Cycle Definitions
A cycle definition is a sterilization recipe defined by sequencing various phases, and setting values to available parameters.
A user interface can be customized for your control system so that cycle definitions can be developed in a familiar environment.
This includes various screens with which cycle definitions are approved, electronically signed (fully 21 CFR Part 11 compliant),
copied, deleted, etc.
For convenience, cycle definitions can be developed on a central server or on the plant’s server eliminating off-line delays and significantly
improving your plant's efficiency and processing capabilities.
Cycle definitions can be rapidly developed using the point and click interface:
Some key features to note are:
- Use of customer’s units of measure
- Addition of phases and loops with sub-phases
- Copy/paste of phases, loops and entire cycles
- Estimation of breathable air, flammability against NFPA560, and relative humidity levels with condensation warnings
- 21 CFR Part 11 Electronic signatures for review and approval of cycle definitions:
- When all electronic signatures are present, cycle definition is approved
- The system detects backdoor altering of approval cycle definitions, recalling the signatures if any tampering is detected
- Changes to any information stored in the database are logged in audit trail tables
- Built in database security with administrator login can be used when accessing, modifying, or deleting database records
.