Pharmaceuticals & Biotechnology

VTU offers specific expertise in all areas of plant construction projects in the pharmaceutical sector.

  
Besides technical and process-related requirements, the production of pharmaceuticals must also strictly adhere to particular aspects regarding the regulation of Good Manufacturing Practices (GMP). From a technical perspective, this requires extensive additional know-how and experience, above all with regard to sterile production. From a regulatory perspective, clear project structures, comprehensive documentation and above all qualification and validation according to cGMP are indispensible requirements for successful projects.

The bandwidth of the technologies being used ranges from active pharmaceutical ingredient production (API), continues with biotechnology with different hosts and complex requirements in downstream processing (also for products from blood), up to a great variety of galenic productions. Auxiliary systems like, for example, ultra-pure media, CIP, clean rooms as well as control and data capture systems also have special requirements.

Smooth cooperation between project management, engineering, GMP qualification and validation are particularly important to us. This way, the shortest possible project runtimes are also possible even with difficult boundary conditions.

Our way of cooperation is built around the requirements and the maximum benefits for the client. VTU delivers consulting on operations, regulations, and project development as well as engineering in all phases right up to EPCM contracts and GMP qualification/validation as an integrated or separated service.
In special cases, turn-key packages are  delivered, for example production systems (UF or chromatography) and batch systems or auxiliary systems like solvent recovery or waste gas and wastewater treatment.

Our technical know-how and our project management accompany you from the scale-up of lab systems up to the start-up of a large scale plant in all areas of the pharmaceuticals industry specifically for:

• active pharmaceutical ingredient synthesis (API)
• fermentation with microorganisms or cells
• downstream processing
• blood plasma fractioning
• liquids and solids production
• sterile filling and lyophilising
• ultrapure media and CIP systems
• clean room facilities
• recycling of solvents
• treatment of exhaust air and wastewater
• systems with explosion protection requirements