ICTP Mini / Thermal Paper specially designed for using with Bionova® Mini Bio, Bionova® Mini Pro Auto-Reader€™s Printer.Thermal Paper specially designed for using with Bionova® Mini Bio, Bionova® Mini Pro Auto-Reader€™s Printer. Specifications: Thermal Paper Roll. Color: White Paper Length: 4.7 m. Paper Width: 57 mm. Roll External Diameter: 23 mm. Roll Internal Diameter: 13.4 mm. Its function is to record the final results of biological indicators subjected to sterilization process and quantitative analysis of hygiene monitoring systems at each activated position of Bionova® Mini Bio and Mini Pro incubators, which allows record keeping in your sterilization records book. Read Bionova® Mini Bio and Mini Pro directions for use, as appropriate.

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ICTP / Incubator Thermal Paper. Accessory for the IC10/20FR and IC10/20FRLCD incubator€™s thermal printer. Thermal Paper specially designed for using with Bionova® IC10/20FR, and Bionova® IC10/20FRLCD Auto-Reader€™s Printer. Specifications: Thermal Paper Roll. Color: white Paper length: 30 m. Paper width: 57 mm. Roll external diameter: 50 mm. Roll internal diameter: 13.4 mm. Its function is to record the final results of biological indicators subjected to sterilization process and quantitative analysis of hygiene monitoring systems at each activated position of IC10/20FR or IC10/20FRLCD, which allows registration into your sterilization record keeping book. Read IC10/20FR or IC10/20FRLCD directions for use, as appropriate.

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Multi-variable Chemical Indicator printed with reactive ink for Steam sterilization processes. Chemdye® CD29 Multivariable Process Indicators (Type 4 according to ISO 11140-1:2014 standard) are single-use chemical indicators that consist of one-side laminated punched paper double strips printed with indicator ink. These indicators have been designed to monitor Steam sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. Innovative highly sensitive yellow ink was developed to turn to dark brown/black when the indicator is exposed to Steam considering the critical process variables which provides additional quality assurance. Endpoint condition: 121 °C, 15 minutes; 134 °C, 3.5 minutes. Indicators 100 % free of toxic heavy metals. Instructions For Use: Place a Chemdye® CD29 Multivariable Process Indicator within each package, bag or tray that will be sterilized by Steam. In rigid containers, place the indicator in every corner, or at least two diagonally opposite corners, to ensure that the sterilization agent has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Steam, the ink must turn to the dark brown/black reference color when the sterilization parameters are reached. For reference color, please refer to Result Reference Guide. Specifications: Process: Steam Initial Color: Yellow Final Color; Black Indicator Type: Type 4 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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CD16 / Multi-variable Chemical Indicators, double card strips printed with reactive ink for Ethylene Oxide sterilization processes. Metals Free. Control of Ethylene Oxide (EO) sterilization processes. Conditions: 600 mg/l EO, RH 60%, 30 °C, 30 minutes // 600 mg/l EO, RH 60%, 54 °C, 20 minutes. Characteristics: Type 4 Chemical Indicator (according to ISO 11140-1). Double punched card strips printed with indicator ink. Specifications: Size: 200 x 15 mm. Initial Color: Purple/Brown. Final Color: Green. 100 % Toxic Heavy Metals free. Instructions For Use: Place a Chemdy® CD16 Multivariable Process Indicator within each package, bag or tray that will be sterilized by Ethylene Oxide. In rigid containers, place the indicator in every corner, or at least two diagonally opposite corners, to ensure mthat the sterilization agent has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Ethylene Oxide, the ink must turn to the green reference color when the sterilization parameters are reached. More Info About This Product: Color Chart

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KPCD224-C / Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes with moving-front Type 5 Integrator and Bionova® Ultra Rapid Self-contained Biological Indicator BT224, plus Bionova® BT224 Biological Indicators Positive Control. Class 5 spores per strip. For routine load release, especially for loads containing implants. For routine sterilizer monitoring. For periodic validation of the sterilizer (after installation, repair, relocation). Detects inadequate air removal and steam penetration in dynamic- airremoval (pre-vacuum) and gravity displacement, steam autoclaves between 132-135 ºC. Characteristics: The kit Consists Of: PCD224-C: Porous Cards System Holding: A Self-contained Biological Indicator Bionova® BT224.A Type 5 chemical indicator Integron® IT26-C (moving-front integrator). A self-adhesive Record Card, PCDBI-C-RC, where data on sterilization cycle may be written. Self-contained Biological Indicator Bionova® BT224 (to be used as a positive control) Specifications: Initial Color: Blue. Final Color: Dark Grey or Black. Process: Steam Microorganism: Geobacillus stearothermophilus (ATCC 7953) Population: 10^6 Spores/carrier Read-Out Time: 20 min Regulations: ANSI/AAMI ST79, ISO 11138-3, ISO 11140-1 IT26-C Integrator Indicator (within the challenge device): The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. Integration condition is calibrated against the kill time of a 106 G. stearothermophilus ATCC 7953 spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 ºC, 128 ºC, 135 ºC. BT224 Self-contained Ultra Rapid Biological Indicator (within the challenge device): 106 G. stearothermophilus ATCC 7953 spores per vial in paper carrier. Glass ampoule with growth indicator medium. Label with chemical indicator line printed with Steam reactive ink (Color change: pink to brown) Final results: by fluorescence after incubation for 20 minutes at 60 ºC (sensitivity 97%). An optional visual pH color change confirmation could be made after 48 hours of incubation. A 7-day readout is optional to confirm 20-minutes results by color change. Note: If sterilization process was not successful, indicator medium will turn yellow after incubation, thus indicating the presence of living G. stearothermophilus spores. If sterilization process was successful, indicator medium will remain purple after incubation.

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KPCD222-C / Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes with moving-front Type 5 Indicator and Bionova® Super Rapid Self-contained Biological Indicator BT222, plus Bionova® BT222 Biological Indicators Positive Control. For routine load release, especially for loads containing implants. For routine sterilizer monitoring. For periodic validation of the sterilizer (after installation, repair, relocation). Detects inadequate air removal and steam penetration in dynamic-airremoval (pre-vacuum) and gravity displacement steam autoclaves between 121-135 ºC. Characteristics: The Kit Consists Of: PCD222-C: Porous cards system holding: A Self-contained Biological Indicator Bionova® BT222. A Type 5 chemical indicator Integron® IT26-C (moving-front integrator). A self-adhesive Record Card, PCDBI-C-RC, where data on sterilization cycle may be written. Self-contained Biological Indicator Bionova® BT222 (to be used as a positive control) Specifications: Initial Color: Blue Final Color: Dark Grey or Black Process: Steam Microorganism: Geobacillus stearothermophilus (ATCC 7953) Population: 10^6 Spores/carrier Read-Out Time: 1 h Regulations: ANSI/AAMI ST79, ISO 11138-1, ISO 11138-3 IT26-C Chemical Integrator (within the challenge device) The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. Integration condition is calibrated against the kill time of a 106 G. stearothermophilus ATCC 7953 spores€™ population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C. BT222 Super Rapid Self-contained Biological Indicator (within the challenge device): ‰¥106 G. stearothermophilus ATCC 7953 spores per vial in paper carrier. Glass ampoule with growth indicator medium. Label with chemical indicator line printed with Steam reactive ink (Color change: pink to brown)

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CT22 / Indicator Tape for Steam sterilization processes. Cintape® CT22 Process Indicators (Type 1 according ISO 11140-1:2014 standard) are single-use chemical indicators that consist of a roll of self-adhesive paper tape printed with indicator ink. These indicators have been designed to monitor Steam sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic being easy to remove and leaving no residues. Innovative highly sensitive yellow ink was developed to turn to dark brown / black when the indicator is exposed to Steam. Endpoint condition: 121 ºC, 10 minutes; 134 ºC, 2 minutes. Instructions For Use: Place within a sterilizer a wrapped package closed with Cintape® CT22 Process Indicator tape that will be sterilized by Steam. Perform the sterilization cycle. After the sterilization process has finished, remove the package from the sterilizer and analyze the indicator results. The indicator must turn to the reference color for considering that it was exposed to Steam. For reference color, please refer to Result Reference Guide. Specifications: Process: Steam Initial Color: Yellow Final Color: Black, Dark Brown Indicator Type: Type 1 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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Indicator Tape for Plasma or Vaporized Hydrogen Peroxide Sterilization Processes. Cintape® CT40 Process Indicators (Type 1 according ISO 11140-1:2014 standard) are single-use chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic being easy to remove and leaving no residues. Innovative highly sensitive purple ink was developed to turn to green when the indicator is exposed to Plasma or Vaporized Hydrogen Peroxide. Endpoint condition: 50 ºC, 6 minutes, 2.3 mg/l H2O2. Indicators 100 % free of toxic heavy metals. Instructions For Use: Place within a sterilizer a wrapped package closed with Cintape® CT40 Process Indicator tape that will be sterilized by Plasma or Vaporized Hydrogen Peroxide. Perform the sterilization cycle. After the sterilization process has finished, remove the package from the sterilizer and analyze the indicator results. The indicator must turn to the reference color for considering that it was exposed to Plasma or Vaporized Hydrogen Peroxide. For reference color, please refer to Result Reference Guide. Specifications: Process: Hydrogen Peroxide Initial Color: Purple Final Color: Green Indicator Type: Type 1 chemical indicator Regulations: ISO 11140-1

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Super Rapid Self-contained Biological Indicator for Plasma or Vaporized Hydrogen Peroxide Sterilization Processes. Final readout: 30 minutes. An optional visual pH color change confirmation could be performed after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to yellow during incubation at 60 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain purple after the incubation process. 7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 30-minute reading. Fluorescence results may be compared to the 7-day visual reading. Note: If 7-day readout is performed, a humidified environment will be required to prevent medium from drying out. Instructions For Use: Identify the Terragene® Bionova® BT96 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT96 SCBI from the sterilized package.( Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature.) Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI has been exposed to Hydrogen Peroxide. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the color of the Process Indicator has not changed, check the sterilization process. 6. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader incubators for a maximum of 30 minutes at (60 ± 2) °C for super rapid readout. Important: Use a non-sterilized SCBI as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that correct incubation conditions were met; the capability of the medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of Terragene® Bionova® Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch. Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means failure in the sterilization process. If no fluorescence is detected after 30 minutes of incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for visual color change. Specifications: Process: Hydrogen peroxide Microorganism: Geobacillus stearothermophilus (ATCC 7953) Population: 10^6 Spores/carrier Read-Out Time: 30 min Regulations: IRAM 37102-1, ISO 11138-1

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Ultra Rapid Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^6 spores per vial. Readout: 20 minutes. An optional visual pH color change confirmation could be made after 48 hours of incubation. If the sterilization process has not been successful, the culture medium will change to a greenish color first, and then to yellow during incubation at 60 ºC, thus showing the presence of living spores. If the sterilization process is successful culture medium will remain purple after the incubation process. 7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 20 minute-reading. Fluorescence results may be compared to the 7-day visual reading. Note: If 7-day readout is performed, a humidified environment will be required to avoid medium to dry out. D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value is informed at 132ºC and at 135ºC. Z-Value is informed. Instructions For Use: Identify the Terragene® Bionova® BT224 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT224 SCBI from the sterilized package. (Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature.) 5. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has been exposed to Steam. ( This color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color has not changed, check the sterilization process.) 6. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. 7. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader Incubators for a maximum of 20 minutes at (60 ± 2) °C for ultra rapid readout. Important: Use a non-sterilized SCBI as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that correct incubation conditions were met; capability of medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of Terragene® Bionova® Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch. Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means a failure in the sterilization process. If no fluorescence is detected at 20-minute incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for a visual color change.

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Hyper Rapid Self-contained Biological Indicator for Vaporized Hydrogen Peroxide sterilization processes. Final readout: 5 minutes. Indications For Use: Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators have been designed for quick and easy monitoring of Plasma or vaporized hydrogen Peroxide sterilization cycles. Device Description: Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearotermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT98 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. Precautions: Warning: Do not use Terragene® Bionova® BT98 SCBI to control EO, Dry Heat, Formaldehyde or other sterilization processes different from specified. Do not reuse SCBI. Warning:  Place one or more SCBI in sterilizing hard-to-reach areas to ensure all areas of the chamber are sterilized. Please evaluate all load configurations to ensure ALL hard-to-reach areas have been identified, and place a SCBI in each of those locations. Warning:  Do not reuse the sterilizer until the SCBI test result is negative. Instructions For Use: Identify the Terragene® Bionova® BT98 SCBI by writing the sterilizer number (incase of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. Caution Wear safety glasses and gloves when removing the Terragene® Bionova® BT98 SCBI from the sterilized package. ( Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature.) Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI has been exposed to Hydrogen Peroxide. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the color of the Process Indicator has not changed, check the sterilization process. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® auto-reader incubators for a maximum of 5 minutes at (60 ± 2) °C for hyper rapid readout. (Holding time between sterilization and incubation should not exceed a 1-hour period.) Important: Use a non-sterilized SCBI as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that correct incubation conditions were met; the capability of the medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of Terragene® Bionova® Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means failure in the sterilization process. If no fluorescence is detected after 5 minutes of incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for visual color change. Record positive results and discard the SCBIs immediately, as it is indicated below. Hyper Rapid Readout: 5 minutes The hyper rapid readout must be carried out in the appropriate Terragene® Bionova® auto-reader incubators. Fluorescence is emitted after the reader stimulates the spore carrier with UV light. Final readout of negative results is readily available after 5 minutes of incubation. Fluorescence readout is an indirect measure of the viability of Geobacillus stearothermophilus spores after the sterilization process (positive results). Furthermore, a failure in the sterilization process can also become evident by culture medium color-change. Due to the high sensitivity of the fluorescence results at 5 minutes, conventional incubation for color change of Terragene® Bionova® SCBI BT98 is not an advantage. Visual Confirmation: 5 days: Optionally, you can perform a visual color-change confirmation after a 5-day incubation. If the sterilization process has not been successful, culture medium will turn to yellow during incubation at (60 ± 2) ºC, indicating the presence of living spores. If sterilization was successful, culture medium will remain purple after incubation. The positive control must show a color change from purple to yellow for results to be valid. ( If 5-day readout is performed, a humidified environment will be required to prevent medium from drying out.) Readout Time: 7 days A 7-day readout is optional and may be routinely performed. This is an initial validation of the 5-minute readout. Fluorescence results are compared to the 7-day visual readouts. Monitoring Frequency: Follow facility policies and procedures which should specify a biological indicator monitoring frequency compliant with professional association recommended practices and/or national guidelines and standards. As the best practice and to provide optimal patient safety, Terragene® recommends that every sterilization load be monitored with an appropriate biological indicator. Storage: Store in a dark place at temperature between 10-30 ºC and 30-80 % relative humidity. Do not freeze. Do not store biological indicators near sterilizing agents or other chemical products. Shelf Life: Biological Indicators have an expiration date of 2 years from the date of manufacture when stored at recommended conditions. Do not use indicators after their expiration date. Chemical Process Indicator on SCBI label have an expiration date of 2 years when used as part of SCBI. Endpoint Stability Reaction: Chemical Process Indicator endpoint shall remain unchanged for a period of 6 months when stored at previously indicated conditions. Disposal: Discard biological indicators after use according to your country’s healthcare and safety regulations. The positive biological indicators can be autoclaved in a gravity air displacement steam sterilizer at 121 ºC for 5 minutes, 132 ºC for 15 minutes or 134 ºC for 10 minutes; or in a dynamic air removal steam sterilizer at 132 °C for 4 minutes or 135 °C for 3 minutes. Specifications: Population: 10^6 Spores/carrier Read-Out Time: 5 min Regulations: IRAM 37102-1:1999, ISO 11138-1:2017, ISO 13485:2016 / NS-EN ISO 13485:2016

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Rapid Self-contained Biological Indicator for Ethylene Oxide sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 4 hours. An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 37 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain blue after the incubation process. 7-day readout for visual confirmation by color change is optional and not intended to be routinely performed; it is an initial validation of the 4 hour-reading. Fluorescence results may be compared to the 7-day visual reading. Instructions For Use: Identify the Terragene® Bionova® BT110 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT110 SCBI from the sterilized package. Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI has been exposed to Ethylene Oxide. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the color of the Process Indicator has not changed, check the sterilization process. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader incubators for a maximum of 4 hours at (37 ± 2) °C for rapid readout. Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means failure in the sterilization process. If no fluorescence is detected after 4 hours of incubation, the result is negative. The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for visual color change. If chamber relative humidity is unknown or < 35 %, continue to incubate the Biological Indicator for a pH color change result, since low relative humidity may increase the fluorescent readout time beyond 4 hours. Specifications: Process: Ethylene Oxide Microorganism: Bacillus atrophaeus (ATCC 9372) Population: 10^6 Spores/carrier Read-Out Time: 4 h Regulations: IRAM 37102-1, IRAM 37102-2, ISO 11138-1, ISO 11138-2 Length: 40 mm

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Super Rapid Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^6 spores per vial. Readout: 1 hour. An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 60 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain purple after the incubation process. 7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 1 hour-reading. Fluorescence results may be compared to the 7-day visual reading. Note: if 7-day readout is performed, a humidified environment will be required to avoid medium to dry out. D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value is informed at 132 ºC and at 135 ºC. Z-Value is informed. Instructions For Use: Identify the Terragene® Bionova® BT222 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label. Pack the SCBI along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door). Sterilize as usual. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT222 SCBI from the sterilized package. WARNING: Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has been exposed to Steam. IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color has not changed, check the sterilization process. Press the lid to seal the tube. Crush the ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the SCBI in the incubator. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader Incubators for a maximum of 1 hour at (60 ± 2) °C for super rapid readout. Specifications: Process: Steam Microorganism: Geobacillus stearothermophilus (ATCC 7953) Population: 10^6 Spores/carrier Read-Out Time: 1 h Regulations: IRAM 37102-1, IRAM 37102-3, ISO 11138-1, ISO 11138-3

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CDWA4 / Cleaning Indicator for cleaning performance tests. Challenge level: very high. Detects all the factors that affect the result of a washing process. Initial Color: Fuchsia. Result: removal of the fuchsia organic substance. Designed for routine control of cleaning processes and for monitoring automatic washing machines effectiveness as well as monitoring ultrasonic washing machines which operate at frequencies equal to or greater than 35 kHz, and temperatures between 30 ºC and 70 ºC. Characteristics: Challenge Level: Very high. Allows detection of all factors affecting the outcome of cleaning process. Initial Color: Fuchsia. Size: 70 mm x 30 mm (approximate). Synthetic temperature-stable support. Result: Elimination of fuchsia organic substance. To interpret results visually, use the results reference guide on product´s instructions for use. Optionally, the readout of the cleaning indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual). Instructions For Use: Choose the Chemdye® Splat CDWA indicator according to the desired difficulty. Place the indicator on the Chemdye® Splat CDWAH or Chemdye® Splat CDWAH-U holder. Place the system on the tray along with the material. Once the cleaning cycle is over, remove the indicator. Analyze Chemdye® Splat CDWA indicators using the reference table and record results. If unfavorable results are obtained, perform the appropriate corrective actions and repeat the washing process. Specifications: Process: Cleaning and thermodisinfection Initial Color: Fuchsia Regulations: ISO 13485, ISO/TS 15883-5

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Instructions For Use: Before The Test: Place the holder around the neck of the capsule. Press the holder down so that the groove of the holder fits securely around the neck of the vial. Insert the L shaped end on either side of the holder into the holes of the Ultrasonic device’s basket to hold the vial in position. The holder can be attached to a wire basket or perforated basket. Vials should be placed in the correct location within a tray / basket according to Ultrasonic Cleaning Indicator´s IFU based on the size of the tank. After the test is complete After the ultrasonic cycle remove the vial holding it with three fingers of one hand and the index finger and thumb of the other hand on the holder and lid of capsule. Place the index finger on the end of the holder, then place the thumb on the lid of the capsule for support, push the holder back off the neck of the capsule and remove the holder with both fingers.

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Holder for cleaning and thermodisinfection Indicators. Stainless Steel re-usable holder of great resistance and durability. Base: 32 mm wide, 72 mm long, pin at the back side. ISO/TS 15883-5. Designed to hold Chemdye® CDWA and Integron® IT27W indicators in order to perform routine control of cleaning and thermal disinfection processes in automatic machines. Characteristics: Chrome plating SUS304 grade stainless steel re-usable holder of great resistance and durability. Base: 32 mm wide, 72.5 mm long, pin at the back side. Basket: 32 mm wide, 37 mm long, 0.5 mm thick. The holder is designed to mimic the cleaning challenges posed by a large process load during the washing cycle and can be fixed on the tray, which allows reproducible location of the cleaning indicator in the washer-disinfector. When CDWA4 is placed within the holder, half of the test soil is obscured, thus simulating the joint of a surgical instrument, with water stream hitting it indirectly. The other half of the test soil is covered by a mesh, thus posing a difficulty for water stream to reach it, mimicking shadowed or occluded surfaces. The new design of CDWAH optimizes the control of the washer disinfectors ability to force water and detergent into and onto the test soil. Specifications: Process: Cleaning and thermodisinfection Regulations: ISO 15883

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CDWAH-U / Stainless steel re-usable holder of great resistance and durability. The holder is designed to be fixed on the tray, which allows reproducible location of the cleaning indicator in ultrasonic washing machines. Base: 32,7 mm wide, 72,5 mm long. Designed to hold Chemdye® CDWA cleaning indicators and perform routine control of cleaning processes in ultrasonic washers. Characteristics: Chrome plating SUS304 grade stainless steel re-usable holder of great resistance and durability. Base: 32 mm wide, 72.5 mm long, pin at the back side. The holder is designed to be fixed on the tray, which allows reproducible location of the cleaning indicator in ultrasonic washing machines, without representing a challenge to the washing process. Specifications: Process: Cleaning and thermodisinfection Regulations: ISO/TS 15883-5

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IT26-1YS / Unique point chemical integrator for Steam sterilization processes between 121° C and 134° C. Control of Steam sterilization processes between 121 ºC and 135 ºC. Characteristics: Type 5 Integrator Indicator (according to ISO 11140-1). One-side-laminated strips printed with indicator ink. Size: 70 mm x 23 mm. Initial Color: Yellow. Final Color: Black. 100 % Toxic Heavy Metal free. Instructions For Use: Place a chemical integrator Integron® IT26-1YS within each package, bag or tray that will be sterilized by Steam. In rigid containers place an IT26-1YS in every corner, or at least two diagonally opposite corners, to ensure that steam has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Steam, the ink must turn to the black reference color when the integration conditions are reached. Specifications: Process: Steam Initial Color: Yellow Final Color: Black Indicator Type: Type 5 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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2 level chemical integrator for Ethylene Oxide sterilization processes. One-side laminated strips. Metals free. Integron® IT12 Chemical Integrators (Type 5 according to ISO 11140-1:2014 standard) are single-use two level chemical indicators that consist of paper strips laminated on the back side and printed with indicator ink. They have been designed for monitoring Ethylene Oxide (EO) sterilization processes. The integration level contains a purple/brown ink which was developed to turn to green when a theoretical spore population reaches its kill time, thus indicating that the SAFE condition has been met. Level 1 – Red: Exposure level. Indicator ink turns yellow to indicate exposition to the process, but does not ensure that the variables required to achieve the integration condition have been achieved (UNSAFE condition). Level 2 – Purple / brown: Integration level. Indicator ink turns green to indicate that the integration condition indicated in the quality certificate has been achieved. This condition consists of the kill time of a theoretical 106 Bacillus atrophaeus spore population, calculated in a BIER (Biological Indicator Evaluator Resistometer), and is called SAFE condition. Indicators 100% free of toxic heavy metals. Instructions For Use: Place a Integron® IT12 Chemical Integrator along with the material to be sterilized in a suitable package according to the recommended sterilization techniques. Place the indicators in those areas of most difficult access to the sterilizing agent. Perform the sterilization cycle. After the sterilization process has finished and evacuation/ventilation process is over, you may:               A. Remove the integrator indicator taking the necessary precaution to avoid                          contact with the remaining sterilizing agent.              B. Ventilate the load together with the integrator indicator and then perform                        the reading. Analyze the results. If the SAFE integration condition has been reached, the        sterilization process has been effective. Specifications: Process: Ethylene Oxide Initial Color: Level 1 Red, Level 2 purple-brown Final Color: Level 1 Yellow, level 2 Green Indicator Type: Type 5 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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IT26-C Extender/ Moving front Chemical Integrator to monitor Steam sterilization processes between 118°C and 138°C. Control of Steam sterilization processes between 118 °C and 138 °C. Characteristics: Type 5 Integrating Indicator (according to ISO 11140-1). Size: 52 mm x 21 mm. Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark bar along the paper wick. The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. The extent of migration depends on steam quality, time, and temperature. The ACCEPT result is reached when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of 106 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C. Optionally, the readout of the chemical indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual). Instructions For Use: Carefully open the package and remove only the number of indicators needed. Reseal the package tightly. Place a Integron® IT26-C indicator in each pack, peel pouch, container system or tray to be steam sterilized in the most inaccessible area to sterilizing agent. Perform de sterilization cycle. 4After the sterilization process has finished, the dark bar should have reached the ACCEPT zone. If the dark bar has not reached the ACCEPT zone, a REJECT result is indicated and the items in the pack, peel pouch, container system, or tray were not exposed to proper steam sterilization conditions. These items should be reprocessed according to established procedures and a new IT26-C has to be used. NOTE: In some extended or wet steam cycles, the dark bar can display discoloration in some zones of the reading window, imposing a difficulty for result´s interpretation (see Result Reference Guide for reference). Despite this, regarding cycle integration parameters, this process can be considered as accepted. In case the IT26-C indicator shows a damp appearance after the sterilization process, Terragene® recommend planning an equipment´s maintenance.

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IT26-C / Moving front Chemical Integrator to monitor Steam sterilization processes between 118°C and 138°C. Control of Steam sterilization processes between 118 °C and 138 °C. Characteristics: Type 5 Integrating Indicator (according to ISO 11140-1). Size: 52 mm x 21 mm. Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark bar along the paper wick. The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. The extent of migration depends on steam quality, time, and temperature. The ACCEPT result is reached when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of 106 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C. Optionally, the readout of the chemical indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual). Instructions For Use: Carefully open the package and remove only the number of indicators needed. Reseal the package tightly. Place a Integron® IT26-C indicator in each pack, peel pouch, container system or tray to be steam sterilized in the most inaccessible area to sterilizing agent. Perform de sterilization cycle. After the sterilization process has finished, the dark bar should have reached the ACCEPT zone. If the dark bar has not reached the ACCEPT zone, a REJECT result is indicated and the items in the pack, peel pouch, container system, or tray were not exposed to proper steam sterilization conditions. These items should be reprocessed according to established procedures and a new IT26-C has to be used. Despite this, regarding cycle integration parameters, this process can be considered as accepted. In case the IT26-C indicator shows a damp appearance after the sterilization process, Terragene® recommend planning an equipment´s maintenance. Specifications: Process: Steam Indicator Type: Type 5 chemical indicator Regulations: ISO 11140-1 More Info About This Product: User Manual

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CD40 / Multi-variable Chemical Indicator, strips printed with reactive ink for Plasma or Vaporized Hydrogen Peroxide sterilization processes. Control of plasma or vaporized H2O2 sterilization processes. Conditions: 6 minutes, 50 °C, 2,3 mg/l H2O2. Characteristics: Type 4 Chemical Indicator (according to ISO 11140-1). Strips printed with indicator ink. Size: 105 x 18 mm (approximate). Initial color: Purple. Final color: Green. 100 % Toxic Heavy Metals free. Instructions For Use: Place a Chemdye® CD40 Multivariable Process Indicator within each package, bag or tray that will be sterilized by Plasma or Vaporized Hydrogen Peroxide. In rigid containers, place the indicator in every corner, or at least two diagonally opposite corners, to ensure that the sterilization agent has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Plasma or Vaporized Hydrogen Peroxide, the ink must turn to the green or lighter reference color when the sterilization parameters are reached. Specifications: Process: Hydrogen peroxide Initial Color: Purple Final Color: Green Indicator Type: Type 4 chemical indicator Regulations: ISO 11140-1 More Info About This Product: Color Chart

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Chemical Indicator, strips printed with reactive ink for Plasma or Vaporized Hydrogen Peroxide sterilization processes.Internal Control. Metals Free. Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are single-use chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. Innovative highly sensitive red ink was developed to turn to yellow when the indicator is exposed to Plasma or Vaporized Hydrogen Peroxide. Endpoint condition: 50 ºC, 6 minutes, 2.3 mg/l H2O2. Indicators 100% free of toxic heavy metals. Instructions For Use: Place a Chemdye® CD42 Process Indicator within each package, bag or tray that will be sterilized by Plasma or Vaporized Hydrogen Peroxide. In rigid containers, place the indicator in every corner, or at least two diagonally opposite corners, to ensure that the sterilization agent has reached the most inaccessible areas. Perform the sterilization cycle. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Plasma or Vaporized Hydrogen Peroxide, the ink must turn to the yellow reference color when the sterilization parameters are reached. For reference color, please refer to Result Reference Guide. More Info About This Product: Color Chart

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