BIOSAFETY COMPLIANCE SERVICES

• BSL-1/2/3/4 Facility Design Consulting
  
• BSL-1/2/3/4 facility inspections and recommendations
  
• CDC and NIH-based operational audits of protocols and procedures
• Select agent protocol and operational compliance consulting
  
• Biosafety Risk vs. Consequence analyses
• Custom Biosafety Training Programs
  

CLEANROOM AND LAB SERVICES

• Equipment Selection (Bioprocess/Homogenization/Fermentation)
• Design Troubleshooting of Existing Cleanrooms/Labs
• Process Design (Aseptic Processing & Air Flow Focus)
• HVAC
• Purified Water Process Evaluation (Water For Injection, R/O, DI)
• Biological Contaminant Solutions
• Material Surface Selection
• Cleanroom Control Systems (Field Bus, DCS, PLC, PC)

VALIDATION, COMMISSIONING & CALIBRATION

• Process Validation
• Master Plan Development
• Lab Equipment Validation & Calibration
• Custom Software for Calibration, Validation & Preventative Maintenance Programs
• Environmental Monitoring System Calibration & Validation

BIOPROCESS CONSULTING & TRAINING

• Process Optimization
• Scale-up Consulting & Analysis
• Cleaning & Sanitation Program Development
• Aseptic Process Training

Download PDF (1.6MB)