Annex 1-compliant processing of highly potent active ingredients
The processing of highly potent active ingredients, such as antibody-drug conjugates (ADCs), places the highest demands on sterility, containment, and operator safety. This presentation demonstrates how Annex 1-compliant machine designs ensure aseptic integrity and comply with current EU GMP guidelines. In addition, solutions for containment strategies will be presented that ensure both product and personnel safety without compromising efficiency or flexibility. Topics such as hygienic […]
Professional project management in cleanroom construction
Carrying out projects can be a complex undertaking not only in residential construction but especially in cleanroom technology, since—unlike traditional construction projects—there are far more interfaces to consider. The demands placed on project management in terms of technical complexity, interface coordination, and adherence to schedules and budgets are immense. In addition, the […]
From AFC to RFC: Experimental and Model-Based Validation
This presentation introduces an integrated approach that combines experimental validation and mechanistic modeling to evaluate the transferability of processes between axial-flow chromatography (AFC) and radial-flow chromatography (RFC). Under strictly harmonized conditions, it was demonstrated that AFC protocols can be transferred to RFC without reoptimization, achieving identical performance parameters such as dynamic binding capacity, purity, and gradient resolution. The geometric […]
Case Study: Process-Based Cleanroom Simulation
The presentation will feature a case study of a project for a client in the pharmaceutical industry, in which the client wanted to know: How can the energy consumption of one or more cleanrooms be reduced while ensuring high effectiveness in removing contaminants? The case study demonstrates that the “rule of thumb” for air change rates is not applied, […]
Quality Decisions with AI: Annex 22 and the EU AI Act
This presentation provides an in-depth look at how AI- and LLM-based systems can effectively support quality decisions in the pharmaceutical industry—navigating the complex balance between efficiency gains, regulatory compliance, and ethical responsibility. Using practical and illustrative examples, our experts demonstrate in detail how solutions compliant with Annex 22 and the EU AI Act can be successfully implemented. This goes far beyond mere theory: You […]
Sustainable Cleanrooms Through Circularity Strategies
This presentation explores potential pathways to sustainable high-tech cleanrooms through circularity strategies. Systems are kept in circulation through maintenance, reuse, and refurbishment, while unusable materials are either repurposed or sent to external recycling facilities. Life cycle assessments (LCA) and environmental product declarations (EPDs) provide the scientific basis for evaluating environmental impacts, particularly global warming potential (GWP) and […]
Biogel Tech – Hand Sanitizer for High-Risk Environments
The presentation “Biogel® Tech – Your Hands Deserve the Best” by Mölnlycke Health Care offers a comprehensive overview of the history, innovations, and quality standards of Biogel® Tech gloves, which were developed specifically for critical environments. Participants will receive an overview of Mölnlycke’s 175-year history of innovation, starting with the industrial production of swabs and bandages and continuing through […]
The Science Behind the Indication System
Presentation Description (German) The presentation “The Science Behind Indicator Systems” by Mölnlycke Health Care focuses on a highly specialized topic in the field of medical safety: the functionality and significance of indicator systems in surgical gloves. These systems are designed to make punctures in the outer glove visible quickly, clearly, and over a large area, so that users are immediately alerted when […]
A New Approach to Aseptic Production
Aseptic fill-and-finish production is undergoing the most significant technological transformation in decades. New solutions such as modern robotics and planar drive systems are not only changing process workflows but also opening up entirely new avenues toward largely hands-free production. This presentation will highlight the opportunities these technologies offer, their limitations, and why their successful implementation requires comprehensive expertise in GMP, integration […]