Formulation of medicines

Formulation Systems: design, construction, automation and validation

The formulation of sterile liquids like parenteral drugs and vaccines have specific high purity requirements that can only be achieved with great technical skills and process knowhow. Agidens' tailor made formulation systems are designed to automate the formulation of complex solutions and suspensions in a completely controlled and documented way providing the following functionalities: 
  • API addition
  • Filtration
  • Temperature regulation
  • Weighing
  • Mixing
  • Integrated CIP/SIP
  • Etc.

Agidens scope for formulation systems

Agidens is able to support its customers from the earliest phase of a formulation project. We help to design the installation, we build it, we take care of automation and in the mean time make sure it functions according the highest quality and safety regulations and guidelines. Depending on the wishes of the customer, we execute the entire project or take on a specific task:
  • Concept study
  • BOD (Basis Of Design)
  • Detailed engineering
  • Risk Analysis, Hazop, etc.
  • Mechanical and electrical construction
  • Automation (PLC & SCADA/HMI)
  • Commissioning & Qualification
  • CE certification
  • Cleaning & Process Validation

Why Agidens for formulation projects?

  • As a specialist in sterile formulation systems our engineers understand your formulation process and the strict regulation (a.o. GMP guidelines and 21 CFR part 11) which apply.
  • The combination of our process knowhow, our automation skills and cGMP compliance expertise makes us unique as a supplier to the Life Sciences industry.
  • Agidens performs A-Z delivery of formulation systems up to process validation of the complete installation.
  • Agidens has established a specific pharma methodology A’GAMP containing general documentation and testing procedures in compliance with ASTM E2500 ensuring a flexible and thorough verification of the assigned requirements.