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such as recipe management, process control technology and MES (Manufacturing Execution System) has also become outdated and cannot really be described as particularly modern and innovative.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.
Advanced aseptic processing
What is aseptic processing for liquid products? Why: Accelerated by the new Annex1, the demand for isolator applications is increasing. How is a production isolator characterized? Design of the machine Choice of materials Bio-decontamination process Air treatment How is an aseptic production isolator operated in a liquid product filling line? What are the typical steps between two production batches. Examples from the [...]
Aesthetics in industrial construction - technology is only half the battle
"Increase performance and well-being with cleanroom aesthetics" Companies have been focusing on the aesthetics of their buildings for some time now. This has proven to be an effective way of increasing not only the well-being but also the performance of employees. An attractive workplace design significantly reduces stress levels. In recent years, [...]
Alternative decontamination using ozone technology
Ozone technology is a very well-known decontamination technology in various markets. To date, however, this type of decontamination has been used almost exclusively as a liquid process. Studies have shown that ozone is a very effective decontamination medium in itself. Ozone as a disinfectant offers some significant advantages: no need for additional chemicals for processing. Self-sufficient systems (neutral in terms of ventilation), without compressed air, [...]