BS ISO 8536-6:2016
Current
The latest, up-to-date edition.
Infusion equipment for medical use Freeze drying closures for infusion bottles
Hardcopy , PDF
English
31-01-2017
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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.
| Committee |
CH/212
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
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.
| 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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