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.
This application is a continuation-in-part of U.S. Ser. No. 66,586, filed June 26, 1987, now abandoned which was a continuation of U.S. Ser. No. 823,535, filed Jan. 29, 1986, now abandoned, which was a continuation-in-part of U.S. Ser. No. 621,554, filed June 18, 1984, now abandoned.
The invention concerns a sealing valve for apertures in containers, the valve comprising a cover element and, running round the edge of the cover element and integral with it, a wall element. In one application of the valve as a gas-release valve for accumulators, the valve (20) is shaped like a cap and has a beading (24) with a sharply projecting sealing edge running round the inside of the cap wall. On the inside of the cap are control channels (25, 25', 25") which extend from the top of the cap to the beading (24) and allow the pressure at which gas is released from the accumulator to be set within a given range.
Microbial spores having increased sensitivity to sterilants are provided. An additive such as a dipeptide, oligosaccharide, and/or polyhydroxyalcohols are added to the spores wherein the additive is bound to sterilant-sensitive sites in the spores. The additive increases sensitivity of the spores to a sterilant. More than one additive can be utilized to alter the sensitivity of the spores to a sterilant. Biological indicators comprising the microbial spores and a solid support are also disclosed and those spores having a dipeptide specifically bound to sterilant-sensitive sites in the spores have an altered sensitivity to a sterilant. Furthermore, a method is disclosed for altering the sensitivity of microbial spores to a sterilant comprising drying the spores at a temperature between 35.degree. C. and 55.degree. C. in a liquid composition having an amount of the additive therein.
A vented cap and capillary tube assembly is disclosed together with a method of use of such assembly. The assembly includes a capillary tube having a bore extending therethrough and a cap slidably mounted to one end of the tube. The cap includes one or more vent grooves therein which allow air to escape therethrough when the cap is in a first slidable position. The walls of the capillary tube prevent air from escaping through the vent when the cap is more fully inserted within the tube. The method provided herein includes the steps of providing such a pre-assembled capillary tube and vented cap assembly, maintaining the cap in the first position while the opposite end of the capillary tube is inserted within a liquid sample, allowing the liquid to enter the tube through capillary action, thereby displacing air within the tube through the vent, and sliding the cap to the fully inserted position, thereby sealing the vent. The cap used in conjunction with the capillary tube is made of an elastomeric material, and has a slippery surface. It includes an enlarged head having a cylindrical plug extending therefrom. The plug includes a sealing ring for engaging the inner wall of the capillary tube. It also includes an annular groove adjacent the enlarged head which facilitates the seating of the head on the end of the capillary tube.
A stopper assembly for a test tube or similar article comprised of an inner elastomeric stopper and an outer semi-rigid cap member that protects the inner elastomeric stopper and assists in the manual manipulation of the inner elastomeric stopper and provides enhanced visible color coding through the combination of colored stoppers and caps. The elastomeric stopper is dimensioned to fit within the open end of a test tube with an interference fit. The lower end of the elastomeric stopper has grooves disposed across its outer surface. When the lower end of the stopper is inserted into the open end of the test tube, gases are permitted to pass through the grooves, and the test tube is vented to its surrounding environment. The upper end of the elastomeric stopper does not include venting grooves. As such, when the upper end of the stopper is inserted into the open end of the test tube, a gas impervious seal is formed between the stopper and the test tube, thereby isolating the contents of the test tube from the surrounding environment.
A method and apparatus for capturing a sample of flowable material from a closed system inside a receptacle without exposing the sample to the ambient environment. The apparatus includes a housing having an opening at one end for receiving a receptacle and stopper. An end cap is removably mounted to the housing for opening and closing the opening. An inlet is provided in the housing for feeding a cleaning or sterilizing agent or the flowable material to be sampled into an interior of the housing. A clasp is provided to manipulate the receptacle to separate the receptacle and the stopper while the stopper and receptacle are inside of the housing. Once the receptacle and the stopper are separated, the flowable material is fed into the receptacle through the inlet. The clasp is then manipulated to reattach the receptacle and the stopper in order to capture the flowable material. The apparatus is particularly useful in the pharmaceutical and biotechnology industries as well as the fine chemical, food and beverage industries where accurate, uncontaminated samples of materials from a closed system are desired without contaminating the sample of material or the closed system.
