Overview
ISO 8871-1:2003 - “Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates” defines chemical evaluation procedures for elastomeric parts (rubber stoppers, seals and similar closures) that contact parenteral preparations. The standard specifies comparative test methods to determine extractables released into aqueous autoclavates after steam sterilization, establishes minimum chemical requirements, and classifies elastomers by intended application.
Key topics and technical requirements
- Scope and classification
- Applies to elastomeric parts for injection vials, infusion bottles, prefilled syringes, freeze-dried products and certain medical devices (gloves and probes excluded).
- Defines Type I (stricter) and Type II elastomers (for special mechanical needs).
- Extraction procedure
- Test solution prepared by autoclaving elastomeric parts in purified water (300 ml per 150 cm² surface area) at ~121 °C; solution S1 is used for chemical tests.
- Parts must withstand steam sterilization (two cycles at 121 ± 2 °C, 30 min each) without losing required properties.
- Chemical test methods (Annexes A–J)
- Appearance/turbidity (visual or turbidimeter) - reference suspensions correspond to FTU limits for Type I/II.
- Colour (reference GY solution), acidity/alkalinity, absorbance (220–360 nm limits: Type I ≤ 0.2 AU; Type II ≤ 4.0 AU).
- Reducing substances, extractable heavy metals (≤ 2.0 mg/L), extractable zinc (≤ 5.0 mg/L), extractable ammonia (≤ 2.0 mg/L).
- Residue on evaporation (Type I ≤ 2.0 mg/50 ml; Type II ≤ 4.0 mg/50 ml), volatile sulfides (limited staining), optional conductivity (Type I ≤ 15 µS/cm; Type II ≤ 30 µS/cm).
- Sampling and test materials
- Samples taken in as-delivered condition; quantities per relevant device standards. Use purified water (conductivity < 3.0 µS/cm) and analytical-grade reagents.
Practical applications
- Ensures chemical safety of elastomeric components used for parenteral drug containers and delivery devices.
- Used by:
- Medical device and pharmaceutical manufacturers to qualify closure materials and production lots.
- Quality control and analytical laboratories performing extractables testing.
- Suppliers of elastomeric parts to demonstrate compliance.
- Regulatory affairs teams preparing technical documentation for submissions.
- Helps reduce risk of contamination, drug instability or adverse interactions caused by extractables released during sterilization or contact with parenteral preparations.
Who should use this standard
- Device designers, packaging engineers, QC/QA staff, contract testing labs, and suppliers of elastomeric closures for injectable and infusion products.
Related standards
- ISO 8871 Parts 2–5 (Identification & characterization; particle counts; biological requirements; functional testing)
- Referenced device standards: ISO 8362 series, ISO 8536 series, ISO 11040 series
- Water quality: ISO 3696 (purified water)
This summary helps manufacturers and testers understand ISO 8871-1:2003 requirements for extractables in aqueous autoclavates and how to apply them in pharmaceutical device qualification and quality control.