Digital Engineered Solutions for Life Science Applications
Improve efficiency and sustainability of manufacturing processes and help meet product safety by leveraging the digital transformation described by the Pharma 4.0 Plug and Produce initiative.
Starting from GMP process compliance
Life science production processes need to respect several Good Manufacturing Practices (GMP). Meeting GMP requirements relies upon the Quality by Design (QbD) approach. Identifying the Critical aterials Attributes and the Critical Process Parameters (CPP) to define the Critical Quality Attributes is pivotal to applying the QbD principles.
Discover key updates to ISPE GAMP 5 Second Edition
Discover key updates Annex 1 of EudraLex GMP guidelines
What is a Digital Engineered Solution?
A Eurotherm Digital Engineered Solution (DES) leverages the available technology to harness a digital manufacturing approach. The DES conceives and documents a path to analyze the CPPs' attributes, helping to optimize operation equipment and processes and meet the Pharma 4.0 expectations.
A DES supports the digital transformation of pharmaceutical laboratories, R&D and manufacturing plants with the potential to improve efficiency, safety, and sustainability.
Bundled documentation:
- ISPE GAMP 5, installation qualification (IQ), and operational qualification (OQ) templates.
- QbD risk assessment forms and identified CPPs.
Leveraging Eurotherm technology:
- Different scalable architecture options
- Modular configurations distributed on multiple cooperating edge controllers
- Range of function blocks to simplify the ISPE GAMP 5 Category 3 part of the configuration
Designed to meet Pharma 4.0 ambitions:
- Informed decisions
- Interoperability
- Aggregated data
- Decentralization
- Plug and produce
Digital Engineered Solutions - areas of interest
EMS/BMS based on plug and produce
- Aids compliance to regulations and data integrity guidelines.
- Flexible, plug and produce technology
- Data measurement and root cause analysis on CPP deviations for increased efficiencies.
Digital Fume Hoods VAV kit
- Simplifies compliance to laboratory chemical fume hood regulations
- Designed to optimize energy consumption
- Industry 4.0 mobile apps to view, operate, and manage laboratory fume hoods.
Data Integration and orchestration
- Agile electronic batch management solution.
- Combine contextualized data to create "prior experience" dashboards.
- Upgrade paperless standards operating procedures, risk and documentation management to adhere to QbD principles.
Modularization for IT/OT convergence
- Leverage IEC 61499 standard to meet Pharma 4.0 "Plug and Produce" goals.
- Simplify data integrity without compromising on flexibility.
- Unifiy instrumentation, automation solutions and electrification.
Freeze drying
- Sequential control of the temperature, vacuum and refrigeration plant.
- Safety strategies to help ensure product is not damaged as a result of plant failure.
- Clear indication of key process parameters and status.
Sterilizer process
- Recipe management system for easy parameterization.
- Sequential control for complex control strategies.
- Tamper resistant data monitoring for analysis, traceability and qualification.
Clean-in-place, sterilization-in-place (CIP/SIP)
- Connected equipment with performance reporting.
- Help to reduce manual operations and move towards people empowerment.
Water purification and distribution
- Precision PID control with setpoint profile programming.
- Sequential control for sanitization/sterilization.
- Duty/standby pump control.