ISO 8871-1:2003 PDF

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