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. […]
Qualification testing of cleanrooms
Cleanrooms must be inspected regularly to ensure that they operate reliably under the conditions required for sensitive production processes. Particularly in industries such as pharmaceuticals, medical technology, and microelectronics, product quality depends heavily on a stable and controlled environment. In this presentation, we will examine at what intervals a cleanroom inspection […]
Pharmaceutical Water: Sensors That Drive Change
Pharmaceutical water processes involve the treatment, storage, and distribution of PW or WFI—monitored by numerous sensors, often complex and expensive. But do they always have to rely on mechanical flow sensors (vane wheels, float switches) that require extensive maintenance, or costly Coriolis sensors? We’d like to show you an alternative: our ultrasonic series—suitable for everything from drinking water to hot WFI withdrawal. There are also numerous temperature measurement points and […]
What the pharmaceutical industry can learn from the semiconductor industry
While Water for Injection (WFI) is often considered the purest process water in the pharmaceutical industry, the semiconductor industry operates under even stricter standards. The Ultrapure Water (UPW) used there for chip production must be virtually free of ionic, organic, and particulate contaminants—measured down to the parts-per-trillion range. Continuous operation, online analytics, and predictive […]
Hot WFI without distillation at SCHOTT Switzerland GmbH
SCHOTT Schweiz GmbH has implemented the first fully membrane-based MWFI system, setting new standards in efficiency and sustainability. Through the intelligent use of excess heat from the chillers (waste heat at 70 °C), steam consumption was reduced to just 20 kWh per m³ of WFI produced—compared to more than 300 kWh/m³ in conventional distillation systems. At the same time, the […]
Modularization Using Pipe Racks in the Life Sciences Sector
Pipe racks are a central element in modern plant engineering and are becoming increasingly important. This presentation demonstrates how modular construction leads to shorter construction times, lower costs, and improved workplace safety. The focus is on planning, prefabrication, and installation—from integration into the plant layout to on-site implementation. Using real, completed projects as examples, it illustrates how […]
Reuse of pharmaceutical-grade water
Currently, the issue of reusing pharmaceutical-grade water is one of the “hottest” and most widely discussed topics in the world of pharmaceutical water treatment. While water recycling has been an established standard for many years in numerous other industries—such as food processing, semiconductor manufacturing, and chemical production—the pharmaceutical industry is still in the early stages of broader implementation. […]
Sampling, Qualification, and Lifecycle of Pharmaceutical Water Systems
C&Q Guide (Third Edition) – What’s New, and What Really Matters? This session provides a detailed overview of the most important updates in the third edition of the C&Q Guide. We will examine which changes have a concrete impact on the qualification process, how they should be classified from a regulatory perspective, and what practical consequences they have for day-to-day operations in GMP-regulated production environments. Qualification […]
Pure Steam – Regulations, Design, Costs
When it comes to new ultra-pure steam systems, there is a need to define the requirements for the necessary steam quality during the planning phase for both generation systems and distribution networks. To this end, the fundamental general requirements, project-specific requirements, and other influencing factors must be considered holistically so that a GMP-compliant assessment can be achieved in line with a risk-based approach. Join us […]