Continuous Environmental Monitoring System for GMP Compliance
The Environmental Monitoring System (EMS) is engineered to continuously observe environmental conditions within controlled areas, critically applying the technology of FMS application software coupled with strategically placed sensors. This setup systematically collects data on crucial process variables and environmental parameters crucial to GMP (Good Manufacturing Practices). EMS ensures adherence to various standards, including ANNEX 1 EU-GMP, which requires rigorous environmental monitoring supported by formal risk analysis and ISO 14644-2:2015, which mandates cleanroom performance validation via particulate concentration. The system boasts robust data management adhering to FDA, EU-GMP Annex-1, and ISO regulations. Key features include reliable audit trails, flexible alarm management, real-time data sharing across numerous global locations, and high compatibility with existing technology. It emphasizes comprehensive risk assessment, system integration with SCADA platforms, and alms for seamless installation, qualification, and ongoing maintenance of critical process instruments.
- Qualified, modulable and customised risk assessment and management approach that satisfy Contamination Control Strategy requirements
- Consolidated experience in integrating EMS systems with other SCADA supervision and control platforms
- Gap analysis and Remediation of existing viable and non-viable particulate monitoring systems (System Design Specification, particle loss mitigation)
- Functional testing of the on-site alarm threshold activation process for each sampling point with characteristic particulate dimensions
- TSI partnership and software licence without an annual subscription fee
- Sound after-sales service, system qualification, plant maintenance and critical process instrument calibration activities
- Cost scalability and as-needed expansion of the variables to be monitored
- Universal data sharing between all facilities
EMS is a continuous environmental condition monitoring system that combines the technology of an FMS application software and the sensors installed in and distributed throughout the environment being monitored, in order to collect information on critical process variables and environmental parameters of critical GMP (good manufacturing practices) interest.
The environmental monitoring system ensures compliance with applicable regulations:
ANNEX 1 EU-GMP – Controlled-contamination areas and UDF equipment must undergo routine monitoring under operational conditions; the monitoring positions must be identified and supported by a formal Risk Analysis study and based on the area and equipment classification results obtained
ISO 14644-2:2015 PART 2 – Monitoring must provide evidence of cleanroom performance in terms of air cleanliness based on the particulate concentration
Criteria and fundamental characteristics of the EMS
- Control, management and centralised retention of critical process variable data inspired by the principles of Data Integrity
- Reliability and robustness in the management of critical process data in compliance with regulatory requirements - FDA, EU-GMP Annex-1, ISO 14644-2
- Audit trail reliability & Part 11 Compliance
- Robust and flexible alarm management and control system with an effective capacity for anomaly detection
- High compatibility with existing technologies
- Real-time data sharing and capacity to analyse data and root causes, even between multiple geographically distant facilities
- Robust and innovative qualification (in compliance with new Annex 1 requirements)
- Adequate characterisation of measurement points and data accuracy supported by correct design and the implementation of sampling geometries