TPSI works with clients to develop Biopharma facility design that meets the compliance requirements of US-FDA and EU on a sustainable basis. Application of “Right First Time” methodology leading to the alignment of the personnel, material, equipment flow as well as segregation with processing requirements.

We develop Basis of Design (BOD) and Detailed Design deliverables. We have worked with fermentation, cell culture and the associated upstream and downstream unit operations for the processing of Biologicals. TPSI will perform a feasibility study and has the ability to provide owner representative engineers to assist with all phases of project execution. As an added benefit, TPSI has depth and experience in the CQV and can provide continuity from design through qualification/validation.
 

• Process Engineering (biologics as well as solid dosage)

• Automation, Instrumentation and Control Systems

• Clean environments, CIP, COP, SIP, Sterilization

• Heating, Ventilating and Air Conditioning (HVAC) Systems

• System Capacity/Performance Capability Studies to justify required upgrades

• Optimization of System Start-up and Operation

• Energy Conservation Systems

• IS / IT Support

• Electrical Power Distribution and Lighting Systems

• Automation, Instrumentation and Control Systems