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Environmental Monitoring Systems

Digitalize environmental monitoring aiding Life Sciences regulatory compliance.

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Life Sciences regulatory compliance

Monitoring storage and production environments typically requires regulatory compliance along with demands for safe and effective monitoring systems that will protect a pharmacy’s livelihood and patient health.

Regulatory bodies including the FDA, EMA, CDSCO, NMPA, MHRA and ANVISA, as well as global institutions and associations like the WHO, ISPE, PIC/S, emphasize the need for accurate measurement, data integrity, and secure recording of critical process parameters (CPP). This requirement exists for pharmaceutical laboratories and manufacturing environments.

Discover key updates to EudraLex GMP guidelines, Annex 1 >

Electronic data recording

FDA 21 CFR Part 11 and EudraLex Annex 11 regulations apply. Recorded data should comply with ALCOA+ principles for data integrity as specified in:

FDA 21 CFR Part 211, 68, 188, and 192
EudraLex Vol. 4, Chapter 4, Guidelines
EudraLex Vol. 4, Annex 17, Real time release testing and parametric release
EudraLex Vol. 4, Chapter 4, Guidelines
MHRA Guidance on GxP data integrity
WHO Guidance on good data and record management practice

EMS Regulations White Paper >

Application guidances

Guidance on how to implement compliant EMS and BMS systems are detailed in:

ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning
ISPE Baseline® Guide: Active Pharmaceutical Ingredients, Revision to Bulk Pharmaceutical Chemicals
ISPE Baseline® Guide, Volume 2: Oral Solid Dosage Forms
ISPE Baseline® Guide, Volume 3: Sterile Product Manufacturing Facilities

EMS ISPE Guidance and Best Practices White Paper >

An optimized approach: BMS and EMS segregation

Traditional facility management systems use a building management system (BMS) to serve GxP and non-GxP areas. However, this method can lead to higher CapEx and significant OpEx.

A GMP compliant EMS performs important data related tasks such as monitoring critical process parameters. This requires qualification and validation activities that are not necessary for the BMS Good engineering practice (GEP) implementation.

ISPE guidance suggests considering the segregation of building management systems and environmental monitoring systems (EMS). Therefore, Eurotherm approaches EMS solutions with segregation in mind to help eliminate unnecessary qualification and validation time and costs in the BMS.

Eurotherm Digital Engineered Solutions for Environmental Monitoring Systems

Embracing digitalization and adopting industry best practices, designed to aid compliance to FDA 21 CFR Part 11, EudraLex Annex 1 and Annex 11, and Good Practice guidelines.

Sustainability

Adopt a paperless environmental monitoring solution to:

Reduce the use of paper records, and historical data archives
Ease compliance to best practices
Help reach net-zero emissions

Digitalization

Digitalize your systems and increase your data utilization to:

Make informed decisions
Easily visualize and analyze information
Help avoid gaps in the historian database and support Data Integrity ALCOA+ principles

Discover ALCOA+ principles >

Efficiency

Future proof the monitoring of your storage and production environments by:

Segregating the BMS from the EMS for a more efficient operation
Generating reports automatically or on-demand
Using fit-for-purpose sensors to help increase accuracy of the EMS and reliability of the BMS (wireless option available)

Cybersecurity

Adopt a defense-in-depth cybersecurity approach to achieve multiple physical and digital protection layers:

Use controller and data acquisition products offering communication robustness and user access features

Explore our cybersecurity expertise >

Discuss your EMS requirements

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Plug and produce

A flexible technology architecture that can deliver:

Operational technology (OT) data processing
Contextualized audit trail
Alarm deviations
Real-time process data
Historical process data

Such data is provided in a format that can serve manufacturing execution system (MES) platforms and analytics services.

Quality by design

In a QbD approach, product quality is continuously monitored and controlled at the earliest stages.

As defined by the process analytical technology (PAT) approach, Eurotherm on-premise or remote EMS digital engineered solutions can assist in achieving manufacturing efficiencies through data measurement and root cause analysis on CPP deviations. Eurotherm digital engineered solutions (DES) can produce exception reports and time-stamped evidence for the correlation of parameter behaviors at their occurrence.

Scalable architectures from room to enterprise level

Simplex architecture

Recorder or PAC based
Report enabled
Entry level, commercial off-the-shelf application

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Redundant architecture

Mid-size applications
Report centric
Peace of mind validation

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Zero downtime architecture

Object oriented
SQL based
Reusability, modularity, open connectivity

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Are you looking for a science-based solution for sterile and aseptic environments?

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System lifecycle support services

Eurotherm has developed a wide range of services, designed to meet the quality standards required by the Life Sciences industry.

Project design and construction per ISPE GAMP 5 good engineering methodology
Calibration services
Service Level Agreements and global alliance agreements for improved plant efficiency

Discover Life Sciences services >