Case 2: Teva Pharmaceuticals

Situation:

The client was developing a sterile API that classified as an OEL 4 potent compound using solvents. This would warrant a manufacturing suite, which was clean and capable of handling solvents as well as potent compounds. With no such suite available with any CMO in the country, the client decided to build a suite meeting their requirements at a CMO site.

The Approach:

Panorama was asked to participate in the conceptual and detailed design of this suite as well as the permitting and process design. Panorama employed its extensive experience and put in two teams one on the process side and the other on the facility side. This suite was determined to be a clean Class 1 Div 2 suite for handling solvents as well to act as an isolator for the potent compounds involved.

Key activities performed by Panorama include:

Team 1 (Process)
Engineering

  • Process Design
  • P&IDs
  • CIP & SIP design
  • Equipment & Instrument specifications
  • Process calculations & line sizing

Procurement

  • Datasheets and submittal review
  • Factory Acceptance Test (FAT)

Team 2 (Facility)
Engineering & Project Management

  • Mechnical & Electrical Design
  • Mechanical & Electrical equipment specification
  • Fire-protection (Specialized inert gas based system)
  • Plumbing design
  • Piping design
  • Architectural layouts and People, Material and waste flows
  • Safety, cGMP & Regulatory review
  • Bid packages

Procurement

  • Submittal review
  • Vendor negotiations

Field services & validation

  • Validation Master Plan
  • IQ/OQ/PQ protocols & SOP’s
  • Permitting

Result:

The client deemed this project in spite of the complexity as fast track. Panorama completed the entire design and permitting process before the expected time-frame.