Astell colour touchscreen control system brings together years of unrivalled experience, enabling us to produced a user friendly, fully automatic control system designed to meet and exceed the expectations of the most demanding laboratories and centres of sterilization.
The controller consists of a wipe clean touchscreen measuring 122 x 94mm and is based on an industrial PLC system, combined with a number of analogue and digital input/output modules. The controller software has been developed by Astell for the precision control of Biowaste Effluent Decontamination Systems.
Icon driven menu system
Simple cycle selection
Continual cycle monitoring
Data archiving for up to 5,000 cycles
Multiple user access levels and multi-level password protection
Digital display of pressure / temperature / level
Cycle counter, stage timer, cycle timer and stage display
Print any cycle from the data archive logs (printer required)
Safety valve test cycle
Fault history log
FDA 21 CFR PART 11
Astell is able to provide EDS controller software that conforms to FDA 21 CFR Part 11 guidelines. The fundamental requirements of 21 CFR 11 are the compliance with Data Security, Data Integrity, Traceability/Audit Trails and Electronic Signature rules. In the case of sterilizers, this means any change made to a cycle, option, or device parameter will require an electronic signature. All device changes and signatures will be electronically logged and can be recalled to provide a clear picture of user input for any given point in time. All audit trails are saved in a file format that cannot be altered in any way.
To achieve this level of compliance requires a dynamic and robust controller, such as the colour touchscreen system Astell provides on its Effluent Decontamination Systems. By incorporating all device settings in to one electronic interface users have the necessary control and security at their fingertips.
For more information on FDA 21 CFR Part 11 software options please Contact us.