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Life Sciences

Eurotherm is committed to deliver digital engineered solutions that make pharmaceutical processes efficient, safe, and sustainable.

Starting from and improving the processes designed to comply with regulations.

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Helping to solve your manufacturing challenges:

  • Development cost and time to market (data analytics and knowledge management)
  • Constraints linked compliance (Quality by Design)
  • Improving process efficiency (through quality and cost control)
  • Adapting to patient centred care (personalised medicines)
  • Target carbon neutrality

Catalyzing the digital transformation in the regulated environment

Embed quality by design in the early stages

Balance the constraints of QTPPs, CQAs , and CPPs, as introduced by PQS with the need for an accelerated scale­up process.

Digitalize the complete project life cycle

Align a validation master plan around the need for flexible process requirements as well as economic and business needs. For example, by adopting paperless documentation management and ‘digital twin’ technology.

Manage changes with minimal impact

Digital engineered solutions allow for easier updating of existing equipment and problem solving of process issues, with minimal, or no impact on SOPs and the validation state.

Automate modular process lines

Increase modularity and flexibility by easily integrating stand-alone assets into a unified plant model designed to meet data integrity ALCOA+ principles.

Meet your sustainability goals

Lifecycle development and manufacturing enhancements in pursuit of 100% sustainability and a circular economy.

Digital Engineered Solutions

A DES is a comprehensive set of predefined Good Engineered Practice and Qualification (according to GAMP) documents, best-of-breed technologies, processes, and configuration designed to reduce project execution costs, risks, and time-to-market for applications such as:

  • Chemical Fume Hoods
  • Environmental Monitoring System
  • Freeze Dryers
  • Sterilizers
  • Clean in Place/ Sterilize in Place
  • Water and Water Distribution (DW, PW, WFI)

 

Discuss your needs and regulatory requirements with a Life Sciences specialist

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What is GxP?

GxP is a general abbreviation for the “good practice” regulations. The “x” stands for the various fields, like Laboratory (GLP), Manufacturing (GMP), Engineering (GEP), and Documentation (GDP). The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The current GMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. Good Engineering Practice (GEP) consists of proven and accepted engineering methods, procedures and practices that provide appropriate, cost-effective, and well-documented solutions to meet user-requirements and compliance with applicable regulations.

Life Sciences services

Leverage our engineering expertise to better monitor performance, productivity, costs, an ultimately your return on investment.

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Life Sciences applications

Discover a wide range of applications that simplify process Quality by Design and help to improve manufacturing and laboratory efficiency.

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Life Sciences data integrity

Pharma 4.0 data management and storage designed to simplify regulatory compliance and enhance trust.

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