08.11.2016 - 09.11.2016 — Hall: 4.0 Stand: A 20
The University of Applied Science OTH Amberg-Weiden (Bavaria, Germany) operates at campus Weiden a laboratory for purity analysis and cleanliness-relevant research tasks in the area of purity and cleaning assessment of components, surfaces and liquids. Center of the laboratory is a 60 square meter class 7 cleanroom (according to ISO 14644-1) with the corresponding analysis of particulate and microbial contamination. Research focuses on the low-particulate and germ-free production and on the areas of clean room concepts and non-steady-state flow and temperature fields in the clean room based on the production processes.
High quality requirements, increasing complexity of components and strict tolerance limits to the low-particulate and germ-free products of medical and pharmaceutical industries require the production, assembly and packaging under cleanroom conditions. The close cooperation with industrial partners within the medical and pharmaceutical industries and related sectors as well as the knowledge transfer into the companies are the most important tasks.
Processes can be analysed along the value chain of the product starting with the production, e.g. injection molding, up to manual or automatic handling and assembly. In the course of this, the particle generation and migration is examined to identify the point of origin, and the nature of the particles. Goal is the optimization of processes and systems in the direction of reduction of particles in the preparation and handling of components in cleanrooms. By the use of intensive analysis existing weaknesses can be identified and measures for optimal operation of the clean room and the manufacturing steps can be set.
Bacterial contamination of the air or on surfaces can be verified quantitatively and qualitatively by standard microbiological methods. As a result there is an accurate assessment of the hygiene standards possible and also the elaboration of corresponding recommendations to act. By using automated Vitek 2 ID / AST system pathogens and problematic bacteria (MRSA, MRGN) can be identified and proved.