ISO 8536-6:2016 PDF

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

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Title (English):

ISO 8536-6:2016

Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles

Document status:: Withdrawn
Format:: Electronic (PDF)
Number of pages:: 16
Publication date:: November 21, 2016
Edition:: ISO IS 8536 edition 3 version 1
ICS:: 11.040.20

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Description (English):

ISO 8536-6:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only.

Technical details

Technical committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
SKU: ISO 8536-6:2016

Abstract

Overview

ISO 8536-6:2016 specifies requirements for freeze drying closures for infusion bottles used in lyophilization (freeze-drying) of drugs and biological materials. It covers the shape, dimensions, materials, performance tests and labelling for elastomeric closures intended for use with infusion glass bottles described in ISO 8536-1. The standard applies to single‑use closures (dimensional requirements exclude barrier‑coated closures) and includes normative test methods for fragmentation (coring), spike penetration, sealability and residual moisture.

Key topics and technical requirements

Scope and designation
- Defines closure design and how to designate a compliant product (e.g., “Freeze drying closure ISO 8536‑6 - 32”).
Dimensions and design
- Shape and dimensional limits are given (see Table 1 and Figure 1 in the standard); spacers and positioning elements are covered to permit sublimation position and final insertion.
Materials
- Elastomeric materials must meet the performance requirements in Clause 7 and withstand two steam‑autoclave cycles at (121 ± 2) °C for 30 min without loss of function. Barrier‑type closures are treated separately.
Physical performance
- Hardness: ±5 Shore A (or ±5 IRHD if tested per ISO 48).
- Fragmentation (coring): ≤ 20 fragments ≥ 50 µm per 10 piercings (Annex A).
- Spike penetration: maximum 80 N, average

Related standards

Standards mentioned in the description

ISO 8536-6:2016 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Related standards

Abstract

Overview

Key topics and technical requirements

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