CRXR
Clean-Room AR QMS Extension for Bio-Pharma
"Minimise compliance errors and workflow disruption when executing quality control procedures in sterile pharmaceutical manufacturing environments"
CRXR is an augmented reality system for bio-pharmaceutical clean-room manufacturing environments. It provides real-time procedural guidance, quality control verification, and compliance documentation directly in the operator field of view without compromising sterile environments or introducing contamination risk.
Validated manufacturing contexts
Aseptic manufacturing procedures
Step-by-step AR guidance for sterile compounding, filling, and packaging procedures with real-time compliance verification and automated documentation.
Bio-Pharmaceutical Manufacturing
Equipment qualification and validation
IQ/OQ/PQ protocols delivered via AR with digital evidence capture, reducing paper documentation and improving audit readiness.
Bio-Pharmaceutical Manufacturing
Operator training and competency assessment
Immersive training scenarios and performance metrics for clean-room operators with automated competency validation and refresher training triggers.
Bio-Pharmaceutical Manufacturing
Clean-room validated capabilities
GMP-compliant hardware
Sterile-compatible AR headsets with cleanable surfaces, particle-free operation, and validated cleaning procedures for ISO Class 5-8 environments.
Procedure-driven AR overlays
Real-time procedural steps, equipment identification, and quality control checkpoints displayed in operator field of view without disrupting workflow.
Automated compliance documentation
Digital batch records, timestamped procedural evidence, and 21 CFR Part 11 compliant electronic signatures captured automatically.
Environmental integration
IoT sensor integration for temperature, humidity, particle count, and differential pressure monitoring with AR-displayed alerts.
Pilot programme results
Measured across pilot deployments through quality management system data
New operators reach validation thresholds faster with AR-guided training
Digital documentation and automated capture reduce manual transcription
Regulatory compliance frameworks
EU GMP Annex 1 (2022)
Compliance with revised sterile manufacturing requirements including contamination control
21 CFR Part 11 (FDA)
Electronic records and electronic signatures for pharmaceutical manufacturing
ISO 14644 Cleanroom Standards
Cleanroom classification, monitoring, and equipment validation requirements
ICH Q10 Pharmaceutical Quality System
Quality risk management and continuous improvement frameworks