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