Environmental Monitoring System

RIGEL DATA Next

Modular EMS architecture engineered for GMP cleanrooms, particle, microbial, microclimate and vacuum, unified under one validated data layer.

  • Modular. Seven hardware modules, configured not customized. Add capacity without rewriting architecture.
  • Validated by design. GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and ALCOA+ are embedded in the architecture, not bolted on.
  • Open. Profinet downstream, OPC UA / Modbus / digital I/O upstream. No proprietary lock-in toward SCADA, BMS, MES or LIMS.
  • Reduced footprint. Up to 50% lower in height vs typical rack-based EMS in equivalent configurations.
  • One software platform. From a single isolator to a multi-department site, the same IEMS Next SCADA and configuration tool.

Contact us to learn more about the RIGELDATA Next

Contact us

Environmental Monitoring System

Monitoring you can defend

A modular EMS architecture engineered for GMP cleanrooms — particle, microbial, microclimate and vacuum, unified under one validated data layer.

In a GMP cleanroom, the environmental monitoring system is the spine your validation rests on. Particle counters, microbial samplers, microclimate sensors and vacuum infrastructure must work together, and the data they produce has to be traceable, defensible in an audit, and integrated with the rest of the facility automation. Data Next is built to do exactly that, without forcing you to compromise on architecture, compliance or footprint.

How the system is organised ​

Seven hardware modules form the foundation of every Data Next installation. They are designed to be configured, not customised: facilities differ, but the building blocks remain the same.

Controller

Central PLC for data acquisition, alarm logic and SCADA communication.

Airflow

8-port Rigel manifold with solenoid valves and integrated flow meters for sampling line management.

I/O

Field expansion (AI / DI / DQ), 8 to 96 channels per module.

Vacuum Controller

Centralised vacuum pump control and diagnostics over Profinet.

Energy

100–240 Vac power distribution with circuit protection and optional UPS interface.

PoE

24-port industrial PoE++ switch for distributed sensor networks.

Data Next OMNIA

Compact all-in-one node with built-in PLC, I/O and onboard SCADA server for plug-and-play small installations.

Integrated Environmental Monitoring System

Architecture overview

At the centre of every Data Next installation is the Controller Module, which orchestrates the field modules over Profinet IRT. Each module is plug-and-play within the configured topology, and exposes its data upstream to the IEMS Next SCADA platform via OPC UA. Modbus TCP/RTU and digital I/O remain available for integration with BMS, MES, LIMS and Active Directory.
Small lab or compounding suite
1× Data Next OMNIA
1–4
Single cleanroom or isolator suite
1× Controller + 2× Airflow + 1× Vacuum
8–16
Mid-size facility, multi-area
1× Controller + 6× Airflow + 2× I/O + 1× Vacuum + 1× PoE
24–48
Multi-department site
Distributed Controllers + multiple Airflow / I/O / PoE + redundant Vacuum
60+

Compliance is built in, not bolted on

GAMP 5 second edition, 21 CFR Part 11, EU GMP Annex 11 and ALCOA+. The audit trail is part of the system architecture, not a separate module. Every record is traceable to the user, the location and the conditions under which it was collected. The evidence an inspector is going to ask for is already there. Calibration of connected instruments is supported by Rigel’s ACCREDIA n. 01837, ISO/IEC 17025 accredited scope.

Footprint and deployment

Three deployment options are supported: standalone, terminal server with thin clients, and virtualised centrally managed VM. The mechanical footprint is reduced by approximately 50% in height, 25% in depth and 15% in width relative to commonly available modular EMS in equivalent configurations, so Data Next easily fits inside standard 19″ rack cabinets and technical rooms where space is already negotiated.

Controller module

Central PLC for data acquisition, alarm logic and SCADA communication

Your monitoring system is only as defensible as the controller that runs it. The Data Next Controller Module is built around a Siemens CPU platform, the same architecture qualified across the pharmaceutical and life sciences industry. It coordinates the Airflow, I/O, Vacuum, PoE and Energy modules over Profinet and communication with the IEMS Next SCADA layer for real-time visualisation, alarm management and 21 CFR Part 11 compliant data integrity. Power is delivered by an internal 24 Vdc supply, with stackable or 19″ rack mounting. The architecture is open: Profinet for the field, OPC UA and Modbus toward the rest of your stack.

Features

  • Powered by Siemens CPU platform
  • Up to 5 configurable I/O sub-modules (AI / DI / DQ)
  • IEMS Next / GE iFIX SCADA communication, 1-second data refresh
  • 21 CFR Part 11 compliant audit trail at controller level
  • Open architecture: Profinet, OPC UA, Modbus TCP/RTU
  • Compact 2U Rigel enclosure
  • Designed for cleanroom environments — EMC, RoHS, CE

Applications

  • Centralised EMS for pharmaceutical cleanrooms
  • Aseptic manufacturing and fill-finish facilities
  • Multi-area / multi-department EMS deployments
  • Integration into existing SCADA, BMS and MES stacks
  • Migration from legacy EMS to modern architectures
  • Hospital pharmacy compounding and ATMP suites

Technical specifications
Product code
Data Next Controller Module
CPU
Siemens CPU
Expansion
Up to 4 sub-modules (AI / DI / DQ in any combination)
Communication
Profinet IRT downstream · OPC UA / Modbus TCP/RTU upstream
Power supply
100–240 Vac → 24 Vdc · 300 W output · internal industrial PSU
Mains inlet
IEC C14 with fuse holder and rocker switch
Mounting
Stackable or 2U — 19″ rack module
Operating temperature
0 to +55 °C · storage −30 to +60 °C, non-condensing
Compliance
GAMP 5 · 21 CFR Part 11 · IEC 62368-1 · EMC · RoHS · CE

Airflow Module

8-port manifold for particle and microbial sampling line management

Sampling reliability comes from the airflow path, not only from the counter. The Data Next Airflow Module is built around a Rigel-branded 8-channel custom manifold with built-in solenoid valves and an integrated mass flow meter on each line. Control is handled by a Siemens ET200SP head with analog inputs and digital outputs, so every valve actuation and every flow reading lives in the same Profinet data stream as the rest of the system.

Features

  • 8-channel Rigel custom manifold, quick-connect fittings
  • Internal 2-way solenoid valves
  • Real-time mass flow meter, one per line
  • Stackable design, VHP-compatible enclosure
  • Internal 100–240 Vac → 24 Vdc / 150 W power supply

Applications

  • Multi-point particle monitoring (multi-brand compatible)
  • Active air microbial sampling with Hebas series (25 / 28.3 LPM)
  • Mixed particle + microbial sampling lines under one manifold
  • Aseptic fill-finish lines with continuous monitoring requirements

Technical specifications
Product code
Data Next Airflow Module
Manifold
Rigel 8-port · 1/4″ G ports · plugs for unused ports
Valves
2-way solenoid · Ø7 mm · 24 Vdc
Flow meter
Integrated mass flow meter · 1% accuracy
Sampling flow rate
Up to 28.3 L/min per channel
Power
100–240 Vac → 24 Vdc · 300 W · IEC C14 inlet with fuse and switch
Mounting
Stackable or 2U — 19″ rack module
Operating temperature
0 to +55 °C, non-condensing
Compliance
GAMP 5 · IEC 62368-1 · CE · EMC · RoHS

I/O Module

Scalable AI / DI / DQ expansion for sensors, alarms and actuators

Every facility wires environmental sensors differently. The Data Next I/O Module is built to absorb that variability without forcing custom hardware. Based on a Siemens ET200SP head, it covers 4–20 mA analog inputs, digital inputs and digital outputs in pre-defined configurations from 8 to 96 channels per module. Wiring is standardised on 16-pin push-in and feed-through connectors, so panel build and field commissioning move faster, and so service interventions do not depend on a single technician’s memory.

Features

  • Mixed AI / DI / DQ configurations up to 96 channels
  • Analog inputs 4–20 mA, isolated
  • Digital inputs 24 Vdc
  • Digital outputs 24 Vdc, 0.5 A
  • Standardised 16-pin push-in connectors
  • Hot-swappable Siemens ET200SP modules

Applications

  • Microclimate sensor integration (T°, RH, ΔP)
  • Door contact and pressure cascade monitoring
  • Alarm beacon / horn / actuation
  • Third-party sensor integration via 4–20 mA
  • Distributed field cabinets requiring local I/O concentration
  • Retrofit projects with mixed analog + digital signal inventory
  • Dry contact exchange signal for third-part machine

Technical specifications
Product code
Data Next I/O Module
Channels
8 to 96 per module · AI / DI / DQ configurable
Analog inputs
4–20 mA, isolated, 16-bit resolution
Digital inputs
24 Vdc, sink/source configurable
Digital outputs
24 Vdc · 0.5 A per channel · short-circuit protected
Power
100–240 Vac → 24 Vdc · 300 W · IEC C14 inlet with fuse
Mounting
Stackable or 2U — 19″ rack module
Operating temperature
0 to +55 °C, non-condensing
Compliance
GAMP 5 · IEC 62368-1 · CE · EMC · RoHS

Vacuum Controller Module

Centralised vacuum generation and diagnostics for sampling networks

Continuous particle monitoring depends on a vacuum source that does not fail silently. The Data Next Vacuum Controller Module provides centralised pump control with motor management over Profinet, real-time diagnostics on line pressure and run hours, and direct integration with the Data Next Controller so sampling cycles only proceed when vacuum conditions are met. Sized for multi-channel pharma installations, the module supports redundant pump configurations on request and exposes alarms to SCADA the moment a deviation appears, not at the end of the shift.

Features

  • Centralised vacuum pump control over Profinet
  • Motor protection and soft-start management
  • Continuous monitoring of motor status and line vacuum
  • Interlock with Airflow Module sampling cycles
  • Run-hour tracking for predictive maintenance
  • Alarm routing to IEMS Next SCADA in real time
  • Redundant pump configuration available on request

Applications

  • Multi-room continuous particle monitoring networks
  • Centralised vacuum systems serving up to 96 sampling points
  • Aseptic processing facilities with 24/7 sampling
  • Installations replacing dedicated pump-per-counter architectures
  • Sites requiring redundant vacuum source for critical points

Technical specifications
Product code
Data Next Vacuum Controller Module
Vacuum sensor
Huba Control 528 pressure transmitter (or equivalent)
Vacuum range
0 to −1 bar · configurable per application
Pump compatibility
Becker, Busch, PWR, DVP and equivalent oil-free rotary vane pumps
Diagnostics
Motor current · line vacuum · run hours · over-temperature
Power
24 Vdc internal · pump motor sized per project (typ. 400 Vac 3-phase)
Mounting
Panel mount
Compliance
GAMP 5 · IEC 62368-1 · CE · EMC · RoHS · UL 508A optional

Energy Module

Cleanroom-grade power distribution with circuit protection and surge management

Every signal in Data Next is only as defensible as the power line behind it. The Energy Module centralises 100–240 Vac mains distribution to the rest of the rack stack, with per-line circuit protection, surge management and an optional UPS interface. Power conversion is handled by industrial Traco Power TXO series supplies, dimensioned per project, and grounding follows a single chassis reference for clean signal integrity across all modules.

Features

  • Centralised 100–240 Vac distribution to the module stack
  • Per-line circuit protection with double fuse holder
  • Single-point chassis grounding for clean signal reference
  • Optional UPS interface for ride-through and graceful shutdown
  • Mains entry via IEC C14 inlet with switch and integrated fuse
  • Compatible with single- and dual-column rack configurations

Applications

  • Centralised power for full Data Next stacks
  • Sites requiring auditable circuit protection traceability
  • Installations with site-level UPS backbone
  • Multi-department deployments with distributed power architecture
  • Facilities upgrading from distributed PSUs to centralised power management

Technical specifications
Product code
Data Next Energy Module
Mains input
100–240 Vac · 50/60 Hz · single-phase
Output
100-240 Vac
Protection
Per-line fuse · thermal protection · surge protection
Distribution
Up to 6 protected DC output lines
UPS
Optional dry-contact / signal interface
Mains inlet
IEC C14 with integrated fuse and rocker switch
Mounting
Stackable or 2U — 19″ rack module
Compliance
IEC 62368-1 · CE · EMC · RoHS

PoE Module

Industrial Power over Ethernet for distributed sensor networks

Modern cleanroom monitoring is moving toward Power over Ethernet: one cable for power, the same cable for data, one less point of failure. The Data Next PoE Module is built around an industrial 24-port PoE++ managed switch (IEEE 802.3bt). It powers PoE-enabled remote particle counters such as the Rigel Aerix Remote⁺ 4101, and any third-party device that supports the standard. Layer-2 management and VLAN support keep monitoring traffic segregated from facility IT.

Features

  • 24 PoE++ ports (IEEE 802.3bt)
  • Industrial-grade managed switch (VLAN, IGMP snooping, QoS)
  • Centralised power for compatible remote sensors
  • Backward compatibility with 802.3af / 802.3at devices
  • Fibre uplinks available for long-run deployments

Applications

  • Distributed networks of Aerix Remote⁺ particle counters
  • New cleanroom builds aiming to reduce cabling footprint
  • Segregated OT networks for environmental monitoring traffic
  • Multi-room installations with shared switch infrastructure

Technical specifications
Product code
Data Next PoE Module
Switch type
Industrial managed Layer-2 PoE++
PoE ports
24 × RJ45 · IEEE 802.3bt
Uplinks
Fibre / copper, configurable per project
Power
100–240 Vac internal supply
Mounting
Stackable or 2U — 19″ rack module
Diagnostics
Per-port link / PoE status · cable diagnostics · port mirroring
Compliance
IEC 62368-1 · IEC 62443 (segmentation) · CE · EMC · RoHS

Data Next OMNIA

Compact field node for reduced sampling installations and remote points

Not every monitoring point justifies a full cabinet. Data Next OMNIA is a compact field node designed for installations with reduced sampling needs — small cleanrooms, isolators with one or two sampling points, satellite labs and laboratory hoods, or sites where a centralised Data Next will be added later. It uses the same Siemens core and the same SCADA layer as the full system, so an OMNIA deployed today integrates cleanly when the site expands tomorrow. No parallel architecture, no rewriting of validation packages.

Features

  • Compact wall-mount or table-top form factor
  • Up to 4-port airflow manifold with valves and flow meters
  • Profinet to centralised SCADA when present, standalone otherwise
  • Integrated power protection
  • Cleanroom-compatible enclosure
  • Same SCADA and configuration tool as full Data Next

Applications

  • Small or pilot cleanrooms (single area, 1–4 sampling points)
  • Isolators, RABS, biosafety cabinets, single-point monitoring
  • Satellite labs and remote QC areas
  • Hospital compounding suites and operating rooms
  • ATMP facilities with distributed small-volume areas

Technical specifications
Product code
Data Next OMNIA
Airflow channels
AI 4–8 ch · DI 8–16 ch · DQ 8–16 ch (configurable)
Communication
Profinet · Modbus TCP/RTU · OPC UA upstream
Vacuum
External pump
Power
100–240 Vac, single-phase
Mounting & enclosure
Wall-mount or table-top · 450 × 300 × 350 mm
SCADA communication
Same IEMS Next platform as full Data Next
Compliance
GAMP 5 · 21 CFR Part 11 · IEC 62368-1 · CE · EMC · RoHS

Learn more about the RIGEL Data Next

Leave your email address, we will write you back

Contact us