Infusion equipment for medical use Freeze drying closures for infusion bottles

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-01-2017

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Shape and dimensions
5 Designation
6 Material
7 Requirements
8 Labelling
Annex A (normative) - Determination
        of fragments
Annex B (normative) - Determination of spike
        penetration force
Annex C (normative) - Spike retention/sealability
Annex D (normative) - Closure piercing device
Annex E (informative) - Determination of residual
        moisture
Bibliography

Defines 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.

This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO8536-1, 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.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Committee	CH/212
DocumentType	Standard
Pages	26
PublisherName	British Standards Institution
Status	Current

Standards	Relationship
ISO 8536-6:2016	Identical

ISO 8871-1:2003	Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 7619-1:2010	Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
ISO 15510:2014	Stainless steels Chemical composition
ISO 8536-3:2009	Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles
ISO 2230:2002	Rubber products — Guidelines for storage
ISO 15378:2017	Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 8871-5:2016	Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
ISO 48:2010	Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 8871-4:2006	Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
ISO 8536-1:2011	Infusion equipment for medical use Part 1: Infusion glass bottles

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BS ISO 8536-6:2016

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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