Pharmaceutical API

BPE have worked in the API sector for many years and have built up a real strength of understanding in relation to process development, scale up and optimisation. We have an excellent, practical working knowledge of Regulatory Compliance and we can fully support you with your commissioning and validation requirements. 

We have worked on many projects involving both batch and continuous processing and our focus is to deliver practical solutions that maximise the available Return on Investment (ROI) in terms of both Capital and Operating Costs. We have a thorough working understanding of PAT (Process Analytical Technology) and we can apply unrivalled experience to projects ranging from simple equipment replacement through to full facility design.

Some of the key areas of expertise that we can offer include:

 

Design Capabilities
  • Concept through to Detailed Engineering Design
  • Technology Transfer
  • Process design and scale up
  • Reactor Design, kinetics, both batch and continuous
  • Emergency relief systems design – full understanding of two-phase flow & DIERS
    including design software to support delivery
  • Heat transfer calculation & systems design
  • Separation and Drying – batch & continuous
  • Materials handling, including reactor charging
Integrated Services
  • Control system design & implementation
  • Equipment design & specification & integration
  • Full suite of design services & documentation including;
    P&ID’s, specifications, datasheets
Facility Support
  • Control system design & implementation
  • Equipment design & specification & integration
Commercialisation
  • Advanced Optimisation
  • Material and Personnel Flows
Regulation/Compliance
  • GMP & GAMP
  • Cleaning
  • Area Classification
  • Operator Training and process operation support
  • Commissioning & validation – strategy, management and execution

 

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