BECKER QUICK OUT Airlock – Safe and Fast Airlocking
After sterile production, materials are typically transferred from GMP Class B to C, from C to D, and then from D to CNC/E. This process is time-consuming and labor-intensive. In this demonstration, you will see a material transfer chamber that allows you to transfer materials directly from GMP Class B to CNC/E in a single step and […]
BECKER QUICK OUT Airlock – Safe and Fast Airlocking
After sterile production, materials are typically transferred from GMP Class B to C, from C to D, and then from D to CNC/E. This process is time-consuming and labor-intensive. In this demonstration, you will see a material transfer chamber that allows you to transfer materials directly from GMP Class B to CNC/E in a single step and […]
Current developments and innovations in cleanroom measurement technology
Two methods are available for conducting standard-compliant leak testing of installed HEPA filter systems in accordance with EN ISO 14644, each of which meets different requirements in terms of operating conditions, accuracy, and reliability: the determination of mass concentration using an aerosol photometer, or the measurement of particle count using a scattered-light single-particle counter. Both leak tests assess the integrity of the filter medium and the correct installation of the entire filter system. To distinguish between the different classes of biological […]
AI Compliance in the Pharmaceutical Industry: Integrating the AI Regulation and GMP
Building on a structured overview of the provisions of the European AI Regulation, this section first explores key aspects in greater depth: the role and risk-based classification of AI systems, including high-risk AI, as well as the resulting obligations. These include, in particular, requirements for a quality management system, data and model governance, technical documentation, transparency, human oversight, robustness, and monitoring throughout the entire […]
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 [...]