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

This patent describes a container and method for storing active agents and diluents as a single entity, conserving space and reducing reconstitution steps. The container is pre-loaded with the active agent and diluent, ensuring sterility and ready-to-use. The container is sealed to prevent contamination and minimize waste. The technical effects include reducing packaging requirements and waste, improving efficiency, and ensuring sterility.

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 contamination does not occur, the combination of the one or more active agents and diluent is carried out using a lengthy and time consuming procedure.

In addition, the use of two containers and two sets of packaging is wasteful and harmful to the environment, creating twice the waste than that created for active agents stored in a single container.

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