Implementation of ISO 14644-16 in Pharmaceutical Manufacturing
Sustainability is also becoming increasingly important in pharmaceutical production. For some time now, there have also been discussions about making sustainability a relevant aspect for market approval. In this context, energy efficiency in manufacturing is becoming increasingly important. Particularly in the manufacture of sterile preparations, the cleanroom is responsible for a high proportion of energy consumption. Thus [...]
Pharma Terrazzo vs alternative flooring systems
Pharma Terrazzo has been the standard in pharmaceutical cleanrooms for decades - robust, proven, recognized. But reality often brings different rules of the game: Liquids, chemicals and narrow time windows for which more flexibility is required. Experience an informative presentation by Dominikus Forsthuber, the leading expert for cleanroom floors. Using a real project, he shows when pharma [...]
Consultation tool: System selection based on CAPEX, OPEX, and CO2
This presentation introduces the consultation tool and explains how it is used to select ultrapure media systems tailored to specific projects. The tool demonstrates how customer requirements can be met while minimizing operating costs, capital expenditure, space requirements, and CO2 emissions. A case study comparing hot and cold WFI technologies illustrates the identified savings potential. Robin Klusch Global Product Manager – Ultra-Pure Media, Process, and Bioprocess Systems […]
AI and VR in cleanroom planning: trend or future?
As in many other areas, AI, VR and other digital technologies are increasingly being used in the design and planning of cleanrooms. And the question of the value of using such technologies also arises in the field of cleanroom planning. In order to answer this question, the state of the art and some examples [...]
Thermocouples in validation: cables have the advantage
Wired validation systems offer clear advantages in certain applications—such as processes involving extreme temperatures or situations where the highest measurement accuracy is required in real time. We examine typical application scenarios for thermocouples, distinguish between wired and wireless systems, and highlight the challenges to consider regarding handling and sensor placement. We also address regulatory requirements (e.g., GAMP5, […]
Definitions
Test methods
Necessity
Implementation
Molecular Containment Control
Airborne contaminants pose a constant risk to health and process safety. In particular, molecular contaminants, harmful gases, and vapors can have a negative impact on human health and product quality. Using the example of NO₂ and the associated formation of nitrosamines in pharmaceutical processes, this section will demonstrate how adsorption—the physical principle utilized in […]