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Autoclave Validation Systems

03 April 2018

The OM-CP-AVS140-1 and OM-CP-AVS140-6 are complete systems used to perform autoclave validations. The OM-CP-AVS140-1 system for autoclave temperature monitoring consists of a NIST traceable OM-CP-HITEMP-140-1 temperature data logger, an OM-CP-IFC400 USB docking station and FDA 21 CFR part 11 secure software.

 For larger size autoclaves or mapping projects, the OM-CP-AVS140-6 is a system for autoclave temperature and pressure monitoring that includes five OM-CP-HITEMP-140-1 temperature data loggers, one OM-CP-PR140 pressure data logger, an OM-CP-IFC406 multiplexer interface (allows up to 6 data loggers to be interfaced to a single USB port on the computer) and the secure software.

The secure software aids users in compliance with FDA 21 CFR Part 11 requirements. The software ensures standards in which electronic files are considered equivalent to paper records, saving time and effort. The secure software contains criteria such as electronic signatures, access codes, secure data files and an audit trail which meets the requirements of 21 CFR Part 11 and helps provide data integrity. IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) protocols are included to validate that the software has been installed and is operating correctly. The layout of the secure software is similar to the OM-CP Series Data Logger standard software, allowing users to easily learn the additional features. The Windows® based software package allows the user to effortlessly collect, display and analyze data. A variety of powerful tools provide the ability to examine, export, and print professional looking data with just a click of the mouse.

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