Abstract: The invention provides a microorganism having an ability to produce a protein having a dipeptide synthesizing activity and in which an activity of the protein to transport a dipeptide in a microbial cell to theoutside of the microbial cell is higher than that of a parental strain.

Abstract: The present disclosure provides a system for inspecting a package (1040) having a substance subject to spoilage. An electromagnetic signal (e.g., a terahertz frequency signal) is directed to the package (1040), and an attenuated signal is received and sampled to generate a set of data points. A peak within the set of data points is detected, and the data points are shifted with respect to time to align the detected peak with a predetermined time. The set of shifted data points are compared to a mathematical model to determine whether the substance in the package (1040) is spoiled.

Abstract: Presently disclosed is a lighting system and methods of using the lighting system for in vitro potency assay for photofrin. The lighting system includes a lamp housing, a first lens, an infrared absorbing filter, an optical filter, and a second lens. The lamp housing includes a lamp and a light-port. In operation, broad spectrum light from the lamp exits the lamp housing by passing through the light-port. The first lens then collimates the broad spectrum light that exits the lamp housing through the light-port. The infrared absorbing filter then passes a first portion of the collimated broad spectrum light to the optical filter and absorbs infrared light of the broad spectrum light. The optical filter then passes a second portion of the collimated broad spectrum light to the second lens. The second lens then disperses the second portion of the collimated light to provide uniform irradiation of a cell culture plate. A method of using the lighting system for studying a photosensitizer is also disclosed.

Abstract: A biological sterilization indicator (BI) and method of using same. The BI can include a housing, and a container positioned in the housing. The container can contain a liquid and at least a portion of the container can be frangible. The BI can further include a first chamber and a second chamber. The second chamber can include at least one source of biological activity. The BI can further include a first fluid path positioned to fluidly couple the first chamber and the second chamber, and a second fluid path positioned to allow displaced gas to move out of the second chamber. The method can include moving displaced gas out of the second chamber via the second fluid path as a sterilant is moved into the second chamber via the first fluid path and/or as the liquid is moved into the second chamber via the first fluid path.

Abstract: Sterilization indicators that include a neutralizer, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.

Abstract: Sterilization indicators that include a unique porous carrier, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.

Abstract: Methods and compositions for detection of microbial contaminants in peritoneal dialysis solutions are provided. The methods and compositions employ modified bioburden testing and the detection of peptidoglycan. A novel cause of aseptic peritonitis is provided—aseptic peritonitis associated with gram positive microbial contamination of a dialysis solution. Peptidoglycan is a major component of a gram positive bacterial cell wall and thus can serve as a marker for gram positive bacteria. In this regard, testing for peptidoglycans can be utilized to effectively prevent peritonitis in patients that use the peritoneal dialysis solutions, such as peritoneal dialysis solutions that contain a glucose polymer including an icodextrin and the like.

Abstract: The present invention provides a device for activating a self-contained biological indicator. The biological indicator includes a casing, an ampule having a growth-promoting medium disposed therein and microorganisms. The ampule and microorganisms are disposed within the casing. The device is comprised of a first lever arm having a cavity formed therein. The cavity is dimensioned to receive a biological indicator. A second lever arm has a protrusion extending from a surface thereof and is moveable relative to the first lever arm to deform a casing of the biological indicator thereby fracturing an ampule in the casing and exposing microorganisms in the casing to a growth-promoting medium in the ampule of the biological indicator.

Abstract: A method for retention testing sterilizing grade filters comprises: a) providing a stock of Acholeplasma laidlawii; b) growing up the stock of A. laidlawii for about 24 hours or less in a single serum-free growth medium that supports cell growth to a high titer and yields a cellular morphology where the cells are small, deaggregated and spherical, thereby producing a bacterial culture; c) challenging a test filter by filtering the bacterial culture through the test filter at a known challenge level, thereby producing a filtrate downstream of the test filter; and d) detecting concentration of A. laidlawii in the filtrate. Serum-free growth media for cultivating or storing A. laidlawii are also described.

Abstract: A testing unit and a method of testing a sterilization packaging unit for microbial contamination of sterilized objects after they have been sterilized are disclosed. The testing unit includes a dry matrix for accommodating a nutrient medium and a receptacle containing a liquid. By applying the liquid onto the matrix, the matrix is provided with a nutrient medium. In the method, the testing unit is inserted into the sterilization packaging unit which is sterilized and stored. At a desired point in time, the receptacle is opened in order to produce the nutrient medium in the matrix. After a possible multiplication of microbes on the matrix, an observation of microbes takes place. The invention also relates to a sterilization packaging unit which has a rigid outer casing and is suitable for the application of the method.

Abstract: The disclosed invention relates to a method for monitoring a sterilization process. The method includes (A) exposing an article to be sterilized and a biological indicator to a sterilization medium during a sterilization process, the biological indicator comprising a cell with a plasma membrane; and (B) incubating the cell and measuring the membrane potential of the cell to detect change in the membrane potential.

Abstract: A method of detecting a biological activity is provided. The method includes contacting; in a liquid medium selected to facilitate a predetermined biological activity; a sample, an indicator reagent, and a substrate that receives and concentrates a biological derivative of the indicator reagent. The method further includes observing a portion of the substrate to detect the biological derivative. The method can be used to detect the presence or absence of a target cell.

Abstract: A device useful in determining the efficacy of a chemical sterilization process includes a dead end cavity closed by an access cap having a port coupled to a challenge tube defining the only path by which a substantial quantity of sterilant can reach the cavity. A biological indicator is located within the cavity and a chemical indicator is also provided. These indicators, and particularly the biological indicator, provide an indication of whether chemical sterilant would reach all interior exposed surfaces of a load in sufficient concentrations to adequately sterilize the load.

Abstract: An aerosol deposition apparatus is described for reproducibly preparing standardized coupon surfaces, which mimic aerosol deposited materials in an uncontrolled environment. The dome shaped apparatus is placed over the surfaces and an aerosol is delivered to the apex of the dome. The aerosol deposited surfaces may be used as standards for evaluating decontamination methods.

Abstract: This disclosure describes example antimicrobial compositions that may be used in combination with IV port cleansing caps, protective caps, or nasal decolonizer devices. According to another implementations, the disclosure describes that the antimicrobial composition may provide an indication that it has come into contact with a contaminant by bubbling or foam on a surface that is being cleaned. According to another implementation, the disclosure describes that the antimicrobial composition may leave a residual film or barrier to inhibit the recontamination of a surface that has been cleaned.

Abstract: Provided are methods for sampling, testing and validating test lots, comprising: assembling a plurality of product portions from each of a plurality of test lots and combining the portions to provide a corresponding set of test lot samples; enriching the test lot samples; removing portions of each enriched sample, and combining the removed portions to provide a modular composite sample; and testing of the modular composite sample, and individual testing of the enriched test lot samples, using at least one suitable detection assay for a target microbe or organism, wherein when such testing is negative all test lots are validated, and wherein when such testing is positive with respect to the modular composite sample, or with respect to an individual enriched test lot sample, individual test lots may nonetheless yet be validated by further testing of a portion of respective initially-negative enriched test lot samples and obtaining negative results.

Abstract: Determining the microorganism load of a substance may be conducted readily using one or more integrated computational elements. By determining a substance's microorganism load, the substance's suitability for a variety of applications may be ascertained. Methods for determining the microorganism load of a substance using one or more integrated computational elements can comprise: providing a substance comprising a plurality of viable microorganisms; exposing the substance to a pulsed light source for a sufficient length of time to form at least some non-viable microorganisms; and determining a microorganism load of the substance using one or more integrated computational elements.

Abstract: A method and system for rapidly detecting Candida on the skin of a host, such as an infant with diaper rash, is provided. The method includes contacting a dermal sample with a colorant that exhibits a certain spectral response (e.g., color change) in the presence of Candida. For example, the colorant may change from a first color to a second color, from colorless to a color, or from a color to colorless. The colorant is typically capable of differentiating between Candida (e.g., Candida albicans) and other microorganisms commonly associated with diaper rash, such as S. aureus and E. coli. Thus, when a dermal sample is placed into contact with the colorant, the color change may simply be observed to determine whether the infection is caused by Candida. If the color change occurs to a certain extent (e.g., from yellow to bright red), it may be determined that the test sample contains Candida. Likewise, if a color change occurs to a lesser extent (e.g.

Abstract: A method for retention testing sterilizing grade filters comprises: a) providing a stock of Acholeplasma laidlawii; b) growing up the stock of A. laidlawii for about 24 hours or less in a single serum-free growth medium that supports cell growth to a high titer and yields a cellular morphology where the cells are small, deaggregated and spherical, thereby producing a bacterial culture; c) challenging a test filter by filtering the bacterial culture through the test filter at a known challenge level, thereby producing a filtrate downstream of the test filter; and d) detecting concentration of A. laidlawii in the filtrate. Serum-free growth media for cultivating or storing A. laidlawii are also described.

Abstract: The present invention provides a sterilization confirmation tester and a test pack which enables effective sterilization to be confirmed in a simple and sure manner by providing a simulation of the structure of an endoscope and so forth. The sterilization confirmation tester according to the present invention has a function of confirming effective sterilization treatment after sterilization performed by a sterilization apparatus. The sterilization confirmation tester includes a structure corresponding to at least one of the components which form the endoscope.

Abstract: Exemplary embodiments provide bioaerosol detection systems and methods for detecting bioaerosols. In one embodiment, the bioaerosol detection system can include a humidifier to increase the humidity of a continuously flowing sample volume of a bioaerosol sample using a biologically compatible liquid medium, and an amplifier to deposit vapor on the bioaerosol sample for a particle size amplification process. Bioaerosol(s) can thus be detected and sampled while simultaneously maintaining their viability. The disclosed bioaerosol detection systems and the methods can provide high efficiency for sampling and detecting ultrafine bioaerosol(s) such as viruses and proteins, which can be smaller than 0.3 ?m in diameter and can be as small as 20 nm.

Abstract: A method for detecting the absence or presence of cells of interest in a liquid sample is provided. The method comprises providing a sample suspected of containing cells of interest that contain an intracellular enzyme with a measurable activity. The sample further comprises an extracellular medium that also includes an extracellular enzyme with the measurable activity. The method further comprises the steps of treating the liquid sample with a reagent that inactivates the measurable activity in the extracellular medium but does not inactivate the measurable activity in the cells of interest, lysing the cells of interest to release the intracellular enzyme, and measuring the measurable activity. Thus, the measurable activity of the intracellular enzyme can be measured without interference from the extracellular enzyme. The invention is particularly useful for treatment of bacterially-infected blood using a detection assay based on adenylate kinase activity.

Abstract: Suitable dyes are used herein to indicate the presence of microbial contamination by spraying them onto surfaces in the form of an aqueous solution. The dye solution may also be allowed to dry, thus producing the dried residue of an aqueous solution. It's believed that these dyes change color in response to a change in polarity of the environment. Since water is a polar solvent and most bacteria are made from non-polar substances, the presence of bacteria changes the polarity of the environment, triggering a change visible by the unaided eye.

Abstract: The invention discloses a system to detect and enumerate diverse biological particles through the use of microbial spores that in the presence of a redox substrate rapidly respond to germination signals by forming discrete intracellular fluorescent formazan granules. The disclosed system enables ultrasensitive detection and enumeration of different analytes including microorganisms, viruses, nucleic acids, polypeptides, and natural or man-made particles bearing analytes.

Abstract: The sterilizing effect of particle irradiation on microorganisms for the sterilizing treatment thereof can be evaluated. The evaluation can be done by supplying microorganisms in the space inside a container (8), allowing particles (7) for the sterilizing treatment of microorganisms to irradiate the microorganisms, sampling the microorganisms by a sampling means (6) after the irradiation of the particles (7) and measuring the sampled microorganisms. The microorganisms as the subject for the sterilizing treatment can be a combination of one or more members selected from the group consisting of bacteria, mycete, viruses and allergens. As the particles, for example, positive ions, negative ions, and gases of positive ions and negative ions in mixture, charged particles such as a rays and ? rays, various plasma gas particles, particles such as ozone and radical particles, and particles of chemical agent can be used.

Abstract: A method for determining the effectiveness of a sterilization and/or disinfection process is disclosed.

Abstract: The present invention provides a method of detecting adventitious agents in a composition comprising a microorganism by using ribozyme-expressing indicator cells, as well as indicator cells useful in such detection.

Abstract: The disclosed technology relates to a sterilization indicator, including a carrier, the carrier having a first surface and a second surface; a support, the support having a first section and a second section, the carrier overlying the first section of the support, the second surface of the carrier being adhered to the first section of the support; and a biological indicator supported by the carrier; the sterilization indicator being formed by applying the biological indicator to the carrier and then adhering the carrier to the support, the carrier being adhered to the support using sonic welding, in which the sonic welding, when applied to the carrier with the biological indicator applied, exhibits no significant difference in viability of the biological indicator following the sonic welding as compared to prior to the sonic welding.

Abstract: A liquid testing assembly for testing a liquid, the assembly comprising a test vessel and a stopper adapted to fit into a free end of the vessel. The stopper substantially hermetically seals the test vessel from the ambient. Further, the assembly includes a support coated with one or more identifying materials for identifying one or more constituents of the liquid. The support is fixed in the stopper and/or the vessel and extends into its interior for a predetermined distance. The liquid testing assembly when assembled is pre-evacuated to a predetermined vacuum sufficient to draw a predetermined volume of liquid to be sampled into the test vessel. The predetermined volume is of such an amount that it wets the one or more identifying materials ensuring identification of one or more constituents present in the liquid. A kit employing the liquid testing assembly is also discussed.

Abstract: The disclosed technology relates to a genetically engineered biological indicator, comprising: at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and at least one repressor gene that inhibits expression of the reporter gene until the reporter gene is exposed to at least one inducer. A process and an apparatus for using the biological indicator are disclosed.

Abstract: The present invention provides a device for activating a self-contained biological indicator. The biological indicator includes a casing, an ampule having a growth-promoting medium disposed therein and microorganisms. The ampule and microorganisms are disposed within the casing. The device is comprised of a first lever arm having a cavity formed therein. The cavity is dimensioned to receive a biological indicator. A second lever arm has a protrusion extending from a surface thereof and is moveable relative to the first lever arm to deform a casing of the biological indicator thereby fracturing an ampule in the casing and exposing microorganisms in the casing to a growth-promoting medium in the ampule of the biological indicator.

Abstract: A biological indicator and method of making same. The biological indicator includes a carrier having a recess formed therein in order to restrict movement of an inoculum deposited onto the carrier. The inoculum includes microorganisms (e.g., bacterial spores) suspended in a suspension medium. The microorganisms are prepared by removing extraneous material and subjecting the microorganisms to sonication to break up agglomerations. The suspension medium includes a wetting agent to reduce surface tension, thereby facilitating flow of the suspension medium to prevent stacking of microorganisms on the surface of the carrier, and to allow the inoculum to more evenly “plate out” on carrier surfaces. The carrier, with inoculum deposited thereon, is enclosed in an envelope made of a material permeable to a vaporous deactivating agent (e.g., vaporized hydrogen peroxide, ozone, chlorine dioxide, ethylene oxide, etc.), thereby facilitating exposure to the vaporous deactivating agent.

Abstract: The disclosed invention provides a self-contained sterilization indicator for evaluating the effectiveness of a sterilization process. The sterilization indicator includes a cap configured for housing a growth medium, the cap being mountable on a container that contains a concentration of microorganisms. The cap comprises an inner chamber for housing the growth media. The inner chamber has an opening and a breakable barrier overlying the opening for encapsulating the growth media within the inner chamber of the cap. The biological indicator is adapted for breaking the breakable barrier at a selected time to introduce the growth medium into the container such that the growth medium contacts the microorganisms.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.

Abstract: The present invention provides a device for activating a self-contained biological indicator. The biological indicator includes a casing, an ampule having a growth-promoting medium disposed therein and microorganisms. The ampule and microorganisms are disposed within the casing. The device is comprised of a first lever arm having a cavity formed therein. The cavity is dimensioned to receive a biological indicator. A second lever arm has a protrusion extending from a surface thereof and is moveable relative to the first lever arm to deform a casing of the biological indicator thereby fracturing an ampule in the casing and exposing microorganisms in the casing to a growth-promoting medium in the ampule of the biological indicator.

Abstract: The invention relates to a method for characterizing the bioindicators in sterilization processes using an autoclave and the like, in which a bioindicator is kept in the same conditions as the sterilization chamber (2) and extracted after a predetermined time interval. For this purpose the chamber (2) has, passing through it, a tube (5) on the ends of which valves (8-9, 10-11) are mounted, said valves allowing the insertion, from above, of a bioindicator sample and its extraction from below, when required, without a significant loss of sterilizing agent. Alternatively, the duct (5) may also be arranged outside the sterilization chamber (2) and kept in communication therewith by a bypass connection.

Abstract: A method for determining microbial contamination of allograft products includes providing an extraction vessel having an outer container and a removable inner basket, placing the allograft product into the inner basket, providing an extraction fluid in the outer container of the extraction vessel, positioning the inner basket in the outer container, so that the allograft product and the inner basket are submerged in the extraction fluid and agitating the extraction fluid for a predetermined amount of time and analyzing the extraction fluid for microbial contamination.

Abstract: The invention relates to the use of a cleaning agent that contains surfactants and has a pH value of at least 11 when diluted in an aqueous solution and ready for use. Said cleaning agent is used to destabilize prions during mechanical and manual cleaning and/or disinfection of medical and/or surgical instruments and appliances. It has been recognized that this combination enables a reliable destabilization of prions during the mechanical reconditioning of surgical instruments.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.

Abstract: A biological indicator for determining the effectiveness of a sterilization process is disclosed having a package and carrier integral therewith. The package includes a first sheet and a second sheet having a bottom portion, side portions and a top portion. The first and second sheets are joined together generally along a periphery of the first and second sheets by a peelable adhesive. A carrier having a plurality of spores thereon for determining the effectiveness of a sterilization process is attached to the package between the first and second sheets and at least a portion of the resealable adhesive. The package may be opened and subsequently partially or fully closed to enclose the carrier.

Abstract: The invention relates to a method for testing a sterilization packaging unit provided for sterilization of objects to be sterilized, in particular medical objects to be sterilized, for its efficacy against microbial recontamination of the sterilized objects after they have been sterilized. In accordance with the invention the packaging unit is charged with nutrient medium, subjected to a sterilization process and then stored for a period of time under ambient conditions. The packaging unit is then kept under conditions in which microbes multiply for cultivation of microbes which are present in or on the nutrient medium. The packaging unit is then opened and microbes, which have multiplied in or on the nutrient medium, are observed. The method permits the efficacy of the packaging unit with respect to its recontamination protection to be tested easily and reliably.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.

Abstract: A system and method for providing 20% ethanol solutions meeting bioburden and endotoxin specifications, which provides the 20% ethanol solution in a ready-to-use form which may be dispensed directly from the container in which the solution is shipped, and which may be used in connection with storage, reuse and/or rejuvination of Protein A.

Abstract: A container is provided for holding a chemical compound or mixture. Areas are provided on the surface of the container which allow for gaseous by-products from the chemical contained within the container to permeate from a chamber through the surface of the container. A septum is over-molded into the surface of the container. The septum is formed in such a manner that it provides a sealing effect to close an opening in the container.

Abstract: The invention provides methods for certification of carcasses, and for detecting a contaminated carcass and preventing its movement into or across a production area. The inventive methods comprise obtaining, early in the production process (pre-fabrication), a test sample from at least one test location of at least one split-portion of each carcass, wherein the test samples are obtained prior to or during chilling of the respective split portions, before entry thereof in the production chain. Composite test samples are assayed for pathogens or microbes, whereby certification is afforded, or whereby entry of the chilled split-carcass-Lot into the production area is precluded if the corresponding composite-Lot test sample is contaminated. Methods for remedial reconditioning of contaminated split-carcasses are provided, wherein essentially 100% of the carcasses are targeted to the production line. The inventive methods provide substantial public health benefit, and are efficient and economical to implement.

Abstract: Methods of sterilizing dermal fillers and injectable collagen material have been developed which reduce the level of active biological contaminants or pathogens without adversely affecting the material, i.e., wherein the dermal fillers and injectable collagen material retain their same properties before and after its terminal sterilization. In one embodiment the method for sterilizing the dermal filler or injectable collagen material that is sensitive to radiation contains the steps of protecting the filler or material from radiation, and irradiating the filler or material with a suitable dose of radiation for a time and at a rate effective to sterilize the filler or injectable material. In a preferred embodiment the method for sterilizing the dermal filler or injectable collagen material that is sensitive to radiation includes the steps of a) freezing the filler or material at a temperature below its freezing temperature, which is generally below 0° C.

Abstract: A testing unit and a method of testing a sterilization packaging unit for microbial contamination of sterilized objects after they have been sterilized are disclosed. The testing unit includes a dry matrix for accommodating a nutrient medium and a receptacle containing a liquid. By applying the liquid onto the matrix, the matrix is provided with a nutrient medium. In the method, the testing unit is inserted into the sterilization packaging unit which is sterilized and stored. At a desired point in time, the receptacle is opened in order to produce the nutrient medium in the matrix. After a possible multiplication of microbes on the matrix, an observation of microbes takes place. The invention also relates to a sterilization packaging unit which has a rigid outer casing and is suitable for the application of the method.

Abstract: The present invention relates to a method of evaluating the efficiency of sterilization processes by measurement of degradation level of prion protein indicators. When exposed to sterilization conditions, prion indicators are degraded in a manner to proportionally indicate the level of degradation of prion proteins themselves on medical devices or other surfaces usable in surgery and health cares.

Abstract: A sterilization challenge specimen holder is used with a test indicator to challenge sterilization on a consistent basis. The holder includes a body having an internal chamber region. A cap is sealable on the holder. An opening is defined in the body or cap that forms a single tortuous ingress and egress path communicating the interior chamber with the environs. An insulating layer is disposed over the body and cap to fully insulate the body and cap other than over the opening so as to not interfere with the ingress and egress path. The insulating layer reduces the heat transference from the environs to the interior chamber region.

Abstract: The disclosed technology relates to a sterilization indicator and a process to concentrate signal generated by constraining it to a minimal surface, in a minimal volume and minimal pH and growth buffering or mediating influences. The sterilization indicator may comprise a carrier 12, the carrier having a first surface 14 and a second surface 16; a support 20, the support having a first section 22 and a second section 24, the carrier 12 overlying the first section 12 of the support 20, the second surface 16 of the carrier being adhered to the first section 22 of the support 20; and a biological indicator 30 supported by the carrier 12. The second section 24 of the support 20 may be of sufficient dimension to permit handling the sterilization indicator 10 without contacting the biological indicator 30. A process for making the sterilization indicator is disclosed. Processes for using the sterilization indicator are disclosed.