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„If I had asked people what they wanted, they would have said faster horses.“

(Henry Ford).

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.

Regulatory affairs

  • Country-specific preparation and submission of packaging system design files.
  • Audit preparation and audit support.


Pharca GmbH