ISO 8871-5:2025 PDF

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing

Название (английский):

ISO 8871-5:2025

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 11
Дата публикации:: 13 марта 2025 г.
Издание:: ISO IS 8871 edition 3 version 1
ICS:: 11.040.20

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Описание (английский):

This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.

Технические детали

Технический комитет: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
SKU: ISO 8871-5:2025

Abstract

Overview

ISO 8871-5:2025 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing defines functional requirements and test methods for elastomeric closures used with vials when pierced by an injection needle. The standard specifies penetrability, fragmentation, self-sealing and dye solution tightness tests (Annexes A–D) and gives preparation, sampling, cleaning and sterilization procedures for test samples. It is a reference method for evaluating closure performance in pharmaceutical primary container systems.

Key topics and technical requirements

Penetrability (Annex A)
- Measures force required to pierce the closure.
- Requirement: maximum piercing force ≤ 10 N per closure.
- Sample size: 10 closures; use long‑bevel 0.8 mm metal hypodermic needles (ISO 7864).
Fragmentation (Annex B)
- Counts elastomeric fragments released during piercing.
- Test uses 12 closures; each closure is pierced 4 times at different sites (48 piercings total).
- Acceptance: ≤ 5 fragments from the total 48 piercings.
- Filtration with pore size maximum 5.0 µm and visual/microscope inspection (visibility assumed from ~100–150 µm).
Self‑sealing (Annex C)
- Assesses the resealing efficiency after needle withdrawal.
- Applies to multi‑dose containers (multiple piercings).
- Acceptance: no visible dye‑coloured solution in any vial when inspected by the naked eye.
Dye solution tightness (Annex D)
- Verifies sealing of a specific closure/vial combination.
- Acceptance: no visible dye‑coloured solution in any vial.
Sample preparation
- Cleaning procedure if not pre‑cleaned: boil in particle‑free water 5 min, then rinse five times.
- Test closures after the sterilization method actually used in production.

Applications and users

ISO 8871-5:2025 is used by:

Pharmaceutical packaging manufacturers and elastomeric closure suppliers for design verification and supplier qualification.
Drug product manufacturers for lot release, compatibility studies and risk assessments (coring, particulate contamination).
Quality control and analytical laboratories performing functional testing of vial closures.
Regulatory and compliance teams referencing standardized test methods during product approval and audits.

Practical uses include acceptance testing, evaluating closed‑system transfer device compatibility, and setting supplier/custody agreements on allowable fragment limits or adapted test conditions.

Related standards

Relevant cross‑references include ISO 7864 (hypodermic needles), ISO 8362 series (vials and caps), and ISO 8536/ISO 8362 parts for spike testing. ISO 8871‑5 complements material and dimensional parts of the ISO 8871 series for elastomeric parts.

Overview

Key topics and technical requirements

Penetrability (Annex A)
- Measures force required to pierce the closure.
- Requirement: maximum piercing force ≤ 10 N per closure.
- Sample size: 10 closures; use long‑bevel 0.8 mm metal hypodermic needles (ISO 7864).
Fragmentation (Annex B)
- Counts elastomeric fragments released during piercing.
- Test uses 12 closures; each closure is pierced 4 times at different sites (48 piercings total).
- Acceptance: ≤ 5 fragments from the total 48 piercings.
- Filtration with pore size maximum 5.0 µm and visual/microscope inspection (visibility assumed from ~100–150 µm).
Self‑sealing (Annex C)
- Assesses the resealing efficiency after needle withdrawal.
- Applies to multi‑dose containers (multiple piercings).
- Acceptance: no visible dye‑coloured solution in any vial when inspected by the naked eye.
Dye solution tightness (Annex D)
- Verifies sealing of a specific closure/vial combination.
- Acceptance: no visible dye‑coloured solution in any vial.
Sample preparation
- Cleaning procedure if not pre‑cleaned: boil in particle‑free water 5 min, then rinse five times.
- Test closures after the sterilization method actually used in production.

Applications and users

ISO 8871-5:2025 is used by:

Pharmaceutical packaging manufacturers and elastomeric closure suppliers for design verification and supplier qualification.
Drug product manufacturers for lot release, compatibility studies and risk assessments (coring, particulate contamination).
Quality control and analytical laboratories performing functional testing of vial closures.
Regulatory and compliance teams referencing standardized test methods during product approval and audits.

Practical uses include acceptance testing, evaluating closed‑system transfer device compatibility, and setting supplier/custody agreements on allowable fragment limits or adapted test conditions.

ISO 8871-5:2025 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Похожие стандарты

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2024)

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