Processing Cap Assembly for Isolating Contents of a Container

Abstract

Improved cap assemblies which isolate materials in containers, e.g., bottles, vials, multi-vial trays, multi-well trays, etc., during processes while permitting vapor to pass into or out of the container, such as during freeze drying and the like, and facilitate subsequent closure of the container to cease such vapor passage (e.g., stoppering, etc.). The cap assembly optimizes containment of solute, prevents contamination, is easy to use and is readily compatible with validated industrial drying processes.

Description

RELATED APPLICATIONS[0001]The present application is a divisional application of U.S. patent application Ser. No. 10 / 693,371 filed Oct. 24, 2003.FIELD OF THE INVENTION[0002]This invention relates to a cap assembly for venting and isolating a container during processes such as freeze-drying, foam-drying, and other forms of evaporative, sublimation, or desorption drying. The cap is designed to isolate the contents of the container, both from contamination and from loss of material, while allowing a path for vapor exchange between the container and an external atmosphere during processing.BACKGROUND OF THE INVENTION[0003]Drying techniques are known for the stabilization of a wide variety of foods, pharmaceuticals, and biological products. Evaporative and / or sublimation drying, as used herein, refers to the removal of liquid from a solution and / or the removal of residual moisture and volatiles from a solid to capture the solute in a container for stabilization, ease of storage, transpor...

AI Technical Summary

Benefits of technology

The present invention is a processing cap assembly for isolating materials in containers during evaporative and sublimation drying processes, such as freeze-drying. The cap assembly includes a cap with a recess for attaching to a container and forming a seal, a venting media attached to the cap, and means for permitting the vapor path to be opened and closed. The cap assembly is adaptable to any number of containers and may hold one or more stoppers prior to the freeze-drying operation. The use of the cap assembly includes filling the container with product, sealing the cap assembly, drying the product, and optionally leaving the cap assembly with the stoppered vial or removing the cap assembly. The technical effects of the invention include optimizing containment of solute, preventing contamination, ease of use, and compatibility with existing validated primary packaging materials, minimizing re-validation requirements.

Problems solved by technology

This practice, however, presents an opportunity for contamination; hence the concern for cleanliness and sterility of the freeze-drying equipment and the area surrounding it.

Cross-contamination between different batches of product being freeze-dried at the same time is also a problem.

Freeze-drying equipment is expensive, and freeze-drying cycles are generally very long, consuming many hours or even several days for the processing of a single batch of material.

This in turn can result in the practice of freeze-drying different materials in the same chamber at the same time.

Since all of the materials are processed in open containers, cross-contamination of product can, and commonly does, occur.

As noted above, many of the challenges encountered with freeze-drying are common to other forms of evaporative drying; yet other challenges can also exist in these other techniques.

For example, in foam-drying processes the volatile nature of the foaming process creates further challenges in product containment due to the sometimes highly effusive nature of the foaming step.

Caps have been developed in the past to address containment; however, limitations with these caps have been identified.

But the problem of contamination of the vial contents when the vials are being loaded into the freeze-drier or during the freeze-dry process itself is not addressed by this patent.

Neither of these patents, however, addresses the concern about rehydrating the contents of the container once the doors of the freeze-drier are opened.

However, a challenge with such a vial cap is the risk of puncturing the venting media with a needle when withdrawing the reconstituted solution, raising the concern of contaminating the injectable solution with media fragments.

A further challenge with the Jones device is the practical size of the venting media in the vial cap, which can negatively impact the drying time of material in the container.

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