Container and Method of Manufacture of Container

Abstract

A pre-loaded container and a method of manufacturing a pre-loaded vial is provided wherein one or more active agents is lyophilised within the vial cap and the vial cap is then sealed onto a vial retaining a suitable diluent to form the pre-loaded vial. Lyophilising the one or more active agents within the vial cap ensures that the one or more active agents are retained in sterile conditions, that the lyophilised one or more active agents and the diluent may be stored efficiently, and that the one or more active agents may be solubilised in a sterile and efficient manner.

Description

FIELD OF THE INVENTION[0001]Methods of manufacturing sterile liquid containers and sterile liquid containers, more specifically methods of manufacturing vials and vials.BACKGROUND TO THE INVENTION[0002]In a number of scientific fields, such as medicine and biochemistry, for example, it is common to handle and use biological species in solution. Many of the biological species used are unstable and short lived in solution in vitro without the supporting infrastructure found in vivo, for example. Examples of such biological species include proteins, enzymes, nucleic acid sequences and vaccines. Many species that are unstable in solution have been found to be relatively stable if stored out of solution, that is, if the diluent used in their synthesis or extraction is removed.[0003]One way of doing this is lyophilisation, where the sample is frozen and then warmed in vacuum so that the solvent sublimes, leaving the species of interest intact. Therefore, for administration of a medicament...

AI Technical Summary

Benefits of technology

[0017]The provision of container made according to the above method allows the active agent and diluent to be stored as a single entity, conserving space. In addition, the process of reconstituting the active agent is greatly reduced to a two step process of breaking the closure to allow the lyophilised active agent to fall into the diluent and then agitating the vial to ensure the lyophilised one or more active agents are fully reconstitute

Problems solved by technology

Many of the biological species used are unstable and short lived in solution in vitro without the supporting infrastructure found in vivo, for example.

However, when the one or more active agents and the diluent are stored separately and combined immediately prior to administration, there is a risk of contamination of the medicament.

To ensure that

Images