Interdisciplinary Design The Pharmaceutical Industry

1. Interdisciplinary DesignThe Pharmaceutical Industry Eur Ing Keith Plumb BSc, MBA, CEng, CSci, FIChemE

2. Who am I? • Owner Director of Integral Pharma Services Ltd • Process and equipment consultant • Over 35 year’s experience of batch design • Experience covers • Fine Chemicals • Chemically derived pharmaceuticals • Biologically derived pharmaceuticals • Food • Other specialist batch processing • Chair of the Pharma SIG • Visiting lecturer at Manchester University for the PEAT MSc course and its replacement that is currently under development.

3. What Drives Big Pharma? • New Molecular Entities both chemical and biological • Patent Life • Speed to market • Most certainly not manufacturing

4. Why Batch? • Flexible – one plant can make many products. • Traditional • Seems simple • Driven by perceived quality issues of moving to continuous. • Actually probably produces lower quality (certainly purity) that could be achieved by continuous processing.

5. Design Issues • Not the ones that typically interest academics. • Pharmaceutical Engineering Advanced Training MSc Course • Considered important by industrial chemical engineers. • Ignored by the Manchester School of Chemical Engineering • Design of processes/equipment using simple tools • Equipment design knowledge lies within vendors • Uncertainty about chemical/biological process and equipment information. • Knowledge of physical properties is usually limited. • P&I diagrams only tell part of the story, time based information required

6. Electronic Design Tools In the order of usage. • Word Processors • Spreadsheets • Simple drawing tools • CAD usually used by designers not engineers as it is too complex to learn and remember • Databases • Project planning software • Quite good for batch modelling • Batch modelling software – usually too inflexible to be of much value.

7. Design Tasks • Process Design • User Requirement Specifications • Mass and energy balance – must be time based. • Block diagrams, PFDs and P&IDs • Equipment and pipe sizing incl. modelling • HAZOPs, risk assessments and safety equip. design • Equipment Design • Equipment, lines, valves, instruments etc. • Equipment specifications • Detail process, mechanical, instrumentation and electrical data sheets. • Documentation requirements – onerous for pharma

8. Typical Processes Most batch processes involve solids handling • Mixing and batch heat transfer • Batch reactions – chemical and biological • Batch distillation, crystallisation, filtration, centrifugation and drying • Milling, grinding, micronisation and granulation • Liquid/liquid centrifugation, membrane filtration and chromatography • Lyophilisation, steam sterilisation and viral removal. • Tableting and packing • Steaming-in-place and cleaning-in-place. These are often more complex than the process

9. Main Issues • Universities do not educate undergraduates for this kind of design. • Companies do not train their staff for this kind of design. • You just pick it up as you go along! Coulson and Richardson is not much help

10. Possible Solutions • Batch based design projects for undergraduates • More industry involvement with undergraduate courses • More distance learning with more chemical engineering academic involvement. • Personal training at a price the individual can afford – after sales opportunity for universities? • Trained mentors in companies

11. Thank you for listening Any questions?