BiOS
Facility Risk Assessment
HelixForge Biologics
Excerpt · Risk register (partial)
Confidential · Sample
Facility / utilities interface risks
HelixForge plans to add a second upstream train inside Building C while retaining shared WFI, clean steam, and corridor airflow with an existing commercial suite. The assessment focuses on failure modes at those shared interfaces—not a full facility redesign.
| ID | Risk | Interface | Likelihood | Impact | Near-term control |
|---|---|---|---|---|---|
| F-03 | WFI peak demand exceeds generation during dual CIP windows | Utilities ↔ Upstream | Med | High | Stagger CIP; meter peak; temporary campaign rule |
| F-07 | Pressure cascade upset when new airlock opened mid-shift | HVAC ↔ Personnel flow | Med | Med | Door interlock SOP + differential alarm response |
| F-11 | Waste hold tank capacity insufficient for dual harvest day | Waste ↔ Scheduling | High | Med | Harvest calendar constraint until tank #2 online |
| F-14 | Emergency power coverage gap for new cold room | Power ↔ Materials | Low | High | UPS bridge + material relocation protocol |
Executive read
Three of four top risks are solvable with operating rules before capital. Capital only required if dual-train campaigns become the steady state within 12 months.
Full sample includes heat map, dependency diagram, and mitigation owners (not shown).