The platform
One autonomy layer for the entire sterile suite.
Sterira unifies aseptic filling, sealing and CCI, lyophilization, AI inspection, contamination control, robotic handling, and batch review into a single validated system of action, with a digital twin that hits spec before the batch.
The agents
Perception to control, at every stage.
Each agent owns one unforgiving step and shares a common perception, reasoning, and audit fabric. Select a stage.
Fill-and-dose agent
Shared fabric
One perception, reasoning, and audit layer.
Every agent draws on the same edge-perception stream, physics-informed reasoning, and Part 11 audit trail, so decisions compound across the suite instead of siloing per machine.
- Unified sensor fusion across fill, seal, lyo, and inspection.
- Shared control envelopes validated once, reused everywhere.
- A single release record instead of seven disconnected logs.
Capabilities
What the platform does out of the box.
Edge perception
Low-latency sensing of fill weight, particulate, CCI, and lyo state directly at the isolator.
Physics-informed control
Process models keep every action inside a validated envelope, not a black box.
Digital twin
Simulate fill, lyo, and contamination flow to converge on spec before the batch.
Contamination intelligence
Live viable/non-viable fusion turns sampled microbiology into real-time risk.
Review by exception
Batch records reduced to the deviations that matter, with a full audit trail.
Data flywheel
Every aseptic and inspection outcome tightens the envelope for the next release.
Architecture
Grounded, auditable, reversible by design.
Every action has a reason
Decisions trace to a specific signal and a specific rule, never an unexplained inference.
Part 11 trail on everything
Actions, alarms, and overrides are logged with attributable, time-stamped records.
Bounded autonomy
Agents act within validated control envelopes and can be reviewed and rolled back.
Runs where the vials are
Perception and control execute at the isolator edge for deterministic latency.
Integrations
Sits on top of the systems you already run.
Sterira connects to filling machines, isolators/RABS, lyophilizers, inspection systems, and MES over API and OPC UA, read-first, then graduating to control as validation is established.
See all integrations →Why unified
Single machines automate a step. Sterira runs the suite.
| Capability | Point systems | Sterira |
|---|---|---|
| Aseptic fill control | Some | Yes |
| AI visual inspection + CCI | Separate vendor | Unified |
| Lyo cycle optimization | Manual | Autonomous |
| Live contamination model | Sampled | Real-time |
| One release audit trail | Fragmented | Single trail |
| Data compounds across steps | No | Flywheel |
"Unifying inspection, environment, and review under one trail changed how fast we release. Deviations that used to take days now surface in minutes."
Sterile injectables manufacturer
Go deeper
Explore each agent.
Fill & Dose →
Aseptic filling control on shear-sensitive biologics.
Inspect & Release →
AI visual inspection without false rejects.
Lyophilization →
Cycle optimization that protects the cake.
Contamination Control →
Live environmental risk under Annex 1.
Robotic Handling →
Gloveless aseptic manipulation.
Batch Review →
Release by exception with a Part 11 trail.
See the whole suite run autonomously.
Start with one line, prove the metric, and expand across the site.