Sterilizers & Autoclaves News

The National Research Council of Canada (NRC) facilities in Winnipeg has conducted the third phase of testing on prions at TSO3 but it has not obtained the results anticipated.

TSO3

TSO3 Inc. is located in Québec City, Canada, and was established in 1998. TSO3 currently has 45 employees, 17 of whom work exclusively in the Research and Development department. The company’s mission is to develop and market innovative and comprehensive sterilization solutions. TSO3 has perfected a novel sterilization process using ozone as a sterilizing agent.

The first product based on this technological platform is the 125L Ozone Sterilizer, which is intended for hospital sterilization units. The 125L - named after its 125-litre/4.3-cubic-foot capacity - was designed to sterilize the new generation of surgical and diagnostic instruments made of non-heat-resistant materials such as polymers and other plastics. The ozone sterilization process is a safe, efficient, fast and cost-effective response to evolving sterilization needs. Health Canada in May 2002 and the U.S. Food and Drug Administration (FDA) on September 3, 2003, have cleared 125L Ozone Sterilizer by TSO3 for commercialization by.

The Company’s R&D team has also undertaken the development of a smaller, point-of-use ozone sterilization device for operating rooms and private clinics, and is planning the development of an industrial-sized device for manufacturers of medical instruments, among others.

Re-evaluation of Protocols

The partial deactivation of prions has generated symptoms of the disease in certain subjects inoculated with substances extracted from plaques sterilized with ozone, which deviates with the results obtained in previous studies where ozone showed a capacity to deactivate prions superior to the level observed during the current phase of testing.

Simon Robitaille, Vice President, Operations, and Director of Research at TSO3 emphasized, that these partial results are disappointing, however the recognized oxidizing power of ozone, as well as the results of our previous studies, moves us to re-evaluate our current protocols and to maintain our research program. We still believe in the superior capacity of ozone to deactivate prions. New scientific publications utilizing a different methodology recently impelled TSO3 to re-evaluate the Company’s protocols so that its results can be compared with other technologies.

The current evaluation consists of taking the brains from sick mice and making a homogenate that is spread on plaques and left to dry, then sterilized in the ozone sterilizer, while other samples are sterilized with steam. Comparison in terms of effectiveness is made between ozone to the autoclave. The residual matter is then recovered and injected into the brains of mice. This phase was planned to take six months, scheduled to conclude at the end of October 2004. TSO3 intends to initiate a new phase of testing, with new protocols, at the end of 2004.

Jocelyn Vézina, the Chief Executive Officer at TSO3 added as far as our commercialization strategy is concerned, the business plan for the 125L Ozone Sterilizer is based on the benefits of our technology, such as its efficiency, its rapidity and cost advantages. This news in no wise affects TSO3’s business plan. Nor will it impact the commercial launch of the 125L or its expected market penetration.

For more information on TSO3, visit www.tso3.com.

The new Eurotherm 5180V 180mm video graphical recorder’s latest firmware update allows for the direct calculation of time at sterilization, providing guaranteed sterilization. It has a large 180mm full color TFT LCD touch screen with a simple to use user interface. The touch screen user interface allows the user to easily access bars and trend graphs, alphanumeric displays as well as customized user displays.

This new function eliminates any guesswork in determining if the appropriate amount of sterilization has been provided to the instruments. This system is ideal for all hospitals, medical laboratories as well any application where sterilization is required, including autoclaves.

This advanced mathematics functions are incorporated in the 5180V, enabling calculation of the equivalent time at sterilizing temperature for temperatures above, at, and below the sterilizing temperature. Calculations for both dry and steam sterilizing environments can be carried out, by entering the appropriate constant in the simple to use embedded calculation. The function value is retained during power off.

User configuration consists of entering the channel, which is measuring temperature, the relevant sterilizing temperature and temperature interval and a low cut-off value, below which killing credits are not to be counted if required.

To ensure that sterilizer loads, which contain materials with differing thermal inertias, are thoroughly sterilized, a typical sterilizer has up to 12 different measuring points within the load. The temperature sensors should be calibrated to ensure accuracy, and the channel adjustment facility used to compensate for any inaccuracies found.

If each of the inputs is used to compute an F value, each of these values can then be used as an input to a Group Minimum function, with a high absolute alarm set at the correct F value. The alarm output can be used to sound a warning, or an associated relay can be linked into the autoclave control system to signify the end of a sterilization cycle.

Equilibration time begins when the drain sensor achieves the sterilizing temperature. It ends when the load sensor achieves the set point. Holding time begins when all sensors have passed the sterilizing temperature and ends when the first sensor falls below it.

Up to 96 channels of data can be recorded via direct analogue inputs, Modbus RS232/RS485 Serial data or Ethernet TCPIP modules. Provided with Ethernet comms as standard, processes can be directly monitored on an existing office computer network via the 5000 Series, allowing real-time viewing and configuration by providing live data to be monitored on any desktop PC connected to the network.

The user has the choice of either automatically downloading the data via the Ethernet comms on demand or the system can be setup to automatically download the data, thus eliminating the possibility of data loss from memory overflow. Data is stored in an encrypted format, ensuring data security and reliability, allowing the 5180V to be using in applications where FDA or EPA regulation needs to be met. The touch screen user interface allows the user to easily access bars and trend graphs, alphanumeric displays as well as customized user displays.

It can also be upgraded via simple key codes on site to add additional features such as advanced mathematics, totalizes and counters, batch control, full audit trail complete with digital signature security meeting CFR21 Part 11. Fully automated data management and archiving software is provided, ensuring data is never lost and allows users to chart recorded data and print in either a graphical or spreadsheet format or export to programs such as Excel.