Services Offered

Containment Technology Consultancy Services

• Studies
• Risk / Impact Assessments
• Process containment & material handling philosophies
• Process containment guidelines & solutions
• Studies to determine engineering controls requirements
• Review / Write Corporate Containment Standards

Containment Engineering

• Specification of Engineering Controls such as LAF (Laminar Air Flow) Booths/Hoods, Downflow Booths, Contained Transfer Systems, Flexible Film & Hard wall Isolators, and Barrier Systems
• Technical Evaluation, Selection and Management of Vendors
• Ergonomic Modeling & Trials of Containment Systems
• Establish Proper Handling Procedures of Containment Systems
• Qualification/Validation of Containment Equipment

Containment Troubleshooting

• Evaluation of Existing Engineering Controls/Containment Equipment/Facilities
• Identification of Issues/Problems
• Develop, Recommend and Implement Containment Solutions

Conceptual Process & Facility Design

• Process work flows
• Conceptual layouts
• Man & material flows
• HVAC, air flow & area classifications

Project Management

• Project scheduling
• Project cost estimating and management
• Subcontractor management
• Internal resource management

Pharmaceuticals in the Environment

• Survey of pharmaceutical sites to assess risk of pharmaceuticals entering the environment
• Evaluation of manufacturing processes to estimate potential of loss of pharmaceuticals to the environment
• Environmental waste water characterization
• Evaluation of waste handling and wastewater facilities to estimate potential of pharmaceuticals entering the environment

Regulatory Compliance

• Assess regulatory gaps / risks as they relate to HAPI manufacturing