Ash Stevens’ corporate headquarters is located with its commercial drug substance development and cGMP manufacturing facility in Riverview, Michigan.
Equipment & Operations
- Glass-lined batch reactors up to 4,000L
- Plant-scale hydrogenation equipment
- Centrifugal and Nutsche filtration equipment
- Contained Rosenmund® filter dryers (glovebox technology)
- Vacuum and convection tray drying ovens
- Stability chambers (all ICH conditions)
- Hazard analyses (RC-1) and API physical characterization equipment
- High containment laboratories (airlocks) and equipment for development and cGMP manufacture of HPAPIs
Safety & Environmental Responsibility
The health and safety of our staff, visitors and community are the primary considerations in the operation of our business. Ash Stevens has an excellent chemical hygiene program in place that closely monitors air quality and other environmental data in our facilities to ensure a safe operating environment. Hazard identification and risk assessments are also an integral part of project management and planning.
Ash Stevens' environmental health, safety and security (EHS&S) program is certified by the Society of Chemical Manufacturers & Associates (SOCMA) ChemStewards® program. ChemStewards® is SOCMA's flagship environmental EHS&S continuous performance improvement program and it ensures companies are compliant with all EHS&S regulations and best practices. Ash Stevens has received multiple awards from SOCMA for continuous improvement in this program.
Process Development & Manufacturing
Ash Stevens' process development and drug manufacturing facility is where we conduct commercial activities. Our 60,000 sq. ft. facility houses eight chemical drug development and production laboratories, four full-scale production areas, and three analytical laboratories for quality control. Projects at this facility involve:
- Process development
- Material manufacture for toxicology studies
- cGMP manufacture of clinical trial materials
- High Potency API drug substance development and cGMP manufacturing
- Post-approval commercial production of drug product
- From grams to metric tons of API
Major Production Equipment Includes:
- Glass-lined batch vessels (up to 4,000L), hydrogenation vessels and other pressure vessels
- Centrifugal, Nutsche and contained filter-dryer equipment (with glovebox technology), and vacuum and convection tray drying ovens
- Barrier isolation systems for manufacture of highly-potent or air-sensitive compounds
Major Quality-Control Instrumentation Includes:
- High performance liquid chromatography (HPLC-equipped with the following detectors: VWD, DAD, CAD, RI and MS)
- Gas chromatography (GC, GC with headspace, GC/MS)
- High field NMR, UV/Vis and FTIR spectrophotometers
- Total organic carbon analyzer and Karl Fischer titrators
- Stability chambers maintained at ICH accelerated, intermediate, room temperature, refrigerator and freezer conditions
- API solid state characterization and hazard analysis equipment
In 2013, Ash Stevens completed a multi-million dollar expansion to its cGMP facility in Riverview, Michigan. The project was completed over several years and added large-scale production capacity to the site, including a commercial-scale reactor bay and a companion isolation bay.
The New Reactor Bay
The new reactor bay houses 2,000–4,000 liter glass-lined vessels with engineering controls for potent compound charging and handling. The adjacent isolation bay features a 1.5m2 fixed filter dryer with glove-box technology for contained isolation, drying and packaging of large-scale batches. This expansion gives Ash Stevens the capacity to meet the needs of most projects, while our company culture and expert personnel still ensure intimate client focus and comprehensive project management, which are fundamental to a successful outsourcing experience.