Cleanroom 4.0 - the future of cleanroom technology
The planning and construction of cleanrooms has changed dramatically in recent years: all project participants work together in an integrated manner and in real time right from the planning phase, which saves time and avoids errors later on during construction. However, technical expertise and precision craftsmanship in execution are still a prerequisite. But what does [...]
Fridge qualification: mappings and validation
This presentation highlights the essential topic of GDP/GMP-compliant implementation of distribution measurements (mappings) in the context of refrigerator qualification. It provides an in-depth insight into the regulatory requirements and best practices that are essential for smooth refrigerator qualification. This includes suitable evaluation methods and forms of presentation of the distribution measurements, as well as essential components of the documentation. The practice-oriented presentation focuses on the importance of [...]
Planning, building and operating cleanrooms sustainably, but how?
Hardly any other term has developed as much in recent years as the term "sustainability". But what does sustainability actually mean and what does it have to do with cleanroom technology? First and foremost, it means using existing resources sparingly and reducing the CO2 footprint, especially with regard to climate change. The presentation shows in [...]
Refurbishment of cleanroom floors
The trade fair presentation presents solutions for the refurbishment of floors in cleanrooms. Discover classic and modular flooring systems, customized to reduce downtime and contamination. We present innovative approaches for an efficient environment. Today's solutions offer the advantage that even on problematic and uneven old substrates, immediate installation is possible without the need for substrate preparation. Learn more [...]
The "do's and dont's" of cleanroom construction - avoiding mistakes
The planning and construction of cleanrooms is a very complex task. Many customers who are building a cleanroom for the first time are overwhelmed or underestimate the number of factors that need to be taken into account. In addition, such projects often have to be implemented "on top" of day-to-day business. On the one hand, the presentation shows the potential errors in the procedure [...]
Energy-efficient cleanroom operation: measurement technology & compliance
Sustainable and economical production in the pharmaceutical industry also requires consideration of the energy efficiency of the various processes. Since the operation of clean rooms and clean areas entails a high energy requirement due to air routing and conditioning, there may be potential for optimization in terms of energy consumption. In this presentation, documentary and metrological solutions are presented with regard to [...]
GMP-compliant calibration
For process control in pharmaceutical production, the collection of measurement data directly in the process and indirectly in the process environment is of crucial importance for the quality of the end product. These measurements require reliable measuring equipment that generates valid measurement results. In order to create confidence in the recorded measurement results, the measuring equipment must be calibrated with suitable traceability. Each measuring point must be [...]
3rd party GMP audits: New VDI expert recommendation 6306
The publication of VDI expert recommendation 6306, which for the first time establishes detailed guidelines for conducting 3rd party GMP audits, is groundbreaking for supplier audits. Learn the reasons behind this innovation and more about the experts who wrote it. Learn the content of the recommendation and its best practices. Hear from the development process to the debate about the [...]
Qualification of a steam sterilizer
The presentation covers the process from load definition to the final qualification of sterilizers, taking into account the challenges of a new load. The focus is on the planning, the measuring system, the OQ work and the qualification of a load. Important standards such as EN 285 and ISO 17665 are emphasized to ensure safe and sterile results. In addition, the [...]
Energy-efficient qualification of depyrogenation tunnels
In this presentation, you will learn how to carry out GMP-compliant qualification of a depyrogenation tunnel and save a lot of money by working energy-efficiently. You will learn which measuring system is best suited to the measuring task and receive helpful tips on the correct positioning and fixing of measuring points at the critical points of the system. The knowledge you gain will enable you to optimize your processes [...]