Modularisation of chemical API synthesis

Abstract

The pharmaceutical industry develops new and more efficient Active Pharmaceutical Ingredients (API’s) in their Research and Development centers. Time-to-Market is a key requirement for new pharmaceutical products, in particular for new API products. Fast and reliable scale-up methods from laboratory to pilot scale and transfer to commercial production are essential for the successful launch and implementation of new pharmaceutical products as well for the increase of capacity of existing production facilities. Pre-designed and flexible plant concepts enable fast and flexible API production under cGMP conditions.
The presentation will give an overview on a fast and flexible design approach by Glatt’s Engineering division for both chemical and biotech API projects. Pre-designed and proven plant modules, layout typicals and facility structures are applied to accomplish rapid and ‘first-time-right’ plant conceptualization. Developing regulation and new trends can be integrated in the approach, which is also used to support the definition of User Requirement Specifications (URS) and design basis documents. The modular approach for both process and facility will be outlined with the help of visual examples for the different modular levels and project objectives.

The presentation will discuss key aspects including basic requirements, critical parameters, flexibility, conventional vs. single-use disposable systems, high active / containment topics, as well as schedule and cost aspects by considering different project examples in Europe, Asia and further geographies, with its different specific and local requirements. The use of the method will be followed along the engineering phases Concept, Basic and Detail Design and continued with a view into construction phase, commissioning and qualification of the completed API plant.
Key success factors and selected challenges encountered in the different project examples will be explored. Conclusions and ‘lessons learnt’ will be shared. Recommendations for users, producers and engineers will be given and discussed.