Appendix XIX A. Containers: An Introduction

This Appendix provides requirements, guidance and information on containers for pharmaceutical use. Additional guidance is provided in a number of British Standards. Attention is drawn in particular to British Standards 1679-5:1973, 1679-6:1994, 1679-7:1968 and 1679-8:1992. The expression 'tamper-evident container' means a closed container fitted with a device that reveals irreversibly whether the container has been opened, whereas, the expression 'tamper-proof container' means a closed container in which access to the contents is prevented under normal conditions of use. The two terms are considered to be synonymous by the European Pharmacopoeia Commission.

A container for pharmaceutical use is an article that contains or is intended to contain a product and is, or may be, in direct contact with it. The closure is a part of the container.

The container (see General Notices section 1.3) is so designed that the contents may be removed in a manner appropriate to the intended use of the preparation. It provides a varying degree of protection depending on the nature of the product and the hazards of the environment, and minimises the loss of constituents. The container does not interact physically or chemically with the contents in a way that alters their quality beyond the limits tolerated by official requirements.

Single-dose container A single-dose container holds a quantity of the preparation intended for total or partial use on 1 occasion only.

Multidose container A multidose container holds a quantity of the preparation suitable for 2 or more doses.

Well-closed container A well-closed container protects the contents from contamination with extraneous solids and liquids and from loss of contents under ordinary conditions of handling, storage and transport.

Airtight container An airtight container is impermeable to solids, liquids and gases under ordinary conditions of handling, storage and transport. If the container is intended to be opened on more than 1 occasion, it must be so designed that it remains airtight after re-closure.

Sealed container A sealed container is a container closed by fusion of the material of the container.

Tamper-proof container A tamper-proof container is a closed container fitted with a device that reveals irreversibly whether the container has been opened.

Child-proof container A container that is fitted with a closure that prevents opening by children.