Integrated Environmental Monitoring System

RIGEL IEMS Next

The most 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 basing on a standard platform fully compliant with 21CFR part11 and Annex 11. The system will assure the availability of the necessary reports to meet the GMP requirements, and will have the possibility to exchange information with different station installed in different areas of the plant, as well as with different repositories. Many different architectures can be foreseen, ranging from the basic 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 his own central system designed in order to customize every solution for each customer. The Integrated Environmental Monitoring System (IEMS) is a distributed open-architecture system designed to provide a complete and singular solution for monitoring all of the environmental parameters required by the GMPs and ISO Standards:
The cabinet is basically composed by 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 generation of trend for non-viable particles based on histogram view – The first environmental monitoring system that uses histogram for describe particles concentration.

Statistical analysis included on IEMSNext software as required from
ISO standard 14644-2:2015

Alternate Stategy 1: A trigger threshold value based on series of consecutive higher readings. The higher readings trigger a warning based upon the occurrence of a higher level of counts being maintened 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