The Experts below are selected from a list of 327 Experts worldwide ranked by ideXlab platform
David J Weber - One of the best experts on this subject based on the ideXlab platform.
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comparison of a rapid readout Biological Indicator for steam sterilization with four conventional Biological Indicators and five chemical Indicators
Infection Control and Hospital Epidemiology, 1996Co-Authors: William A Rutala, Suzanne M Jones, David J WeberAbstract:OBJECTIVE: In this study, we compare a new Biological Indicator that provides results within 3 hours with four conventional, 48-hour Biological Indicators and five chemical Indicators. DESIGN: Biological Indicators tested included the conventional Attest 1262, Proof Plus, Assert, and Biosign, and the new Attest 1292 Rapid Readout Biological Indicator. Chemical Indicators tested included Comply, Propper, Chemdi, Sterigage, and Thermalog S. Spore survival following 121 degrees C in a gravity displacement sterilizer was measured by media color change after incubation for 24 and 48 hours at 56 degrees C for the conventional Biological Indicators, fluorescence at 3 hours for the Attest 1292 Rapid Readout Biological Indicator, and color change for the chemical Indicators. Each exposure time was replicated 12 times with 5 samples of each Indicator per run (ie, 60 replicates per Indicator). RESULTS: At 48 hours, the conventional Biological Indicators Attest 1262, Proof Plus, Assert, and Biosign showed 100%, 95%, 88%, and 93% spore survival at 5 minutes' exposure 0%, 0%, 0% and 8% at 10 minutes; and all showed 0% survival at 15 minutes' exposure. Following a 3-hour incubation, the Attest 1292 Rapid Readout Biological Indicator showed fluorescence at 100%, 72%, and 0% at 5, 10, and 15 minutes, respectively. The chemical Indicators Comply, Propper, Chemdi, Sterigage, and Thermalog S revealed sterilization failure rates of 100%, 100%, 100%, 100%, and 100% at 5 minutes' exposure; 0%, 0%, 0%, 92%, and 100% at 10 minutes; and 0%, 0%, 0%, 3%, and 27% at 15 minutes' exposure, respectively. CONCLUSIONS: The sensitivity of the Attest 1292 Rapid Readout Biological Indicator parallels that of conventional Biological Indicators. These data suggest that a 3-hour rapid readout Biological Indicator is equivalent to a standard 48-hour Biological Indicator. Some chemical Indicators (eg, Thermalog S) failed to indicate adequate sterilization at 15 minutes' exposure. These chemical Indicators have the potential of causing unnecessary recall of adequately sterilized items.
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comparison of a rapid readout Biological Indicator for steam sterilization with four conventional Biological Indicators and five chemical Indicators
Infection Control and Hospital Epidemiology, 1996Co-Authors: William A Rutala, Suzanne M Jones, David J WeberAbstract:Objective: In this study, we compare a new Biological Indicator that provides results within 3 hours with four conventional, 48-hour Biological Indicators and five chemical Indicators.Design: Biological Indicators tested included the conventional Attest 1262, Proof Plus, Assert, and Biosign, and the new Attest 1292 Rapid Readout Biological Indicator. Chemical Indicators tested included Comply, Propper, Chemdi, Sterigage, and Thermalog S. Spore survival following 121°C in a gravity displacement sterilizer was measured by media color change after incubation for 24 and 48 hours at 56°C for the conventional Biological Indicators, fluorescence at 3 hours for the Attest 1292 Rapid Readout Biological Indicator, and color change for the chemical Indicators. Each exposure time was replicated 12 times with five samples of each Indicator per run (ie, 60 replicates per Indicator).Results: At 48 hours, the conventional Biological Indicators Attest 1262, Proof Plus, Assert, and Biosign showed 100%, 95%, 88%, and 93% spore survival at 5 minutes' exposure; 0%, 0%, 0%, and 8% at 10 minutes; and all showed 0% survival at 15 minutes' exposure. Following a 3hour incubation, the Attest 1292 Rapid Readout Biological Indicator showed fluorescence at 100%, 72%, and 0% at 5, 10, and 15 minutes, respectively. The chemical Indicators Comply, Propper, Chemdi, Sterigage, and Thermalog S revealed sterilization failure rates of 100%, 100%, 100%, 100%, and 100% at 5 minutes' exposure; 0%, 0%, 0%, 92%, and 100% at 10 minutes; and, 0%, 0%, 0%, 3%, and 27% at 15 minutes' exposure, respectively.Conclusions: The sensitivity of the Attest 1292 Rapid Readout Biological Indicator parallels that of conventional Biological Indicators. These data suggest that a 3hour rapid readout Biological Indicator is equivalent to a standard 48-hour Biological Indicator. Some chemical Indicators (eg, Thermalog S) failed to indicate adequate sterilization at 15 minutes' exposure. These chemical Indicators have the potential of causing unnecessary recall of adequately sterilized items.
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evaluation of a rapid readout Biological Indicator for flash sterilization with three Biological Indicators and three chemical Indicators
Infection Control and Hospital Epidemiology, 1993Co-Authors: William A Rutala, Maria F Gergen, David J WeberAbstract:Objective: Flash sterilization is most commonly used for emergency sterilization of unwrapped items in a gravity displacement sterilizer for three minutes. Sterilization quality assurance is monitored by Biological Indicators that require a 24-hour incubation prior to reading. In this study, we compared a new Biological Indicator that provides results within 60 minutes with three conventional, 24-hour Biological Indicators for monitoring flash sterilization and three chemical Indicators. Design: Conventional Biological Indicators tested included the conventional Attest 1261, Proof Flash and Assert, while the rapid readout Indicator tested was Attest 1291. Attest Rapid Readout detects the presence of a Bacillus stearothermophilus enzyme by reading a fluorescent product that is produced by the enzymatic break-down of a nonfluorescent substrate. Chemical Indicators tested included Comply, Incheque, and Thermalog S. Survival at 132°C in a gravity displacement sterilizer was measured by media color change after incubation for 24 hours at 56°C for the three conventional Biological Indicators, fluorescence at 60 minutes for the Attest Rapid Readout Biological Indicator, and color change for the chemical Indicators. Each exposure time was replicated four times with 10 of each Biological and chemical Indicator per run. Results: The conventional Biological Indicators (Attest, Proof Flash, and Assert) had 90%, 48%, and 40% spore survival at two minutes exposure; 23%, 3%, and 0% at three minutes exposure; and 3%, 0%, and 0% at four minutes exposure respectively. The Attest Rapid Readout Biological Indicator had 88%, 33%, and 0% enzyme activity detectable at 2, 3, and 4 minutes exposure. The chemical Indicators Comply, Incheque, and Thermalog S revealed sterilization failure rates of 100%, 100%, and 100% at 0 minutes exposure; 100%, 100%, and 45% at one minute; 0%, 0%, and 28% at two minutes exposure; 0%, 0%, and 18% at three minutes exposure; and 0%, 0%, and 0% at four minutes exposure, respectively. Conclusion: The sensitivity of the Attest Rapid Readout parallels the conventional Biological Indicators. These data suggest that a 60-minute rapid readout Biological Indicator is equivalent to the 24-hour Biological Indicators. If further studies demonstrate that a four-minute flash sterilization cycle provides a needed safety margin to ensure sterilization, then consideration should be given to requiring a four-minute flash sterilization cycle. Chemical Indicators were too sensitive to the processing conditions (eg, steam) and are inadequate to ensure adequate sterilization.
C J Soper - One of the best experts on this subject based on the ideXlab platform.
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Biological Indicators for steam sterilization characterization of a rapid Biological Indicator utilizing bacillus stearothermophilus spore associated alpha glucosidase enzyme
Journal of Applied Microbiology, 1998Co-Authors: H Albert, D J G Davies, L P Woodson, C J SoperAbstract:Sterilization is the act or process, physical or chemical, that destroys or eliminates all forms of life, especially micro-organisms. This term is absolute, i.e. a substance cannot be partially sterile (Joslyn 1991). Due to the difficulty in confirming sterility, a more practical definition of sterility has been adopted, defining sterility as the process by which living organisms are removed or killed to an extent that they are no longer detectable in standard culture media in which they have previously been found to proliferate (Joslyn 1991). In practice, assurance of a low probability of any living micro-organisms remaining is used as a measure of sterility. Sterility of a particular item can only be confirmed by destructive testing of the item, which is not practical for most purposes.
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Biological Indicators for steam sterilization characterization of a rapid Biological Indicator utilizing bacillus stearothermophilus spore associated alpha glucosidase enzyme
Journal of Applied Microbiology, 1998Co-Authors: H Albert, D J G Davies, L P Woodson, C J SoperAbstract:The alpha-glucosidase enzyme was isolated from vegetative cells and spores of Bacillus stearothermophilus, ATCC 7953. Spore-associated enzyme had a molecular weight of approximately 92,700, a temperature optimum of 60 degrees C, and a pH optimum of 7.0-7.5. The enzyme in crude aqueous spore extract was stable for 30 min up to a temperature of 65 degrees C, above which the enzyme was rapidly denatured. The optimal pH for stability of the enzyme was approximately 7.2. The alpha-glucosidase in crude vegetative cell extract had similar characteristics to the spore-associated enzyme but its molecular weight was 86,700. The vegetative cell and spore-associated enzymes were cross-reactive. The enzymes are postulated to derive from a single gene product, which undergoes modification to produce the spore-associated form. The location of alpha-glucosidase in the spore coats (outside the spore protoplast) is consistent with the location of most enzymes involved in activation, germination and outgrowth.
William A Rutala - One of the best experts on this subject based on the ideXlab platform.
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comparison of a rapid readout Biological Indicator for steam sterilization with four conventional Biological Indicators and five chemical Indicators
Infection Control and Hospital Epidemiology, 1996Co-Authors: William A Rutala, Suzanne M Jones, David J WeberAbstract:OBJECTIVE: In this study, we compare a new Biological Indicator that provides results within 3 hours with four conventional, 48-hour Biological Indicators and five chemical Indicators. DESIGN: Biological Indicators tested included the conventional Attest 1262, Proof Plus, Assert, and Biosign, and the new Attest 1292 Rapid Readout Biological Indicator. Chemical Indicators tested included Comply, Propper, Chemdi, Sterigage, and Thermalog S. Spore survival following 121 degrees C in a gravity displacement sterilizer was measured by media color change after incubation for 24 and 48 hours at 56 degrees C for the conventional Biological Indicators, fluorescence at 3 hours for the Attest 1292 Rapid Readout Biological Indicator, and color change for the chemical Indicators. Each exposure time was replicated 12 times with 5 samples of each Indicator per run (ie, 60 replicates per Indicator). RESULTS: At 48 hours, the conventional Biological Indicators Attest 1262, Proof Plus, Assert, and Biosign showed 100%, 95%, 88%, and 93% spore survival at 5 minutes' exposure 0%, 0%, 0% and 8% at 10 minutes; and all showed 0% survival at 15 minutes' exposure. Following a 3-hour incubation, the Attest 1292 Rapid Readout Biological Indicator showed fluorescence at 100%, 72%, and 0% at 5, 10, and 15 minutes, respectively. The chemical Indicators Comply, Propper, Chemdi, Sterigage, and Thermalog S revealed sterilization failure rates of 100%, 100%, 100%, 100%, and 100% at 5 minutes' exposure; 0%, 0%, 0%, 92%, and 100% at 10 minutes; and 0%, 0%, 0%, 3%, and 27% at 15 minutes' exposure, respectively. CONCLUSIONS: The sensitivity of the Attest 1292 Rapid Readout Biological Indicator parallels that of conventional Biological Indicators. These data suggest that a 3-hour rapid readout Biological Indicator is equivalent to a standard 48-hour Biological Indicator. Some chemical Indicators (eg, Thermalog S) failed to indicate adequate sterilization at 15 minutes' exposure. These chemical Indicators have the potential of causing unnecessary recall of adequately sterilized items.
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comparison of a rapid readout Biological Indicator for steam sterilization with four conventional Biological Indicators and five chemical Indicators
Infection Control and Hospital Epidemiology, 1996Co-Authors: William A Rutala, Suzanne M Jones, David J WeberAbstract:Objective: In this study, we compare a new Biological Indicator that provides results within 3 hours with four conventional, 48-hour Biological Indicators and five chemical Indicators.Design: Biological Indicators tested included the conventional Attest 1262, Proof Plus, Assert, and Biosign, and the new Attest 1292 Rapid Readout Biological Indicator. Chemical Indicators tested included Comply, Propper, Chemdi, Sterigage, and Thermalog S. Spore survival following 121°C in a gravity displacement sterilizer was measured by media color change after incubation for 24 and 48 hours at 56°C for the conventional Biological Indicators, fluorescence at 3 hours for the Attest 1292 Rapid Readout Biological Indicator, and color change for the chemical Indicators. Each exposure time was replicated 12 times with five samples of each Indicator per run (ie, 60 replicates per Indicator).Results: At 48 hours, the conventional Biological Indicators Attest 1262, Proof Plus, Assert, and Biosign showed 100%, 95%, 88%, and 93% spore survival at 5 minutes' exposure; 0%, 0%, 0%, and 8% at 10 minutes; and all showed 0% survival at 15 minutes' exposure. Following a 3hour incubation, the Attest 1292 Rapid Readout Biological Indicator showed fluorescence at 100%, 72%, and 0% at 5, 10, and 15 minutes, respectively. The chemical Indicators Comply, Propper, Chemdi, Sterigage, and Thermalog S revealed sterilization failure rates of 100%, 100%, 100%, 100%, and 100% at 5 minutes' exposure; 0%, 0%, 0%, 92%, and 100% at 10 minutes; and, 0%, 0%, 0%, 3%, and 27% at 15 minutes' exposure, respectively.Conclusions: The sensitivity of the Attest 1292 Rapid Readout Biological Indicator parallels that of conventional Biological Indicators. These data suggest that a 3hour rapid readout Biological Indicator is equivalent to a standard 48-hour Biological Indicator. Some chemical Indicators (eg, Thermalog S) failed to indicate adequate sterilization at 15 minutes' exposure. These chemical Indicators have the potential of causing unnecessary recall of adequately sterilized items.
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evaluation of a rapid readout Biological Indicator for flash sterilization with three Biological Indicators and three chemical Indicators
Infection Control and Hospital Epidemiology, 1993Co-Authors: William A Rutala, Maria F Gergen, David J WeberAbstract:Objective: Flash sterilization is most commonly used for emergency sterilization of unwrapped items in a gravity displacement sterilizer for three minutes. Sterilization quality assurance is monitored by Biological Indicators that require a 24-hour incubation prior to reading. In this study, we compared a new Biological Indicator that provides results within 60 minutes with three conventional, 24-hour Biological Indicators for monitoring flash sterilization and three chemical Indicators. Design: Conventional Biological Indicators tested included the conventional Attest 1261, Proof Flash and Assert, while the rapid readout Indicator tested was Attest 1291. Attest Rapid Readout detects the presence of a Bacillus stearothermophilus enzyme by reading a fluorescent product that is produced by the enzymatic break-down of a nonfluorescent substrate. Chemical Indicators tested included Comply, Incheque, and Thermalog S. Survival at 132°C in a gravity displacement sterilizer was measured by media color change after incubation for 24 hours at 56°C for the three conventional Biological Indicators, fluorescence at 60 minutes for the Attest Rapid Readout Biological Indicator, and color change for the chemical Indicators. Each exposure time was replicated four times with 10 of each Biological and chemical Indicator per run. Results: The conventional Biological Indicators (Attest, Proof Flash, and Assert) had 90%, 48%, and 40% spore survival at two minutes exposure; 23%, 3%, and 0% at three minutes exposure; and 3%, 0%, and 0% at four minutes exposure respectively. The Attest Rapid Readout Biological Indicator had 88%, 33%, and 0% enzyme activity detectable at 2, 3, and 4 minutes exposure. The chemical Indicators Comply, Incheque, and Thermalog S revealed sterilization failure rates of 100%, 100%, and 100% at 0 minutes exposure; 100%, 100%, and 45% at one minute; 0%, 0%, and 28% at two minutes exposure; 0%, 0%, and 18% at three minutes exposure; and 0%, 0%, and 0% at four minutes exposure, respectively. Conclusion: The sensitivity of the Attest Rapid Readout parallels the conventional Biological Indicators. These data suggest that a 60-minute rapid readout Biological Indicator is equivalent to the 24-hour Biological Indicators. If further studies demonstrate that a four-minute flash sterilization cycle provides a needed safety margin to ensure sterilization, then consideration should be given to requiring a four-minute flash sterilization cycle. Chemical Indicators were too sensitive to the processing conditions (eg, steam) and are inadequate to ensure adequate sterilization.
Goro Nishioka - One of the best experts on this subject based on the ideXlab platform.
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evaluation of bacillus oleronius as a Biological Indicator for terminal sterilization of large volume parenterals
Pda Journal of Pharmaceutical Science and Technology, 2016Co-Authors: Masamitsu Izumi, Masato Fujifuru, Aki Okada, Katsuya Takai, Takeshi Udagawa, Makoto Miyake, Shintaro Naruyama, Hiroshi Tokuda, Kazuhiro Takahashi, Goro NishiokaAbstract:In the production of large-volume parenterals in Japan, equipment and devices such as tanks, pipework, and filters used in production processes are exhaustively cleaned and sterilized, and the cleanliness of water for injection, drug materials, packaging materials, and manufacturing areas is well controlled. In this environment, the bioburden is relatively low, and less heat resistant compared with microorganisms frequently used as Biological Indicators such as Geobacillus stearothermophilus (ATCC 7953) and Bacillus subtilis 5230 (ATCC 35021). Consequently, the majority of large-volume parenteral solutions in Japan are manufactured under low-heat sterilization conditions of F0
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evaluation of bacillus oleronius as a Biological Indicator for terminal sterilization of large volume parenterals
Pda Journal of Pharmaceutical Science and Technology, 2016Co-Authors: Masamitsu Izumi, Masato Fujifuru, Aki Okada, Katsuya Takai, Takeshi Udagawa, Makoto Miyake, Shintaro Naruyama, Hiroshi Tokuda, Kazuhiro Takahashi, Goro NishiokaAbstract:In the production of large-volume parenterals in Japan, equipment and devices such as tanks, pipework, and filters used in production processes are exhaustively cleaned and sterilized, and the cleanliness of water for injection, drug materials, packaging materials, and manufacturing areas is well controlled. In this environment, the bioburden is relatively low, and less heat resistant compared with microorganisms frequently used as Biological Indicators such as Geobacillus stearothermophilus (ATCC 7953) and Bacillus subtilis 5230 (ATCC 35021). Consequently, the majority of large-volume parenteral solutions in Japan are manufactured under low-heat sterilization conditions of F0 <2 min, so that loss of clarity of solutions and formation of degradation products of constituents are minimized. Bacillus oleronius (ATCC 700005) is listed as a Biological Indicator in "Guidance on the Manufacture of Sterile Pharmaceutical Products Produced by Terminal Sterilization" (guidance in Japan, issued in 2012). In this study, we investigated whether B. oleronius is an appropriate Biological Indicator of the efficacy of low-heat, moist-heat sterilization of large-volume parenterals. Specifically, we investigated the spore-forming ability of this microorganism in various cultivation media and measured the D-values and z-values as parameters of heat resistance. The D-values and z-values changed depending on the constituents of large-volume parenteral products. Also, the spores from B. oleronius showed a moist-heat resistance that was similar to or greater than many of the spore-forming organisms isolated from Japanese parenteral manufacturing processes. Taken together, these results indicate that B. oleronius is suitable as a Biological Indicator for sterility assurance of large-volume parenteral solutions subjected to low-heat, moist-heat terminal sterilization.
H Albert - One of the best experts on this subject based on the ideXlab platform.
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Biological Indicators for steam sterilization characterization of a rapid Biological Indicator utilizing bacillus stearothermophilus spore associated alpha glucosidase enzyme
Journal of Applied Microbiology, 1998Co-Authors: H Albert, D J G Davies, L P Woodson, C J SoperAbstract:Sterilization is the act or process, physical or chemical, that destroys or eliminates all forms of life, especially micro-organisms. This term is absolute, i.e. a substance cannot be partially sterile (Joslyn 1991). Due to the difficulty in confirming sterility, a more practical definition of sterility has been adopted, defining sterility as the process by which living organisms are removed or killed to an extent that they are no longer detectable in standard culture media in which they have previously been found to proliferate (Joslyn 1991). In practice, assurance of a low probability of any living micro-organisms remaining is used as a measure of sterility. Sterility of a particular item can only be confirmed by destructive testing of the item, which is not practical for most purposes.
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Biological Indicators for steam sterilization characterization of a rapid Biological Indicator utilizing bacillus stearothermophilus spore associated alpha glucosidase enzyme
Journal of Applied Microbiology, 1998Co-Authors: H Albert, D J G Davies, L P Woodson, C J SoperAbstract:The alpha-glucosidase enzyme was isolated from vegetative cells and spores of Bacillus stearothermophilus, ATCC 7953. Spore-associated enzyme had a molecular weight of approximately 92,700, a temperature optimum of 60 degrees C, and a pH optimum of 7.0-7.5. The enzyme in crude aqueous spore extract was stable for 30 min up to a temperature of 65 degrees C, above which the enzyme was rapidly denatured. The optimal pH for stability of the enzyme was approximately 7.2. The alpha-glucosidase in crude vegetative cell extract had similar characteristics to the spore-associated enzyme but its molecular weight was 86,700. The vegetative cell and spore-associated enzymes were cross-reactive. The enzymes are postulated to derive from a single gene product, which undergoes modification to produce the spore-associated form. The location of alpha-glucosidase in the spore coats (outside the spore protoplast) is consistent with the location of most enzymes involved in activation, germination and outgrowth.