New techniques

Continuous processing, periodic countercurrent chromatography (PCC), RNA production lines.

Process development

Unit operation scouting, equipment sizing. Choose and build setups, execute runs, report results. Obtain a process fit for production.

Process engineering

Design specifications, also for automation. Sequence of unit operations, flow diagrams, URS´s, PID´s, instrument lists, fitting in between existing installations, utilities and automation. Creating operating procedures. Extractables and leachables assessments.

Project lead / Commissioning and qualification / CSV

Move between business expectations and expectations of the other departments for realistic project delivery. Plan and test the equipment/installation/automation to prepare for risk based verification. Embed vendor equipment in client network. Prepare verification protocols. Execute and report. Provide training. Follow up punch items.

Troubleshooting/events

Depending on the available knowledge and data, an investigation is performed, following typical methods for problem solving. Plan made to solve punch item. If needed, through change control.