Our Commissioning and Validation work covers Facility, Equipment, Computer, Cleaning, CIP/SIP, Lab and Process Validation. Below is some of the equipment and processes that SAVIS has engineered, commissioned and validated over the years.

Facility / Utility:

• - Classified rooms (ISO Class 100 to 100k)
• - HVAC (Johnson Controls, Invensys, Andover, Barber-Colman, York, Carrier, Trane)
•    including smoke studies
• - Regulatory Filings/Submissions
• - Process/Plant Air Systems
• - RO Generation
• - Process Run Data Analysis
• - WPU (Purified Water)
• - WFI Stills (Finn-Aqua)
• - Compressed Air Systems (Atlas Copco)
• - Plant Steam Systems
• - Pure Steam generation (Finn-Aqua)
• - Glycol Systems

Lab Equipment:

• - HPLC (Waters) and GC (Perkins Elmer)
• - PE TurboChrom Software
• - FTIR (Mattson)
• - Incubators
• - TCUs

Process Equipment:

• - Bioreactors
• - Process Tanks
• - Autoclaves (Steris, ETC, Finn Aqua, Getinge, AMSCO, Fedegari)
• - CIP Systems
• - Homogenizers (Cleveland Eastern Mixers, Admix, IKA Works, KADY)
• - Centrifuges (Alfa Lavel, Ferrum, QCG Systems, Carr, BHS Filtration)
• - Chromatography Skids (Yokogawa, Millipore, Pall, ITT)
• - UF/DF Skids (Technikrom)

Packaging Equipment:

• - Vial Washers (Cozzoli, Bosch, Penn Tech Machinery, Bausch & Strobel, CIMA)
• - Stopper Washer (Cascadex)
• - Depyrogenation Tunnels (Bosch, Krup, Gruenberg, Despatch, Sterline, CIMA, Genesis)
• - Fillers both Aseptic and Non-Aseptic (Stokes-Merrill, Bosch)
• - Vision Systems (Eisai, Acuity, Bosch, MOCON)
• - lyophilizers (Hull, Serai, BOC Edwards, Millrock)
• - Labelers (NJM, Accraply, Theile)
• - Cappers (Westcapper)
• - Cartoners (Marchesini)
• - Shakers
• - Wrappers
• - Shippers

Computer Equipment:

• - PLCs
• - HMIs
• - SCADAs
• - GMP Servers
• - Including: Rockwell/AB, Emerson, Siemens, GE Fanuc, Honeywell, HP/Compaq, Dell,
•    Sun