Purpose-built for high-value, GMP-regulated Production.
Comecer MyDataMonitoring is a cutting-edge, real-time platform designed to transform production environments. Engineered for the stringent requirements of radiopharma and pharma environments, where short isotope half-lives, high batch value, and strict GMP/Annex 1 compliance define operational priorities, Illuminate stands as a trusted digital partner for smarter, faster, and more reliable operations.
Whether supporting automated dispensing systems or containment equipment, Comecer MyDataMonitoring ensures process integrity, maximum uptime, and predictable performance when every minute – and every dose – matters.
The OEE module delivers comprehensive real-time visibility into equipment performance by integrating three critical dimensions: Availability, Performance, and Quality – all tailored to the realities of your production:
Real-Time Monitoring
Track equipment performance continuously across all three dimensions, enabling immediate response to emerging issues.
Loss Identification
Pinpoint production losses from downtime, blocking alarms, and defects with precision analytic.
Throughput Optimisation
Identify bottlenecks and make data-driven decisions to maximise production output.
The SPC module ensures real-time tracking of all relevant critical process parameters – from chamber pressures to LAF speed, temperature/humidity, dispensing weight/activity accuracy, radiation levels, and more. With Cp, Cpk, mean, min/max, trend and drift analysis, Illuminate empowers teams to prevent out-of-spec conditions before they compromise a batch – crucial when waste is not an option.
Stability and Purity under tight tolerance
Essential for accurate dosing and radiochemical purity and to early detect deviations that would jeopardize the entire production run.
Cost control
Instead of replacing components based on rigid, pre-defined schedules, SPC leverages real-time data and advanced statistical analysis to determine exactly when intervention is needed. This data-driven approach minimizes unnecessary maintenance, reduces waste, and optimizes resource allocation – delivering significant cost savings without compromising quality.
Supports FDA / CPV compliance
By continuously monitoring critical process parameters and ensuring stability, SPC supports proactive quality management and guarantees that production remains within validated limits. The result: consistent product integrity, streamlined operations, and full regulatory confidence.
The Preventive Maintenance module provides comprehensive planning tools that span from daily operational needs to long-term life cycle strategies. With full visibility across all time horizons, maintenance teams can orchestrate both ad hoc interventions and scheduled activities with unprecedented precision, ensuring maximum equipment availability during dosing campaigns.
Strategic Planning Horizons
Plan maintenance activities across short and long-term
time frames with complete visibility, ensuring optimal resource allocation and minimal production disruption.
Intelligent Resource Management
The intuitive interface simplifies planning, resource allocation, and workflow scheduling. Configure flexible maintenance triggers based on multiple parameters: elapsed time intervals, production part counts, cumulative device runtime, and air consumption thresholds.
Integrated Dashboard Intelligence
Color-coded maintenance schedule dashboard seamlessly integrates with production data, delivering early warning alerts and real-time status updates.
The Vision Package module integrates event-triggered and high definition video capture technology to provide unprecedented visibility into the process. This powerful diagnostic tool enables rapid root cause analysis and effective troubleshooting of complex issues that would otherwise remain invisible.
Flexible Deployment
Camera systems support integrated mounting for wide-angle view of the main chamber or Drawing System installation, and standalone configurations for close-up view of the process, adapting seamlessly to diverse production environments and specific operational requirements.
Recording Modes
Live stream mode: Real-time visualization enables immediate service monitoring and instant issue detection, allowing operators and engineers to observe processes as they occur.
Time frame mode: captures short recordings before and after trigger events for detailed incident analysis.
Accelerated Maintenance and Troubleshooting
Streamlines maintenance workflow and dramatically reduces troubleshooting time through visual evidence and remote support capabilities. An essential tool for troubleshooting in closed, shielded environments where direct observation is not possible.
The Parts Traceability module provides a complete serialized history and birth record for every vial, delivering unparalleled visibility into the entire production life cycle. By capturing detailed information on the status of each vial and process characteristics, this solution ensures full compliance, quality assurance, and operational transparency.
Comprehensive Data Captures
The module captures every detail required for complete
part traceability, ensuring that no step in the process is overlooked.
Operator actions and process characteristics are logged alongside incoming IoT data, creating a rich, real-time view of production. This depth of information empowers radiopharma and pharma manufacturers to maintain strict quality standards, streamline audits, and achieve full transparency across the entire life cycle.
Full GMP/FDA Compliance
Where dose sterility and radiation safety are crucial, full traceability minimizes risk and dramatically reduces investigation times. By providing complete and verifiable records in compliance with GMP and FDA requirements, this module speeds up investigations and supports seamless validation, which is essential for preserving product integrity and patient safety.
The Predictive Maintenance module leverages advanced analytics to monitor equipment performance and detect anomalies before they lead to downtime. By analyzing device cycle time data and assigning health scores, this solution enables proactive maintenance planning and minimizes unexpected failures – ensuring maximum efficiency and reliability. Built around the unique constraints of radiopharmaceutical and pharmaceutical production.
Proactive Anomaly Detection
Continuously evaluates historical and real-time data to identify subtle changes in equipment behavior, allowing early intervention and reducing costly disruptions.
Comprehensive Health Scoring
Generates device health scores based on consolidated metrics and trends, providing clear visibility into performance status and prioritizing maintenance action.
Performance Without Surprises
Supports predictive strategies that extend equipment life, optimize maintenance schedules, and safeguard production continuity – critical for high-compliance environments.
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