The MadgeTech AVS140 is a comprehensive autoclave validation system designed to assist with 21 CFR Part 11 compliance. This complete kit includes five HiTemp140 high-temperature data loggers, a PR140 pressure data logger, an IFC406 multiplexer interface, and MadgeTech 4 Secure Software with IQ/OQ/PQ validation protocols. Each component is supplied with ISO17025 accredited calibration certificates, ensuring traceability and accuracy for critical validation processes.
Key Features & Highlights
- Complete Validation Kit: Includes (5) HiTemp140 loggers, (1) PR140 pressure logger, IFC406 interface, and MadgeTech 4 Secure Software.
- High Accuracy: Temperature accuracy of ±0.1°C (0.18°F) and pressure accuracy of ±0.03 Bar (±0.435 PSI) across a wide temperature range.
- Wide Temperature Range: HiTemp140 loggers operate from -40°C to 140°C, suitable for demanding autoclave cycles.
- Rugged & Submersible: Stainless steel construction makes both loggers completely submersible and resistant to harsh environments.
- 21 CFR Part 11 Compliance: MadgeTech 4 Secure Software includes electronic signatures, access codes, secure data files, and an audit trail to meet regulatory requirements.
- NIST-Traceable Calibration: ISO17025 accredited calibration certificates are included for each logger.
Applications
The AVS140 is ideal for autoclave validation in pharmaceutical, biotechnology, medical device, and laboratory settings. It ensures accurate temperature and pressure monitoring during sterilization cycles, supporting compliance with regulatory standards and quality assurance protocols.
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