Biological control solutions

ABB has introduced its Environmental Contamination Monitoring Control System (ECMS) automation package for sterile manufacturing lines that are subject to GMP Annex 1. This integrated solution manages viable particulate sampling and controls non-viable particulates using structured recipes to monitor critical areas inside isolators during the production phases.

EMCS can be integrated in existing plants to control the CQAs (critical quality attributes) profiles and the environmental status. It does this by managing sensors, actuators, in-process samples, particle counters, biological impactors and new-generation rapid biological detection systems.

GMP Annex 1 requires the detection of particles sized between 0.5 µm and 5 µm and also a specific air flow profile through the biological impactors where the Petri dishes are housed. ECMS manages the particle counters and maintains the flow rate profile by controlling valves according to the mass flow-meter readings as per the GMP Annex 1 requirements. The EMCS program generates deviation alarms and allows the operators to perform bio-decontamination sequences on a batch production and sterilize the isolator by using VHP — vapors of hydrogen peroxide.

The EMCS system is equipped with both ABB Essential Automation and 800xA Extended Automation lines, which have a modern and modular DCS-based architecture. EMCS is supplied in a rack version, suitable for pharmaceutical applications, complying with 21CFR part 11, and can be standalone or integrated into a wider automation system.

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