Computerimplementiertes Verfahren zur Berechnung eines Prozessrisikos bei Biopharmazeutischen Herstellungsverfahren

Details

Veröffentlichungs-Nr.

EP4756686

Anmeldetag

6. Dezember 2024

Veröffentlichung

10. Juni 2026

Rechtsraum

EP

Abstract

The invention relates to a computer implemented method (100,200,300) for automatically determining a process risk (62) of a biopharmaceutical manufacturing process. A video-recorded process is segmented (120) into microsteps (34), for each microstep (34) a complete list of all possible hazards (54) is retrieved. For each hazard (54), a weighted hazard criticality (WHC) (58) is calculated based on automatically determined risk factors (56) as well as additional risk moderators (72). A process frame library (50), based on a property graph database (74) architecture, stores verified reference process frames (34) along with potential hazards (54) and associated risk data (56). Manufacturing process simulation is enhanced by this data-driven and automated risk assessment, enabling more effective risk management and advanced manufacturing process optimization.

Anmelder

Firma

Innerspace GmbH

Land

🇦🇹 Österreich