The key to successful small-batch production
The pharmaceutical industry is faced with the challenge of meeting the growing demand for flexible and versatile manufacturing processes in order to efficiently produce a wide range of pharmaceutical products. In this dynamic environment, flexible filling and packaging systems are becoming increasingly important. Pre-sterilized packaging has long been an essential part of pharmaceutical production. RTU (ready-to-use) syringes, in particular, have become increasingly popular due to their numerous [...]
Practical tips for modern aseptic sampling
This presentation covers key aspects of aseptic sampling. The selection of the correct valve is explained, taking into account factors such as chemical resistance, pressure and temperature requirements and the avoidance of contamination. Sampling in bottle systems is then discussed, including the correct handling and sealing of bottles to ensure sterile sampling. Practical examples of [...]
Innovation and knowledge transfer:Paving the way 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 [...]
Cleanroom training: Practical training in 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 [...]
Sterile barriers: GMP garment systems and RFID solutions
Annex 1 of the EU Guide to Good Manufacturing Practice (GMP) is considered the most important European regulatory standard for the manufacture of sterile pharmaceutical products. The revised version of GMP Annex 1 (2022) now places stricter requirements on cleanroom gowning systems. These are now coming into focus as part of the contamination control strategy (CCS). The implementation of a contamination control strategy brings advantages and new [...]
The journey through the cleanroom - Pharma XR shapes the future
The requirements for cleanrooms have changed considerably over the years. The understanding of possible contamination has grown steadily. This is not only due to increased knowledge of contamination sources, but also to improved technical monitoring capabilities that allow for better control. New strategies increasingly rely on automation and the use of IoT devices to provide real-time monitoring [...]
Digital learning using the case study of a vaccine company
This presentation addresses the transformation of learning through adaptive technologies and virtual reality (VR). It will show how traditional approaches are being replaced by modern methods that focus on individualization, real-time feedback and practical applications. Adaptive learning systems offer customized learning paths that take into account the progress of each individual. Virtual reality enables immersive training environments that are safe and hands-on. The goal [...]
Management of investment projects in the pharmaceutical industry
Investment projects are omnipresent in pharmaceutical companies. In addition to the individual project objectives, they differ mainly in size and complexity. What all projects have in common is that they must meet the client's expectations in terms of deadlines, costs and performance targets in order to be successful. In addition to quality, performance targets also include the satisfaction of those directly or indirectly [...]
Lessons learned from monitoring project with Daiichi Sankyo
The presentation aims to review and discuss the experience gained from a current cleanroom monitoring project between Daiichi Sankyo and Particle Measuring Systems. The project includes modern monitoring technologies that comply with the latest Annex 1 regulations. Also part of the project was the initial cleanroom classification, as well as the development of standard operating procedures (SOPs) and extensive staff training. To [...]
Gaps to Annex 1? Solutions from practice
The starting point for any successful adaptation to the updated GMP Annex 1 is to carry out a comprehensive GAP analysis. The aim is to identify deviations between the existing processes and the new regulatory requirements. The revision of Annex 1 represents an increased emphasis on risk assessment and the introduction of a Contamination Control Strategy (CCS). The GAP analysis [...]