Method and apparatus for sterility monitoring

Abstract

Abstract A method and apparatus for monitoring the effectiveness of a sterilization cycle of a product that is sterilized inside a container are provided. The apparatus comprises an elongated, preferably plastic rod which is designed to extend interiorly of a container into the center or most difficult point to sterilize in the contents thereof, a reservoir located internally of the rod for receiving a sterilization sensitive agent, a means for hermetically sealing the reservoir to isolate the sterilization-sensitive agent from the contents of the container, and a mechanical means for rigidly attaching or fastening the rod to the container. The container which will usually be filled with a food or drug product, may be of conventional construction, such as a metallic can, glass or plastic bottle, or flexible package. The length of the rod is chosen such that the internal reservoir will be positioned within the slowest heating zone within the container. The method disclosed herein comprises the steps of hermetically sealing a predetermined quantity of a sterilization-sensitive agent within a reservoir provided in a rod, rigidly fastening the rod to an end of the container whereby the rod extends interiorly of the container and is rigidly positioned there within during the sterilization process, conventionally filling the container with food or the like and sealing same, subjecting the container to the sterilization cycle to be monitored, and subsequently analyzing the sterilization-sensitive agent to determine the effects of the sterilization process just completed. The sterilization-sensitive agent preferably employed comprises a viable bacteria in a liquid suspending menstrum. A sterilization-sensitive chemical such as thiamine hydrochloride can also be used.

Inventors

• 👤 Irving J. Pflug

Bibliographic Details