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 […]
Aseptic Transfer: The Impact of Annex 1 on Gloveless Solutions
Human intervention remains one of the greatest risks in sterile manufacturing, and Annex 1 has further sharpened the industry-wide focus on minimizing this risk. This session examines the transition from internally to externally operated rapid transfer ports—an important advancement that reduces operator intervention and simplifies aseptic transfer processes. In addition, […]
Modularization of Biopharmaceutical Processes and Facilities
The term “modular” buildings and processes is popping up everywhere. This article introduces the main modular construction methods used in the pharmaceutical industry and examines their applications and operational conditions. Just as with buildings, there is a trend toward modularization in processes as well, to ensure a high degree of flexibility in the face of future process changes. Using an example from pharmaceutical biotechnology (monoclonal […]
Reliable inspection processes with validated test kits
This presentation focuses on one of the often underestimated yet critical components of aseptic quality control: validated test kits for visual inspection. In GMP-regulated production environments, visual inspection serves as a final safeguard to ensure that contaminated, damaged, or incomplete products do not leave the sterile zone. For this process to function reliably, inspectors must be regularly trained, qualified, and supervised […]
Appendix 1: Safe Loading and Unloading of Freeze Dryers
This presentation provides a concise, practical, and forward-looking overview of how modern loading and unloading systems meet the current requirements of EU GMP Annex 1—and why many pharmaceutical companies are reevaluating their processes right now. We’ll show how regulatory expectations regarding closed systems, contamination control, and the reduction of manual intervention directly impact vial handling […]
Safe Use of AI in a GMP Environment Thanks to RAG Technology
The safe use of AI in a GMP environment requires an understanding of how language models work and what their limitations are. Models like ChatGPT can structure content and explain complex topics in an understandable way, but they are based on statistical probabilities rather than verified facts. This can lead to misinterpretations or fabricated statements—which is problematic in a highly regulated environment where […]
How do I write a standard operating procedure (SOP) for quality risk management?
Quality risk management is a central component of the pharmaceutical quality system. All quality-critical decisions should be made on a risk-based basis. This can be done both prospectively (e.g., to determine the scope of a qualification) and retrospectively (e.g., to assess the consequences of a deviation). In this context, QRM is closely integrated with many other processes of the pharmaceutical quality system. The application of […]