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SteriSense-bowie-dick-test-ENG

SteriSense-bowie-dick-test-ENG

SteriSense-bowie-dick-test-ENG

Product catalog summary
Introduction
SteriSense® is an advanced electronic device designed for conducting Bowie Dick Tests, ensuring the accuracy, performance, and reliability of steam sterilizers. It provides comprehensive verification of sterilization parameters, surpassing traditional chemical indicators by offering objective results and electronic documentation.

Specifications and Compliance
SteriSense complies with ISO 11140-4 standards and has been tested by a third-party institute. It is suitable for steam sterilizers qualified for sterilization at +134 °C according to EN 285 and EN ISO 17665. The device features a strain gauge and Pt1000 temperature sensors, with a temperature range of 0 to +140 °C and pressure range of 10 mBar to 6 Bar.

Advantages Over Traditional Methods
SteriSense eliminates subjective interpretation by providing detailed verification of sterilization parameters. It offers economic efficiency, improved safety, and additional critical information checks according to ISO 17665. The device is user-friendly, requiring minimal training, and stores data electronically for easy retrieval and comparison.

Device Components
The SteriSense system includes a Process Challenge Device (PCD), a triple sensor setup, and a data logger. The PCD is designed to challenge steam penetration and can be easily replaced to minimize downtime. The data logger stores data for up to 1,000 test cycles and is based on Ellab’s TrackSense® Pro technology.

Usage Procedure
Using SteriSense involves placing the measuring device in the reader station, starting the logger, conducting the Bowie Dick test, and then reading the data post-test. Results are automatically processed and stored, with reports generated in PDF format.

Advanced Features
SteriSense can perform complex analyses, including validation studies, batch control, vacuum leak tests, and post-service checks. These require additional software packages like ValSuite® Medical or ValSuite® Plus.

Purchase and Subscription Options
Customers can choose from three options: purchase without a service plan, purchase with a service plan, or a subscription plan. Each option offers different levels of service and maintenance, catering to various customer needs.

Technical Specifications
The device is made from durable materials like 316L stainless steel and PEEK, with a compact design. It supports a wide range of operating temperatures and pressures, and its memory can store up to 40,000 data points.

Company Background
Ellab A/S, the manufacturer of SteriSense, has been a leader in validation solutions since 1949, serving industries such as pharmaceutical, medical, and food. The company is ISO 9001 and ATEX IEC 80079-34 certified, with accredited calibration laboratories.
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Catalog excerpts

SteriSense-bowie-dick-test-ENG-1

The Ultimate Electronic Bowie Dick Test

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The Ultimate Electronic Bowie Dick Test ISO 11140-4 Compliant Tested by 3rd Party Test Institute Peace of Mind SteriSense is a brand new and innovative device for Electronic Bowie Dick Tests that is unmatched in accuracy, performance and reliability. SteriSense provides you with the ultimate peace of mind, by ensuring that your Steam Sterilizer functions in accordance with current norms and is sterilizing as expected. Why use SteriSense® Instead of Traditional Indicators? Unlike traditional chemical indicators, where you subjectively decide according to a change in color, SteriSense provides...

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SteriSense® Measuring Device A SteriSense measuring device consists of three main parts. Process Challenge Device (PCD) The PCD has been specially designed to reflect the reference method originally developed by Dr. J. Bowie and J. Dick in the 1960's. The function of the PCD is to “challenge” the steam penetration of a steam sterilizer in accordance with EN ISO 11140-4. Between tests, the PCD needs to be cooled down to ambient temperature (approx. 90 minutes), which is why it is a big advantage that the device can easily be disassembled from the body (logger) and be changed with a spare. Due...

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The software is almost autonomous Absolute Compliance When compared to traditional methods, the SteriSense provides far more insight into critical sterilization parameters than previously possible. The standard report showcases all the results from the optional 'checks' performed by the software. When using the standard settings, a routine control test will be performed in accordance with EN ISO 17665. SteriSense has been tested by a 3rd party certified test institute to comply with the reference method originally developed by Dr. J. Bowie and J. Dick, using a test procedure described in EN ISO...

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Place the SteriSense measuring device in the reader station and open the SteriSense Software. Define a unique Session Name. Press Start to activate the SteriSense measuring device, and place the device inside the steam sterilizer. After the test program is completed, place the SteriSense measuring device back in the reader station to read the data. The result of the test will either pass or fail, which will appear on the screen shortly after the data has been processed. Detailed performance information and time stamps are included to increase reliability. The test results will be stored in the...

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Purchase or Subscription? We know our customers have different needs, which is why we have made three options available to choose from when investing in a SteriSense system. 1. Purchase Excl. Service Plan This is the most straight forward option. You buy the equipment and get full ownership and control of when to calibrate and conduct service. Ellab recommends a maximum of 1,000 test cycles or 12 months between each calibration (whichever comes first). 2. Purchase Incl. Service Plan In addition to buying the equipment with full ownership, this option includes an all-inclusive service plan. The...

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Technical Specifications SteriSense Unit Expected Battery Lifetime: 1,000 Tests / 500 Hours (at +134 °C with Sample Rate of 1 Sec) Up to 1,000 test cycles between each calibration

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Ellab has been your validation partner since 1949, offering wireless data loggers and thermocouple systems for thermal validation processes. We serve both small and large companies within the Pharmaceutical, Medical and Food industries. We have solutions for many applications such as sterilization, freeze drying, heat tunnels, pasteurization and many more. Ellab develops unique and innovative solutions based on input from close interactions and dialogues with our customers. Our goal is to help our customers overcome challenges and increase their productivity by providing reliable and efficient...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.