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)

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

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

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

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

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Meet the Life Science Team