Our process engineers have extensive experience with both Upstream and Downstream API manufacturing processes. They are highly knowledgeable in the process support of Fermentation, Recovery, Peptide synthesis and Purification facilities; as well as having expertise in all areas of process engineering and primary production, including supporting systems such as Clean Utility and Black Utility.
Furthermore, our engineers have experience in introducing automated solutions into manufacturing/production processes at various stages of a project, from conceptual, to basic, or detailed design. This enables us to assist you in achieving the appropriate level of automation based on your processes needs. Our services include consulting in proper electrical equipment installation, PLC/SCADA solutions and integrated solutions with MES and ERP systems. In addition to this, our consultants have expert insights when it comes to the correct setup of IT/backbone systems that support the processes with data integrity, storage, and security for your valuable data.
In addition to this, our process engineers also have experience with the overall requirements for validation of GMP regulated systems and processes, as well as systems where GEP can be applied.
We support all aspects of validation activities including validation planning, requirement setting, supplier selection, design review/qualification, and completion of verification/qualification activities.
We excel at providing expert knowledge and support at all levels within Process Qualification, Process Validation, Cleaning and Sterilization Validation, as well as clean room validation (grade C and D).
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