SIST EN ISO 8871-3:2004 PDF

Overview

SIST EN ISO 8871-3:2004 is a critical international standard developed by CEN and ISO that specifies methods for evaluating elastomeric parts used in parenteral and pharmaceutical devices. Specifically, it focuses on the determination of released-particle count from elastomeric closures, which are commonly employed in pharmaceutical packaging and medical devices. These elastomeric parts may release visible and subvisible particles either from surface contamination or when pierced by needles, potentially compromising the quality and safety of pharmaceutical products.

This standard outlines rigorous test methods to quantify the number of particles detached from these elastomeric components via rinsing. It is designed to support manufacturers and users in assessing contamination risks, although it does not define particle contamination limits, leaving those criteria to be mutually agreed upon by the involved parties.

Key Topics

• Particle Contamination Risks Elastomeric closures can harbor visible (>25 µm) and subvisible particles (<25 µm) on their surfaces or generate fragments during needle puncturing. These particles may contaminate injectable pharmaceuticals, affecting safety and efficacy.

• Determination Methods The standard defines two main test methods:

  • Visible-particle count determination: Using rinse fluid filtration and microscopy to count particles classified into three size categories (>25 µm to >100 µm).
  • Subvisible-particle count determination: Using light extinction particle counters to detect particles in four size ranges (2 µm to