The SL 2001 Complete Validation Set is a premium, all-in-one system designed specifically for the professional validation of Washer-Disinfectors (WDs) and steam sterilizers. This comprehensive kit provides the specialized high-precision hardware and TÜV-certified software required to meet the rigorous testing standards of ISO 15883 and GxP guidelines in medical and pharmaceutical environments.
The SL 2001 Set (Part No. 1250-2001) is a specialized collection of ebro®’s top-tier EBI 12 series data loggers, curated to cover all critical measurement points in a disinfection cycle. It includes a pressure and temperature logger (EBI 12-TP231) for monitoring chamber conditions and multiple temperature loggers with flexible and bendable probes (EBI 12-T220 and EBI 12-T441), allowing for precise placement in hard-to-reach areas like drains and hollow instruments. The heart of the system is the Winlog.validation software, which offers automated, tamper-proof evaluation and report generation. The entire set is housed in a robust SYSTAINER® carrying case, ensuring all components are protected and organized for mobile use during facility audits and routine validations.
Advantages
- Comprehensive Kit: Includes four specialized data loggers, a 4-port interface, and professional software, eliminating the need for separate sourcing.
- ISO 15883 Compliance: Specifically configured to meet the requirements for validating washer-disinfectors and steam sterilizers.
- High Precision Pt 1000 Sensors: Delivers outstanding accuracy (up to ±0.05 °C) essential for medical-grade thermal process validation.
- Flexible Measurement: The combination of bendable and flexible cable probes allows for accurate monitoring of "cold spots" in complex equipment.
- TÜV Certified Software: Includes Winlog.validation, which is fully FDA 21 CFR Part 11 compliant, ensuring data integrity and security.
- Expandable System: The included IF 200 interface can be used to add more EBI 12 or EBI 11 series loggers as your validation needs grow.
Instructions for use
The SL 2001 Set is designed for high-level technical validation procedures. Preparation: Install the Winlog.validation software and connect the IF 200 4-port interface to your PC. Place the four loggers into the interface slots to program them with the required measurement intervals and start triggers. Note: Position the EBI 12-TP231 to monitor pressure and temperature, use the EBI 12-T220 for the drain, and the EBI 12-T441 loggers for instrument cavities. Start the disinfection or sterilization cycle. After completion, return all loggers to the interface to download the data. The software will automatically evaluate the cycle against pre-set limits and generate a professional validation report.
Technical specifications
| Catalogue number | 1250-2001 |
| Brand | ebro® (Xylem) |
| Application | Validation of Washer-Disinfectors (ISO 15883) and Sterilizers |
| Included Loggers | 1x EBI 12-T220, 2x EBI 12-T441, 1x EBI 12-TP231 |
| Interface | EBI IF 200 (4-port USB with antenna) |
| Software | Winlog.validation (FDA 21 CFR Part 11 compliant) |
| Accuracy (Temp) | Up to ±0.05 °C |
| Case Type | SYSTAINER® Carrying Case |
Available packaging options
| 1250-2001 | SL 2001 Complete Validation Set for RDG/WD |
| Brand | Ebro |
