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PRZOOM - /newswire/ -
Warner, NH, United States, 2014/09/09 - Autoclaves are essential components for a wide variety of industries that require steam sterilization to be performed on metal instruments, glassware and other essential materials - MadgeTech.com.
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Such industries include, but are not limited to medical, hospital, pharmaceutical, and laboratory equipment sectors. By subjecting items to highly pressurized steam for short periods of time, steam sterilization effectively neutralizes any potential contaminants. Therefore, it is extremely critical that all variables are measured for accuracy to ensure that the process is smooth and effective.
MadgeTech’s AVS140-6 kit for autoclave validation includes six data loggers that can monitor both the temperature and the pressure of an autoclave environment. As a compliment to this process, MadgeTech also offers the MadgeTech Secure Data Logger Software to aid users with compliance of all 21 CFR Part 11 requirements instituted by the FDA. This includes electronic signatures, access codes, secure data files, and an audit trail. This secure software package is included with the AVS140-6 autoclave validation system.
MadgeTech’s latest Secure Software release includes the capability of calculating F0 and A0 statistics, which are essential to the sterilization industry for compliance with CFR Part 11.
Many facilities are required to perform step-by-step validation and record keeping by regulation. MadgeTech’s IQ/OQ/PQ guide provides step by step documentation to ensure this process is done in a timely manner and meets all standards.
MadgeTech (madgetech.com) also offers on-site IQ/OQ/PQ services to help facilities validate their data logging systems. Our well trained staff will provide the protocol needed to expedite the required validation for your facility. MadgeTech performs extensive independent testing prior to new product releases and is up to date with regulations required by the end-user to validate data logging systems in the environment they will be used. With these on-site services, a MadgeTech professional can establish that the system has been received as specified, is properly installed on the computer in the intended environment, and that this environment is suitable for use of the MadgeTech system. All areas of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) will be evaluated.
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info[.]madgetech.com 
