Flexible parallelization of ATMP production
More and more cell therapy products are showing promising therapeutic success. Nevertheless, commercial success and market success are still pending. Why? Most current approaches face the challenge of bridging the gap between early clinical trials and efficient production. In this presentation, we will introduce MOSAIC, our vision of the production system of the future. The goal of MOSAIC is to [...]
Development of a hygiene concept within the framework of GMP Annex 1
Ms. Ernst will take you on an exciting journey on how a hygiene concept can be rolled out for a manufacturing company, starting with the regulatory requirements such as Annex 1, DIN EN 14644, VDI 2083 through to the awarding of services. She reports from the experience of past projects on how to sustainably manage to train your own staff [...].
The new ISO 17665 - Validation of sterilization processes
Ensuring the safety and quality of products in the pharmaceutical industry relies heavily on effective sterilization processes. Validation of these processes is essential, and detailed guidance on developing, validating and controlling the use of sterilization processes is provided in the current edition of the ISO 17665 standard from 2024. In addition, the guidelines of the European Pharmacopoeia [...]
Annex1: CCS for the transfer of sterilized material
The newly published version of Annex 1 emphasizes the need for sterilization packaging that is compatible with disinfectants and can be used for material transfer into the aseptic area. Sterilization packaging is designed to allow steam to diffuse during autoclaving - but is the same true for surface disinfectants? In this presentation, new studies will be presented [...]
From mapping to GMP-compliant monitoring
Introduction: Definition of storage space mapping and routine monitoring. Important significance for warehouse management and quality assurance. Regulatory framework: Compliance with national and international regulations. Consideration of environmental and safety standards. Procedure for warehouse mapping: selection of suitable technologies such as sensors, data loggers, etc. Systematic recording of room parameters such as temperature and relative humidity Set schedule for mapping activities. Data analysis and interpretation: Evaluation of the collected data [...]
Evolution of pressure measurement in pharmaceutical processes
Only a fraction of people working in production today can remember the days of purely mechanical pressure monitoring with on-site displays. For decades, however, electrical pressure gauges have performed a crucial monitoring function. Without them, automated processes would be unthinkable. And sensor technology is becoming ever more powerful in the course of digitalization. Under critical process conditions, pressure sensors can [...]
Ebro a Xylem Brand - Cold Chain and Sterilization Logger
ebro® is part of Xylem Analytics and a leading provider of professional measurement technology for the food, medical, pharmaceutical and industrial sectors. Xylem Analytics' global brands have led the laboratory instrumentation market for decades and are used every day in more than 150 countries. We work in true partnership with our customers, listening, learning [...]
Cleanroom personnel
There are various types of contamination in cleanrooms that need to be avoided. The presentation will define, describe and explain the different types of contamination. In addition, the main source of all contamination - people in the cleanroom - will be discussed. Furthermore, rules of conduct that cleanroom personnel should observe in order to avoid contamination are described. To [...]
Cleaning and disinfection in cleanrooms
There are various types of contamination in cleanrooms that need to be avoided. The presentation will define and describe the different types of contamination. In addition, the main source of all contamination - humans - will be discussed. Furthermore, rules of conduct that cleanroom personnel should observe in order to avoid contamination are described. Finally, [...]
Improving energy management
Legal requirements on the part of the EU, the issue of climate change, availability and, last but not least, cost-effectiveness are key factors in the pharmaceutical industry alongside purity, safety and hygiene. Some solutions, such as heat recovery in ventilation systems or the use of waste heat, have long been state of the art. Others, such as the generation of steam using heat pumps or the use of [...]