Current developments and innovations in cleanroom measurement technology
The qualification of cleanrooms and clean air systems includes the entire assessment process for compliance with the relevant normative requirements for the intended use of typical trades. A decisive component of this qualification process is the application of EN ISO 14644 and its harmonization - including the corresponding particulate limit values - with Annex 1 in the EU GMP [...].
GMP-compliant and efficient cleanroom measurement technology
The provisions for the qualification of cleanliness zones in the manufacture of sterile medicinal products are set out in the current Annex 1. A crucial part of this qualification process includes the application of the classification according to EN ISO 14644 in order to ensure that measurements are carried out in compliance with the standard. Particular attention is paid to the measures from the contamination control strategy. In order to meet the requirements of the Annex [...]
TDL (tunable diode laser) O2 analyzers in pharmaceutical processes
Industrial processes are usually multi-stage and require process analytical measurement technology to ensure the safety, efficiency and reliability of the processes. Among the various process analytical measurements (pH, conductivity, turbidity, etc.), the measurement and monitoring or control of oxygen also plays a central role in many pharmaceutical processes. Accurate and continuous measurement of the O2 concentration is essential in numerous manufacturing processes in [...]
Communication in a cleanroom environment
Cleanroom loudspeakers should be of extremely high quality and durability, absolutely maintenance-free, installable in various ways and encapsulated in order to exclude any contamination of the clean environments by the acoustic system and to withstand various pressure influences in cleanroom environments. A typical application in such an environment is gassing with H2O2 for disinfection. In this case it is of [...]
Ventilation technology + digitalization: future-proof solutions
What are the benefits of digitalization in technical building services? What effect does the integration of BIM have on the planning process for ventilation technology for clean rooms? What advantages does digitalization offer in the manufacture of ventilation and air-conditioning equipment and what new opportunities does this open up for the entire value creation process? This presentation will address these and other questions. [...]
LCA: Ecological footprint of ventilation and air-conditioning appliances
The presentation highlights the methodology for determining the ecological footprint of ventilation and air-conditioning appliances. Using the example of an air handling unit for a production and filling line for pharmaceutical products, it will be shown how intelligent technologies open up new perspectives in terms of sustainability. Study results from a life cycle assessment show that the utilization phase of these air handling units has an even greater influence on the overall efficiency [...].
Efficient inspection of industrial ventilation systems
The challenges, advantages and solutions of inspections using indoor drones will be presented and discussed.
Flow visualization: The impact of Annex 1
We explain the impact of the updated Annex 1 on flow visualization in cleanrooms. It explains how smoke studies should be correctly conducted, documented and integrated into a comprehensive contamination control strategy (CCS). Special attention is given to determining the frequency of such visualizations to meet GMP standards and ensure a safe, contamination-free environment. This content [...]
A detailed look at environmental monitoring systems
Modern systems for environmental monitoring of cleanrooms and production facilities have become indispensable in pharmaceutical companies. To release a production batch, a large amount of data must be viewed and released. The storage of the data must meet all the requirements of current data integrity specifications. At the same time, the data must be available quickly. Trends must be generated and analyzed quickly [...]
Qualification and monitoring of a warehouse
In this presentation you will learn how to perform efficient warehouse validation and monitoring with Ellab data loggers and the TrackView Pro monitoring system. It will explain why mappings are required, which guidelines need to be taken into account, how many sensors are used and what needs to be considered when positioning sensors. In addition, it is shown which report functions you can use with the [...]