MadgeTech AVS140-1 Autoclave Validation System
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MadgeTech AVS140-1 is a complete autoclave validation system with HiTemp140 data logger, software suite with IQ/OQ/PQ protocols, and 21 CFR Part 11 compliance.
Product details
| Model | AVS140-1 |
| Manufacturer | MadgeTech |
| Category | Environmental Data Loggers |
| Availability | Made to order |
Description
Overview
The MadgeTech AVS140-1 is a comprehensive autoclave validation system designed for pharmaceutical, medical device, and laboratory sterilization applications. It provides all necessary tools for performing autoclave validations while maintaining compliance with FDA 21 CFR Part 11 regulations for electronic records and digital signatures.
Key Features
- Includes HiTemp140 high-temperature data logger with stainless steel housing
- Submersible and rated for temperatures up to 140°C (284°F)
- Temperature accuracy of ±0.1°C (±0.18°F)
- Includes 1-inch probe and ISO17025 accredited calibration certificate
- MadgeTech 4 Secure Software with IQ/OQ/PQ validation protocols
- 21 CFR Part 11 compliance features including electronic signatures and audit trails
- Includes IFC400 interface cable for data transfer
Included Accessories
- HiTemp140 Data Logger with Calibration Certificate
- IFC400 Interface Cable
- MadgeTech Secure Data Logger Software with IQ/OQ/PQ Validation Workbook
Applications
- Pharmaceutical autoclave validation
- Medical device sterilization validation
- Laboratory equipment sterilization protocols
- Regulatory compliance documentation
Specifications
| Logger Model | HiTemp140 |
| Maximum Temperature | 140°C (284°F) |
| Temperature Accuracy | ±0.1°C (±0.18°F) |
| Probe Length | 1 in. |
| Housing Material | Stainless steel |
| Waterproof Rating | Submersible |
| Calibration Certificate | ISO17025 accredited |
| Software Compliance | FDA 21 CFR Part 11 |
| Validation Protocols | IQ/OQ/PQ |
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MadgeTech AVS140-1 Autoclave Validation System
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