SAFC® – Madison Facility

Madison, Wisconsin (USA) is the industry leader in highly-potent API (HPAPIs – HPAIs) manufacturing. This flagship Safebridge® certified manufacturing site features the highest level of quality and containment engineering to handle cytotoxics and category IV potent compounds.

With more than 15 years experience and highly trained personnel, SAFC's Madison facility is at the leading edge to support development and manufacturing of high-potent APIs from pre-clinical to commercial-scale quantities.

Capabilities Overview   Eight process development labs   Eight kilo labs featuring:   Barrier isolators   Powder weighing hoods   Closed system glassware   Local exhaust ventilation   Chromatography systems   Class 100,000 (ISO 8) single pass HVAC   Dedicated glassware and equipment       Two category IV potent drying/packaging rooms   Two pilot plants (200 L and 800 L) featuring:   Barrier isolators   Alpha beta valves for reactor charging   Chromatography systems including Biotage medium pressure chromatography (up to 40 kg cartridges)   Nutsche filter/dryer/isolators (category IV substance handling)   Class 100,000 (ISO 8) single pass HVAC   Dedicated suites for each project   Process equipment includes up to 800 L glass lined reactors, 200 L Hastelloy® reactor and distillation capabilities   Cleaning In Place (CIP) containment cleaning systems Containment and Safety: Purpose built, the fully validated cGMP site is designed to follow the most stringent criteria for high-potent compounds manufacturing.   Engineering controls are used as the primary means for containment and isolation of potent compounds   Room pressure differentials designed for containment (with monitoring and verification)   Airlocks / vestibules around manufacturing / lab spaces   Single pass air   Filtration/capture of contaminants, with safe-change filters          cGMP Manufacturing    Small Molecule cGMP Manufacturing