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 alogn with demands for safe and effective monitoring systems hat 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 requirements exists for pharmaceutical laboratories and manufacturing environments.
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 paramedic 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
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
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 visualized and analyze information.
- Help avoid gaps in the historian database and support Data Integrity 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:
- User controller and data acquisition products offering communication robustness and user access features.
Are you looking for a science-based solution for sterile and aseptic environments?
Plug and produce
A flexible technology architecture that can deliver:
- Operational technology (OTP) data processing
- Contextualized audit trail
- Alarm deviations
- Real-time process data
- 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 in-premise or remote EMS digital engineered solutions can assist in achieving manufacturing efficiencies through data measurement and root cause analysis on CPP deviations. Eurotherm digita 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
Redundant architecture
- Mid-size applications.
- Report centric.
- Peace of mind validation.
Zero downtime architecture
- Object oriented
- SQL based
- Reusability, modularity, open connectivity.
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
