GMP non-compliance in the tension between quality, cost, and time
Based on many years of consulting experience, certain GMP issues frequently arise in the manufacture of healthcare products. These issues are examined in detail, along with proven countermeasures and ways to mitigate deficiencies. Underestimated GMP deficiencies can quickly become a threat to the very existence of companies in the GXP sector—but this does not have to be the case. At first glance, it is surprising that certain […]
Humidity as a Key Factor in Cleanrooms
Controlling humidity in cleanrooms is a key factor in ensuring stable production processes and compliance with quality standards. The presentation will explore the technical fundamentals of air humidification, typical challenges such as particle prevention and hygienic design, as well as integration into existing ventilation and HVAC systems. Using practical examples, various solution approaches will be presented that focus on energy efficiency, operational reliability, and standard-compliant design […]
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 […]