Modular design frameworks in pharmaceutical production
In the increasingly demanding field of pharmaceutical manufacturing, the need for improved functionality, flexibility and compliance has never been greater. This presentation will focus on the implementation of modular design frameworks - for hardware and especially for software - as advanced control strategies to meet this need. A comprehensive description of these frameworks [...]
Cleanroom cleaning - new builds and conversions, what needs to be considered?
Every construction project is contaminated with dust and particles. These are undesirable in cleanrooms. We clean every cleanroom system so that it complies with the legal regulations of the respective RR class from day one, both in terms of particles and microbiology. Are you planning to convert your existing cleanroom facilities, do you want to expand your facility or are you a planner or cleanroom constructor? [...]
FacilityPro: A modern environmental monitoring system
Modern systems for environmental monitoring of cleanrooms and production facilities have become indispensable in pharmaceutical companies. They are a relatively simple tool for collecting and processing a wide range of data required for the release of a batch. The systems not only meet the data integrity requirements, but also provide additional [...]
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 [...]