Abstract: An indicator composition and process capable of changing color in relationship to its exposure to a temperature above and below a base line temperature and to the time of said exposure, for monitoring the time-temperature history of a substrate, depositable as a layer on said substrate, comprising a dispersion of either a binder comprising a reaction inert, neutral finely divided absorbent, in the presence of a reactant comprising a salt of an acid or an organic compound substituted by at least one moiety which, in ionic form, is an anion or a binder/reactant, comprising at least one solid organic polymer whose constituent units contain, as a covalent substituent, at least one moiety which, in ionic form, is an anion; as indicator, at least one acid sensitive pH dye and as activator, at least one base. This composition and process may be utilized to form a solid state device for monitoring integral values of time and temperature during storage of perishables.

Abstract: A sterilization biological test pack comprises a first plurality of apertured planar sheets of substantially porous paper disposed to form a stack. Each of the sheets defines a generally centrally disposed aperture, the apertures operatively defining together a single cavity extending through the stack. Second and third pluralities of unapertured planar sheets of substantially porous paper are disposed on opposed sides of the stack and aligned therewith to close the stack cavity at either end thereof and define a chamber about the cavity configured and dimensioned to receive a biological indicator. Fourth and fifth pluralities of unapertured planar sheets of paper of intermediate porosity are disposed on exposed sides of the third and fourth pluralities, respectively, and aligned therewith.

Abstract: There is disclosed an automated system for testing the sterility of products intended for human health administration or for human consumption. The system permits a plurality of samples of a product to be concurrently tested and is arranged so that multiple samples of a product to be tested can be mixed and then conveyed to test canisters along with appropriate growth media prior to determining that the product is sterile or is free from microbial contamination.

Abstract: A permanent record test device tests the efficiency of a steam sterilizer apparatus to create a vacuum satisfying the Bowie-Dick test procedure. A sheet of selectively porous material such as one hundred pound blotter paper having a steam sensitive indicator ink printed thereon is laminated between layers of steam and air impermeable polymeric material to substantially occlude the sheet from ambient atmosphere, except for a small metering region. The small metering region may include a hole punched through the laminated sheet. Two parallel and spaced apart strips can be used with a metering hole punched at one end of each of the strips or, alternatively, a metering hole is punched at one end of any one of the strips and the strips can be connected with a fluid passageway at the opposite end of the strips. Strips other then straight strips can be used, e.g., an L-shaped strip can be used with a V-shaped strip.

Abstract: A prevacuum steam sterilization test pack, for testing the efficiency of the vacuum system of a steam sterilizer apparatus to create a vacuum, comprises a bundle of layers and a porous overwrap folded about the bundle to maintain the integrity thereof. The bundle includes a porous test sheet with a steam sensitive indicator ink printed thereon positioned between layers of the bundle to indicate the efficiency of the vacuum system of a sterilizer, a plurality of selectively porous layers within the bundle above and below said test sheet, and at least one pair of non-porous gas-impermeable layers disposed intermediate the test sheet and one of the bundle end surfaces. The pair of non-porous layers is spaced from both the test sheet and the one bundle end surface by at least one of the porous layers, and the non-porous layers are spaced apart by at least one and no more than two of the porous layers.

Abstract: A sterility indicator of the type used in hospitals and laboratories. The device uses a cylindrical ampule holder with an ampule containing nutrient media and spore strip disposed therein. One or more gas pervious, liquid impervious tortuous paths lie between the interior and exterior of the ampule holder. Fracturing of the ampule is by the combination of a rotation and rotation prevention means with respect to the cylindrical axis.

Abstract: The present invention provides a chemical indicator for the detection of hydrogen peroxide. A composition containing an aqueous solution of potassium dichromate is applied to a porous substrate. The reaction between the dichromate and chromate ions present in solution and hydrogen peroxide is accompanied by a dramatic color change which is visible to the naked eye. The initial color of the potassium dichromate solution may be enhanced by adjusting the pH of the solution to be basic. The rate of reaction between the dichromate and chromate ions and the hydrogen peroxide may be increased by the addition of the humectant urea to the potassium dichromate solution.

Abstract: Packages which are subject to tampering while in a store or deterioration over time due to the presence of oxygen may be readily identified by placing therein a multi-component visual indicator system which is sensitive to the presence of oxygen. The system, which may be prepared aerobically and then placed into an anaerobic environment for use, is not effected by the presence of reducing agents found commonly in foods, drugs, and cosmetics.

Abstract: A Bowie and Dick type prevacuum steam sterilization test pack for insertion into a sterilization chamber for indicating the presence of unacceptable levels of uncondensable gas comprises a housing, a heat sink and an indicator. The housing defines a single chamber having a large open end, a relatively small closed end opposite the open end, and a sidewall smoothly tapering from the open end to the closed end. The heat sink is disposed in the chamber and extends substantially from the open end to the closed end to define a path through which the steam travels from the open end toward the closed end, the path being adapted to provide sufficient exposure of the steam to the heat sink so that the steam condenses within the path, releasing any noncondensable gas associated with the steam, forcing the noncondensable gas so released toward and concentrating such noncondensable gas within the closed end.

Abstract: An indicator element which provides a visual indication when subjected to correct steam sterilization conditions in an autoclave, the element comprising a substrate having coated thereon an ink formulation comprising as the primary visual change component: (i) a sulfur-containing compound capable of decomposition to yield a metal sulfide under steam sterilization conditions, or (ii) the precursors of which a sulfur-containing compound which will yield said sulfur-containing compound under aqueous conditions.

Abstract: The disclosed pressurized vessel has a door seal which is pressurized by a steam supply. A diaphragm actuated solenoid valve is connected between the steam supply and the door seal. The diaphragm solenoid valve precludes the door seal from depressurizing unless the pressure within the vessel is within a preselected pressure tolerance. Also, a check valve is provided to preclude the door seal from completely depressurizing if the pressure at the steam supply is interrupted.

Abstract: Contact lenses can be sterilized effectively in a short time, by using a kit for contact lens sterilization which comprises an oxidizing agent for sterilizing contact lenses and a reducing agent for making nontoxic the oxidizing agent still remaining after sterilization and wherein the oxidizing agent and the reducing agent each have such a property and form that they do not substantially react with each other in the kit and that when they are placed in water substantially simultaneously, the major portion of the oxidizing agent dissolves in water more rapidly than the major portion of the reducing agent. Further, with this kit, the sterilized contact lenses can be made nontoxic without fail.

Abstract: The invention includes a method and apparatus for recovering one or more components of a sterilizing gas. Typically, the sterilizing gas is ethylene oxide, mixed with a relatively inert diluent such as a halocarbon. The sterilizing gas discharged from a sterilizing chamber is cryogenically cooled in a condenser, such that the ethylene oxide and the diluent are liquefied. The remaining gaseous impurities, such as air, are removed from the condenser, filtered, and vented to the atmosphere. The liquefied mixture of ethylene oxide and diluent is periodically drained from the condenser, and filtered to remove impurities. This liquid mixture can then be separated into its constituent components for later use. The liquid mixture can also be vaporized and combined with fresh ethylene oxide, as needed, to produce a fresh sterilizing gas mixture which is recycled to the sterilizing chamber.

Abstract: An apparatus for detecting oil and other lighter-than-water contaminants in an effluent stream in a sewage system. The apparatus includes a disposable detector which floats in the effluent stream and detects oil and other contaminants having a specific gravity lighter than the water by absorbing the oil and such contaminants in an oleophilic material, permitting the oil and other contaminants to rise and collect in a collection tube. The acidity of pH of the effluent being monitored is determined by routing a portion of the effluent stream across a litmus paper.

Abstract: A disposable package is adapted to simulate the steam permeability and other qualities of the linen pack previously used to test the functioning of a steam sterilizer using a biological test device. The biological test device comprises spores on an appropriate carrier, either in a self-contained biological device or as a spore strip. The biological test device is placed within applicant's specially constructed package and the package is placed within the sterilizer, which is then cycled through a conventional sterilization cycle. During the sterilization cycle, applicant's package simulates the standard sterilizer linen pack previously used for such tests. After the sterilization cycle, sterility of the spore preparation is evaluated by incubating the spores in a culture medium to determine whether the spore population has been adequately destroyed.

Abstract: The present application is directed to medical sterilizer device with an improved latch mechanism and method and, more particularly, to a new and improved sterilization device in the form of a sterilizer case of medical applications relative to the use of instrument sterilization and storage. The case of the invention provides an effective storage container and method for sterilizing medical instruments and/or equipment by fluid (gas or steam) techniques.

Abstract: This invention relates to a method for detecting whether contaminants are on or have migrated into the body of a plastic reusable food or beverage container. The invention uses a sensor attached to the inside of the container which changes optical density when it is exposed to certain contaminants. The change in optical density is detected by illuminating the sensor with ultraviolet light and then measuring the effect that the sensor has on the ultraviolet light.

Abstract: An indicator sheet for an autoclave test pack wherein a pair of porous masses (10) are held in close superimposed relationship by means of a clamp (13) with the indicator sheet (12) sandwiched between them. The indicator sheet (12) has printed thereon a pattern of markings (14) formed from one or more substances which are adapted under steam sterilizing conditions to provide an indication of the presence of air and/or excessive moisture such that each is evident and individually identifiable.

Abstract: The interference of dehydroascorbic acid, an oxidation product of ascorbic acid, in analytical methods is reduced with the use of certain nitrogen-containing organic buffers. Dehydroascorbic acid tends to cause premature reduction of reducible compounds which are used to provide detectable species in the presence of an analyte. These organic buffers, as opposed to inorganic buffers, prevent premature reduction of the reducible compounds. An analytical method can be carried out in solution or in a dry analytical element.

Abstract: A pipette canister formed from a thermoplastic material. The canister withstands dry heat above 160.degree. C. reduces breakage of glass pipettes stored within, and the material is free from metal oxide residues.

Abstract: A method is described for treating consumable products, such as foods, drugs or dietary supplements, for example drugs enclosed in capsules, to detect contamination. A colorimetric indicator, which can react with a contaminating substance such as cyanide, is incorporated into the consumable product or the packaging for the product. When the indicator comes in contact with the contaminating substance, a readily detectable color signal is produced.

Abstract: A biological test pack adapted for use in testing the efficacy of an ethylene oxide sterilization process is described. The test pack is a clear plastic tray containing an sterilization sensitive ink which has been imprinted on a card which faces out of the bottom of the plastic tray. In addition, the tray contains a plastic syringe which holds a biological indicator. On top of the plastic syringe, absorbent paper is placed. The entire pack has a Tyvek sheet which seals it until it is used. The plastic tray is molded into a shape for holding the various items in particularly desirable locations. Accordingly, a disposable test pack which is uniformly manufactured and which should yield consistent results, is described. It can be used either as a general purpose routine test pack or as a validation challenge test pack.

Abstract: Monitoring exposure to ethylene oxide using a dosimeter or monitoring device avoids using devices that collect a sample for future testing or devices that must be sent away for lab analysis. The device comprises a reactive coating including a layer of activated alumina particles coated with p-nitrobenzyl pyridine and ammonium chloride, and is adapted to instantly produce a color intensity change directly related to the dosage of the reactive coating to ethylene oxide upon the addition of a developer.

Abstract: To eliminate the necessity for additional seals or indicator tapes in a closure for a sterilizing container comprising a bottom part and a lid, with a pivotable locking bar which in a closed position fixes the lid in the closed position on the bottom part and in an open position releases the lid for removal from the bottom part, and with a safety closure for the locking bar which is damaged when the locking bar is pivoted from the closed position to the open position, the safety closure includes (i) a data carrier card which can be pushed into or put into a holding device on the locking bar, on the lid, or on the bottom part, (ii) a securing member to prevent removal of the data carrier card from the holding device when the locking bar is in the closed state, and (iii) a marking element to penetrate the data carrier card secured in the holding device during pivotal motion of the locking bar from the closed position to the open position.

Abstract: A method is described for treating consumable products, such as foods, drugs or dietary supplements, for example drugs enclosed in capsules, to detect contamination. A colorimetric indicator, which can react with a contaminating substance such as cyanide, is incorporated into the consumable product or the packaging for the product. When the indicator comes in contact with the contaminating substance, a readily detectable color signal is produced.

Abstract: The application discloses a test vial including a test article for immersion into a fluid medium, a sealed chamber which contains the fluid medium, and an open chamber which is external to the sealed chamber and which supports the test article. The sealed and open chambers define a barrier which isolates the fluid medium from the test article. The open chamber is covered by a closure. Retaining means are positioned on the closure and cooperatively support the closure in a first position and cooperatively receive the closure in a second position. The closure has a means for penetrating the barrier and for injecting the test article into the fluid medium when the closure is moved from the first position to the second position while maintaining the sealed chamber in a sealed condition upon movement of the closure from the first position to the second position.

Abstract: A quick open syringe for use in testing an ethylene oxide sterilizer comprises a vented hollow container for receiving and holding a test unit therein. A lid with a handle covers an opening to the container and the container itself is formed with a piercing point. The quick open syringe and enclosed test unit can be positioned in a sterilizable peel pouch. After completion of a sterilization cycle, the container and lid handle may be grasped to remove the lid from the container and puncture the peel pouch with the point to enable removal of the test unit from the quick open syringe and the pouch.

Abstract: A device for testing the efficiency of autoclaves of the type used in hospitals for steam sterilizing porous loads such as surgical dressings, and particularly for detecting the presence of air in such a system, comprising first and second porous masses (10, 11) of a substantially man-made material such as spun bonded polypropylene, superimposed so as to sandwich therebetween an indicator sheet (12) and a pair of porous and absorbent sheets (12a). This assembly is held firmly together within a perforated stainless steel box (13) having a closable lid (14). For the test the whole device is placed in a steam sterilizer under normal working conditions. Subsequently, the test device is removed and the indicator sheet (12) inspected, any color variation across the sheet providing an indication of incomplete sterilizing conditions.

Abstract: A can container made of soft material such as aluminum having a wall thickness of less than 0.2 mm is used for low acid foods or drinks having pH of more than 5.0. A controlled quantity of liquified nitrogen is introduced into the can filled with the low acid foods or drinks and then the can is hermetically sealed off by double-seaming. The liquid nitrogen is soon gasified in the sealed can to increase internal pressure of the can to a level sufficient to prevent the can from being deformed. Then the can is subjected to retort sterilization treatment at a predetermined high steam temperature for a predetermined period of time for sterilization of any possible bacilli and bacteria in the low acid foods or drinks in the can. Prior to retort sterilization treatment, a thermal sensitive paint is applied to the can, which will change color when exposed to a steam of a predetermined temperature for a predetermined period.

Abstract: An adjustable test pack for determining the efficiency of a vacuum in an autoclave comprises a porous bundle partially including open cell foam and having non-porous layers placed on its surface to leave a portion thereof exposed. A sheet with a steam sensitive indicator ink printed thereon is selectively embedded in the bundle for placement in an autoclave where a vacuum is drawn to evacuate air from the bundle through its exposed surface portions. Steam is then introduced to replace the evacuated air and react with the indicator ink wherever there is contact. The amount of indicator ink contacted by the steam may be varied according to the selected placement of the indicator sheet in the bundle and provides a measure of the efficiency of the vacuum.

Abstract: An indicator for detecting residual ethylene oxide comprising a substrate impregnated with a solution of 4-(4-nitrobenzyl)pyridine and an envelope of the substrate which is at least partially transparent and has low permeability to gaseous ethylene oxide is provided, the envelope being preferably made of a transparent plastic film. With the indicator, an amount of ethylene oxide remaining in various medical instruments, etc. may be estimated by the naked eye since the color of the indicator changes step by step in the course of the release of residual ethylene oxide.

Abstract: An indicator comprising azo dye(s), epoxy compound(s) and a separating membrane can be utilized for detection of the completion of thermal sterilization treatment in the medical field and also for thermal inspection in such various fields as testing, instrumentation and the like. The indicator can be used also for detection of the completion of alkylene oxide gas sterilization treatment by ethylene oxide gas or the like.

Abstract: Means are provided for the monitoring of a sterilization procedure employing alkylene oxide, particularly ethylene oxide, to sterilize medical equipment, especially heat-sensitive equipment, and especially for monitoring the aeration of the so-sterilized goods and articles to desorb the retained alkylene oxide, which means employ interaction of the alkylene oxide with a cation-exchange resin and subsequent aeration of the cation exchange resin coupled with pH indicator means sensitive to changes in the ion exchange resin effected by the alkylene oxide employed in the sterilization and subsequently by the air employed in the desorption step.

Abstract: A visual indicator device and dosimeter in which a liquid crystal composition deposited on an opaque dark-colored carrier substrate undergoes color changes which depend on the concentration, and total quantity, of ethylene oxide to which the device has been exposed. The device serves both to monitor the concentration of ethylene oxide in the environment and to indicate a time-weighted average exposure.

Abstract: A device for indicating the presence of unacceptable levels of noncondensable gas, such as air, in a stream sterilization chamber. The device includes an insulated heat sink having an upper end and a lower end. The upper end of the heat sink is in such open communication with the sterilization chamber that the steam enters the heat sink. The device also includes a chamber proximate the lower end of the heat sink. The heat sink defines a path through which the steam travels from the upper end toward the chamber. The path is adapted to provide sufficient exposure of the steam to the heat sink so that the steam condenses within the path, releasing any noncondensable gas associated with the steam and forcing it toward the chamber. The chamber includes means for indicating the presence of noncondensable gas accumulated therein. The device also includes means for preventing the condensate from effecting the indicating means.

Abstract: The application discloses a test vial including a test article for immersion into a fluid medium, a sealed chamber which contains the fluid medium, and an open chamber which is external to the sealed chamber and which supports the test article. The sealed and open chambers define a barrier which isolates the fluid medium from the test article. The open chamber is covered by a closure. Retaining means are positioned on the open chamber and on the closure. The retaining means cooperatively support the closure in a first position and cooperatively receive the closure in a second position. The closure has a means for detaching the barrier from the open and sealed chambers and for injecting the test article in the fluid medium when the closure is moved from the first position to the second position.

Abstract: A test pack for determining the efficiency of a vacuum in an autoclave comprises a porous bundle having a plurality of nonporous layers placed on its surface to leave a portion thereof exposed. A sheet with a steam sensitive indicator ink printed thereon is embedded in the bundle for placement in an autoclave where a vacuum is drawn to evacuate air therefrom through the exposed surface portions of the bundle. Steam is then introduced to replace the evacuated air and react with the indicator ink wherever there is contact. The amount of indicator ink contacted by the steam is a measure of the efficiency of the vacuum.

Abstract: A method and apparatus for determining the composition and the concentration of biocidal gas and other gases contained in a reaction chamber during processing of material contained in the chamber and exposed to the treating gas. A valved pre-evacuated gas-sampling vessel is positioned in the reaction chamber and, thereafter, opened by remote control to receive a gas sample representative of the gaseous atmosphere present in the chamber. The sampling vessel is then closed, removed from the treatment chamber, and connected to apparatus for analyzing the gas in the vessel. The qualitative and quantitative composition of the treating gas is thus determined.

Abstract: An improved test pack for determining the efficiency of a vacuum in an autoclave comprises a porous bundle partially including open cell foam and having a plurality of non-porous gas impermeable layers placed on its surface to leave a portion thereof exposed. A sheet with a steam sensitive indicator ink printed thereon is embedded in the bundle for placement in an autoclave where a vacuum is drawn to evacuate air therefrom through the exposed surface portions of the bundle. Steam is then introduced to replace the evacuated air and react with the indicator ink wherever there is contact. The amount of indicator ink contacted by the steam is a measure of the efficiency of the vacuum.

Abstract: A sterilizer container includes a seal member so positioned on the container that movement of the outer cover of the container to a contaminating position requires fracturing the seal, thereby destroying the utility of the seal member and thus providing a visual indication that the articles within the container are contaminated. Further, the seal member includes a sterilization indicator which provides a further indication that the articles contained within the container are sterile.

Abstract: A procedure is described whereby it can be determined to what extent the non-ionic constituents of a rosin flux, employed during soldering operations in the manufacture of electronic circuit boards, have been removed following the flux removal step. The procedure also permits conductivity readings to be made on the test solution to determine the extent of residual ionic constituents on such boards.

Abstract: Apparatus and method for testing the sufficiency of sterilization includes a test tube having a distal end in which a bacterial spore element is disposed. A sealed glass ampule containing a sterile liquid culture medium is disposed in the test tube and a plunger having a fenestration closed with a hydrophobic filter is fitted slidingly in the open end of the test tube. In use, the apparatus is exposed to sterilization, and thereafter the plunger is pushed down into the test tube to engage the ampule to slide the latter into engagement with an ampule-engaging means to thereby fracture or break the ampule so that the contents of the ampule are released into the test tube to contact the spore element, whereby the apparatus is then subjected to incubation, the sufficiency of the sterilization being thereby determined.

Abstract: A tamper-resistant package containing in an anerobic environment a leuco dye free of reducing agent which dye becomes colored upon reaction with oxygen.

Abstract: A steam sterilization indicator including a carrier, a pH value indicator that changes color at a predetermined pH value affixed to the carrier and a chemical composition associated with the carrier. The chemical composition contains a mixture of at least two different carboxyl group-containing submixtures, wherein the first carboxyl group containing submixture is a mixture of 2,4-dihydroxybenzoic acid and a metal salt of 2,4-dihydroxybenzoic acid, and the second carboxyl group containing submixture is a mixture of phenylpropiolic acid and a metal salt of phenylpropiolic acid, wherein the molar ratio of the first submixture to the second submixture is about 1:4 to 4:1. Under steam sterilization conditions, the pH value of the chemical composition exceeds the predetermined pH value, causing the pH value indicator to change color and indicate that sterilization is complete.

Abstract: A device for giving a visual indication of the amount of residual ethylene oxide present in ethylene oxide treated solid hospital articles and other health devices. The amount of residual ethylene oxide is indicated by the difference in color exhibited by different sensitized areas of the device in the form of an opaque dark colored support member having bonded to its surface a thin film of a cholesteric liquid crystal composition in a solid film-forming binder. The film is made by laying down on the surface of the support member a solution or dispersion of liquid crystals which exhibits a change in color when in contact with ethylene oxide at a temperature from 60.degree. to 100.degree. F. in a solution of the solid binder, then evaporating the solvent.

Abstract: A disposable test package for testing the proper functioning of a steam sterilizer is formed with a test sheet adapted to change color in response to the presence of steam under preselected sterilization conditions. The sheet is surrounded by disposable nonwoven porous material, above and below, forming a core region around the test sheet having desired height and porosity parameters and a shell region around the core having different height and porosity parameters which are adapted to permit the test pack to simulate a Bowie and Dick challenge pack for the testing of steam sterilizers.

Abstract: Apparatus for indicating whether the contents of a container have been sterilized during a sterilization process including a first member having a portion for coacting with the sterilization agent to indicate the sterility of the contents of the container. A second member is adapted to extend into the interior of the container to be sterilized and receive and releasably engage the first member so that said first member can be positioned within the interior of the container to be sterilized during the sterilization process and so that the first member can be placed in and withdrawn from the second member without exposing the contents of the container to the surrounding environment or the operator to the contents of the container.

Abstract: A device for chemically quantifying ethylene oxide exposure is disclosed as are methods for its use. The device comprises an ethylene oxide-permeable layer exhibiting unusual non-Fickian EO transport and containing a controlled amount of compound which forms a colored species upon reaction with ethylene oxide. Optionally, the response layer is laminated or otherwise joined with a support layer. The device can be used to quantify in industry accepted units of time and concentration sterilization dosages of ethylene oxide.

Abstract: A radionuclide quality control test kit includes a disposable chromatography chamber. A premeasured amount of a solvent solution is provided in the chamber. A disposable test strip has spaced opposite first and second ends. The first end is immersible in the solvent solution in the chamber upon being spotted by a radiopharmaceutical to be tested to enable the solvent solution to ascend the strip to the second end whereat radiochemical impurities of the radiopharmaceutical migrating to the second end are radiologically countable to permit computation of such impurities.

Abstract: A method of quantitatively determining the amount of exposure of an object to ethylene oxide gas. A pre-weighed ethylene oxide-permeable container, which encloses a predetermined amount of catalyst for the reaction of the ethylene oxide gas to form a liquid, is placed adjacent to the object. The object and container are then exposed to ethylene oxide gas for controlled time and at a known humidity and temperature. The container is then reweighed. The weight gain of the container is a quantitative indication of the amount of exposure to ethylene oxide gas. The test system may be calibrated against its effect in known concentrations of ethylene oxide gas, so that the precise amount of exposure to ethylene oxide gas can be determined.