Glatt Ingenieurtechnik GmbH

The production of pharmaceuticals and biotech products has become more and more international in recent years. Especially during the recent SARS COV-2 pandemic the supply, production and tech transfer for regional production have boosted a faster globalization not only in production but also in projects, from development via design and engineering, to construction and implementation, commissioning and qualification. 

Global setup supports international project approach 

The Glatt Process & Plant Engineering Division of international Glatt group (www.glatt.com) has several offices and hubs in different continents. Using this setup Glatt Engineering applies the approach of ‘Global Engineering’, which was introduced decades ago from Chemical Engineering firms in the Oil & Gas industry, already more than 10 years successfully in the Pharma, Biotech, Food, Feed and Fine Chemicals industry in a variety of geography. The presentation outlines methods of cooperation, communication, shared tools, work processes and standardization among different Engineering hubs in various geographies by the help of views into selected project examples. Success factors and potential pitfalls will be discussed.

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 a modular design approach, related practical aspects and experiences will be considered for different project cases, which comprises raw material preparation, 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, the MENA region and in 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.