Table of Contents

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

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/212