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.Download Brochure
Balance the constraints of QTPPs, CQAs , and CPPs, as introduced by PQS with the need for an accelerated scaleup process.
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.
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.
Increase modularity and flexibility by easily integrating stand-alone assets into a unified plant model designed to meet data integrity ALCOA+ principles.
Lifecycle development and manufacturing enhancements in pursuit of 100% sustainability and a circular economy.
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:
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.
Leverage our engineering expertise to better monitor performance, productivity, costs, an ultimately your return on investment.
Discover a wide range of applications that simplify process Quality by Design and help to improve manufacturing and laboratory efficiency.
Pharma 4.0 data management and storage designed to simplify regulatory compliance and enhance trust.