Glatt Ingenieurtechnik GmbHhttp://www.glatt.com
12.06.2018 - 12.06.2018 in Messe Frankfurt, Frankfurt/Main, Germany
ACHEMA Congress 2018: Modular Plant Concepts for Biotechnological and Pharmaceutical Production
The pharmaceutical industry develops new and more efficient Active Pharmaceutical Ingredients (API’s) and finished Dosage Forms (DF’s) in their Research and Development centers at global scale. Time-to-Market is a key requirement for new pharmaceutical products and as well for the increase of capacity of existing production facilities. 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. Pre-designed and flexible plant concepts enable fast and flexible API and DF production under GMP conditions.
Systematic and modular approach
The presentation will introduce a systematic and hierarchical modular structure which provides a fast and flexible design approach for biotechnology and pharmaceutical projects. Production plants are primarily determined by their core process tasks, which are embedded in a suitable and flexible facility, complying with the specific requirements defined for pharmaceuticals, biotechnology and GMP. 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.
Practical application and comparison
The application of the modular design approach, related practical aspects and experiences will be considered for different project cases, which comprises raw material sourcing, API production and dosage form manufacturing for different applications. The use of the method will be followed along the engineering phases Concept, Basic and Detail Design. The discussion and comparison will include project examples in Europe (EU), Russia/CIS region and Asia with different specific and local requirements. Conventional as well as single-use disposable systems will be discussed regarding the different aspects, including fulfillment of basic requirements, critical parameters, flexibility, schedule and cost aspects.
Conclusion and recommendations
Key success factors and selected challenges encountered in the different project examples will be discussed. Conclusions and ‘lessons learnt’ will be shared. Recommendations for users, producers and engineers will be given and discussed.
For ACHEMA Congress 2018 program please cklick here.