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		<title>BPH Photon AutoReader Incubator</title>
		<link>https://terragene.com/product/bph-photon/</link>
					<comments>https://terragene.com/product/bph-photon/#respond</comments>
		
		<dc:creator><![CDATA[Agustin Alvarez]]></dc:creator>
		<pubDate>Sun, 25 Aug 2024 10:53:18 +0000</pubDate>
				<guid isPermaLink="false">https://terragene.com/?post_type=product&#038;p=27673</guid>

					<description><![CDATA[<p><strong>BPH-Photon</strong>. 7 sec. Designed for the incubation and automatic readout of Biological Indicator for Steam sterilization processes. Final readout: 7".</p>
<p><strong>FDA granted</strong></p>
<p><strong>Product description<br />
</strong>Terragene® Bionova® Photon Auto-reader Incubator (BPH) has been designed for the incubation and automatic readout of the Bionova® Photon line of Self-contained Biological Indicators (SCBIs) appropriate for monitoring Steam Sterilization Cycles. Bionova® Photon Auto-reader presents two independent readout positions. Each position automatically detects whenever a SCBI is placed for incubation and delivers a readout result after a few seconds using advanced fluorescence techniques.</p>
<p>Bionova® Photon Auto-reader allows easy and rapid detection of positive and negative SCBIs. A positive result can also be evidenced by culture medium color change when performing extended incubations. Read the instructions for use of each SCBI for more information. The option to perform or not an extended incubation depends on the internal protocols of<br />
each laboratory or hospital.</p>
<p>Bionova® Photon Auto-reader has built-in USB, Wi-Fi, and Bluetooth® technology connectivity capabilities. The electronic tickets (e-tickets) created for each readout process can be accessed using a compatible device thus allowing easy documentation compliance and traceability.</p>
<p><strong>Instructions for use</strong></p>
<p><strong>1)</strong> Place the Bionova® Photon Auto-reader on a firm surface, free from vibrations, away from direct sunlight, currents of hot or cold air, chemical and corrosive or flammable substances.</p>
<p>Do not place the Incubator in a way that disconnection of the power supply’s AC plug from mains could be difficult. Leave a space of at least 10 cm from the Incubator to the closest wall. Do not move the Incubator periodically or during its use. Connect the Incubator to a secure and stable electrical mains outlet socket. Do not wet or heat the device. If liquid is spilled on the Incubator, disconnect it and follow the instructions on the Cleaning and maintenance section.</p>
<p><strong>2)</strong> Power on your Bionova® Photon Auto-reader by connecting the power supply’s AC plug to mains and then connect the plug at the other end of power supply to the rear of the Auto-reader. Before power on, verify that all incubation positions are empty.</p>
<p><strong>3)</strong> Set-up the Auto-reader local date and time running the Bionova® Wireless Assistant on a compatible mobile device. Refer to the Bionova® Wireless Assistant section for more information. All devices are manufactured with the following settings: Time zone: UTC +0:00</p>
<p><strong>4)</strong> After turning on the device, a two-steps initialization sequence will start. Please wait until the sequence is complete before using the Auto-reader.</p>
<p>During the first step, the Auto-reader will set and stabilize the incubation temperature. When the correct temperature is reached, the Temperature progress &#38; stability indicator will stop blinking. During the final step, the Auto-reader will set the readout system of each incubation position. When the readout system is ready for a reading, the Terragene® logo will stop blinking. Once both indicators have stopped blinking, the initialization sequence is complete.</p>
<p><strong>Do not place an indicator on an incubation position before initialization sequence is complete.</strong></p>
<p><strong>5)</strong> Once the initialization sequence is complete, a one-time automated test to check each position internal status will be carried out (Auto-test).</p>
<p>Once the test has been completed, the Position status indicator will turn green to indicate that the position can be used to perform readings, or it will turn red to indicate that an error has occurred. When the Auto-reader detects an error in a position, such position will be disabled to guarantee the reliability of the results and it can not be used to perform any further readings.</p>
<p>To indicate that a position has been disabled, the Position status indicator will turn red and will blink indefinitely. For the correct performance of the Auto-test keep the Protective Cover closed when the Auto-test is running.</p>
<p><strong>6)</strong> After the Auto-test has been completed, readings can be initiated on any incubation position if the position is not disabled. Place an indicator in a SCBI reading position. The reading process will start automatically after placing the SCBI.</p>
<p>The Auto-reader will emit an audible notification indicating that a reading has successfully began, at the same time the position status lights will start blinking. Close the Protective Cover, and wait until a readout result is informed. Read and follow the SCBI’s instructions for use. Before placing an SCBI in the Auto-reader, press the top to seal the tube. Crush the internal ampoule (using the Auto-reader’s Ampoule Crusher, or using the Ampoule Crusher included on the SCBI’s box). Make sure that culture medium completely wets the spore carrier at the base of the SCBI’s tube.</p>
<p><strong>Do not remove or change the SCBI’s placement</strong> once a reading process has begun. If this occurs, results may be invalidated.</p>
<p>See Cancelling a reading section for further details. If the incubator does not start a reading immediately after placing an SCBI in a reading position, refer to the Troubleshooting section for more information.</p>
<p><strong>7)</strong> When a positive result is detected in a reading position, the Position status indicator will turn red and an audible alarm will activate. This indicates that the sterilization process to which the SCBI was exposed, has failed. Once the SCBI is removed, the alarm and the red light will turn off automatically after 30 seconds. The position will be available to start a new reading once the Position status indicator has turned off. Press the button to cancel the audible alarm.</p>
<p>When a negative result is detected in a reading position, the Position status indicator will turn green. This indicates that the sterilization process to which the SCBI was exposed, has been successful. Once the SCBI is removed, the green light will turn off automatically after 30 seconds. The position will be available to start a new reading once the Position status indicator has turned off.</p>
<p><strong>Note:</strong> The incubation time setting defines the upper time limit in which an Auto-reader can inform a fluorescence readout. Nevertheless, the Auto-reader can detect and inform a positive result before the selected time limit as part of its normal operation.</p>
<p><strong>8)</strong> Each time a readout is carried out the Auto-reader will store the fluorescence readout result along with an uniquely assigned ID identifier in its internal memory. Refer to the Results management section to learn more. Positive, Negative, and Canceled Results will be stored in the internal memory.</p>
<p>The post <a href="https://terragene.com/product/bph-photon/">BPH Photon AutoReader Incubator</a> first appeared on <a href="https://terragene.com">Terragene</a>.</p>]]></description>
										<content:encoded><![CDATA[<p><strong>BPH-Photon</strong>. 7 sec. Designed for the incubation and automatic readout of Biological Indicator for Steam sterilization processes. Final readout: 7".</p>
<p><strong>FDA granted</strong></p>
<p><strong>Product description<br />
</strong>Terragene® Bionova® Photon Auto-reader Incubator (BPH) has been designed for the incubation and automatic readout of the Bionova® Photon line of Self-contained Biological Indicators (SCBIs) appropriate for monitoring Steam Sterilization Cycles. Bionova® Photon Auto-reader presents two independent readout positions. Each position automatically detects whenever a SCBI is placed for incubation and delivers a readout result after a few seconds using advanced fluorescence techniques.</p>
<p>Bionova® Photon Auto-reader allows easy and rapid detection of positive and negative SCBIs. A positive result can also be evidenced by culture medium color change when performing extended incubations. Read the instructions for use of each SCBI for more information. The option to perform or not an extended incubation depends on the internal protocols of<br />
each laboratory or hospital.</p>
<p>Bionova® Photon Auto-reader has built-in USB, Wi-Fi, and Bluetooth® technology connectivity capabilities. The electronic tickets (e-tickets) created for each readout process can be accessed using a compatible device thus allowing easy documentation compliance and traceability.</p>
<p><strong>Instructions for use</strong></p>
<p><strong>1)</strong> Place the Bionova® Photon Auto-reader on a firm surface, free from vibrations, away from direct sunlight, currents of hot or cold air, chemical and corrosive or flammable substances.</p>
<p>Do not place the Incubator in a way that disconnection of the power supply’s AC plug from mains could be difficult. Leave a space of at least 10 cm from the Incubator to the closest wall. Do not move the Incubator periodically or during its use. Connect the Incubator to a secure and stable electrical mains outlet socket. Do not wet or heat the device. If liquid is spilled on the Incubator, disconnect it and follow the instructions on the Cleaning and maintenance section.</p>
<p><strong>2)</strong> Power on your Bionova® Photon Auto-reader by connecting the power supply’s AC plug to mains and then connect the plug at the other end of power supply to the rear of the Auto-reader. Before power on, verify that all incubation positions are empty.</p>
<p><strong>3)</strong> Set-up the Auto-reader local date and time running the Bionova® Wireless Assistant on a compatible mobile device. Refer to the Bionova® Wireless Assistant section for more information. All devices are manufactured with the following settings: Time zone: UTC +0:00</p>
<p><strong>4)</strong> After turning on the device, a two-steps initialization sequence will start. Please wait until the sequence is complete before using the Auto-reader.</p>
<p>During the first step, the Auto-reader will set and stabilize the incubation temperature. When the correct temperature is reached, the Temperature progress &#38; stability indicator will stop blinking. During the final step, the Auto-reader will set the readout system of each incubation position. When the readout system is ready for a reading, the Terragene® logo will stop blinking. Once both indicators have stopped blinking, the initialization sequence is complete.</p>
<p><strong>Do not place an indicator on an incubation position before initialization sequence is complete.</strong></p>
<p><strong>5)</strong> Once the initialization sequence is complete, a one-time automated test to check each position internal status will be carried out (Auto-test).</p>
<p>Once the test has been completed, the Position status indicator will turn green to indicate that the position can be used to perform readings, or it will turn red to indicate that an error has occurred. When the Auto-reader detects an error in a position, such position will be disabled to guarantee the reliability of the results and it can not be used to perform any further readings.</p>
<p>To indicate that a position has been disabled, the Position status indicator will turn red and will blink indefinitely. For the correct performance of the Auto-test keep the Protective Cover closed when the Auto-test is running.</p>
<p><strong>6)</strong> After the Auto-test has been completed, readings can be initiated on any incubation position if the position is not disabled. Place an indicator in a SCBI reading position. The reading process will start automatically after placing the SCBI.</p>
<p>The Auto-reader will emit an audible notification indicating that a reading has successfully began, at the same time the position status lights will start blinking. Close the Protective Cover, and wait until a readout result is informed. Read and follow the SCBI’s instructions for use. Before placing an SCBI in the Auto-reader, press the top to seal the tube. Crush the internal ampoule (using the Auto-reader’s Ampoule Crusher, or using the Ampoule Crusher included on the SCBI’s box). Make sure that culture medium completely wets the spore carrier at the base of the SCBI’s tube.</p>
<p><strong>Do not remove or change the SCBI’s placement</strong> once a reading process has begun. If this occurs, results may be invalidated.</p>
<p>See Cancelling a reading section for further details. If the incubator does not start a reading immediately after placing an SCBI in a reading position, refer to the Troubleshooting section for more information.</p>
<p><strong>7)</strong> When a positive result is detected in a reading position, the Position status indicator will turn red and an audible alarm will activate. This indicates that the sterilization process to which the SCBI was exposed, has failed. Once the SCBI is removed, the alarm and the red light will turn off automatically after 30 seconds. The position will be available to start a new reading once the Position status indicator has turned off. Press the button to cancel the audible alarm.</p>
<p>When a negative result is detected in a reading position, the Position status indicator will turn green. This indicates that the sterilization process to which the SCBI was exposed, has been successful. Once the SCBI is removed, the green light will turn off automatically after 30 seconds. The position will be available to start a new reading once the Position status indicator has turned off.</p>
<p><strong>Note:</strong> The incubation time setting defines the upper time limit in which an Auto-reader can inform a fluorescence readout. Nevertheless, the Auto-reader can detect and inform a positive result before the selected time limit as part of its normal operation.</p>
<p><strong>8)</strong> Each time a readout is carried out the Auto-reader will store the fluorescence readout result along with an uniquely assigned ID identifier in its internal memory. Refer to the Results management section to learn more. Positive, Negative, and Canceled Results will be stored in the internal memory.</p>
<p>The post <a href="https://terragene.com/product/bph-photon/">BPH Photon AutoReader Incubator</a> first appeared on <a href="https://terragene.com">Terragene</a>.</p>]]></content:encoded>
					
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			</item>
		<item>
		<title>7 sec Biological Indicator for Steam &#8211; Photon</title>
		<link>https://terragene.com/product/7-sec-biological-indicator-for-steam/</link>
					<comments>https://terragene.com/product/7-sec-biological-indicator-for-steam/#respond</comments>
		
		<dc:creator><![CDATA[Agustin Alvarez]]></dc:creator>
		<pubDate>Sat, 24 Aug 2024 15:04:03 +0000</pubDate>
				<guid isPermaLink="false">https://terragene.com/?post_type=product&#038;p=23870</guid>

					<description><![CDATA[<div>Photon Self-Contained Biological Indicator (SCBI) for Steam sterilization processes. <b><em>Geobacillus stearothermophilus</em></b> (ATCC® 7953, <span style="font-weight: 400;">ATCC is a registered trademark of American Type Culture Collection</span>) 10^6 spores per vial. Readout: 7 seconds.</div>
<div></div>
<div>FDA granted</div>
<div>
<p>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.</p>
<p>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.<br />
NOTE: if 7-day readout is performed, a humidified environment will be required to avoid medium to dry out.</p>
<p>D-Value: Not lower than 1.5 minutes at 121 °C. Another D-value is informed at 132 °C and at 135 °C.</p>
<p>Z-Value is informed</p>
</div>
<div></div>
<div><strong>Instructions for Use<br />
</strong><br />
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.</div>
<div>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).</div>
<div>3. Perform sterilization cycle.</div>
<div>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.</div>
<div>5. Let the SCBI cool down until it reaches room temperature.</div>
<div>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.<br />
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.</div>
<p>The post <a href="https://terragene.com/product/7-sec-biological-indicator-for-steam/">7 sec Biological Indicator for Steam – Photon</a> first appeared on <a href="https://terragene.com">Terragene</a>.</p>]]></description>
										<content:encoded><![CDATA[<div>Photon Self-Contained Biological Indicator (SCBI) for Steam sterilization processes. <b><em>Geobacillus stearothermophilus</em></b> (ATCC® 7953, <span style="font-weight: 400;">ATCC is a registered trademark of American Type Culture Collection</span>) 10^6 spores per vial. Readout: 7 seconds.</div>
<div></div>
<div>FDA granted</div>
<div>
<p>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.</p>
<p>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.<br />
NOTE: if 7-day readout is performed, a humidified environment will be required to avoid medium to dry out.</p>
<p>D-Value: Not lower than 1.5 minutes at 121 °C. Another D-value is informed at 132 °C and at 135 °C.</p>
<p>Z-Value is informed</p>
</div>
<div></div>
<div><strong>Instructions for Use<br />
</strong><br />
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.</div>
<div>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).</div>
<div>3. Perform sterilization cycle.</div>
<div>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.</div>
<div>5. Let the SCBI cool down until it reaches room temperature.</div>
<div>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.<br />
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.</div>
<p>The post <a href="https://terragene.com/product/7-sec-biological-indicator-for-steam/">7 sec Biological Indicator for Steam – Photon</a> first appeared on <a href="https://terragene.com">Terragene</a>.</p>]]></content:encoded>
					
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			</item>
		<item>
		<title>7 sec Steam Test Pack Kit (with moving front integrator) &#8211; Photon</title>
		<link>https://terragene.com/product/7-sec-steam-test-pack-with-moving-front-integrator/</link>
					<comments>https://terragene.com/product/7-sec-steam-test-pack-with-moving-front-integrator/#respond</comments>
		
		<dc:creator><![CDATA[Agustin Alvarez]]></dc:creator>
		<pubDate>Thu, 20 Jan 2022 16:19:53 +0000</pubDate>
				<guid isPermaLink="false">https://terragene.com/?post_type=product&#038;p=23877</guid>

					<description><![CDATA[<p>Process Challenge Device for Steam sterilization processes.</p>
<p><strong>Usage</strong></p>
<p>For routine load release, especially for loads containing implants. For routine sterilizer monitoring. For periodic validation of the sterilizer (after installation, repair, relocation).</p>
<p>Detects inadequate air removal and steam penetration in dynamic- airremoval (pre-vacuum) and gravity displacement, steam autoclaves between 132-135 ºC.</p>
<p><strong>Applicable regulation </strong></p>
<p>Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016. ISO 11140-1:2014, ISO 11138-1:2017, ISO 11138-3:2017, ANSI/AAMI ST79.</p>
<p><strong>Authorization</strong></p>
<p>ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-4.</p>
<p><strong>Classification </strong></p>
<p>Class 1, according to risk (ANMAT).</p>
<p><strong>Characteristics</strong></p>
<p>The kit consist of:<br />
- PCD225-C: Porous cards system holding:<br />
A Self-contained Biological Indicator Bionova® BT225 (Photon).<br />
A Type 5 chemical indicator Integron® IT26-C (moving-front<br />
integrator).<br />
A self-adhesive Record Card, PCDBI-C-RC, where data on sterilization<br />
cycle may be written.<br />
- Self-contained Biological Indicator Bionova® BT225 (to be used as a<br />
positive control)</p>
<p><strong>Process Indicator:</strong></p>
<p>Initial color: light blue<br />
Final color: dark grey or black</p>
<p><strong>IT26-C Integrator Indicator (within the challenge device):</strong> 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® (ATCC is <span style="font-weight: 400;">a registered trademark of American Type Culture Collection)</span> 7953 spores’ population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C.</p>
<p><strong>BT225 (Photon) the Instant Self-contained Biological Indicator (within the challenge device): </strong>≥ 106 G. stearothermophilus ATCC® (<span style="font-weight: 400;">ATCC is a registered trademark of American Type Culture Collection) </span>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).</p>
<p><strong>Final results:</strong> instant fluorescence readout (7 second readout) after incubation at 60 °C (sensitivity ≥ 97%). A visual confirmation of the result is optional (color change of the medium caused by pH change) and can be made after incubation at 60 °C for 48 hours and/or for 7 days.</p>
<p><strong>NOTE:</strong> 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. Environmental conditions during manufacture T= 15-30 °C, RH= 30-80 %.</p>
<p><strong>Storage conditions</strong></p>
<p>T= 10-30 °C, RH= 30-80 %, keep out of direct ligh Transport conditions Storage conditions should be strictly followed. Carry in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent a risk for health.</p>
<p><strong>Shelf life</strong></p>
<p>18 months.</p>
<p><strong>Packing</strong></p>
<p>Presentations: 25 PCD225-C + 25 BT225 Biological Indicators per box.</p>
<p>25 PCD225-C + 5 BT225 Biological Indicators per box.</p>
<p>16 PCD225-C + 4 BT225 Biological Indicators per box. Packing information: product code and description, regulation, conditions for use, instructions for use, storage conditions, manufacturer information and data on box´s label.</p>
<p>Labelling</p>
<p>On product’s packing: product code and description, presentation, regulation, batch number, batch number of the Self-contained Biological Indicator, manufacture and expiration date, bar code and datamatrix code.</p>
<p><strong>Possible target markets</strong></p>
<p>Healthcare, Food, Pharmaceutical and Medical Industries.</p>
<p><strong>Other important information </strong></p>
<p>Read product’s instructions for use thoroughly before use.</p>
<p><strong>Precautions</strong></p>
<p>Do not store the product near sterilizing agents.</p>
<p>Do not expose this product to EO, Dry Heat, Radiation or any sterilization process other than Steam.</p>
<p>The post <a href="https://terragene.com/product/7-sec-steam-test-pack-with-moving-front-integrator/">7 sec Steam Test Pack Kit (with moving front integrator) – Photon</a> first appeared on <a href="https://terragene.com">Terragene</a>.</p>]]></description>
										<content:encoded><![CDATA[<p>Process Challenge Device for Steam sterilization processes.</p>
<p><strong>Usage</strong></p>
<p>For routine load release, especially for loads containing implants. For routine sterilizer monitoring. For periodic validation of the sterilizer (after installation, repair, relocation).</p>
<p>Detects inadequate air removal and steam penetration in dynamic- airremoval (pre-vacuum) and gravity displacement, steam autoclaves between 132-135 ºC.</p>
<p><strong>Applicable regulation </strong></p>
<p>Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016. ISO 11140-1:2014, ISO 11138-1:2017, ISO 11138-3:2017, ANSI/AAMI ST79.</p>
<p><strong>Authorization</strong></p>
<p>ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-4.</p>
<p><strong>Classification </strong></p>
<p>Class 1, according to risk (ANMAT).</p>
<p><strong>Characteristics</strong></p>
<p>The kit consist of:<br />
- PCD225-C: Porous cards system holding:<br />
A Self-contained Biological Indicator Bionova® BT225 (Photon).<br />
A Type 5 chemical indicator Integron® IT26-C (moving-front<br />
integrator).<br />
A self-adhesive Record Card, PCDBI-C-RC, where data on sterilization<br />
cycle may be written.<br />
- Self-contained Biological Indicator Bionova® BT225 (to be used as a<br />
positive control)</p>
<p><strong>Process Indicator:</strong></p>
<p>Initial color: light blue<br />
Final color: dark grey or black</p>
<p><strong>IT26-C Integrator Indicator (within the challenge device):</strong> 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® (ATCC is <span style="font-weight: 400;">a registered trademark of American Type Culture Collection)</span> 7953 spores’ population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C.</p>
<p><strong>BT225 (Photon) the Instant Self-contained Biological Indicator (within the challenge device): </strong>≥ 106 G. stearothermophilus ATCC® (<span style="font-weight: 400;">ATCC is a registered trademark of American Type Culture Collection) </span>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).</p>
<p><strong>Final results:</strong> instant fluorescence readout (7 second readout) after incubation at 60 °C (sensitivity ≥ 97%). A visual confirmation of the result is optional (color change of the medium caused by pH change) and can be made after incubation at 60 °C for 48 hours and/or for 7 days.</p>
<p><strong>NOTE:</strong> 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. Environmental conditions during manufacture T= 15-30 °C, RH= 30-80 %.</p>
<p><strong>Storage conditions</strong></p>
<p>T= 10-30 °C, RH= 30-80 %, keep out of direct ligh Transport conditions Storage conditions should be strictly followed. Carry in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent a risk for health.</p>
<p><strong>Shelf life</strong></p>
<p>18 months.</p>
<p><strong>Packing</strong></p>
<p>Presentations: 25 PCD225-C + 25 BT225 Biological Indicators per box.</p>
<p>25 PCD225-C + 5 BT225 Biological Indicators per box.</p>
<p>16 PCD225-C + 4 BT225 Biological Indicators per box. Packing information: product code and description, regulation, conditions for use, instructions for use, storage conditions, manufacturer information and data on box´s label.</p>
<p>Labelling</p>
<p>On product’s packing: product code and description, presentation, regulation, batch number, batch number of the Self-contained Biological Indicator, manufacture and expiration date, bar code and datamatrix code.</p>
<p><strong>Possible target markets</strong></p>
<p>Healthcare, Food, Pharmaceutical and Medical Industries.</p>
<p><strong>Other important information </strong></p>
<p>Read product’s instructions for use thoroughly before use.</p>
<p><strong>Precautions</strong></p>
<p>Do not store the product near sterilizing agents.</p>
<p>Do not expose this product to EO, Dry Heat, Radiation or any sterilization process other than Steam.</p>
<p>The post <a href="https://terragene.com/product/7-sec-steam-test-pack-with-moving-front-integrator/">7 sec Steam Test Pack Kit (with moving front integrator) – Photon</a> first appeared on <a href="https://terragene.com">Terragene</a>.</p>]]></content:encoded>
					
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		<title>BHY Hyper AutoReader Incubator</title>
		<link>https://terragene.com/product/bhy-hyper/</link>
					<comments>https://terragene.com/product/bhy-hyper/#respond</comments>
		
		<dc:creator><![CDATA[Agustin Alvarez]]></dc:creator>
		<pubDate>Fri, 23 Aug 2024 14:09:19 +0000</pubDate>
				<guid isPermaLink="false">https://terragene.com/?post_type=product&#038;p=23863</guid>

					<description><![CDATA[<p>BHY HYPER / Auto-reader Incubator for incubation and readout of Hyper Rapid Self-Contained Biological Indicators.</p>
<p>For incubation and readout of Hyper Rapid Self-Contained Biological Indicators BT98 (VH2O2) readout fluorescense system after 5 minutes of incubation at 60 ºC. Please review the instructions for use for applicable cycles in your country</p>
<p><strong>Characteristics</strong></p>
<p>2 readout positions (38 mm deep, 9 mm diameter) for incubation of Hyper Rapid Biological Indicators.</p>
<p>1 ampoule crusher.</p>
<p>Special hole for external thermometer.</p>
<p>Unique ID Number for each carried out results for audit purposes.</p>
<p>Easy access to the last 50 results.</p>
<p>USB connection for registering results in a PC through Reading and Traceability Software.</p>
<p>Bluetooth wireless technology connectivity.</p>
<p>Fully compatible with Bionova Cloud Traceability Software.</p>
<p>Fully compatible with Terragene Wireless Assistant App for Mobile Devices.</p>
<p>Sound alarm for event indication.</p>
<p>Detection and automatic cancellation of the fluorescence reading of the biological indicator.</p>
<p>-Fluorescence reading wavelength: ~ 460 nm</p>
<p>-Firmware update by the user.</p>
<p>-Dimensions: 10 mm high, 97 mm wide and 103 mm deep.</p>
<p>-Power: 18 W</p>
<p>-Frequency: 50-60 Hz</p>
<p>The post <a href="https://terragene.com/product/bhy-hyper/">BHY Hyper AutoReader Incubator</a> first appeared on <a href="https://terragene.com">Terragene</a>.</p>]]></description>
										<content:encoded><![CDATA[<p>BHY HYPER / Auto-reader Incubator for incubation and readout of Hyper Rapid Self-Contained Biological Indicators.</p>
<p>For incubation and readout of Hyper Rapid Self-Contained Biological Indicators BT98 (VH2O2) readout fluorescense system after 5 minutes of incubation at 60 ºC. Please review the instructions for use for applicable cycles in your country</p>
<p><strong>Characteristics</strong></p>
<p>2 readout positions (38 mm deep, 9 mm diameter) for incubation of Hyper Rapid Biological Indicators.</p>
<p>1 ampoule crusher.</p>
<p>Special hole for external thermometer.</p>
<p>Unique ID Number for each carried out results for audit purposes.</p>
<p>Easy access to the last 50 results.</p>
<p>USB connection for registering results in a PC through Reading and Traceability Software.</p>
<p>Bluetooth wireless technology connectivity.</p>
<p>Fully compatible with Bionova Cloud Traceability Software.</p>
<p>Fully compatible with Terragene Wireless Assistant App for Mobile Devices.</p>
<p>Sound alarm for event indication.</p>
<p>Detection and automatic cancellation of the fluorescence reading of the biological indicator.</p>
<p>-Fluorescence reading wavelength: ~ 460 nm</p>
<p>-Firmware update by the user.</p>
<p>-Dimensions: 10 mm high, 97 mm wide and 103 mm deep.</p>
<p>-Power: 18 W</p>
<p>-Frequency: 50-60 Hz</p>
<p>The post <a href="https://terragene.com/product/bhy-hyper/">BHY Hyper AutoReader Incubator</a> first appeared on <a href="https://terragene.com">Terragene</a>.</p>]]></content:encoded>
					
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