Steam - Terragene https://terragene.com Biotechnology Company Tue, 03 Feb 2026 11:05:14 +0000 en hourly 1 https://wordpress.org/?v=6.9.4 https://terragene.com/wp-content/uploads/2020/12/cropped-FAVICON-TERRAGENE-AZUL-Rev.1-32x32.png Steam - Terragene https://terragene.com 32 32 7 sec Biological Indicator for Steam – Photon https://terragene.com/product/7-sec-biological-indicator-for-steam/ https://terragene.com/product/7-sec-biological-indicator-for-steam/#respond Sat, 24 Aug 2024 15:04:03 +0000 https://terragene.com/?post_type=product&p=23870 Photon Self-Contained Biological Indicator (SCBI) for Steam sterilization processes. Geobacillus stearothermophilus (ATCC® 7953, ATCC is a registered trademark of American Type Culture Collection) 10^6 spores per vial. Readout: 7 seconds.
FDA granted

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 °C, 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 7-seconds readout. 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 °C. Another D-value is informed at 132 °C and at 135 °C.

Z-Value is informed

Instructions for Use

1. Identify the Bionova® BT225 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label.
2. 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).
3. Perform sterilization cycle.
4. 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 Bionova® BT225 SCBI from the sterilized package. WARNING: Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst.
5. Let the SCBI cool down until it reaches room temperature.
6. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBIhas 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.
7. 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 at the rear of the Bionova® Photon® Auto-reader Incubator (BPH). Then shake the tube down vigorously, until the medium reaches the base of the tube and soaks the spore carrier entirely. Incomplete wetting of the spore carrier may lead to an incorrect fluorescence readout. Finally, place the SCBI in the incubator.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 the Auto-reader incubator. Both, the positive control indicator and the processed indicator, should belong to the same batch.8. Incubate the processed biological indicator and the positive control indicator in the Bionova® Photon® BPH Auto-reader incubator for 7 seconds at (60 ± 2) °C for instant readout. NOTE: Holding time between sterilization and incubation should not exceed a 7-day period. The fluorescence intensity detected by the auto-reader (excitation 340-380 nm / emission 455-465 nm) after 7 seconds of incubation determines the efficiency of the sterilization process. It is good practice to incubate a positive control for a visual color change.Record the positive results and discard the SCBIs immediately, as it is indicated below.

The post 7 sec Biological Indicator for Steam – Photon first appeared on Terragene.

]]> Photon Self-Contained Biological Indicator (SCBI) for Steam sterilization processes. Geobacillus stearothermophilus (ATCC® 7953, ATCC is a registered trademark of American Type Culture Collection) 10^6 spores per vial. Readout: 7 seconds.
FDA granted

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 °C, 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 7-seconds readout. 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 °C. Another D-value is informed at 132 °C and at 135 °C.

Z-Value is informed

Instructions for Use

1. Identify the Bionova® BT225 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label.
2. 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).
3. Perform sterilization cycle.
4. 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 Bionova® BT225 SCBI from the sterilized package. WARNING: Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst.
5. Let the SCBI cool down until it reaches room temperature.
6. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBIhas 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.
7. 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 at the rear of the Bionova® Photon® Auto-reader Incubator (BPH). Then shake the tube down vigorously, until the medium reaches the base of the tube and soaks the spore carrier entirely. Incomplete wetting of the spore carrier may lead to an incorrect fluorescence readout. Finally, place the SCBI in the incubator.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 the Auto-reader incubator. Both, the positive control indicator and the processed indicator, should belong to the same batch.8. Incubate the processed biological indicator and the positive control indicator in the Bionova® Photon® BPH Auto-reader incubator for 7 seconds at (60 ± 2) °C for instant readout. NOTE: Holding time between sterilization and incubation should not exceed a 7-day period. The fluorescence intensity detected by the auto-reader (excitation 340-380 nm / emission 455-465 nm) after 7 seconds of incubation determines the efficiency of the sterilization process. It is good practice to incubate a positive control for a visual color change.Record the positive results and discard the SCBIs immediately, as it is indicated below.

The post 7 sec Biological Indicator for Steam – Photon first appeared on Terragene.

]]> https://terragene.com/product/7-sec-biological-indicator-for-steam/feed/ 0 IT26-C – Chemical Integrator for Steam https://terragene.com/product/chemical-integrator-for-steam-5/ https://terragene.com/product/chemical-integrator-for-steam-5/#respond Wed, 21 Aug 2024 15:49:16 +0000 https://uvcindicators.com/?post_type=product&p=3023 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.

FDA cleared

Please review the instructions for use for applicable cycles in your country

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 10^6 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

1. Carefully open the package and remove only the number of indicators needed.

Reseal the package tightly.

2. 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.

3. Perform de sterilization cycle.

4. 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.

The post IT26-C – Chemical Integrator for Steam first appeared on Terragene.

]]> 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.

FDA cleared

Please review the instructions for use for applicable cycles in your country

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 10^6 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

1. Carefully open the package and remove only the number of indicators needed.

Reseal the package tightly.

2. 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.

3. Perform de sterilization cycle.

4. 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.

The post IT26-C – Chemical Integrator for Steam first appeared on Terragene.

]]> https://terragene.com/product/chemical-integrator-for-steam-5/feed/ 0 24h Biological Indicator for Steam https://terragene.com/product/24h-biological-indicator-for-steam/ https://terragene.com/product/24h-biological-indicator-for-steam/#respond Thu, 11 Jul 2024 18:00:19 +0000 https://uvcindicators.com/?post_type=product&p=3175 BT20 / Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC® 7953, ATCC is a registered trademark of American Type Culture Collection) 10^5 or 10^6 spores per vial. Readout: 24 hours. Monitoring vacuum-assisted and gravity air-displacement Steam Sterilization processes at 121-135 °C.

Instructions for use

1. Identify the Bionova® BT20 Indicator by writing the sterilizer number (in case of having  more than one), load number and processing date on the indicator label.

2. Pack the biological indicator along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place this package in those areas which a priori you consider most inaccessible for the sterilizing agent (Steam). Generally, the center of the load and areas near the door are problematic.

3. Perform sterilization cycle.

4. After the sterilization process has finished, open the sterilizer door, wait for 5 minutes and remove the biological indicator from the package. CAUTION: Wear safety glasses and gloves when removing the Bionova® BT20 Biological Indicator from the sterilized package. WARNING: Do not crush or handle the biological indicator excessively, since this might cause the glass ampoule to burst.

5. Allow the biological indicator to cool down to room temperature.

6. Check the chemical indicator on the label of the biological indicator. A color change to brown confirms that the biological indicator has been exposed to steam. IMPORTANT: this color change does not indicate that the process was sufficient to achieve sterility. If the chemical indicator is unchanged, check the sterilization process.

7. Crush the ampoule contained in the biological indicator with an individual ampoule crusher or with the ampoule crusher placed within the top of the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature of a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the biological indicator in the incubator.

IMPORTANT: Use a non-sterilized biological indicator as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that appropriate incubation conditions were met. Both the positive control indicator and the processed indicator should belong to the same batch.

8. Incubate the processed biological indicator and the indicator used as a positive control for a maximum of 24 hours between 58-62 ºC. Readout should be carried out at convenient intervals of 10 hours. Color change of the growth indicator medium from purple to yellow means that a sterilization process failure has occurred.

If at 24 hours there is no color change in the processed indicators, a final negative result is obtained (the sterilization process was effective). The positive control indicator should show a purple to yellow color change for the results to be valid. NOTE: To extend the incubation time beyond 24 hours, we recommend using a humidified environment to prevent complete evaporation of the culture medium contained within the indicator.

The post 24h Biological Indicator for Steam first appeared on Terragene.

]]> BT20 / Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC® 7953, ATCC is a registered trademark of American Type Culture Collection) 10^5 or 10^6 spores per vial. Readout: 24 hours. Monitoring vacuum-assisted and gravity air-displacement Steam Sterilization processes at 121-135 °C.

Instructions for use

1. Identify the Bionova® BT20 Indicator by writing the sterilizer number (in case of having  more than one), load number and processing date on the indicator label.

2. Pack the biological indicator along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place this package in those areas which a priori you consider most inaccessible for the sterilizing agent (Steam). Generally, the center of the load and areas near the door are problematic.

3. Perform sterilization cycle.

4. After the sterilization process has finished, open the sterilizer door, wait for 5 minutes and remove the biological indicator from the package. CAUTION: Wear safety glasses and gloves when removing the Bionova® BT20 Biological Indicator from the sterilized package. WARNING: Do not crush or handle the biological indicator excessively, since this might cause the glass ampoule to burst.

5. Allow the biological indicator to cool down to room temperature.

6. Check the chemical indicator on the label of the biological indicator. A color change to brown confirms that the biological indicator has been exposed to steam. IMPORTANT: this color change does not indicate that the process was sufficient to achieve sterility. If the chemical indicator is unchanged, check the sterilization process.

7. Crush the ampoule contained in the biological indicator with an individual ampoule crusher or with the ampoule crusher placed within the top of the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature of a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the biological indicator in the incubator.

IMPORTANT: Use a non-sterilized biological indicator as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that appropriate incubation conditions were met. Both the positive control indicator and the processed indicator should belong to the same batch.

8. Incubate the processed biological indicator and the indicator used as a positive control for a maximum of 24 hours between 58-62 ºC. Readout should be carried out at convenient intervals of 10 hours. Color change of the growth indicator medium from purple to yellow means that a sterilization process failure has occurred.

If at 24 hours there is no color change in the processed indicators, a final negative result is obtained (the sterilization process was effective). The positive control indicator should show a purple to yellow color change for the results to be valid. NOTE: To extend the incubation time beyond 24 hours, we recommend using a humidified environment to prevent complete evaporation of the culture medium contained within the indicator.

The post 24h Biological Indicator for Steam first appeared on Terragene.

]]> https://terragene.com/product/24h-biological-indicator-for-steam/feed/ 0 IT26-1YS Chemical Integrator for Steam https://terragene.com/product/chemical-integrator-for-steam-2/ https://terragene.com/product/chemical-integrator-for-steam-2/#respond Thu, 11 Jul 2024 17:50:01 +0000 https://uvcindicators.com/?post_type=product&p=2910 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.

FDA cleared

Please review the instructions for use for applicable cycles in your country

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

1. 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.

2. Perform the sterilization cycle.

3. 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.

The post IT26-1YS Chemical Integrator for Steam first appeared on Terragene.

]]> 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.

FDA cleared

Please review the instructions for use for applicable cycles in your country

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

1. 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.

2. Perform the sterilization cycle.

3. 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.

The post IT26-1YS Chemical Integrator for Steam first appeared on Terragene.

]]> https://terragene.com/product/chemical-integrator-for-steam-2/feed/ 0