1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com

Course Content:

PROJECT DEFINITION

DESIGN APPROACH

REGULATORY CONSIDERATIONS

• Current Good Manufacturing Practices
• International GMPs
• Safety and Biocontainment

ARCHITECTURAL, SITE AND LAYOUT CONSIDERATIONs

• Site Selection
• Masterplanning
• Unidirectional Flow
• Schematic Design
• Building and Site Security
• Architectural Finishes

PHARMACEUTICALS

• Pharmaceutical Fine Chemicals
• Aseptic Liquid Filling
• Oral Dosages
• Specific Facility Requirements

BIOTECHNOLOGY

• Fermenters and Bioreactors
• Equipment for Recovery
• Purification
• Formulation
• Filling and Packaging
• Specific Facility Requirements

CIP AND SIP DESIGN

• Equipment Design Details
• Sterile Piping Designs

INSTRUMENTATION AND CONTROLS

UTILITY SYSTEMS

• Compendial Water
• Clean Steam
• Biowaste Inactivation
• Mechanical Building Utilities

CLEANROOM AND HVAC DESIGN

FACILITY MAINTENANCE

BUILDING AND SITE SECURITY

WAREHOUSING

PROJECT PLANNING AND SCHEDULING

• Specifications
• Cost Estimating

PROCUREMENT

CONSTRUCTION

COMMISSIONING AND START-UP

VALIDATION

 

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