Accelerated Times: Leadership Toward Project Excellence 4.0
In an increasingly dynamic market environment, leading engineering firms are evolving into strategic partners for project execution. Drees & Sommer has purposefully refined its organizational structure—with dedicated client teams and frameworks that enable efficient and customized project delivery. A clear organizational structure, supported by an open corporate culture, future-proof processes, and state-of-the-art technology, paves the way to Project Excellence […]
Process Linking – Greater Efficiency and Safety
The presentation introduces the Process Linking concept using the example of OSD production. The traditional approach to OSD production is compared with the innovative Process Linking concept, which creates closed systems by directly linking processes and minimizes interfaces. The PTS powder transfer system is central to the concept and enables the safe and efficient transport of powders. The […]
Determination of the bacterial count in pharmaceutical water in real time
Until now, determining the microbial count in purified water and water for injection has relied almost exclusively on time-consuming laboratory culture tests. Under Monograph 0169 of the European Pharmacopoeia (04/2017), WFI no longer has to be produced exclusively by distillation (the USP has always required this). Consequently, the requirements for monitoring water quality have increased. The latest technical developments enable accurate […]
Ozone measurements during cold sanitization
Dissolved ozone is one of the key parameters for monitoring water used for pharmaceutical purposes, as required by pharmacopoeias—particularly with regard to cold production and cold sanitization—and is measured online in real time. The presentation covers important information regarding water treatment using ozone, the relevant pharmacopoeia regulations, current technologies […]
Conductivity measurements according to USP and Ph. Eur.
Conductivity measurement is a well-established and widely used analytical technique that has been in use for many years to monitor the quality of water for pharmaceutical purposes. In addition to the fundamentals of conductivity measurement, this presentation will also provide a detailed overview of the requirements set forth by pharmacopoeias. The structure of the measurement technology and the latest developments in this field will also be covered in the presentation. […]
Disinfectant Testing: Validation in Accordance with Regulations
Regulatory requirements and guidelines for the pharmaceutical industry now require that disinfectant efficacy tests (DET) for the validation of biocides be conducted with even greater care. Validation is expected to be performed using the minimum contact time, typical microbial flora, and surface materials, as well as in the specific manner in which a biocide is used in each facility. The presentation summarizes the existing methods for […]
Greater efficiency in training – thanks to Ellab
In this presentation, discover how Ellab helps make projects in the pharmaceutical and life sciences industries more efficient and successful. We’ll show you why it’s crucial to have a partner by your side who not only reliably performs measurements and tasks but also proactively supports you with advice and assistance before, during, and after the project. You […]
Communication for Cleanroom Environments
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 [...]
Calibration of Air Particle Counters: Insights into ISO 21501
All airborne particle counters that detect and classify particles using laser scattering are calibrated in accordance with ISO 21501-4. Calibration should take place annually. However, most users do not know exactly what this calibration entails, what the statements “calibration passed” or “failed” mean in detail, or why two identical devices at the same installation site still do not […]
Appendix 1 – Microbiology, Monitoring, and Sampling
In the context of Annex 1, microbiology, monitoring, and sampling play a central role in ensuring the reliability and compliance of pharmaceutical water systems. A well-structured risk assessment of the sampling strategy is crucial for identifying critical sampling points, understanding potential contamination pathways, and determining appropriate sampling methods and frequencies. Equally important is the proper design and implementation of sampling points. […]