Continuous microbial monitoring in accordance with EU GMP Annex 1
Good environmental monitoring is mandatory in the pharmaceutical industry and the data generated is highly relevant. Calibration and qualification data are considered separately from routine monitoring data. The latter are proof that the framework conditions defined in the qualification process are also adhered to during operation and that the data is consistent over time. Particularly [...]
A detailed look at environmental monitoring systems
Modern systems for environmental monitoring of cleanrooms and production facilities have become indispensable in pharmaceutical companies. To release a production batch, a large amount of data must be viewed and released. The storage of the data must meet all the requirements of current data integrity specifications. At the same time, the data must be available quickly. Trends must be generated and analyzed quickly [...]
Challenges in particle counting
Since the publication of the new Annex 1 at the latest, the discussion of hose lengths for particle counters has been part of every risk assessment. The defined hose length for particle counters of one meter specified in Annex 1 often causes challenges in the design of new systems and in the justification of existing systems. But how justified is the limitation to one meter and why [...]
Annex 1 Impact on insulator technology
The final version of Annex 1 asks organizations to adopt a new mindset that is top-down, holistic and may require cultural change. Novel technologies such as the use of barrier technology, online CCIT and rapid/alternative monitoring methods are expected to be considered. They all serve the purpose of improving product quality and [...]
Advanced H2O2 decontamination in pharmaceutical isolators
The use of hydrogen peroxide for bio-decontamination is widespread and opens up countless possibilities for application in a wide variety of areas due to its user-friendliness, but above all due to the rapid and reliable killing of microorganisms. As both the mode of action of H2O2 and the factors influencing the killing of microorganisms in bio-decontamination are well researched and understood, there are [...]
Clean enough? - Required cleanliness levels
Aseptic cleaning and decontamination processes are integral parts of pharmaceutical production to prevent contamination and ensure product quality and personnel safety. This study examines the crucial question: "How clean is clean enough?" Specifically, it looks at the impact of chemical contaminants, particularly product residues or contaminants that originate from sources within the [...]
Packaging materials in insulators
The packaging materials used and the product make a fundamental contribution to the loading of the isolator. When developing and implementing a robust and functional decontamination cycle using H2O2, the user should be aware of the nature of these materials. The possibilities of determining the material and product behavior towards H2O2, including individual process parameters, are [...]
Influences on the effectiveness of an H2O2 deco cycle
Although H2O2 decontamination is an established process in the pharmaceutical industry, there are many theoretical and practical aspects that need to be considered. Some of them are well known and obvious but are not taken into account in the development of modern isolators, others depend to a large extent on the knowledge, experience and practical skills of the team that [...]
Robotic solutions in aseptic production
Practical example of robots in pharmaceutical production in cleanroom class A. Three case studies show examples of ongoing customer processes and the experience behind them. All projects are running with different robot manufacturers and processes. By automating processes, efficiency, product quality and production capacity can be increased. The experience gained from these projects shows that the use of robots in [...]
ATMP Manufacturing: the path to the future
In recent years, the number of approved ATMPs has grown rapidly, and the scientific development of new technologies has been just as fast. We can now treat many diseases that were previously a death sentence for patients instead. Yet, ATMPs still reach few patients, for a variety of reasons. We need to change the situation today in order to bring therapies to [...]