Agent 05 · environment-and-contamination
Contamination risk you can see in real time.
Sterility is proven days late by plates in an incubator. The environment-and-contamination agent fuses viable, non-viable, air, and personnel data into a live risk model, the Contamination Control Strategy that Annex 1 now demands, made continuous.
The problem
Sterility assurance arrives too late to act on.
Viable monitoring is inherently retrospective, you learn about a contamination event days after the batch is filled. Meanwhile Annex 1 demands a holistic, live Contamination Control Strategy that manual monitoring can't produce.
- Plates read days after the risk occurred.
- Signals live in disconnected monitoring systems.
- Personnel interventions are the top risk, unquantified.
How it works
Fuse every signal into one live picture.
- 01
Ingest all monitoring
Viable, non-viable, air velocity, differential pressure, and personnel data streamed together.
- 02
Model the environment
Airflow and ingress physics turn point samples into a spatial risk field.
- 03
Score risk live
A continuous contamination-risk index replaces the days-late plate result.
- 04
Trigger action
Rising risk prompts intervention, robotic handling, or line hold before the excursion.
Capabilities
A living Contamination Control Strategy.
Sensor fusion
Unifies viable, non-viable, air, and utility monitoring in one model.
Personnel risk
Quantifies the contamination risk of each gowned intervention.
Airflow modeling
Spatial ingress and recovery modeled from real velocity data.
Early warning
Flags rising risk before a formal excursion is recorded.
Annex 1 evidence
Generates the holistic CCS documentation regulators expect.
Robotics handoff
Routes high-risk tasks to the robotic-handling agent to remove people.
Interventions
Remove people, remove the top risk.
Gowned human interventions are the single largest source of contamination. By quantifying each one and routing high-risk tasks to robotics, the agent drives aseptic-intervention deviations down sharply.
See robotic handling →Under the hood
Continuous, holistic, defensible.
Risk, not retrospect
A continuous index instead of a plate result days later.
One CCS model
All monitoring streams fused into the strategy Annex 1 requires.
Pre-excursion action
Interventions and holds triggered before a deviation is written.
Manual monitoring vs. Sterira
Live beats retrospective.
| Behavior | Manual monitoring | Contamination agent |
|---|---|---|
| Risk timing | Days late | Real-time |
| Fuses all signals | No | Yes |
| Quantifies interventions | No | Yes |
| Annex 1 CCS evidence | Manual | Generated |
"For the first time we can act on contamination risk during the batch instead of investigating it a week later. Annex 1 stopped being a documentation exercise and became an operational tool."
Aseptic fill-finish site
FAQ
Common questions.
No. It fuses your existing viable and non-viable monitoring into a live risk model, the microbiology still happens; the agent makes it actionable in real time.
It produces the holistic, continuously updated Contamination Control Strategy that the revised EU GMP Annex 1 expects, with the supporting evidence. See validation.
Yes, within a validated envelope. Actions escalate from alert to intervention to hold based on the autonomy level you set per workflow.
Turn Annex 1 into a live operational tool.
Pilot the contamination agent and act on risk during the batch.