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 [...]
EMSuite® Monitoring Next Generation
The Ellab monitoring system is based on state-of-the-art software architecture and offers a flexible solution for data acquisition, report generation and visualization. It complies with FDA 21 CFR Part 11 regulations and is validated by Ellab in accordance with GAMP5. The EMS can be installed on almost any IT infrastructure. The Ellab Smart Sensors enable the most cost-effective calibrations and [...]
Planning process in cleanroom projects
The planning process for cleanroom projects usually follows a structured process that ensures that all relevant aspects are considered in order to design and construct a cleanroom according to the specific requirements. The presentation will focus on the steps that are typically part of the planning process. It will focus on the essential element of integration for the success of the project [...]
Assisted reproduction techniques - clean room in existing buildings
GMP and cleanrooms in the ART sector are gaining momentum and the authorities are increasingly scrutinizing the requirements of the regulations. IVF practices and centers are facing major challenges when the authorities suddenly appear on their doorstep. Is cleanroom technology in the ART sector bad per se or are there possibly good compromise solutions? Approaches also with regard to increased patient safety: Where are [...]