For terminally sterilized products, routine sterility testing examines only a limited sample of the production batch and requires incubation time before results become available. Parametric Release follows a different approach: where authorized, batch release can be based on documented evidence that the predefined critical sterilization parameters remained within their validated acceptance limits throughout the production cycle.
Applying this strategy requires more than collecting process data.
Every approved release criterion must be evaluated consistently, deviations must be made immediately visible, and the resulting evidence must be complete, traceable and available to the authorized quality function.
Our Parametric Release application extends the Technology Hub with the digital capabilities required to apply the customer’s validated release criteria to every production cycle.
Critical sterilization parameters and their approved acceptance limits are configured within the system. During cycle execution, thanks to the parametric release capability the process controller automatically evaluates the recorded process data against these criteria and classifies each result as compliant, non-compliant or not evaluated.
At cycle completion, the authorized quality function receives documented and traceable evidence supporting the batch-release decision, without having to reconstruct parameter compliance through prolonged manual review.
The Parametric Release application is natively integrated into the TH Technology Hub—the same digital environment that executes the sterilization cycle, records process data and governs the batch record.
Validated release criteria are therefore evaluated against the original process data, within the context of the phases in which they apply. No separate software, manual data transfer or retrospective reconstruction of compliance is required.
Each criterion is explicitly classified as compliant, non-compliant or not evaluated, making exceptions immediately visible and providing the authorized quality function with consistent, traceable evidence from a single governed source.
Validated criteria applied automatically.
Every phase evaluated in context.
No unevaluated criterion reported as compliant.
Release evidence ready at cycle completion.
The customer’s validated release criteria are configured in a dedicated Critical Parameter Table and associated with the process phases in which they apply.
Each table can include up to 300 critical parameters, reflecting the specific sterilization process, product and load configuration.
Criteria can include minimum and maximum values, values at phase start or completion, measurements at a defined time offset, rates of change, F(T,z), time above or below a threshold, alarm activation and time-weighted averages.
Virtual parameters—such as the point-by-point difference between two probes—can be created and combined using arithmetic and logical operators.
Because each criterion is anchored to a process phase rather than a generic cycle profile, evaluation remains consistent even when execution is not linear.
Repeated phases are assessed individually, while recoverable interruptions are handled so the affected phase remains subject to the applicable release criteria.
Every critical parameter returns one of three results:
Compliant
Non-compliant
If a required phase or probe is absent, the criterion is classified as not evaluated. A condition that could not be assessed is never reported as compliant.
Parametric Release results are embedded in the process report and archived under the same 21 CFR Part 11 controls.
Values and outcomes can be exported as OPC or Modbus TCP tags or in structured XML and PDF formats, allowing MES, SCADA and quality systems to use them directly within the batch-release workflow.
When Parametric Release results govern cycle acceptance, a cycle that completed sterilization but returned a non-compliant or unevaluated criterion cannot proceed directly to unloading.
The TH Technology Hub requests a decision from an authorized user and records their identity, timestamp, comment and selected unloading door in the process report and audit trail.
Your company has established—or is developing—an authorized Parametric Release program for terminally sterilized products.
Routine sterility testing and manual batch-record review significantly delay product release.
Release criteria must be evaluated consistently across different phases or repeated phase executions.
Deviations that do not necessarily trigger conventional equipment alarms must still be identified against validated limits.
Structured release results must be transferred to MES, SCADA or enterprise quality systems.
You want to implement the required digital capabilities directly within the platform controlling the sterilization process, without introducing separate software and data reconciliation.
No. The application automatically evaluates and documents compliance with the customer’s validated release criteria. It provides the authorized quality function with the evidence required to support the release decision, but it does not replace the customer’s quality governance or authorized batch-release responsibilities.
No. Eligibility depends on the sterilization method, product and process knowledge, validated critical parameters, demonstrated process control, the sterility assurance program and the applicable regulatory authorization. The application makes an established Parametric Release strategy operational within the TH Technology Hub.
The application can evaluate recorded process data using minimum and maximum values, phase durations, values at defined points, rates of change, F(T,z), threshold durations, alarm status, time-weighted averages and calculated relationships between multiple variables. The criteria used for release are defined and validated by the customer.
The relevant criterion is classified as not evaluated, rather than compliant. This makes incomplete evidence immediately visible and prevents the absence of data from being interpreted as a successful result.
Conventional alarms primarily identify equipment faults or predefined operating deviations. The Parametric Release application evaluates customer-defined release criteria against the recorded process data, within the specific phase in which each criterion applies, and documents the resulting compliance status.
Parametric Release evaluates defined process parameters against validated acceptance limits at phase level. Golden Cycle analysis compares the overall profile of a completed cycle with a qualified reference profile. The two functions address different forms of process evidence and can be enabled together.
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