Continuous API manufacturing (small molecule API)
Working with global stakeholders on an FDA critical, small molecule API manufacturing facility.
Engaged in 2015, our team completed a conceptual study to upgrade the lab area into a continuous processing facility for multiple products.
This high-profile, €35 million, project included demolishing the existing PMO facility and expanding it for infrastructure to support cGMP continuous processing. The facility needed to allow complete synthesis of a small molecule API, up to four manufacturing steps, crystallisation, drying, and isolation of the final API.For this API manufacturing facility, planning requirements such as BCAR, Fire certification, DAC, etc., needed to be met. We worked with fire to meet fire protection requirements for ATEX and solvent manufacturing facilities.
The project included charge room with reactors, a solvent feed and prep area, twelve walk-in fume heads, and a finishing suite with dryers. Tech services included scrubbers, a heating and cooling skid, and vacuum skids. Not only did the project include these lab services, but it also incorporated offices and operator facilities such as changing rooms and meeting rooms.
The project, delivered in under 24 months, met tight timelines and new product launch deadlines.
Front end study
Mechanical piping design
Electrical & instrumentation design
HVAC & building services
Estimate & cost control
Commissioning & qualification
Health & safety management
FOYA 2019: Facility of the Year Awards, Category Winner: Process Innovation