Engineering

Our engineers have extensive experience and knowledge regarding processes and unit operations in the pharmaceutical and biopharmaceutical industries. Moreover, we have in-depth knowledge of regulatory guidelines for small molecules, large molecules (biologicals) and ATMP products, such as: 2017_11_22_guidelines_gmp_for_atmps_0.pdf (europa.eu). Our engineering expertise, combined with extensive process and GMP knowledge, ensures that the design will meet all your needs and requirements.

  • New- and revamp of buildings
  • Cleanrooms and air processing (HVAC)
  • Upstream processes
  • Downstream processes
  • Aseptic filling
  • Cleaning-In-Place (CIP)
  • Sterilization-in-Place (SIP)
  • Sterilization
  • Freeze drying
  • Water- and steam preparation (water for injection (WFI), purified water, clean steam)
  • Containment / operator exposure reduction (for example facilities for BSL-2, BSL-3, highly potent substances and radioactive substances)
  • Destruction autoclave and kill systems
  • Powder or liquid transport and handling systems

Thanks to the numerous projects that we have successfully xcompleted, we have a strong knowledge base of these systems. We provide excellent consultancy services in this area. We can identify any bottlenecks during implementation in advance to improve quality and user-friendliness. 

Clean room where contaminants are controlled within specified limits
Clean room where contaminants are controlled within specified limits

Brown field: Revamp projects: upgrade current facilities
In many cases, existing facilities no longer meet current pharmaceutical standards, the level of process automation needs an update or the capacity of the cleanrooms does not meet current demand.

In these cases, strong interaction across departments is critical to minimize downtime, prevent out-of-stock situations and minimize the impact of other operational processes and projects. 

These “brown field” projects require different project management, project organization and communication than “green field facilities” to mitigate business risks.
Progress project managers and engineers have solid experience with revamp projects and work closely with your organization.

Our seasoned experts can help you bring your facility up to current standards
Our seasoned experts can help you bring your facility up to current standards