Best Practice - Cleanroom Monitoring System
Best practice cleanroom monitoring system: What does implementation look like in practice? How is the system set up? How are the measuring devices installed in practice? What do processes such as alerting or reporting look like in practice? Experience a practical overview of the topic of monitoring.
Phase III: Performance qualification of the disinfection regime
Phase III: Performance qualification of the disinfection regime A review of the final phase of the implementation of a cleaning and disinfection system; the performance qualification phase, also called Phase III or in-situ field studies. The purpose of this phase is to demonstrate, through the generation of data, the effectiveness of a cleaning and disinfection procedure once it is used in the facility. The presentation outlines possible structures [...]
IT infrastructure on the way to 4.0
About Dr. Georg SchwarzDr. Georg Schwarz is a chemist and has been responsible for IT validation at gempex for over 6 years, before that he gained 20 years of experience in the pharmaceutical industry (IT trainer, application manager, IT quality and security manager) The presentationInfrastructure 4.0 is a presentation about the advantages and disadvantages of a GMP-compliant, [...]
Impact of the new Annex 1 on cleanroom qualification
After a long wait, the European Commission published the revised Annex 1 "Manufacture of Sterile Medicinal Products" of the "Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use" on 22.08.2022. In this presentation, the resulting changes and concretizations in the area of cleanroom qualification and with regard to the maintenance [...]
Microfiber in the cleanroom
Microfiber is particularly suitable for cleanroom cleaning due to its special properties in terms of dirt absorption of lipophilic and hydrophilic soiling. It leaves hardly any particles behind during the cleaning process and is therefore suitable for both particle-sensitive and germ-sensitive cleanrooms. It is used as a cloth and mop.
Progress in automation?
The automation of manufacturing processes in the pharmaceutical industry has been common practice for decades. The use of special technologies such as recipe management, process control technology and MES (Manufacturing Execution System) has also become outdated and cannot really be described as particularly modern and innovative.
Selection of packaging materials for sterilization processes
The new Annex 1 emphasizes the importance of material selection to minimize particle formation in the cleanroom. The goods to be sterilized must be dry and packaged in a protective barrier system that allows air extraction and steam penetration and prevents recontamination. When sterilizing in the [...]
FLOW & PRESSURE CONTROL VALVES for WFI and other systems
This presentation is about the general discussion of flow and pressure control valves, where there are still many problems of understanding and incorrect approaches in planning and project implementation. It is generally about explaining how the valves work and what is behind them in order to avoid expensive design errors in WFI systems. Many practical examples are given [...]
Cleanroom 4.0 - the cleanroom of tomorrow
The planning and construction of cleanrooms is constantly evolving.BECKER Reinraumtechnik and the CleanRoomNet network show you the possibilities around the "Cleanroom 4.0" using a concrete application - Cleanroom planning yesterday - today - tomorrow- Cleanroom plan with BIM - advantages and prerequisites- Digital cleanroom twin- What could the cleanroom of the future look like? a case study
Analysis of in-house and external cleaning in the cleanroom
What advantages and disadvantages does the customer have when he hands over the cleaning of his cleanroom to a service provider? Information about the win-win situation and how we benefit from each other.