The continuation of DTC's sterile monitoring and sterile filling expertise into a comprehensive AI software suite. SterileOps AI brings pharmaceutical-grade contamination control to hospitals, elder-care facilities, food processors, and sterile packaging lines — with digital audit trails, QA batch linking, and FDA PAT-aligned documentation.
Core Features
- Gowning compliance vision — camera-based donning/doffing verification
- Surface contamination risk scoring from swab and sensor data
- Airlock event logging with door-open and pressure-differential alerts
- HEPA filter status and airflow monitoring integration
- Sterile line intervention tracking and deviation logging
- Batch contamination risk score tied to BioCommand alerts
- Cleaning verification records with timestamp and staff assignment
- Digital audit packet generation for FDA 21 CFR Part 11 compliance
Target Markets
- Pharmaceutical fill-finish suites and CMOs
- Hospital operating rooms and ICU environments
- Ambulance and emergency vehicle contamination tracking
- Food processing and packaging cleanrooms
- Elder-care and nursing home infection-control programs
- University research labs with biosafety requirements
- USDA and FDA inspected food production facilities
FDA Alignment
- Process Analytical Technology (PAT) framework compliant
- 21 CFR Part 11 electronic records and signature support
- Risk-based contamination scoring per ICH Q10 pharmaceutical QMS
- Cleaning validation documentation for drug manufacturing suites
- Environmental monitoring data trending for NDA/BLA submissions
Learn More About SterileOps AI
Contact the PandemiCure team to discuss pilot programs, integration with your existing systems, or investment opportunities.