AdvantaPass - Fluid transfer in cleanrooms with wall-through
AdvantaPass® - Clean Room Pass Through Technology Cleanroom wall portal for customized single-use systems AdvantaPass is a patented system that enables the aseptic transfer of liquids between rooms in pharmaceutical production facilities. The system provides complete separation between different cleanroom classes when transferring liquids. AdvantaPass offers a practical, safe and easy way to transfer large volumes of liquids from room to room [...]
Best Practice Cleanroom Monitoring System:
Best practice cleanroom monitoring system: What does implementation look like in practice? How is the system set up? How are the measuring devices installed in practice? What do processes such as alerting or reporting look like in practice? Experience a practical overview of the topic of monitoring. The basis for this is an implemented project, into which we provide exclusive insights.
Cleanroom-based process reliability & yield
The topic of this presentation is the influence of AMC on process safety and process yield. Current cleanrooms are designed with the best process flow in mind, with the main focus on meeting process window conditions, process tool serviceability and accessibility, logistically optimized paths between process steps, and cost and space optimization in building design. However, AMCs can significantly [...]
Cleanroom cleaning: From the general to the specific
Standards and guidelines are essential components in the cleaning of a cleanroom, but how do we implement them correctly in daily use? It is obvious that there is a wide range of tools and aids for carrying out cleaning and disinfection measures. But which equipment should be used when, where exactly the advantages lie and [...]
Standard-compliant and effective test equipment management
Standard-compliant and effective test equipment management and calibration - Evidence for continuous process verification in accordance with Annex 15 What does test equipment management involve? Difference between factory and accredited calibrations What needs to be calibrated and how? Determining the points and references to be calibrated - based on what? How do I integrate this into the continuous process verification required by Annex 15 [...]?
Laboratories as a real estate asset class
A new trend has recently emerged in the field of laboratory projects in Germany: Increasingly, "rental laboratories" or incubators are being set up by project developers for users who are usually not fixed. While this is already common practice in some European countries, laboratories in Germany have so far mainly been planned and created by the users themselves. The particular challenges for users [...]
Practical tips for setting up a personnel airlock
Personnel airlocks serve as access to pharmaceutical production and cleanrooms or as a transition between two cleanroom classes and play a decisive role in ensuring production safety. What needs to be considered when choosing materials, equipment and processes and what options are available? We provide answers to these questions using practical examples.
Cleanroom cleaning: From the general to the specific
Standards and guidelines are essential components in the cleaning of a cleanroom, but how do we implement them correctly in daily use? It is obvious that there is a wide range of tools and aids for carrying out cleaning and disinfection measures. But which equipment should be used when, where exactly the advantages lie and [...]
Support for the CCS (Contamination Control Strategy)
Supporting the CCS (Contamination Control Strategy) through metrological testing and verification What does a CCS involve - how can it be supported/implemented metrologically? How does cyclical cleanroom qualification fit into the concept and what are the findings? What can flow visualization contribute and what needs to be considered? What needs to be considered for calibration & mapping [...]?
Filtration technology for production processes in cleanrooms
This presentation will discuss contamination control in cleanrooms, highlighting the challenges in the various process steps in relation to HEPA and AMC filtration. Process safety and risk management are the key success factors for efficient processes and product reliability. Product contamination is not only problematic and costly - it also damages reputation and image and delays [...]