Contamination-control layer
Asepta
Live contamination control for the sterile core.
Asepta fuses every contamination signal in the suite into one live risk picture, and it is the shared context every other Sterira agent checks before it acts.
The problem
Why this station is so unforgiving.
Under Annex 1, contamination control is the master discipline of fill-finish. Yet most plant managers run blind on real-time risk.
Viable and non-viable counts, air and pressure, glove and door events, personnel movement, all of it is monitored offline and in silos, and microbiology results lag by days. One excursion, one failed media fill, or one human-borne contamination can shut a suite down, scrap batches, and trigger a 483.
What Asepta does
Live contamination control for the sterile core.
Asepta fuses viable and non-viable particle counts, airflow, glove and door events, and personnel-risk signals into one live picture, and predicts excursions before they breach.
It grounds an Annex 1 contamination-control strategy in a Part 11 record, and it is the risk layer Fillix, Roboq, and every other agent consults before they move.
Capabilities
Built for the contamination-control layer.
One fused, live contamination-risk picture across the suite and its isolators
Excursion prediction and intervention-risk scoring from glove, door, and personnel perception
Annex 1 contamination-control-strategy tracking with a grounded rationale
Media-fill and environmental-trend analytics, with alerting and containment guidance
Part 11 audit trail and connectors for EM systems and MES
At a glance
Where Asepta runs, and for whom.
Recurring SaaS that lands on one station and expands across the suite and the fleet, on a paid pilot measured against a hard reject, deviation, or yield metric.
See pricing →One ecosystem
Asepta is one station of the Sterira suite.
Every other agent reads Asepta before it acts. Roboq and Fillix move with its contamination awareness, and Simura simulates the airflow it monitors.
Roboq
Fillix
Simura