Modular Design: Innovative Structures & Robotics
The company “Digitales Bauen” serves as a center of excellence for modular building design and digital innovation within the Drees & Sommer Group. The first section examines modular design in practice. The importance of modular design is illustrated through completed projects, such as Roche’s pRED Center laboratory building in Basel and designs for battery and chip factories. […]
Planning Steps & Project Workflow for Cleanroom Systems
This presentation lays the groundwork for efficient project management and describes the individual planning steps in the comprehensive project workflow for cleanroom systems. The following sections address topics that should be defined and established during the preliminary project phase—that is, before the actual planning begins. Particular attention is given to the requirements, which are specified in the form of a URS, a statement of requirements, and […]
Rethinking Knowledge for Industry 4.0
Knowledge transfer and intelligent knowledge management systems are crucial for sustainable competitiveness in the pharmaceutical industry. Changeability and the rapid implementation of innovations are achieved by actively shaping knowledge transfer within the company and external research institutions. Industry 4.0 is revolutionizing companies through digital technologies such as Extended Reality (XR) and Artificial Intelligence (AI). How can these technologies be used to [...]
Digital cleanroom training for safe hygiene standards
Effective cleanroom training is a decisive factor for compliance with hygiene standards in the pharmaceutical industry. The PharmaXR research project uses innovative extended reality (XR) technologies to develop practical training scenarios. The use of virtual and augmented reality as well as AI-supported activity recognition improves training quality, reduces errors and increases efficiency. The presentation highlights the integration of immersive technologies [...]
Implementation
Test methods
Necessity
Definitions
Regulatory requirements for gloves in aseptic environments
This presentation provides an overview of glove integrity testing in isolators and restricted access barrier systems (RABS). It explains the current requirements in accordance with EU GMP Annex 1 and highlights the critical importance of glove integrity testing. It also presents typical sources of contamination from gloves as well as common methods for glove testing. Finally, the SKAN […]
Reliable & flexible - cleanroom monitoring system for all
Modern systems for environmental monitoring of cleanrooms and production facilities are indispensable in the pharmaceutical industry. They serve as an essential tool for capturing and processing a wide range of data required for batch release. These systems not only meet data integrity requirements, but also provide advanced features to detect and analyze [...]