Hot or cold WFI generation
Whether hot or cold WFI generation. It is definitely a hot discussion. Both technologies have advantages and disadvantages. There is no universal answer to the question of which is the ideal technology. It depends on the individual framework conditions. Two experts from BWT, Mr. Philipp Ettle and Mr. Marcel Zehnder, will exchange arguments and [...]
Flow measurement: calibration and heartbeat technology
The flow of pharmaceutical media can be recorded and balanced using various measuring principles. The required system availability requires the measurement technology to function perfectly and essential maintenance and calibration aspects to be taken into account. This presentation highlights the possibilities of calibration and self-monitoring of flow measurement technology via heartbeat technology.
Information security in the pharmaceutical environment
The increasing networking of computerized equipment and systems in pharmaceutical production and the digital transformation towards a smart factory brings new challenges and risks - because everything that is connected via information technology is also under attack. The attacks on pharmaceutical companies over the past decade show that process and automation technology is becoming a [...]
Modular system for individual bioreactors and fermenters
Bioreactors and fermenters are as diverse as their applications in industry. They are used wherever biotechnological processes need to be simulated in production. For example, in the production of cells, bacterial cultures, enzymes, microorganisms or the fermentation of food. With its modular system, Ruland adapts the fermenters and bioreactors precisely to the respective [...]
Cleaning validation with a parts washer
According to the 2011 FDA guidelines for process validation best practices, which are also in line with international guidelines ICH Q8, 9 and 10, it is crucial to first understand the process to be validated before performing the validation activities as such. To achieve this, this presentation summarizes the various points that [...]
Applications Temperature calibrators in pharmaceuticals and cleanrooms
Today's applications of temperature calibrators in pharmaceutical and cleanroom applications have evolved in terms of technical possibilities. This makes it possible to save time during the actual calibration process. The presentation deals with the individual applications in practice.
Sustainable CO2 savings in storage & transportation
GMP:talk Sustainable CO2 savings in storage & transportation Why are the temperature limits for ambient storage under discussion right now? How can sustainability be established in transportation? Do quality processes need to be adapted for sustainability strategies? What are the most common pitfalls? What are the challenges of the next few years? Dr. Christoph Frick, Head of Quality Assurance at Kohlpharma GmbH, discusses these questions with Thomas Peither, [...]
The development of the pharmaceutical fermenter
The bioreactor has been around for as long as human society has used bioprocesses in the form of fermentation and cell culture to discover, improve and produce vital foods and medicines. Throughout its long history, the bioreactor has constantly evolved to meet the demands of new product applications that have emerged since the 1980s with the advent of [...]
Accredited calibration according to EN/ISO 17025
In recent years, the importance of an accredited calibration certificate in accordance with EN/ISO 17025 has increased significantly. Only this accredited calibration guarantees internationally comparable measurement results thanks to the seamless traceability chain to the basic SI units. As part of your quality/test equipment system, you can implement traceability to the basic SI units both internally and externally. As an independent Designated Institute (DI) and independent [...]
Measuring device development in accordance with FDA and GAMP regulations
The FDA "Process Validation" and ISPE GAMP "risk based approach to calibration" guidelines contain a series of regulations on process control and the calibration of measuring devices. Many of these rules can be taken into account during the development of a new measuring device so that it can be integrated much more easily into a regulated environment.