Overview
ISO 8871-3:2003 specifies laboratory methods to determine the number of visible and subvisible particles released from elastomeric parts used with parenterals and pharmaceutical devices. The standard addresses particle contamination that can occur from superficial contamination or from fragments produced when closures are pierced. ISO 8871-3:2003 defines sampling, rinse and measurement techniques but does not set acceptance limits - those are to be agreed between manufacturer and user.
Key topics and technical requirements
- Scope: Tests quantify particles detached from elastomeric closures by rinsing; applicable to primary packaging and device elastomeric parts.
- Visible-particle method (Clauses 3.x):
- Particle size classes by longest dimension: Class I >25–≤50 µm, Class II >50–≤100 µm, Class III >100 µm.
- Use membrane filters (max pore 0.8 µm) with 3 mm × 3 mm grid; filter color recommendations provided (medium grey, CIE coordinates).
- Rinse fluid: 3 g polysorbate 80 (Tween 80) per 10 L purified water (ISO 3696 grade).
- Shaking: horizontal circle 12 mm ±1 mm at 300–350 min⁻¹; two 50 ml rinse steps per test.
- Microscope: ~×50 magnification for counting.
- Blank-test acceptance: ≤5 particles Class I, ≤1 particle Class II, none Class III.
- Subvisible-particle method (Clauses 4.x):
- Particle classes (equivalent-sphere diameter): ≥2–<5 µm, ≥5–<10 µm, ≥10–<25 µm, ≥25 µm.
- Use particle-free water (≤100 particles >2 µm per 5 ml) and a light-extinction particle counter (light obscuration).
- Test uses 100 ml water with same shaking profile; counts measured 15–30 minutes after shaking.
- Blank-test acceptance: not more than 100 particles >2 µm per 5 ml.
- Reporting: surface area tested, number of parts, individual and average counts per 10 cm², blank results and total counts.
Applications and users
- Quality control and incoming inspection of elastomeric stoppers, seals and closures for injectable products.
- Used by pharmaceutical manufacturers, rubber/elastomer suppliers, contract testing labs, and regulatory QA teams to characterize particulate-release potential.
- Supports risk assessments for sterile parenteral packaging, contamination control, and supplier qualification.
Related standards
- ISO 8871 (other parts): Part 1 (extractables), Part 2 (identification), Part 4 (biological), Part 5 (functional tests).
- ISO 3696:1997 - Water for analytical laboratory use (used for rinse water quality).
- ISO 14644-1 - Cleanroom classification (environmental control recommendations).
Keywords: ISO 8871-3:2003, elastomeric parts, parenterals, released-particle count, visible particles, subvisible particles, particle counting, pharmaceutical packaging.