EMS – Environmental Monitoring System
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
Project life cycle overview
Our approach for the implementation of an effective and robust EMS is based on design and executive stages that satisfy regulatory requirements with simple integration between the hardware and software of manufacturing equipment.