Bio-contained transfer system for ATMP production
The BetaBioBox is a GMP-compliant, bioconfinement transfer system designed to maintain Class A cleanroom aseptic conditions throughout the transfer of cultured cells from an isolator to standard external CO₂ incubators. It was specifically developed to support the growing demands in ATMP manufacturing and enables users to prepare cell culture flasks within a closed Grade A system and […]
Focus on Project Risks in Life Sciences Construction Projects
Investments in new research and production capacity drive innovation in the life sciences industry. They lay the groundwork for the development of modern therapies and medications. Yet it is precisely these multimillion-dollar construction projects that often run into trouble: there are many reasons for this—but five seem to be particularly common. Anyone who wants to successfully implement investment projects must take numerous factors into account from the very beginning […]
Life Cycle Management in the Context of GMP
The presentation will examine the lifecycle management of an ultra-pure media system using a flexible, modular, and risk-based maintenance concept. The focus is on ensuring consistently high system availability: through proactively planned maintenance measures, comprehensive documentation, clearly defined procedures for replacing spare and wear parts, as well as short response times and precise troubleshooting in the event of a malfunction—sustainably.
Smart Lab: The Benefits of Digitizing Laboratory Facilities
Using real-world examples, we present proven digitalization components for laboratory buildings. We highlight which solutions have proven effective in laboratory settings and the challenges that arise when implementing them in both new and existing buildings. We also explain how the management of smart labs differs from that of traditional laboratories—particularly in terms of organization and the use of the data collected […]
Drinking water treatment for membrane separation processes (cold
Depending on the source of the drinking water, significantly higher standards for microbiological and organic safety apply, particularly in the production of cold WFI—that is, water used directly on patients. This presentation examines the various water treatment methods, analyzes their respective advantages and disadvantages, and reviews the associated risk assessment to provide a comprehensive understanding of the safety and operational requirements for ultrapure water systems.
Opportunities for Energy Savings in Ultra-Pure Media Systems
The presentation will provide a brief overview of the various ultra-pure media systems and the process media required for their operation. Typical errors and weaknesses in terms of energy savings will be analyzed, and possible measures to improve efficiency will be examined and discussed in detail. Using real-world examples, specific savings potentials and their practical implementation will be clearly illustrated to achieve sustainable, long-term optimization of the systems […]
Accelerated Times: Leadership Toward Project Excellence 4.0
In an increasingly dynamic market environment, leading engineering firms are evolving into strategic partners for project execution. Drees & Sommer has purposefully refined its organizational structure—with dedicated client teams and frameworks that enable efficient and customized project delivery. A clear organizational structure, supported by an open corporate culture, future-proof processes, and state-of-the-art technology, paves the way to Project Excellence […]
Process Linking – Greater Efficiency and Safety
The presentation introduces the Process Linking concept using the example of OSD production. The traditional approach to OSD production is compared with the innovative Process Linking concept, which creates closed systems by directly linking processes and minimizes interfaces. The PTS powder transfer system is central to the concept and enables the safe and efficient transport of powders. The […]
Determination of the bacterial count in pharmaceutical water in real time
Until now, determining the microbial count in purified water and water for injection has relied almost exclusively on time-consuming laboratory culture tests. Under Monograph 0169 of the European Pharmacopoeia (04/2017), WFI no longer has to be produced exclusively by distillation (the USP has always required this). Consequently, the requirements for monitoring water quality have increased. The latest technical developments enable accurate […]
Ozone measurements during cold sanitization
Dissolved ozone is one of the key parameters for monitoring water used for pharmaceutical purposes, as required by pharmacopoeias—particularly with regard to cold production and cold sanitization—and is measured online in real time. The presentation covers important information regarding water treatment using ozone, the relevant pharmacopoeia regulations, current technologies […]