Room air technology: individual, hygienic and efficient
Ventilation and air conditioning units must ensure the quality of the treated air on a permanent basis. Individual ventilation and air conditioning units offer many advantages. Using examples, robatherm shows what individual solutions can look like and how they always meet the high requirements for hygiene and efficiency. robatherm's experience with air handling units for increased hygiene requirements is reflected in many details, [...]
Isolator design: individual vs. standard
The future lies in isolating entire production lines, production processes and critical work processes from environmental influences and integrating them into fully automated safety systems. Isolators and isolator technology can be divided into two categories: standard systems and individual user-specific systems. Based on technologies from the automotive and aviation industries, isolators are equipped with new measuring and monitoring technology. [...]
Fill & Finish - solutions to reduce interventions
Reducing glove interventions in a pharmaceutical containment system increases sterility assurance and minimizes contamination risks. This presentation highlights strategies to achieve these goals and emphasizes the importance of automation, advanced glove technology and stringent process controls. By implementing these measures, pharmaceutical processes can optimize efficiency, ensure product quality and meet regulatory standards within a contained environment [...].
O3 measurement in pharmaceutical water systems during cold sanitization
Ozone is a strong oxidizing agent that is able to kill microorganisms particularly effectively, thus making it possible to disinfect water safely and effectively. Ozone has been used to treat drinking water for over 130 years. Ozonization is an effective method with an increasing trend towards the sanitization of ultrapure water in pharmaceutical and semiconductor production as well as [...]
Cleanroom - Troubleshooting 4.0 in building technology
We want to show you the options for recording measurement data and storing it for carrying out fault analyses with historical data. The integration of conscious data collection makes fault analysis more complex on the one hand, but also clearer. Which systems will make our work easier in the future by collecting and processing all relevant data and then storing it in a [...]
Smart Lab Ecosystem: modular system for laboratories and cleanrooms
The Smart Lab Ecosystem was founded by Siemens AG, H. Lüdi + Co. AG and Inside Reality AG in order to better manage the complexity of the laboratory environment, significantly increase the flexibility of the infrastructure and minimize energy requirements. Various experts are creating a modular system kit consisting of proven and tested solutions. The digital planning [...]
Annex 1 contamination control strategy - one year later
Annex 1 requires that processes, equipment, facilities and manufacturing activities should be considered in accordance with the QRM principles. This is a proactive means of identifying risks and scientifically assessing the risks. This expectation requires the development of an effective contamination control strategy (CCS) based on a scientific assessment to understand the process. In the Annex [...]
Responsibility for sustainable product development
Plant engineering is undergoing a transition to sustainable engineering that emphasizes the integration of innovative solutions and standards. The focus is on redesigning cleanroom technology, which opens up fresh perspectives in planning. Central aspects are sustainable product development, re-use concepts and circular economy, complemented by the importance of standardization and process parameters. The CO2 equivalent is moving into the spotlight as an indicator for [...]
Determination of the bacterial count in pharmaceutical water in real time
The determination of the bacterial content in purified water and water for injection purposes was previously based almost exclusively on time-consuming laboratory tests based on cell cultures. However, plate counting, which has been practiced for over 130 years, is an estimation of bacteria with high variability. This is based on the visual counting of a colony of cells. The pharmaceutical industry estimates that over 80 % [...]
From the world of paper to digitalization in the GxP environment
The digital revolution has long since begun and the buzzwords artificial intelligence (AI) and big data are on everyone's lips. In the GxP regulatory environment, however, many companies are still at the beginning of their digital journey. The integration of artificial intelligence and big data not only opens up modernized workflows, but also advanced analytics, predictive analytics and data-driven [...]