Biological Monitors

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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Ensure Sterilization Accuracy with ConFirm Value Test Service! The ConFirm Value Test Service from Crosstex offers a reliable and efficient monitoring solution for sterilization processes in dental practices. This essential service provides third-party documentation of testing and results, ensuring compliance and safety in your office. Whether you're using steam, EtO, chemical vapor, or dry heat sterilizers, this service is designed to deliver peace of mind and maintain the highest standards of patient care. Key Features of ConFirm Value Test Service Comprehensive sterilization monitoring compatible with multiple sterilization methods ensure versatility for your practice. Rapid-results notification system provides results in 24 hours for steam, 72 hours for chemical vapor, and 7 days for dry heat and EtO. Immediate test failure notifications via fax or email with a follow-up courtesy call from a clinical advisor the next day. Easy access to results online 24/7 on our secure, confidential platform, ensuring that you have the information you need at your fingertips. Complimentary reminder service to notify your practice of missed testing dates, helping to maintain regulatory compliance. Enhance Clinical Efficiency and Patient Satisfaction Utilizing the ConFirm Value Test Service improves your clinical workflow by ensuring thorough monitoring of sterilization processes without the manual hassle. Make data-driven decisions with the comprehensive test results sent quarterly and annually via fax or email. This information strengthens your practice's commitment to infection control and patient safety. Technical Specifications Our service offers various test options to suit your practice's volume: Ref.# Description Quantity CVT120 12 Tests (Each Packet Contains 1 Test Strip and 1 Control Strip) Each CVT520 52 Tests (Each Packet Contains 1 Test Strip and 1 Control Strip) Each Why Choose ConFirm Value Test Service? By choosing the ConFirm Value Test Service, you're not just purchasing a monitoring tool; you are investing in patient trust and practice credibility. Our spore strips contain highly resistant dual-species bacterial spores, ensuring the most reliable method of testing for an effective sterilization cycle. This service is particularly beneficial for practices with multiple locations, thanks to our MSM™ (Multi-Site Monitoring) Compliance Bridge complimentary service. Please note: Mailing costs are not included. Take control of sterilization processes in your dental practice today! Invest in the ConFirm Value Test Service and enhance patient safety, meet compliance standards, and improve clinical outcomes. Order now to ensure your practice's commitment to sterilization excellence!

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Ensure optimal safety and compliance in your dental practice with the Crosstex SporView Self-Contained Biological Indicators. These innovative biological indicators (BIs) are essential for verifying that your steam sterilization processes meet the highest standards of efficacy. Perfect for dental professionals who prioritize patient safety, the SporView system simplifies the monitoring process and enhances your practice’s reliability. Why Choose Crosstex SporView Biological Indicators? Identifying the effectiveness of your sterilization procedures is crucial in maintaining a safe clinical environment. The Crosstex SporView system is specifically designed for comprehensive monitoring and quick results, making it an invaluable tool in any dental office. Key Features: Rapid Results: Results are available after just 24 hours of incubation, ensuring that you can act quickly if a sterilization failure is detected. Universal Compatibility: Certified for use with all steam sterilization cycles, making it a versatile solution for your practice’s sterilization needs. How It Works The Crosstex SporView Biological Indicator uses a straightforward process that integrates seamlessly into your routines. Simply insert the self-contained BI into your sterilizer before a sterilization cycle, then incubate the indicator in any compatible dry block incubator operating at temperatures between 55-60°C. The clear and easy-to-interpret results will inform you about the effectiveness of the sterilization process. Benefits of Using Crosstex SporView Utilizing the SporView system guarantees improved clinical efficiency while significantly enhancing patient comfort and outcomes. The peace of mind that comes with knowing your sterilization process is validated allows you to focus more on patient care rather than concerns about infection control. Competitive Advantage Unlike other biological indicators, the Crosstex SporView system offers a combination of speed and reliability that sets it apart. Its ease of use, rapid results, and comprehensive compatibility with various sterilization cycles make it a leading choice in the dental field. Enhance Your Practice Today! Don’t compromise on safety in your dental practice. With Crosstex SporView Self-Contained Biological Indicators, you can confidently ensure that your sterilization processes are effective and compliant. Invest in your patients’ health and your practice’s reputation by integrating SporView into your sterilization safety protocols. Order now and experience the Crosstex difference!

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Ensure the highest standard of sterilization with the EMS Sterilizer Monitoring Service, Certified for Use in Steam. This top-tier monitoring service is tailored for dental practices seeking to enhance patient safety and improve clinical efficiency. Why Choose EMS Sterilizer Monitoring Service? In the dental industry, sterilization is non-negotiable. The EMS Sterilizer Monitoring Service offers comprehensive solutions certified for Steam, EO gas, Dry heat, and Chemical vapor processes. This service not only safeguards your practice but also boosts your reputation by guaranteeing that all sterilization protocols are meticulously monitored. Key Features 24/7 Access to Test Results: Enjoy round-the-clock access to your sterilization test results through a secure online platform, allowing for immediate oversight of sterilization performance. Proactive Alerts: In the event of a positive failed test, receive immediate notification via phone call, ensuring you can take quick corrective action to maintain patient safety. Technical Specifications The EMS Sterilization Monitoring Service is backed by rigorous laboratory testing, providing you with detailed laboratory reports that substantiate compliance with sterilization standards. Our system is designed to integrate seamlessly into your current sterilization practices, enhancing the overall workflow of your dental office. Benefits for Your Dental Practice Utilizing the EMS service not only protects your patients but also enhances your operational efficiency. By adopting a state-of-the-art monitoring system, you can: Minimize risk factors associated with ineffective sterilization. Boost patient comfort and confidence knowing that your practice adheres to the highest sterilization standards. Stay Ahead in Patient Care With the EMS Sterilizer Monitoring Service, you position your dental practice at the forefront of patient care excellence. Our service streamlines your sterilization processes while ensuring compliance with the latest regulations, ultimately leading to improved clinical outcomes. Enhance Your Practice Today! Elevate your dental practice with the EMS Sterilizer Monitoring Service. Contact us today to learn more about our certification process and how we can help you prioritize patient safety in your office. Don’t compromise on sterilization—choose EMS for peace of mind and superior patient care!

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Ensure Sterilization Success with the ConFirm Record Keeper Booklet The ConFirm Record Keeper Booklet is an essential tool for dental practices committed to maintaining the highest standards of sterilization. This innovative in-office system is designed to monitor steam sterilizers effectively, providing quick and reliable results so you can ensure every sterilization cycle is successful. Why Choose the ConFirm Record Keeper Booklet? As a dental professional, the safety and comfort of your patients are paramount. Utilizing the ConFirm Record Keeper Booklet helps enhance your clinical efficiency by confirming that your sterilization processes are functioning optimally. With easy-to-interpret results available within 24 hours, this tool helps you maintain compliance with industry standards, providing peace of mind for both you and your patients. Key Features and Benefits Rapid Results: Simply process the vial in a normal sterilization cycle, activate it, and incubate. Results are ready in just 24 hours! Easy Interpretation: The vial medium turns yellow if spores survive the sterilization process, making it simple to assess the efficacy of your sterilization cycles. Technical Specifications The ConFirm Record Keeper Booklet includes a 24-volt incubator capable of holding up to 14 indicators, offering significant versatility in your practice. Additionally, it is compatible with the current 3M Attest incubator, making it a seamless fit for your existing equipment. Enhance Clinical Efficiency and Patient Safety In a dental setting, the disinfection process must be flawless. The ConFirm system reduces the risk of contamination and infections, promoting a safe environment for your patients. By integrating this practical tool into your protocol, you can confidently uphold your practice’s commitment to health and safety standards. Stand Out from Competitors Unlike other sterilization monitoring systems, the ConFirm Record Keeper Booklet focuses on simplicity and rapidity, ensuring that you never compromise on patient care. Its easy-to-read results and quick processing time enable you to act decisively—an essential advantage over competitors. Take Action for a Safer Practice Don’t wait to improve your sterilization protocol. Equip your dental practice with the ConFirm Record Keeper Booklet today and ensure the safety and satisfaction of your patients. Order now and experience the difference that this monitoring system can make in your practice efficiency and patient care quality.

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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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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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IC10/20FRLCD / Auto-Reader Incubator For incubation and readout of Rapid, Super Rapid or Ultra Rapid Biological Indicators and Hygiene Monitoring Systems with 3.5″ touchscreen display. For Incubation And Readout Of: Bionova® Rapid Fluorescence Readout Biological Indicators: BT220 (Steam): 3 hs. at 60 ºC, BT221 (Steam): 1 h. at 60 ºC and BT110 (EO): 4 hs. at 37 ºC, BT102 (Formaldehyde): 2 hs. at 60 ºC. BT95 (VH2O2): 2 hs. at 60ºC. Bionova® Super Rapid Fluorescence Readout Biological Indicators: BT222 (Steam): 1 h. at 60 ºC, BT223 (Steam): 30 min. at 60 ºC, BT96 (VH2O2): 30 min. at 60ºC. Bionova® Ultra Rapid Fluorescence Readout Biological Indicators: BT224 (Steam): 20 min. at 60ºC. Chemdye® PRO1 MICRO Pen Protein System: 15 min at 60 ºC . Characteristics: 12 metal positions (3.8 cm deep, 0.9 cm diameter) to incubate Rapid/Super Rapid/Ultra Rapid Fluorescence Readout Self-contained biological indicators. 1 metal position (3.8 cm deep, 1.0 cm diameter) to incubate Protein Pen. Special hole for external thermometer. 1 ampoule crusher. 3.5 ” touchscreen LCD. Visual information of the remaining time of the incubation process. Temperature display on the screen and remaining time for each position. Dual Temperature System: Allows selecting between two different incubation temperatures (37ºC y 60ºC). Allows running different incubation times simultaneously, provided they are of equal incubation temperature. Audible alarm for event indications. ETHERNET connection for recording results on PC using a Reading and Traceability software. Remote display of the screen in PC and Smartphones. It stores the last 208 results. Thermal Printer of Results. Allows reprinting the last 208 results. Automatic detection and cancelation of biological indicator fluorescence reading. Specifications: Fluorescence reading wave length: ~ 460 nm Dimensions: 18.0 cm high, 26.0 cm diameter. Weight: 1.92 Kg. Voltage range: 100 €“ 240 V AC Power: 28 W Frequency: 50-60 Hz Operating Specifications: Input 100/240V 0.2A (50/60Hz)|Output: 12V 4A Working Temperature: 37 ± 2°C, 60 ± 2°C More Info About This Product: User Manual

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IC10/20FR / Auto-Reader Incubator For incubation and readout of Rapid, Super Rapid or Ultra Rapid Biological Indicators and Hygiene Monitoring Systems. For Incubation And Readout Of: Bionova® Rapid Fluorescence Readout Biological Indicators: BT220 (Steam): 3 hs. at 60 ºC, BT221 (Steam): 1 h. at 60 ºC and BT110 (EO): 4 hs. at 37 ºC, BT102 (Formaldehyde): 2 hs. at 60 ºC. BT95 (VH2O2): 2 hs. at 60ºC. Bionova® Super Rapid Fluorescence Readout Biological Indicators: BT222 (Steam): 1 h. at 60 ºC, BT223 (Steam): 30 min. at 60 ºC, BT96 (VH2O2): 30 min. at 60ºC. Bionova® Ultra Rapid Fluorescence Readout Biological Indicators: BT224 (Steam): 20 min. at 60ºC. Chemdye® PRO1 MICRO Pen Protein System: 15 min at 60 ºC . Characteristics: 12 metal positions (3.8 cm deep, 0.9 cm diameter) to incubate Rapid/Super Rapid/Ultra Rapid Fluorescence Readout Self-contained biological indicators. 1 metal position (3.8 cm deep, 1.0 cm diameter) to incubate Protein Pen. Special hole for external thermometer. 1 ampoule crusher. Dual Temperature System: Allows selecting between two different incubation temperatures. Allows running different incubation times simultaneously. USB connection for registering results in a PC through Reading and Traceability Software. Thermal Printer to record results in sterilization book. Automatic detection and cancelation of biological indicator fluorescence reading. Specifications: Fluorescence Reading Wave Length: ~ 460 nm Dimensions: 18.0 cm high, 26.0 cm diameter. Weight: 1.92 Kg. Voltage Range: 100 €“ 240 V AC Power: 28 W Frequency: 50-60 Hz Operating Specifications: Input 100/240V 0.2A (50/60Hz)|Output: 12V 4A Working Temperature: 37 ± 2°C, 60 ± 2°C More Info About This Product: User Manual

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BHY HYPER / Auto-reader Incubator for incubation and readout of Hyper Rapid Self-Contained Biological Indicators. For incubation and readout of Hyper Rapid Self-Contained Biological Indicators BT98 (VH2O2) readout fluorescense system after 5 minutes of incubation at 60 ºC. Characteristics: 2 readout positions (38 mm deep, 9 mm diameter) for incubation of Hyper Rapid Biological Indicators. 1 ampoule crusher. Special hole for external thermometer. Unique ID Number for each carried out results for audit purposes. Easy access to the last 50 results. USB connection for registering results in a PC through Reading and Traceability Software. Bluetooth wireless technology connectivity. Fully compatible with Bionova Cloud Traceability Software. Fully compatible with Terragene Wireless Assistant App for Mobile Devices. Sound alarm for event indication. Detection and automatic cancellation of the fluorescence reading of the biological indicator. Specifications: Fluorescence reading wavelength: ~ 460 nm Firmware update by the user. Dimensions: 10 mm high, 97 mm wide and 103 mm deep. Power: 18 W Frequency: 50-60 Hz Read-Out Time: 5 min Operating specifications: Input 100/240V 0.2A (50/60Hz)|Output: 12V 4A Working temperature: 60 ± 2°C More Info About This Product: User Manual

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Revolutionize Your Sterilization Process with Crosstex Spore Testing Kit As a dental professional, ensuring the efficacy of your sterilization process is paramount for patient safety and confidence. The Crosstex Spore Testing Kit is designed specifically for dental practices, making it easier than ever to validate your sterilization protocols with reliable, rapid results. Key Features Immediate Readout Integrator: Unique to Crosstex, our kit includes an immediate readout integrator, giving you instant feedback on sterilization effectiveness, helping you act swiftly and maintain compliance. Comprehensive Testing: Each kit contains one test strip and one control strip for accurate results, alongside the integrator to enhance your testing protocols. Technical Specifications This spore testing kit is designed for use with steam sterilizers in accordance with current dental industry standards. Each test strip undergoes a specific incubation process, and results are documented and reported back after 24 hours. This robust process ensures nothing is overlooked in your infection control measures. Professional Uses The Crosstex Spore Testing Kit is an essential tool for dental laboratories and clinics looking to uphold the highest hygiene standards. Use it biweekly as recommended by dental regulatory bodies to ensure consistent sterilization practices. Ideal for: Dental clinics Orthodontic practices Oral surgery facilities Why Choose Crosstex? When it comes to quality assurance in sterilization, Crosstex outmatches competitors with innovative technology and a proven track record in the dental field. Our spore testing kit not only reinforces safety but also enhances operational efficiency. Save time, reduce anxiety around compliance checks, and focus more on providing excellent patient care. Invest in Patient Safety Today! Don’t compromise on sterilization efficacy in your dental practice. Ensure a safe environment for your patients and staff with the Crosstex Spore Testing Kit. It’s time to elevate your sterilization validation process—order yours today and experience the Crosstex advantage that sets your practice apart!

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The SporeCheck Starter Kit contains a Dry Block Incubator with built-in vial crusher, 1 record notebook, and 1 box of SporeCheck™ Biological Indicator Vials, 25 count.

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Hu-Friedy SporeCheck In-Office Spore Test 100/Pk. The in-office test show results within 24 hours.

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SporeCheck™ Self Contained Biological Indicator Vials contain Geobacillus stearothermophilus bacteria spores and are intended for monitoring the efficacy of steam sterilization with results in 24 hours. 25 vials per box. Self-contained biological indicator for in-office monitoring with results in 24 hours, after incubation if test vial remains purple it indicates a pass or turns yellow indicating a failure, process indicator on label for easy identification of sterilized vials, compatible with incubators operating at 55-60°C

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The exclusive, Sterisil® Starter Kit is waterline management made simple. Save by purchasing this all-in-one kit for each operatory in your practice to achieve optimal results. 20x better treatment efficacy than iodine straws Continual waterline treatment guaranteed for 365 days Built-in initial shock treatment No oxidizers that may damage handpieces or affect amalgam separators Compatible products that work together Pass more waterline tests No foul odor or taste. No staining. No daily maintenance, iodine testing, or need for dummy straws when shocking  EPA-registered to provide ≤ 10 CFU/ml, 50x lower than the current CDC guidelines Powerful Silver-Ion technology Includes: Sterisil Straw - (1 straw) Citrisil Shock tablets (4 pk) 2 FASTCheck15 In-Office Waterline Test Strips Sterisil® R2A Mail-In Waterline Test  Sterisil® SafeWater Solution Brochure

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The Sterisil® Starter Kit – Municipal is a complete waterline treatment solution designed for dental practices connected to municipal water supplies. This kit provides everything you need to start and maintain compliant, safe, and clean dental unit waterlines. With advanced silver-based technology, Sterisil ensures effective microbial control without the use of harsh chemicals, while also maintaining neutral pH for patient and equipment safety. Purpose: Complete starter kit for municipal waterline treatment Compatibility: Dental offices using municipal water supply Technology: Silver ion antimicrobial treatment Compliance: Meets EPA and CDC standards for dental waterline safety Convenience: Includes essential components for setup and ongoing treatment

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Sterisil R2A bacterial tests utilizes an EPA validated R2A plating method to grow and count HPC bacterial colonies in samples collected from dental unit waterlines. Tests are conducted at EPA Certified 3rd party lab (#37917). Lab results with the Gold Standard Early notification within 24 hours Offers detailed CFU counts for long-term tracking and compliance documentation Includes 1 (one) water sample vial, ice pack, return shipping envelope, and prepaid shipping. Additional vials cannot be sent separately, as the lab will only accept samples in the provided shipment. Selecting the correct quantity ensures your test is processed without delays.

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Sterisil R2A bacterial tests utilizes an EPA validated R2A plating method to grow and count HPC bacterial colonies in samples collected from dental unit waterlines. Tests are conducted at EPA Certified 3rd party lab (#37917). Lab results with the Gold Standard Early notification within 24 hours Offers detailed CFU counts for long-term tracking and compliance documentation Includes 1 (one) water sample vial, ice pack, return shipping envelope, and prepaid shipping. Additional vials cannot be sent separately, as the lab will only accept samples in the provided shipment. Selecting the correct quantity ensures your test is processed without delays.

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Sterisil R2A bacterial tests utilizes an EPA validated R2A plating method to grow and count HPC bacterial colonies in samples collected from dental unit waterlines. Tests are conducted at EPA Certified 3rd party lab (#37917). Lab results with the Gold Standard Early notification within 24 hours Offers detailed CFU counts for long-term tracking and compliance documentation Includes 1 (one) water sample vial, ice pack, return shipping envelope, and prepaid shipping. Additional vials cannot be sent separately, as the lab will only accept samples in the provided shipment. Selecting the correct quantity ensures your test is processed without delays.

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Sterisil R2A bacterial tests utilizes an EPA validated R2A plating method to grow and count HPC bacterial colonies in samples collected from dental unit waterlines. Tests are conducted at EPA Certified 3rd party lab (#37917). Lab results with the Gold Standard Early notification within 24 hours Offers detailed CFU counts for long-term tracking and compliance documentation Includes 1 (one) water sample vial, ice pack, return shipping envelope, and prepaid shipping. Additional vials cannot be sent separately, as the lab will only accept samples in the provided shipment. Selecting the correct quantity ensures your test is processed without delays.

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Sterisil R2A bacterial tests utilizes an EPA validated R2A plating method to grow and count HPC bacterial colonies in samples collected from dental unit waterlines. Tests are conducted at EPA Certified 3rd party lab (#37917). Lab results with the Gold Standard Early notification within 24 hours Offers detailed CFU counts for long-term tracking and compliance documentation Includes 1 (one) water sample vial, ice pack, return shipping envelope, and prepaid shipping. Additional vials cannot be sent separately, as the lab will only accept samples in the provided shipment. Selecting the correct quantity ensures your test is processed without delays.

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Sterisil R2A bacterial tests utilizes an EPA validated R2A plating method to grow and count HPC bacterial colonies in samples collected from dental unit waterlines. Tests are conducted at EPA Certified 3rd party lab (#37917). Lab results with the Gold Standard Early notification within 24 hours Offers detailed CFU counts for long-term tracking and compliance documentation Includes 1 (one) water sample vial, ice pack, return shipping envelope, and prepaid shipping. Additional vials cannot be sent separately, as the lab will only accept samples in the provided shipment. Selecting the correct quantity ensures your test is processed without delays.

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Sterisil Paddle Test screens dental unit waterlines for bacteria and provides an estimated heterotrophic plate count (HPC) to indicate probable compliance with the CDC & EPA guidelines of ≤500CFU/mL

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Sterisil Paddle Test screens dental unit waterlines for bacteria and provides an estimated heterotrophic plate count (HPC) to indicate probable compliance with the CDC & EPA guidelines of ≤500CFU/mL

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The fastest, most affordable way to monitor water quality for harmful bacteria. Fast Know your water is safe in 15 minutes (vs 3 days for paddle test results) FASTCheck15™ removes the risk of bacteria growing to harmful levels in between water sampling and results Detects microbials exceeding 500CFU/mL Simple to Use. Simple to Read. No counting red dots or color matching Easy-to-read test strip that provides clear results: 1 line = Pass, 2 lines = Fail Lower Cost with High Accuracy A fraction of the cost of other waterline tests

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Streamline Your Sterilization Process with EMS Mail-In Sterilizer Monitoring Service Ensure optimal safety and compliance in your dental practice with the EMS Mail-In Sterilizer Monitoring Service. This comprehensive monitoring solution is designed to provide dentists with peace of mind, ensuring that all sterilization processes meet the highest standards. With 52 tests per box, you can easily maintain the performance of your sterilizers and enhance patient care. Key Features of EMS Mail-In Sterilizer Monitoring Service Versatile Usage: Certified for multiple sterilization methods including Steam, EO gas, Dry heat, and Chemical vapor processes, ensuring compatibility with your existing equipment. 24/7 Test Results Access: Enjoy around-the-clock access to your test results via a secured website, providing you with immediate insights and peace of mind. Why Choose EMS Mail-In Sterilizer Monitoring Service? In the competitive dental landscape, maintaining strict compliance with sterilization processes is non-negotiable. The EMS Mail-In Sterilizer Monitoring Service is designed to enhance clinical efficiency and ensure patient comfort. Each monitoring service includes comprehensive laboratory reports which detail every aspect of sterilization performance, allowing for proactive adjustments in your practice. Unlike other services, EMS offers immediate notification via phone if a test result is positive or indicative of a failure, enabling you to respond promptly to any potential issues. This swift action can prevent complications that may arise from inadequate sterilization, ensuring a safe environment for your patients and staff. Enhanced Clinical Outcomes Using EMS Mail-In Sterilizer Monitoring not only fosters better operational outcomes but also reinforces your commitment to patient safety. By ensuring that your sterilizers are performing at peak efficiency, you can enhance trust with your patients, leading to better retention and satisfaction rates. Additionally, regular testing helps to identify any potential problems before they escalate, thereby improving the longevity of your equipment while adhering to regulatory standards. Order Your EMS Mail-In Sterilizer Monitoring Service Today! Don’t compromise on safety and compliance within your dental practice. With 52 tests per box, the EMS Mail-In Sterilizer Monitoring Service equips you with the tools necessary for maintaining sterile environments while supporting your commitment to excellence in patient care. Streamline your sterilization process today and ensure your practice operates at the highest level of safety and efficiency! Contact us now to place your order and take the first step towards exceptional sterilization monitoring!

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An immediate readout integrator for use in gravity, pre-vacuum and flash cycles. This product is tested to ST-60 and ISO 11140-1:2005 performance claims of Class 5 integrating integrators. 4" strip has distinct pass/fail criteria and allows for easy removal from packs. FDA cleared as, equivalent in performance to a biological indicator, and offers the highest level of sterility assurance form a chemical indicator. Does not replace the routine use of a biological indicator.

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Biological Monitoring System Starter Kit - 24 hours. Kit includes: 25 Indicators, Incubator, Crusher, Record Keeper. Fast results in just 24 hours.

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