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Life Science applications

Advancing process efficiency and sustainability, through state-of-the-art technology architectures and services designed with GMP regulations and guidance in mind.

Understanding life science applications to keep them current through an agile lifecycle

Our application approach starts with GMP regulations and guidance to identify the Critical Process Parameters (CPPs), followed by our suggested technology, architecture and services designed to offer efficiency, robustness, and sustainability advancements. This approach also helps plant operations to monitor and assess equipment and asset performance.

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What is our approach to develop an application?

For each specific life science application, we follow a rigorous methodology addressing the following topics:

  • Examination of relevant regulations
  • Examination of related guidances (ISPE, ICH, PIC/S)
  • Exploration of the process and/or equipment
  • Identification of the Critical Process Parameters (CPP) and Design of Experiment space
  • Focus on relevant CPPs
  • Description of the Eurotherm key differentiators
  • Recommendation of best of breed technology

Applications – our differentiators

Designed to help decrease risks

  • Knowledge of the regulatory framework
  • Awareness of the most current interpretation
  • Easy to read fishbone diagram (or equivalent)
  • Process understanding

Focused on Quality by Design

  • Critical process parameters
  • Design of Experiments (DoE) experience
  • Risk assessment and management
  • Suggested control strategies

Targeting efficiency and sustainability

  • Efficiency gap analysis of current electrical and automation infrastructure
  • Cybersecurity impact and risk mitigation
  • Operation procedures to help reduce environmental footprint

Mixing/Blending

  • Precision loop control with setpoint profile programming
  • Recipe Management System for easy parameterization
  • Sequential control for complex control strategies
  • High-integrity data recording and archiving for analysis and evidence

Cold chain

  • Employs a risk-based process to maximize tolerance levels under different product-loading patterns
  • Helps to design and control temperature profiles
  • Services for sensor mapping and calibration

Bioreactor

  • Precision control loop (Multi-heat temperature, DO2, pH, DCO2, antifoam, redox, conductivity, weight, agitation)
  • Batch, fed-batch and continuous batch management
  • High-integrity data recording and archiving for analysis and evidence

HVAC

  • Optional redundant architecture with ‘store & forward’ self-healing data archiving feature
  • ISPE GAMP Category 3 object for calculation of enthalpy, wet-bulb, dew point
  • Range of pre-configured air handling units (AHU) controls
  • Use of electrical heaters

Climatic Chambers

  • ISPE GAMP Category 3 function block for Mean Kinetic Temperature
  • Chamber simulation under various conditions (CO2, temperature, humidity)
  • Precision loop control (temperature and humidity interaction)
Explore environmental chamber control >

Hydrogenation

  • Sequential control for vessel pressure testing, purging and hydrogen addition
  • Precision loop control for temperature and pressure
  • Tamper-resistant data acquisition and storage for analysis and evidence
Explore hydrogenation >

Tablet coating

  • Precision control loop with multi profiles (drying and cooling)
  • Batch Management for easy operations
  • High accuracy loading and dispensing
  • Tamper-resistant data acquisition and storage for analysis and evidence
Explore tablet coating >

Spray Drying

  • Precision loop control with setpoint profile programminge
  • Recipe management system for easy parameterization
  • Sequential control for complex control strategies
  • Tamper-resistant data acquisition and storage for data analysis and evidence
Explore spray drying >

Contact us today to discuss best of breed solutions for your life science application

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