We design and automate mixing installations for the production of your medicines. We place the production in closed and sterile conditions, from formulation to filtration and the final filling. In addition, we ensure that you have each production phase under control.
Delivered ready-made
Egemin Automation is an expert in the field of process installations in sterile environments. We also design and install process installations for the formulation of fluids and powders (compounding) and for cleaning and sterilisation (CIP and SIP units).
We are able to take charge of the entire project, from the draft study to construction, installation, implementation and qualification.
Our process installations are delivered ready-made. We make use of all necessary disciplines to arrive at the validation of your processes, such as:
-
Mechanical engineering
-
Engineering of installation of piping
-
Process and cleaning equipment
-
Electrical engineering and installation
-
Automation
Our modular standard components can be adapted to your needs and can be delivered in different capacities and sizes. Thanks to mounting on skids you can quickly carry out tests on the individual parts and acceptance, qualification and validation goes smoothly.
Ready validation
We carefully control our projects in accordance with the cGMP regulations. We introduce various qualification steps during the course of the project, in accordance with GAMP and/or ASTM-E2500. This ensures a thorough validation.
If needed, we can help you during the Performance Qualification (PQ) and during inspections by governmental bodies such as the Federal Agency for Safety in the Food Chain.