Validation of an RMM for pharmaceutical water
Alternative methods for microbiological monitoring offer significant advantages over conventional plate testing. However, none of these alternative methods have yet been validated for pharmaceutical water. In this presentation, we will walk you through all the procedures and steps required for successful validation. Once validated, alternative methods can be used not only for in-process control but also for quality control. This means […]
Innovative Solutions for CERN
In addition to cleanroom technology and the resulting requirements for ambient air, “clean” cooling is also becoming increasingly important in building services engineering. Alongside the impact of the EU’s F-Gas Regulation, a growing segment of the population is becoming aware of the environmental risks associated with the continued use of PFAS, HFO, and TFA. The […]
Online microbial monitoring using flow cytometry
Alternative methods for monitoring microbial contamination in pharmaceutical water have been sought for many years, and various technologies are now available on the market. Each method has its own specific advantages and disadvantages. In this presentation, we will demonstrate examples of the use of flow cytometry as a microbiological monitoring tool for pharmaceutical water. Continuous monitoring enables the application of trend rules to the process data. […]
Room Monitoring in Practice: Compliant, Precise, Transparent
Focus on Cleanrooms – Best Practices for Monitoring: How Does ELPRO Do It? • Combining Room Parameters and Particles • Fixed Sensors Plus Mobile Sampling • Sensor and Measurement Module Placement • Integrating Device Sensors into the CMS • Different Setups by Zone and Class: Variety and Typical Setups—What Can Be Measured? What Makes Sense? There are various […]
Immersive Reality: Design, Training, and Operation
Exyte will demonstrate how the Pharma Campus enables customers and manufacturers to experience specific use cases in the pharmaceutical industry within a virtual reality environment. By creating detailed virtual models, complex facilities can be visualized as early as the planning phase, long before construction begins. This not only facilitates more efficient collaboration among project stakeholders, but also contributes […]
Commissioning & Qualification – The Key Phases
Traditional C&Q processes (commissioning and qualification) are often time-consuming and costly, as many tests must be performed and documented separately, resulting in duplication of effort. The goal of the leveraging approach is to eliminate these redundancies: tests that are relevant for both commissioning and qualification are performed and documented only once. Through early planning and organization of the teams […]
The Evolution of Monitoring in the Age of AI and the Cloud
Storing temperature-sensitive products is a challenge in many pharmaceutical and biological processes. Continuous monitoring and alerts when thresholds are exceeded are the current standard. While this allows for the detection of refrigeration equipment failures, it cannot prevent them. Integrating artificial intelligence, machine learning, and cloud solutions into monitoring systems can help drive the transformation of the pharmaceutical and […]
The risk-based approach to commissioning/qualification
EU GMP Annex 15 stipulates that essential quality elements related to patient safety and product quality must be incorporated into the User Requirement Specification (URS) from the outset. A detailed risk analysis conducted prior to the URS can optimize quality risk management. This approach allows risk-mitigating measures to be incorporated into the machine design while simultaneously paving the way for lean qualification. Through early risk assessment […]
Annex 1-compliant processing of highly potent active ingredients
The processing of highly potent active ingredients, such as antibody-drug conjugates (ADCs), places the highest demands on sterility, containment, and operator safety. This presentation demonstrates how Annex 1-compliant machine designs ensure aseptic integrity and comply with current EU GMP guidelines. In addition, solutions for containment strategies will be presented that ensure both product and personnel safety without compromising efficiency or flexibility. Topics such as hygienic […]
Professional project management in cleanroom construction
Carrying out projects can be a complex undertaking not only in residential construction but especially in cleanroom technology, since—unlike traditional construction projects—there are far more interfaces to consider. The demands placed on project management in terms of technical complexity, interface coordination, and adherence to schedules and budgets are immense. In addition, the […]