Integrated Environmental Monitoring System
RIGEL IEMS Next®
Advanced air monitoring system for clean environments
- Multiple instruments integration
- Superior real-time characterization of the area being monitored
- Rapid Assessment of the alert and action levels
- Fully optimized reporting for a comprehensive events' analysis
- Statistical trend analysis of the rare and impulsive events
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Integrated Environmental Monitoring System
RIGELIEMS Next® video
Integrated Environmental Monitoring System
SCADASOFTWARE
The SCADA will be developed on the basis of a standard platform fully compliant with 21CFR part11 and Annex 11. The system will ensure the availability of the necessary reports to meet the GMP requirements and will have the possibility to exchange information with different stations installed in different areas of the plant, as well as with various repositories. Many different architectures can be foreseen, from the basic one with a single server on a physical machine, to more complex architectures with redundant servers and/or multiple client stations, on physical or virtual machines.
Integrated Environmental Monitoring System
IEMS Next® Architecture
IEMS Next® system architecture with built-in-pump sensors
IEMS Next® system architecture with remote sensors and dedicated vacuum source
Integrated Environmental Monitoring System
RIGELMain Electrical Cabinet
Rigel has its own central system designed to customize each solution for each customer. The Integrated Environmental Monitoring System (IEMS Next®) is a open-architecture distributed system designed to provide a complete and unique solution for monitoring all environmental parameters required by the GMPs and ISO Standards:
- Room and building environment;
- Continuous airborne particulate;
- Airborne viable particulate;
- Air velocity;
- Continuous airborne real time viable particulate.
The cabinet is basically composed of three main parts:
- An electrical section, providing the necessary power supply to the cabinet itself and the on-field instruments;
- An electronic section based on a PLC, managing all the components of the monitoring system and exchanging data with the SCADA and all the eventual HMIs
- Manifold section able to supply and ensure a continuous and efficient vacuum condition for each vacuum line .
Integrated Environmental Monitoring System
NEXTGeneration of Trend & Report
IEMS Next® provides the most advanced solution for detect rare event (macro particles >5.0µm) on Grade A (ISO 4.8) through an innovative algorithm under patent protection ™
New trend generation for non-viable particles based on histogram display – The first environmental monitoring system that uses the histogram to describe particle concentration.
Statistical analysis included on IEMSNext® software as required by
ISO standard 14644-2:2015
Alternative Stategy 1: A trigger threshold value based on series of consecutive higher readings. Higher readings trigger an alert based on the occurrence of a higher level of counts held over a period of time (for example, three consecutive 1-min readings all above a specified level).
Alternative Stategy 2: A threshold value trigger based on a high frequency of elevated readings. Sometimes referred to as “x out of y”, this strategy records readings that are above a specified threshold; if a sufficient number of readings in a series are above the specified values then an alert or action alarm is triggered. For example, if 3 out of the last 10 readings are above a threshold then an alert or action alarm will be triggered
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Integrated Environmental Monitoring System
Compliance with latest regulatory requirements
