Clean Room Design

• Design Reviews
• Process/Material/Personnel Flows
• User Specifications
• Room Data Sheets
• Design Qualification
• Installation/Operational Qualification
• Environmental Monitoring Programs

Validation

• Facilities (New Build or Upgrade)
• Clean Utilities, including High Purity Water Systems, Clean Steam and Clean Gases
• Processing Equipment, including Isolators, RABS and Filling Machines
• Sterilisation, including Depyrogenation and Autoclaving
• Process Qualification, including Process Simulation (Media Fills)

GMP Documentation

• Facility/Equipment Specifications
• Room Data Sheets
• Standard Operating Procedures
• Qualification Protocols
• Impact Assessments
• Risk Assessments
• Quality Investigations

Training

• GMP Documentation
• Cleanroom Operation
• Cleanroom Qualification
• Equipment Operation
• Equipment Qualification
• Process Qualification