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:
- Room and building environment
- Continuous airborne particulate
- Airborne viable particulate
Rigel’s IEMS incorporates “best of class” environmental probes, CLiMET particle counters and the Rigel High Efficiency Biological Air Sampler (HEBAS) and integrates them into the most popular interface, communication, storage and reporting technologies. The IEMS is ideal for monitoring clean rooms, filling machines, isolators, and similar controlled environments like advanced therapies laboratories, surgical theatres and micro-electronic production.
The concept of “open architecture” is fundamental to the IEMS, supplying optimal compliance while providing the flexibility to easily adapt to future requirements.
The innovative HEBAS sampling head uses the Inertial Impaction Technology to maximize the effectiveness of standard culture media.
The HEBAS head is designed to precisely direct the sample air at a low velocity onto the culture media surface:
- To assure high collection efficiency (validated according to ISO 14698/1 Annex B)
- While minimizing the severe stress and trauma of each micro-organism
In addition, contamination formed outside the controlled environment can be immediately and easily identified, significantly reducing the risk of false positives.
Each Integrated Environmental Monitoring System (IEMS) delivered is customized to precisely meet each clients individual User Requirement Specifications (URS), utilizing the best and most appropriate SCADA platform.