Immersive Reality: Design, Training, and Operation
Exyte will demonstrate how the Pharma Campus enables customers and manufacturers to experience specific use cases in the pharmaceutical industry within a virtual reality environment. By creating detailed virtual models, complex facilities can be visualized as early as the planning phase, long before construction begins. This not only facilitates more efficient collaboration among project stakeholders, but also contributes […]
Commissioning & Qualification – The Key Phases
Traditional C&Q processes (commissioning and qualification) are often time-consuming and costly, as many tests must be performed and documented separately, resulting in duplication of effort. The goal of the leveraging approach is to eliminate these redundancies: tests that are relevant for both commissioning and qualification are performed and documented only once. Through early planning and organization of the teams […]
The Evolution of Monitoring in the Age of AI and the Cloud
Storing temperature-sensitive products is a challenge in many pharmaceutical and biological processes. Continuous monitoring and alerts when thresholds are exceeded are the current standard. While this allows for the detection of refrigeration equipment failures, it cannot prevent them. Integrating artificial intelligence, machine learning, and cloud solutions into monitoring systems can help drive the transformation of the pharmaceutical and […]
The risk-based approach to commissioning/qualification
EU GMP Annex 15 stipulates that essential quality elements related to patient safety and product quality must be incorporated into the User Requirement Specification (URS) from the outset. A detailed risk analysis conducted prior to the URS can optimize quality risk management. This approach allows risk-mitigating measures to be incorporated into the machine design while simultaneously paving the way for lean qualification. Through early risk assessment […]
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 […]