EN ISO 8362-5:2016
Current
The latest, up-to-date edition.
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
16-03-2016
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Shape and dimensions
5 Designation
6 Material
7 Performance requirements
8 Labelling
Annex A (informative) - Determination of moisture
Bibliography
ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362‑1 and ISO 8362‑4, which 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 part of ISO 8362 are intended for single use only.NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| NF EN ISO 8362-5 : 2016 | Identical |
| I.S. EN ISO 8362-5:2016 | Identical |
| BS EN ISO 8362-5:2016 | Identical |
| SN EN ISO 8362-5:2016 | Identical |
| NS EN ISO 8362-5 : 2016 | Identical |
| UNE-EN ISO 8362-5:2016 | Identical |
| UNI EN ISO 8362-5 : 2016 | Identical |
| NBN EN ISO 8362-5 : 2016 | Identical |
| ISO 8362-5:2016 | Identical |
| DIN EN ISO 8362-5:2016-07 | Identical |
| NEN EN ISO 8362-5 : 2016 | Identical |
| PN EN ISO 8362-5 : 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 2230:2002 | Rubber products — Guidelines for storage |
| ISO 3302-1:2014 | Rubber — Tolerances for products — Part 1: Dimensional tolerances |
| 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 3302-2:2008 | Rubber Tolerances for products Part 2: Geometrical tolerances |
| ISO 554:1976 | Standard atmospheres for conditioning and/or testing — Specifications |
| 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 |
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