Thesis: No successful CCS without systematic QRM
The explicit requirement for a contamination control strategy originates from the current version of GMP guideline Annex 1 and applies in principle to sterile medicinal products. Our thesis: "There is no successful contamination control strategy without systematic quality risk management". How is the development of a CCS influenced by the processes and the type of product? How should a CCS file be structured? What role [...]
Pharma 4.0 Pract. Application examples and challenges
The demand for intelligent plants and systems for the control, monitoring and documentation of workflows is becoming increasingly important in the international process industry. The conditions of resource efficiency, flexibility and optimized decision-making imposed by the constantly growing market pressure are increasing the need for automation of the associated components as part of the Pharma 4.0 concept. This presentation uses practical examples to [...]
Long-term storage - transfer of organic contact
The content of the presentation is the various applications in industry based on aerospace. Furthermore, the evaluation of PAC and MOC contamination, the storage conditions and the interpretation of the results and transfer to other applications.
The evolution of cleanroom cleaning
An insight into the development of the first cleanroom mop system made of carbon (CFRP), the ultra-durable high-performance material. Find out how the development of new, cleanroom-compatible materials can lead to a breakthrough in terms of ergonomics, functionality and sustainability for cleaning equipment and mops.
Calibration of humidity sensors
Due to the design and measuring technology of the sensor, humidity sensors are naturally inert and react to different influences. The precise determination of humidity values in production facilities, clean rooms and storage locations is becoming increasingly important, as incorrect climate values can damage a product and, under certain circumstances, unnecessarily increase operating costs. The presentation shows how the humidity sensors available today are constructed [...]
Cleanroom packaging to protect against contamination
Packaging in a cleanroom environment must fulfill an adequate product specification.
Integration of robotics in pharma/biotech production facilities
Robotic solutions cannot simply be "glued" onto a pharma/biotech production line. Robotic solutions are part of the plant and can only be efficient and safe if they are fully integrated: - Robotics must be integrated into the generation of production data (electronic batch record, event and alarm logs, ...): The actions performed by the robots must be described and recorded, [...]
BLOCK® Isolator Technology
We develop, produce and supply insulator technology, technological equipment and stainless steel furniture. We have been active in this field since 2004. We are based in the Czech Republic, where we have our own first-class experts, know-how carriers and our production facility for insulator technology and technological equipment. We offer both standard range and customized solutions according to special requirements.
Dehumidification in a clean environment, adsorption dehumidification
Dehumidification in a clean environment, adsorption dehumidification, dehumidification through condensation, areas of application & application limits What common methods are there for dehumidifying air in air conditioning systems? Dehumidification of the air by falling below the dew point temperature - Cold water - Brine - Direct evaporation - Adsorption dehumidification Which technology is used for air dehumidification depends on various factors, there is no generally [...]
The new Annex 1 | Contamination Control Strategy (CCS)
The core topics and correlations for developing an appropriate contamination control strategy in accordance with the current Annex 1 of the EU GMP guidelines are explained clearly and concisely.