Piotr K. Wagner, West Pharmaceutical Services Deutschland GmbH & Co KG - Qepler Conferences & Summits

Piotr K. Wagner

Senior Specialist, Product Management Daikyo Portfolio,
West Pharmaceutical Services Deutschland GmbH & Co KG,
Eschweiler, Germany
West Pharmaceutical Services Deutschland GmbH & Co KG

Piotr joined West in January 2017 and holds a position as a Senior Specialist, Product Management Daikyo Portfolio. He’s supporting mutual West/Daikyo Seiko efforts to industrialize packaging components that meet industry’s demand for higher performance and quality products. In his previous position, he worked for Zeon Corp. as Technical Sales Representative in the area of engineered polymers with focus on sealing applications.

He holds a Dipl.-Chem. degree from University of Hannover. In his scientific career as a Research Fellow at the German Institute for Rubber Technology in Hannover he developed nanoengineered magneto-active polymers for industrial applications. Part of this project included 8-months collaboration with Prof. Matyjaszewski at his Polymer Group at the Carnegie Mellon University in Pittsburgh (PA, USA).

Related Sessions:

Pre-Filled Syringes
Summit 2018

Enhance a fully integrated system approach for developing pre-filled syringes to maintain patient centricity.
  • 31-May-2018
  • Berlin, DE
  • Pharma
Day 2: Friday 01, June 2018
BLOCK: COMPONENT SELECTION AND PRIMARY PACKAGING.
CASE STUDY: Approaching the goal of zero particles in the production line: Daikyo’s D Sigma quality of elastomeric components.

This presentation will provide a contribution to the topic of particles, which is one of today’s major challenges in the pharmaceutical industry. Goal of significantly reduced particulate contamination is achieved via:

  • Elastomer molding to packaging performed in classified ISO 7 and 8 cleanrooms.
  • 100% vision inspection of particulate contamination down to 0.01 mm2 detection limit.
  • 100% vision inspection of critical dimensions of the components.
  • Particulate specification includes quality assurance via light obscuration and filtration methodologies.
  • Tighter AQL.

The discussion will include various studies demonstrating vision inspection of major/critical dimensions leading to reduced variability; particle characterization of various lots; and effect of shipment on particle loads within the package. Additionally, the overall improvement and in-process control will be quantified and visualized on examples of enhanced CpK values of the elastomeric components.

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