EN ISO 8871-3:2004 PDF

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

Название (английский):

EN ISO 8871-3:2004

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count (ISO 8871-3:2003)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 8
Дата публикации:: 26 мая 2004 г.
Издание:: CEN EN 8871 edition 2 version 1
ICS:: 11.040.20

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Описание (английский):

Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations. ISO 8871-3:2003 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing. It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.

Технические детали

Технический комитет: CEN/TC 205 - Non-active medical devices
SKU: EN ISO 8871-3:2004

Abstract

Overview

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

Overview

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

EN ISO 8871-3:2004 PDF

Технические детали

Abstract

Overview

Key Topics

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Abstract

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