Located adjacent to our pharmaceutical development laboratories, our 50,000 sqft state-of-the-art GMP manufacturing and testing facility is perfectly placed to offer Seda clients a seamless transition from development through to clinic. Equally, we are able to transfer established products directly into the GMP facility.
Purpose built with its own dedicated team of experts and pharmaceutical quality system, the CMS facility has been optimally designed with quality control laboratories, production rooms including high potency, clean rooms, containment systems and office space, to assure compliance and maximum efficiency.
The Quality Control laboratory is equipped with the latest analytical equipment and data integrity systems to assure the provision robust and reproducible release and stability data.
The GMP manufacturing facility has been designed as a multi-product facility with 5 Grade D cleanrooms. Containment is achieved via a single pass (no recirculation) HEPA filtered air flow which maintains a pressure cascade into each room. Processing rooms are equipped with secondary air-locks to provide a barrier to common areas. Manufacture of high potent materials is achieved via both fixed and flexible secondary containment within each room.
Available manufacturing equipment includes:
The facility is ‘solvent rated’ to enable spray drying from volatile/flammable solvent systems.