The Application of iQ process observer in the Validation of Injection Moulding Processes

Abstract

Validation of the entire manufacturing process is required for the series production and market launch of medical devices and in vitro diagnostics. This applies in particular to the injection molding process, which is the main focus of this master thesis. This thesis goes beyond traditional validation approaches by using a digital tool, the iQ process observer, to support validation in order to make process validation more e cient. Main goal of this work is to develop and evaluate applications of the iQ process observer during validation to reduce time and e ort. Attention must be paid to the implementation of the applicable standards in accordance with the guidelines. The developed strategy is based on the requirements of EN ISO 13485:2016, 21 Code of Federal Regulation Part 820 and guideline `EU Good Manufacturing Practice - Annex 15` and is divided into five subsequent phases. In each of these phases, specific tasks must be fulfilled to prove that the machine and process can consistently deliver good parts of consistent quality. All phases and tasks are explained in more detail and the application of the iQ process observer is discussed in this thesis. In the test phase, the validation strategy was evaluated, resulting in a 21 % reduction in the duration of the Design of Experiments. The analysis shows that the iQ process observer helps to reduce time, increase process understanding and minimises process risk.

Date of Award	2025
Original language	English
Supervisor	Robert Merwa (Supervisor)