Integration of self-calibrating devices in existing systems
Modern measuring devices provide additional quality indicators about their own condition, which can be retrieved as a verification report or calibration certificate. In existing plants, however, the process control systems are often not able to process this data. Using the example of self-calibrating thermometers, it is shown how "heartbeat technology" can be integrated and used without having to re-validate the system [...].
cGMP process and plant planning
There are many unique considerations and features of CGMP facilities, such as containment and segregation strategies, GMP flows and cleanroom performance requirements. Some of these concepts may seem complex and challenging, but it's worth remembering that each concept is linked to ensuring product safety and purity. One of the most important aspects is the correct application [...]
Safe design of shear-sensitive sterile processes
The use of magnetic stirring systems in shear-sensitive sterile processes meets the highest demands in terms of safety and sterility as well as product quality. The magnetic coupling ensures that the container integrity is fully maintained - contamination of the cost-intensive media by penetrating contaminants can be ruled out. The use of stainless steels, such as 1.4435; 1.4539; 1.4539 or 2.4602 (the latter three are special alloys) and high-performance ceramic materials, such as [...]
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, [...]