The AVS140-6 is a complete system used to perform autoclave validations. The AVS140-6 consists of six NIST traceable high temperature and pressure data loggers, an IFC406 Multiplexer Interface and the MadgeTech 4 Secure Software providing tools to users to assist with FDA 21 CFR Part 11 compliance.
The AVS140-6 kit includes:
(5) HiTemp140 High Temperature Data Loggers with 1 in probe style, all with NIST Calibration Certificates
(1) PR140-NPT Pressure Data Logger with an NPT port, with NIST Calibration Certificate
(1) IFC406 Multiplexer interface
(1) MadgeTech Secure Data Logger Software, complete with IQ/OQ/PQ validation protocols and workbook
(other data logger probe lengths and styles available, call for details)
The HiTemp140 is a rugged, high precision, temperature data logger that is built for use with autoclaves and harsh environments. This stainless steel device is submersible, can withstand temperatures up to 140 °C (284 °F) and has an accuracy of +/-0.1 °C (0.18 °F).
The PR140 is a pressure data logger designed for use in autoclave validation and mapping. This rugged data logger can withstand temperatures up to 140 °C and is completely submersible (IP68). The PR140 is built with a precision stainless steel pressure gauge. The data logger has an accuracy of ±0.03 Bar (±0.435 PSI), which can be achieved over a wide temperature range, from 20 °C to +140 °C (68 °F to 284 °F). The PR140 can be programmed to take readings as often as once per second (1 Hz), and has non-volatile memory that can store up to 32,700 measurements.
The MadgeTech 4 Secure Software aids customers in compliance with 21 CFR Part 11 requirements. The software ensures standards in which electronic files are considered equivalent to paper records, saving time and effort. MadgeTech 4 Secure Software contains criteria such as electronic signatures, access codes, secure data files, and an audit trail which meet the requirements of 21 CFR Part 11 and help provide data integrity.
Also available, the AVS140-1, a single logger autoclave validation system.