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.
Cleanroom monitoring: Has data integrity been considered?
Cleanroom monitoring: Data - Has data integrity been considered? Timo Kretzschmar sheds light on the topic of data integrity in valid applications on qualified infrastructure. Is it the great unknown? What needs to be considered when it comes to backups and archiving. Can cloud systems be used and what needs to be considered when using them? How can cloud systems be used for control and data management. [...]
Working and acting in accordance with Annex 1 (Part 3)
We discuss the issues that need to be clarified for staff, management and supervision.
Pharma/biotech robotics: so much more than just logistics
The real added value of robotics in production plants lies in productivity and product safety. The natural trend towards automation through the use of a robotic solution often relates to logistical tasks: Depalletizing, palletizing, transporting material between different locations. However, in pharma/biotech production facilities, there are many challenging and ground-breaking tasks that can be solved with creative robotic solutions, [...]
Annex 1 - What does this mean for your monitoring system?
Do you produce according to Annex 1? What requirements result from Annex 1 for the cleanroom monitoring system? What are the requirements and how should Annex 1 be classified? What has changed with the new version published in 2022? Get a compact overview with all the essential information on the topic of monitoring in Annex 1
Cleanroom technology - Energy efficiency, VDI 2083 Sheet 4.2
Cleanroom technology - Energy efficiency, VDI 2083 Sheet 4.2, Why a standard - there are laws and regulations? The standard VDI 2083 Sheet 4.1 Cleanroom technology "Energy efficiency" Why this standard, when there are laws, regulations and other rules on energy saving? Content of this standard: Which topics are dealt with specifically for the cleanroom? - Planning requirements [...]
Presentation of a Fast Track Brown Field Project in Biotech
Two additional production lines of 16 tons of immunoglobulins per year are created. CSL Behring is expanding its production capacity in Berne to meet the high demand for immunoglobulin products. The project, called Protinus, is being realized at the Wankdorf site. It includes the construction of a multi-storey building with two production lines. The new building will be connected to the [...]
Fully automated and validatable decontamination processes
The basis of the pharmaceutical industry is the GMP-compliant (Good Manufacturing Practice) production of sterile and high-quality products. The aseptic production of parenterals must take place under controlled process conditions, which is why effective and tested disinfection processes are required to minimize the bacterial contamination of surfaces (bioburden). Due to the high time expenditure and the risk of insufficient [...]