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.
Good practices
Data integrity in pharma - what does it mean for your automation systems? The reliability and trustworthiness of data must be guaranteed throughout its entire life cycle. To ensure data integrity, it must be constantly monitored. The importance of the data and how it can be maintained in the process is also determined. Quality and efficiency of data integrity Data redundancy/backup [...]
Decontamination by light: UV-C
Decontamination by light: UV-C 1. The new world of LEDsA. The historical technologiesB. The state of the art of LEDsC. Advantages and disadvantages,D. How to approach the use of UV_C LEDs in cleanrooms.E. Application examples
Data integrity in cleanroom monitoring
The FDA uses the abbreviation ALCOA and its extensions to describe its concept of data integrity. The EU has regulated electronic signatures in Regulation 910/2014. Both concepts are explained. Potential weaknesses in the integrity of monitoring data are also discussed.
Security concepts for building automation networks
With the rise of Bitcoin, the digital internet currency, blockchain technology suddenly became a hype. Internet giants are planning their own digital cryptocurrencies and threatening the traditional world of reserve currencies and banks. Away from these megatrends, SAUTER is taking a completely different approach and is aiming for a "peaceful" use of blockchain technology by protecting the data and processes of building automation.
Annex 1 - Significance and implementation of CCS
In the topic "Annex 1 - Importance and implementation of the CCS", we will highlight the contents and existing stumbling blocks and discuss the expectations for implementation.