Overview
ISO 8871-3:2003/Amd 1:2018 is an essential international standard concerning elastomeric parts used in parenteral and pharmaceutical devices. This document is an amendment to Part 3 of ISO 8871-3, focusing on the determination of released-particle count, a critical parameter for ensuring the safety and quality of pharmaceutical elastomeric components. Developed by ISO Technical Committee 76 (TC 76), which specializes in transfusion, infusion, injection, and blood processing equipment, this amendment updates testing methods and standards related to particle release from elastomeric parts in direct contact with pharmaceuticals.
Key Topics
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Elastomeric Components for Parenterals
The standard addresses elastomeric materials commonly used in syringes, vial stoppers, and other devices requiring strict contamination control.
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Released-Particle Count Testing
This amendment clarifies procedures to measure particles released from elastomeric parts during simulated handling or use. The count of released particles is a crucial measure to prevent contamination in injectable products.
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Use of Shaking Machines
An important update introduced in Amendment 1 allows the use of shaking machines with different horizontal circle parameters, provided comparability or equivalency with existing methods is demonstrated. This gives flexibility to pharmaceutical manufacturers in adapting test equipment without compromising consistency.
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Quality and Compliance
The document supports adherence to stringent pharmaceutical quality standards by ensuring elastomeric parts meet required limits for particulate contamination.
Applications
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Pharmaceutical Packaging
Manufacturers of elastomeric stoppers, seals, and syringe components apply this standard to validate their products’ particulate release characteristics.
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Medical Device Manufacturing
Companies producing devices for drug delivery and parenteral administration use ISO 8871-3 to ensure components do not introduce contamination risks.
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Quality Control Laboratories
QC labs in pharmaceutical companies utilize the released-particle counting methods defined by the standard to verify product compliance before release.
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Regulatory Compliance
Compliance with ISO 8871-3:2003/Amd 1:2018 supports meeting regulatory requirements concerning particulate contamination, crucial for market approval and safety assurance.
Related Standards
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ISO 8871 Series
The ISO 8871 family covers elastomeric parts for parenterals and pharmaceutical devices broadly, including testing for properties such as chemical resistance and integrity.
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ISO/IEC Directives
The standard follows ISO/IEC Directives Part 1 and Part 2 for development and editorial consistency.
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ISO 10993 Series
Related to biological evaluation of medical devices, complementing particle release tests by assessing biocompatibility.
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Pharmacopoeia Standards
Regional and international pharmacopoeias (e.g., USP, EP) often reference particle contamination limits aligned with ISO 8871 standards.
Adherence to ISO 8871-3:2003/Amd 1:2018 ensures pharmaceutical and medical device manufacturers maintain high standards for particle contamination control in elastomeric parts. This contributes significantly to product safety, quality assurance, and regulatory compliance in the healthcare industry. For more information and access to ISO standards, visit www.iso.org.
Open preview (PDF)Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle count — Amendment 1