, and chemical/physical characterization of elastomeric parts are required to ensure pharmaceutical safety, compatibility, and product consistency.
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