Run by Xperts: Cleanroom services in action
CWS Cleanrooms is an integrated solution provider for all aspects of cleanrooms. On the action area, the full-service provider will show you where and how the various services are used and how cleanroom processes can be designed reliably, efficiently and sustainably. Find out more about cleanroom garments and their reprocessing, the right consumables, the right cleaning equipment & the right application with specialist staff, [...]
Contamination prevention through closed process control
The contamination control strategy (CCS) required by Annex 1 for aseptic processes triggers similar strategies for the production of biologically active substances with a low bioburden according to Annex 2. Maximum contamination prevention is achieved by developing solutions with integrated monitoring. Such solutions are referred to as "functionally closed". This presentation provides practical examples of possible improvements [...]
Key Factors for the Successful Implementation of Fill-and-Finish Projects
The presentation uses the example of a Fill&Finish project to show how CAPEX projects can be successfully implemented in a pharmaceutical environment. It is aimed at experts who plan and implement complex projects. The focus is on transferable principles that contribute to adherence to quality, time and budget, regardless of the project type. The presentation provides valuable impulses for project work and shows [...]
Legal basis and risk analysis for machines
This section provides the foundation for understanding and legally classifying hygienic design. It explains the relationship between laws and regulations in relation to the interpretation of standards and guidelines. In summary, it introduces all major organizations involved in hygienic design and outlines the information they can provide. In the second […]
Introduction Hygienic Design
Die Präsentation erläutert Hygienic Design als ganzheitliche konstruktive Gestaltung von Anlagen und Umfeld, um sichere Lebensmittel zu gewährleisten. Zentrale Elemente sind reinigbare Konstruktionen, geeignete Werkstoffe, Fremdkörpervermeidung, gute Wartbarkeit und klare Zonenkonzepte. Die fünf Kernthemen umfassen Fabrikgestaltung, Versorgungssysteme, reinigungsgerechte Apparate, Reinigungs- und Desinfektionsprozesse sowie Personalhygiene. Hygienic Design reduziert Risiken wie Kontamination, Rückrufe und Kosten, verbessert Produktqualität […]