Hartmut Schaz

Global Technology Partner - Sterile fill and finish

 The shift from a “once validated” approach to an emphasis on continued process verification based on updated process knowledge, science and risk management, improves companies’ ability – and readiness – to implement changes and improvements.”

Hartmut Schaz has extensive knowledge of aseptic processing for the design of small volume parenteral production plants, from conceptual design to commissioning of new builds or remodeling/upgrading of existing facilities.

He focuses on the optimisation of facility and equipment design to meet project-specific goals in terms of product quality, operator and environmental protection and productivity as well as investment and running costs.

Hartmut Schaz is a regular speaker at international engineering conferences in Europe, India, China and the USA. He holds a Master’s degree in pharmaceutical engineering from the University of Applied Sciences in Sigmaringen, Germany. Since he graduated in 1991, he has been responsible for engineering and commissioning of pharmaceutical plants in more than 20 countries.

The fast growth in the biopharmaceutical market will pave the way for new ways of doing things – also inspired by developments such as continuous manufacturing for high volume of small molecule products.

Hartmut Schaz

What's your view on the industry?

"I believe that the shift in mindset will accelerate the use of new technologies such as single-use and ready-to-use components or advanced barrier systems. Today, we are facing a fast growth in the biopharmaceutical market, with decreasing batch sizes paving the way for new ways of doing things – also inspired by developments such as robot technology to completely eliminate human handling within critical aseptic processes. Our high level of process know-how, specifically within the area of small and large volume parenteral processes, combined with our expertise within the new qualification and validation approach, makes NNE an ideal partner in the creation of next generation production facilities."

Why do you work in the industry?

"For more than 20 years now I have had the chance to support and lead a large variety of fill and finish projects for the manufacturing of small volume parenteral products in more than 20 countries around the world. Each and every new project has its own specific targets and challenges. Personally, these diversified assignments continuously motivate me to develop innovative and inspiring solutions, with the aim of creating a long term partnership with our customers that goes beyond the project duration."

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Expert in:

  • Aseptic and sterile SVP products (small molecules and biopharmaceuticals)
  • State-of-the-art production facility design (pilot plant and commercial production)
  • Cleaning and sterilisation technology
  • Aseptic process design from API weighing up to inspection
  • Barrier Technology (RABS and Isolator)
  • Single Use and Ready to Use technology
  • Handling of high potent products
  • Freeze dryer technology including loading and unloading system

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