Line
$14k/ line / mo
One process agent on a single fill or inspection line.
- Edge perception & control
- Part 11 audit trail
- Defined-metric pilot
Physical AI · Sterile fill-finish autonomy
Every dose,
perfectly sterile.
Sterira is the autonomous operations layer for sterile pharmaceutical fill-finish. It runs aseptic filling, seal & container-closure integrity, lyophilization, AI visual inspection, contamination control, robotic handling, and batch review, all inside your validated envelope.
- Validated for
- Annex 1 · 21 CFR Part 11 · GAMP 5
- Deploys at
- The isolator edge
GRADE A ISOLATOR · LINE 03AUTONOMOUS
Fill accuracy0%
Viable count0 CFU
CCISEALED
Rejects0%
The formats, isolators, and standards you already run.
VIALS
PREFILLED SYRINGES
CARTRIDGES
LYOPHILIZED
GRADE A ISOLATOR
RABS
EU GMP ANNEX 1
21 CFR PART 11
GAMP 5
OPC UA / MES
The problem
Fill-finish is a black art run at the edge of physics and biology.
Sterile injectables go straight into the bloodstream, so one viable microbe, a stray glass particle, or a hairline seal breach can harm a patient and halt a line.
- Fill weights must hit micro-tolerances on shear-sensitive biologics without foaming.
- Lyo cycles span days where one wrong ramp collapses the cake or ruins potency.
- Every gowned intervention is a contamination risk a failed media fill can shut down.
- The aseptic experts who govern release are a scarce, aging craft.
- #1
- cause of FDA 483 observations: deviations and human-borne contamination
- 100%
- of units must pass inspection before a batch can ship
- $1M+
- per batch, where a single false reject scraps good product
- ~15%
- annual growth in sterile capacity demand, against a shrinking expert pool
Seven agents and a digital twin for the whole suite.
Sterira closes the loop from perception to line-and-isolator control across every stage of fill-finish. Select a stage.
Fill-and-dose agent
Controls fill weight and volume, pump and peristaltic parameters, foaming, and in-process weight checks.
The products
Six products. One aseptic suite.
Each product owns a station of the line and shares the same edge runtime, data flywheel, and Part 11 audit spine. Land one, expand to the whole suite.
FillixFill & dose
Autonomous aseptic filling that holds micro-tolerance fill weights without foaming or a gowned operator.
Explore Fillix →
VistraInspect & release
Visual inspection and CCI that catch real defects at line speed while cutting false rejects.
Explore Vistra →
LyovexLyophilization
Freeze-dry cycles you can shorten safely, without collapsing the cake or losing potency.
Explore Lyovex →
AseptaContamination control
Every contamination signal fused into one live risk picture that every other agent consults.
Explore Asepta →
RoboqRobotic handling
Gloveless robotic handling that removes the operator interventions behind most contamination.
Explore Roboq →
SimuraDigital twin
The twin and synthetic-data engine that hits spec before the batch and trains every other product.
Explore Simura →Purpose-built for each unforgiving step.
Fill & Dose
Aseptic filling control for fill weight, foaming, and in-process checks on shear-sensitive biologics.
Learn more →Inspect & Release
AI visual inspection that catches particulates, cracks, and CCI without scrapping good units.
Learn more →Lyophilization
Cycle optimization that protects cake structure and potency while cutting cycle time.
Learn more →Contamination Control
Live viable, non-viable, and personnel monitoring fused into one real-time risk picture.
Learn more →Robotic Handling
Gloveless-isolator manipulation that removes the gowned interventions driving contamination.
Learn more →Batch Review
Review by exception with a Part 11 audit trail on every decision, surfacing only what matters.
Learn more →Aseptic-line & lyo digital twin
Hit the target spec before the batch.
Sterira simulates filling, the lyophilization cycle, and contamination flow across the isolator, so the line converges on spec in silico before a single vial is filled.
Explore the digital twin →LYO CYCLE · SIMULATIONCONVERGED
Target envelopeOptimized cycle
A closed loop, from perception to control.
Sterira doesn't just observe. It acts on the line, inside your validated envelope, with a Part 11 audit trail on every decision.
- Perceive
See every vial
Edge perception fuses fill weight, particulate, CCI, and lyo state at line speed.
- Reason
Predict & decide
Physics-informed models reason against validated control envelopes and the twin.
- Act
Control the line
Agents adjust fill, seal, lyo, inspection, and handling: grounded and reversible.
- Compound
Learn per batch
Every outcome feeds the data flywheel, tightening the envelope with each release.
Built for release
Validation is the product, not an afterthought.
Sterira is architected for GMP, GAMP 5, 21 CFR Part 11 data integrity, and EU GMP Annex 1's contamination-control strategy, with grounded, auditable outputs at every step.
EU GMP Annex 121 CFR Part 11GAMP 5Grade A / RABSAudit trail by design
See our validation approach →
Grounded & auditable
Every decision traces to a signal and a rule, with a Part 11 audit trail.
Deep integration
Connects to filling, isolator/RABS, lyo, and inspection systems plus MES over API/OPC.
Edge deployment
Low-latency perception and control run at the isolator edge.
Reversible by design
Actions stay within validated envelopes and can be reviewed and rolled back.
"We stopped scrapping good, million-dollar units. Sterira's inspection agent cut our false rejects by more than half in the first quarter, and QA finally trusts the release trail."
DRDirector of Sterile Manufacturing
Top-10 CDMO · design partner
Top-10 CDMO · design partner
Land one line. Expand the suite.
Recurring SaaS with a line + site + outcome hybrid. Start on a paid pilot with a hard reject, deviation, or yield metric.
Site
$90k/ mo
The whole suite: fill/seal, inspection, lyo, environment, robotics, review, twin.
- All seven agents + twin
- Contamination intelligence
- Batch review by exception
Enterprise
Custom$0.7-8M ACV
Multi-site autonomy with custom models and a validated edge fleet.
- Multi-site & custom models
- Validation support & SLAs
- Dedicated team
What manufacturers ask first.
Yes, within validated control envelopes and with a Part 11 audit trail. Every action is grounded in a signal and a rule, is reviewable, and is reversible. You choose the autonomy level per workflow, from advisory to closed-loop control.
Sterira connects to filling machines, isolator/RABS, lyophilizers, and inspection systems plus MES over API and OPC UA. Integrations are read-first, then graduate to control as validation is established. See the integrations page.
We land with a single high-ROI workflow on a paid pilot, measured on a hard reject, deviation, or yield metric. Once proven, you expand line-by-line and site-by-site.
Sterira is architected for GMP, GAMP 5, 21 CFR Part 11, and EU GMP Annex 1. We provide validation support and documentation for regulated deployments. See validation.
Run the fill-finish suite autonomously.
Land with a single high-ROI workflow on a paid pilot, measured on a hard reject, deviation, or yield metric. Then expand line-by-line and site-by-site.
For CDMOs and pharma/biotech manufacturers running aseptic fill-finish.