Gen II SteriDry Dry Heat Sterilization White Paper

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1 Gen II SteriDry Dry Heat Sterilization White Paper Sustainability is an increasingly important consideration. Water is an issue of particular concern. The world s water problems and the looming water-security crisis were ranked high by the World Economic Forum (WEF) 2013 Global Risk Survey. In every sector, the demand for water is expected to increase, and analysis suggests that the world will face a 40% global shortfall between forecast demand and available supply by 2030, WEF concluded. 76% of respondents named water as the resource most at risk, above oil, metals, minerals, others Source: Ernst & Young 2013 Six Growing Trends in Corporate Sustainability: Based on a survey of executives at organizations with over $1 billion annual revenue, in 17 industry groups Industry has recently seen a demand for greener technologies that require less energy, less water, and less maintenance. This puts the pressure on equipment engineers to develop innovative ways to approach sterilization. While traditional steam autoclaves use water, dry heat sterilization provides an alternative to steam that uses no water, less energy and requires less maintenance. Green Technology Compared with steam dry heat is a greener technology that eliminates water usage, provides more flexibility for installation locations and costs less to own and operate. Dry heat sterilization systems using focused forced air convection technology, PrecisionFlo TM, are consistently decreasing the cycle time and cool down requirements; the typical cycle lasts less than 3 hours, with higher throughput. Gen II SteriDry system - Model Year 2014 Temperature ability: Programmable up to 400F Load Capacity: Two Ventilated cage racks, or Two standard 3 sided facility load carts, 504 nested cages or Four purpose built load carts, 680 nested cages. Gen II SteriDry system model # VST40H349.3PTSS

2 Installation Advantage Bulk sterilizers are large units which often need to be located in areas that are prohibitive to moving such heavy, cumbersome equipment into position. A dry heat sterilizer is two to three times lighter than an equivalent steam system, takes less floor space and by design can be moved through a facility and rigged into place as modules/panels assembled at site; presenting considerably less challenges, costs and time delays. Operational Advantages -Provides a sterilized cage for usage with dry bedding -Non pressurized system provides for safer operation -Less impact on the work environment Utility Costs The dry heat sterilizer uses just one utility, electricity. In comparison to other sterilization methods the cycle operational cost can be considerably less. The graph below depicts a Gen II SteriDry system model # VST40H349.3PTSS, 350cuft of process area, The dry heat sterilizer does not need to be pit mounted. Instead, a steel plate floor in the sterilizer allows the load of animal cages to be rolled in directly from the facility floor. The dry heat sterilizer requires No drain, No steam and No cooling of reject water as there is none. -Low thermal impact to surrounding room -Low noise levels loaded with two load trucks and 504 nested mouse cages plus bedding. The cycle is validated to prove 100% spore kill. The total electrical usage is KWH. Obviously electrical costs vary but based on a $0.10 per KWH this translates to $6.40 per cycle or $ per cage. One cent!

3 Controls New sterilizers provide control options using a programmable logic controller (PLC) and human machine interface (HMI) based control systems. These controls are simple to use and allow the technician to configure and record the temperature of the sterilization cycle. Technicians can control various processes, such as start/stop, fault indicators, temperature displays, timers, and alarms in a secure manner preventing accidental changes to stored sterilization programs. Strip Chart recorder is included. A slave HMI is also located at the unload side of the sterilizer to allow visibility to the cycle timing and performance. More advanced screens are available by password protection. Screens include: Recipe creation Current recipe Trending Maintenance Filter pressure Digital inputs Alarms Administrator Evolution of control technology has eliminated the need for technicians to be in the same room as the sterilizer. Remote control ability makes it possible for the technician to operate, monitor, and diagnose problems from other locations using a computer or other device with web access. Reports and data can be stored and printed at the lab or at other authorized locations per security protocols.

4 Proven Validation The dry heat sterilizers are validated in the following manner: 1. Balancing of airflow. 2. Thermally map an empty chamber and tune pressure ducts to achieve the correct chamber temperature uniformity. 3. Load the chamber with rodent cages and bedding. 4. Thermally map the cages to determine the slowest point to reach temperature. 5. Place the BI s in selected cages and operate the sterilizer cycle. 6. Incubate the BI s for any signs of growth. The biological indicators used are designed specifically for usage with a dry heat system. Type of BI s used for test: Bacillus Atrophaeus (formerly Bacillus Subtilis) 3.9 x 10 6 CFU (colony forming units)..

5 Sterilization cycles operated using Gen II SteriDry system model # VST40H349.3PTSS, 350cuft of process area, loaded with 2 load trucks and 504 nested mouse cages plus bedding. Cycle example A includes a cooling cycle within the SteriDry. Cycle example B is a validated cycle with the loaded trucks being removed from the SteriDry at completion of the heat process. All cooling external to the SteriDry chamber.

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