„If I had asked people what they wanted, they would have said faster horses.“
I believe one can only develop better solutions if one understands the needs of one’s customers – what they truly need, not only what they want. My eyes are always on the future and I’m known to be a collector of ideas. One of my greatest strengths is developing innovative ideas and concepts, thanks to my extensive work experience and keen observations. Creating user-friendly and visually-appealing medical device and pharmaceutical packaging systems is my passion. I provide my clients with support from the early stages of conceptual packaging development right up to design transfer and verification of the complete packaging system. Further, I provide packaging engineering services with regard to lifecycle management, packaging process validation activities and regulatory affairs.
Packaging design and packaging process development
- Analysis of intended use, performance requirements, as well as user need and conversion into design input.
- Development of sterile and non-sterile packaging systems for medical devices according to the requirements of the ISO 11607-1 standard.
- Development of primary, secondary and tertiary packaging for pharmaceutical products.
- Application of human factors and usability engineering according to IEC62366-1:2015 in order to develop user-friendly packaging systems.
- Evaluation of appropriate packaging materials while considering the sterilization method, interaction between packaging and product, as well as aging resistance.
- Evaluation of appropriate suppliers for packaging materials and packaging machines.
Packaging lifecycle management
- Assessment of packaging systems during due diligence activities.
- Creation and improvement of packaging specifications and drawings.
- Design history file gap analysis of existing packaging systems.
- Harmonization and optimization of existing packaging systems, packaging components and packaging processes.
- Manufacturing transfers and integration of registered packaging systems.
- Implementation of packaging serialization.
- Implementation of electronic IFUs.
Packaging design transfer and process validation activities
- Transfer of packaging design into manufacturing.
- Implementation support of automated and semi-automated packaging processes in and outside of the cleanroom.
- Validation support (IQ, OQ, PQ) of packaging processes according to the requirements of ISO 11607-2.
- Preparation of validation plans for packaging processes.
- Planning and conduction of validation tests.
- Preparation of SOPs for packaging processes.
Packaging design verification
- Planning and conducting of packaging performance, stability, and usability studies according to current ISO and ASTM standards.
- Country-specific preparation and submission of packaging system design files.
- Audit preparation and audit support.
CONSULTANT & CEO