Integrated Environmental Monitoring System

RIGEL IEMS Next

Advanced air monitoring system for clean environments

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Integrated Environmental Monitoring System

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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

IEMSArchitecture

IEMS system architecture with built-in-pump sensors
IEMS 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) 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:

The cabinet is basically composed of three main parts:

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

Alternate 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).

Alternate 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