A biochemical test system is disclosed for use in a biological fermentation sterilization indicator. The carbohydrate component of a nutrient broth media is removed from the media. The carbohydrate component may be disposed in the cavity of an encapsulated sealed glass ampul which contains a non-carbohydrated test solution. Microorganism spores are also disposed in the cavity. Upon completion of sterilization the ampul is broken; the contents mix. Fermentation of viable spores yields growth and color change and is a positive test (unsatisfactory sterilization); no fermentation yields no growth, no color change and satisfactory sterilization. The separation of carbohydrate prevents non-microorganism fermentation in the test reaction, and the appearance of a "false positive".

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.

This invention relates to methods and the use of biological indicator systems to assess and determine the effectiveness of sterilization processes comprising the steps of contacting an indicator comprising microbial spores with a sterilant; a medium selected to germinate the spores; and calculating a germination rate of the exposed spores to determine the effectiveness of the sterilization process. A method for rapidly determining the effectiveness of the gemination rate of microbial spores with spore viability is also described.

A closure and container assembly biological sterility indicator having a container, a closure, test spores, growth and indicator media, and a frangible barrier for separating the growth medium from the test spores is shown. The closure is moveable in the container between open and closed positions. When in the open position, sterilant may flow into and out of the container via a tortuous pathway defined by the interior surface of the container or the exterior surface of the closure. The tortuous pathway may also include one or more openings in the wall of the closure. When the closure is in the closed position, the container is sealed. The sterility indicator may be assembled with the test spores impregnated on a spore strip which is placed in close proximity to the closure.

A non-culture method and instrument for a rapid presumptive test for gonorrhea in which a specimen of exudate from a suspected case is placed in direct contact with a pledget containing a compound which reacts with Neisseria gonorrheae to produce a color change. The pledget, before the test, is in a dry condition and is activated by a wetting agent such as saline, when placed in contact with the pledget. The chemical compound used and incorporated into the pledget is selected from a group consisting of phenylenediamines. The instrument used consists of a flexible tube containing a fluid-filled frangible ampul at one end and the chemically impregnated pledget disposed immediately above same. A separate sterile swab is supplied for taking the specimen. The swab containing the specimen is inserted into the flexible tube. The flexible tube is then squeezed at the ampul portion, releasing the wetting agent by breaking the frangible ampul. The wetting agent when thus released activates the reagents in the pledget. A downward pressure of the swab containing the specimen places it in direct contact with the activated pledget. If gonorrhea is present in the specimen on the swab, a distinctive coloration of the specimen takes place within 2 minutes.