BUILD THE REFERENCE FROM VALIDATION DATA
A real validation process report can be displayed behind the graphical editor, providing a direct reference for the definition of the expected temperature and pressure profiles.
Golden cycle
Sterilization achieved, but did the process behave as expected?
A sterilization cycle may meet its fundamental acceptance criteria while behaving differently from the process established during validation. Temperature, pressure and exposure can reach their required values even when the complete process profile no longer reproduces the expected temperature and pressure behaviour.
A conventional batch report shows what happened.
Golden Cycle answers the more critical question: Did the process behave as expected throughout the cycle?
And makes the answer part of the release decision.
VALIDATED BEHAVIOUR BECOMES A RELEASE CONDITION
Golden Cycle converts the temperature and pressure behaviour established during validation into a configurable reference profile, with acceptance boundaries defined throughout the cycle.
At program completion, selected process-controller and external recorder channels are compared against this reference. The system identifies every interval in which the executed process moved above or below the accepted profile, ended too early or continued beyond its defined boundaries.
We are the only one bringing this evaluation directly into the process controller logic. When Golden Cycle Acceptance is enabled, an out-of-profile result keeps the doors locked and prevents a new program from starting until an authorised user evaluates and documents the outcome.
Golden Cycle does not simply record deviation from validated behaviour. It turns that deviation into a controlled, attributable release decision.
FOR EACH STERILIZATION PROGRAM, THE ENABLED CONTROLS VERIFY FOUR DISTINCT DIMENSIONS OF PROCESS BEHAVIOUR.
Together, these controls establish whether the executed cycle remained consistent with the process conditions defined during validation.
Did the complete cycle follow the validated profile? Selected temperature and pressure channels are compared against the reference profile and its acceptance boundaries. Every interval above, below or outside the expected duration is identified.
Were temperatures uniform across the load and over time? The process controller verifies both the temperature spread across the selected probes and the variation recorded by each probe during sterilization.
Did temperature and pressure confirm saturated-steam conditions? Chamber pressure is continuously checked against the saturated-steam pressure range corresponding to the minimum and maximum sterilization temperatures.
Did the entire load reach sterilization conditions in time? The process controller measures the time between the reference probe reaching the sterilization threshold and all selected product probes reaching the same condition. The result is checked against the configured maximum equilibration time.
Every result triggers a controlled action.
Failed sterilization refuses the cycle.
Confirmed process behaviour authorises release.
Out-of-profile behaviour requires an authorised decision.
PROVEN BY NUMBERS
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faster batch release with Parametric Release capability
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critical parameters per table
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explicit evaluation outcomes: compliant, non-compliant or not evaluated
DEFINE ACCEPTANCE BOUNDARIES ACROSS THE CYCLE
Nominal values and independent upper and lower tolerances create acceptance bands that follow the complete evolution of the process, rather than controlling isolated limits.
ASSOCIATE EACH PROFILE WITH ITS PROGRAM
Every Golden Cycle profile is linked to the corresponding sterilization program, ensuring that the correct reference is loaded before execution. If the profile or probe configuration is missing or inconsistent, the program cannot start.
SELECT THE EVIDENCE THAT MATTERS
The comparison can use freely selected internal process-controller probes, external recorder channels or both.
IDENTIFY EVERY ANOMALOUS INTERVAL
The analytical report shows where the executed process moved above or below the reference profile and identifies missing or excess process data.
KEEP THE DECISION WITH THE BATCH RECORD
The Golden Cycle definition, comparison result and analytical report are stored with the electronic process report. When an authorised decision is required, the user, timestamp, comment and unloading-door selection are also recorded in the process report and audit trail.
WHEN SHOULD YOU CHOOSE GOLDEN CYCLE
GOLDEN CYCLE Brings the Greatest Value When:
PRESSURE CONTROL
In saturated steam sterilization, pressure governs steam conditions. Controlling pressure supports temperature uniformity and repeatable process behavior. ±0.5°C UNIFORMITY
Temperature standard deviation is a key indicator of process behavior. The tighter the deviation, the greater the stability and repeatability across the entire load. DRY-LOADS
Critical components emerge sterile, dry and ready for immediate use.
CANISTER PROVEN
We support advanced canister-based transfer strategies while preserving filter integrity, drying performance and sterile transfer conditions.Release requires evidence that the complete cycle reproduced validated process behaviour, not only that its fundamental sterilization criteria were achieved.
Temperature and pressure must be evaluated against acceptance boundaries that follow the complete process profile.
Process data from internal probes and external recorder channels must contribute to the same evaluation.
An out-of-profile load must not be transferred automatically through a double-door sterilizer.
Every exception must lead to an attributable, documented and authorised decision.
Process knowledge established during validation must remain active in routine production rather than confined to qualification documentation.
Does Golden Cycle replace the sterilization acceptance criteria?
No. The fundamental sterilization acceptance criteria remain active. Golden Cycle adds another level of process governance by verifying whether the complete executed profile remained within the behaviour established during validation.
What Is a Golden Cycle?
A Golden Cycle is a configurable temperature and pressure reference profile based on validated process behaviour. It includes upper and lower acceptance boundaries against which routine cycle data are compared.
How Is the reference profile created?
The temperature and pressure profiles can be configured graphically or numerically. A real validation process report can be displayed in the graphical editor as a reference when defining nominal values and their upper and lower tolerances.
Is the release decision traceable?
Yes. The user identity, timestamp, comment and unloading-door decision are recorded in the process report and audit trail. The acceptance data are also available for SCADA communication.
What happens when sterilization succeeds but the golden cycle comparison fails?
When Golden Cycle Acceptance is enabled, the process controller requests an authorised decision. The doors remain locked and no new program can start until a user with the required permission evaluates the result and completes the acceptance or rejection process.
When Is the golden cycle comparison performed?
The comparison is performed at program termination. During execution, temperature uniformity, saturated-steam conditions and equilibration time are monitored independently when their respective functions are enabled.
Which process data can be compared?
Golden Cycle can compare selected temperature and pressure channels from the Fedegari process controller, an integrated external recorder or both. Probe selection is configured at program level.
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