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Packaging & Process

grundlegende Fähigkeiten Chemie, Physik und Mathematik


  • ICH guideline Q9, Q10, Q11, and Q13

  • ISO 14971

  • Packaging Standards, e.g., ISO, DIN, ASTM and ISTA

  • IT technology -Asset Management

  • Child resistance packaging

  • People Management and Coaching to high performer attitude

Breaking news: Amendment 1 of ISO 11607-1 issued in Sept. 2023 requires a Risk Management for packaging system.

  • Therefore, risk evaluation and risk control are commonly recognized as essential parts of risk management of packaging and finally a sterile Medical Device and applicable in: 


  • Design and development phase (e.g. D-FMEA)

  • Validation phase (Performance and stability testing)

  • Usability evaluation (U-FMEA)

  • Process validation (P-FMEA)

  • Production phase (e.g. In-Process-Control)

  • Packaging system changes (update of Risk Assessment might be necessary)

Our SOP consistently follows a holistic approach and comprehensively covers the Packaging Development phases.


Risk Management SOP and templates already available.

Effective and efficient management of packaging development activities and ensure compliance to ISO 11607-1.

Why external support?

  • We are experts in packaging design control and processes for Medical Devices and Pharma packaging.


  • bleyco swiss consulting supports you in changing perspectives and challenging the status quo.

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