Typical Systems and Environments


Process Environment

Aseptic, Sterile and Non-sterile

Utilities

Clean Steam
Compressed Air
HVAC
USP Purified Water
WFI/DIW
Environmental Monitoring

Process Equipment / Systems

Autoclaves
CIP/SIP
Continuous & Batch Manufacturing
Encapsulators
Fermentors
Filling/Packaging
Fluid Bed Dryers
Freezers
Glassware Washers/Sterilizing Tunnels
Incubators
Lyophilizers
Tableting/Tablet Coating

Temperature Control Units

Incubators
Refrigerators/Freezers
Cold Rooms
Stability Chambers
Warehouses

Vendor Acceptance Testing

Packaging Equipment
Autoclaves
Blow/Fill/Seal
Skid-Mounted Process Equipment
Lyophilizers
Filling Systems
Isolator Technology

Process Automation

PLC, DCS, SCADA, MES

Laboratory Systems

Centrifuges
Gas Chromatographs
HPLC
Spectrophotometers
Stability Chambers

Information Systems

Batch Management
Document Management
ERP 
Facility Management
LIMS
Warehouse Management



Prior to Production Startup Equipment Validation Facilities Validation Computer System Validation

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