CONTROL & TRACEABILITY
The primary functions of the system monitor, record measurements and generate out-of-specification alarms for the temperature, humidity and gas levels within the Ethylene
Oxide Chambers. The monitoring is a live and dynamic process capable of reporting out of specification results live and at the point of report generation. Following completion of a steriliser run, the system is able outputting an electronic batch record automatically. This auto reviewed batch is available for export to the client. Hence, the batch file is protected in format that may not be manipulated during transit or review. The system is compliant with 21 CFR Part 11 (Electronic Records & Signatures). The monitoring system generates a date/time stamped audit trail for configuration changes and alarm conditions.
Key Objectives and Benefits
- Provide secure and reliable monitoring system.
- Provide interfaces for operators and maintenance personnel.
- Accurately record and log parameters and events.
- Provide chamber monitoring and alarming
- Ensure reliable and secure Remote / Manual and Maintenance control.
- Enable the systematic and comprehensive display of chamber conditions and major
- operating parameters to facility personnel.
- Ensure the safety of plant, environment and personnel at all times.
- Provide system expansion capability.
- Provide an intuitive and robust system with low maintenance overheads.
- Provide a System compliant with 21CFR Part11electronic storage