Efficient filter systems ensure compliance with HACCP principles
The supply of room air in the life science industry and the food and beverage industry can cause "biological contamination". In the medical technology, pharmaceutical and food technology production areas, a great deal of effort is put into hygiene. Especially in the life science industry and food and beverage industry, the reduction of germ concentration is of substantial importance. Because [...]
Clean room for medical products
Medical device manufacturing and cleanrooms very often go hand in hand. What constitutes a medical device and an in vitro diagnostic medical device is precisely defined in the two EU regulations. After a transitional period, the Medical Devices Act was replaced by the Medical Devices Regulation in May 2021 and the In Vitro Diagnostics Regulation in May 2022. What has changed for installers of cleanroom systems? What are the [...]
Planning, construction and initial commissioning of cleanrooms
The construction of a cleanroom technology system is not just one piece of cleanroom. The process is multi-layered. The user, the planner and the installer of the systems have various tasks to fulfill. It all starts with the industrial sector for which the cleanroom is required: Pharmaceutical, medical, food, automotive, battery, etc. The legal requirements are correspondingly different [...]
Cleanroom technology (ventilation) and energy efficiency
Cleanroom systems for the various sectors of industry are air conditioning systems for the "process" and not for the comfort of the people in the cleanroom. Various boundary parameters influence the energy requirement, sometimes considerably. Heat loads in the room, outside air content, pollutant loads, special climatic requirements, such as dew points down to -60°C TP in the battery production sector, to name but a few. The task of the [...]
Cleaning and disinfection in cleanrooms
In this presentation you will learn the most important basics about cleaning and disinfection in cleanrooms. Practical tips will be presented using examples. The cleaning and disinfection of cleanrooms is an important part of cleanroom hygiene, so you will learn more about what needs to be taken into account when planning cleaning processes, how cleaning [...].
Setting sail for the requirements of Annex 1
It is undisputed that pharmaceutical production is facing major changes. One of the most important drivers of these changes is the new GMP Annex 1, which contains new guidelines for the manufacture of sterile medicinal products. But how can requirements such as the elimination of GMP-critical interventions be implemented today and in the future? Barrier systems, robots and automated systems play a key role in [...]
Processing models in life sciences projects
Every project is different - and therefore requires an individually tailored approach. But how do I find the right execution model for my project? Which models are available and which one is best suited to my specific task and the project management organization within my company? Stephan Hintzen and Kai Liebermeister report from their many years of experience in project management [...]
The end is over: How learning continues after training
The question of whether learning ends with the completion of a training course is becoming the focus of a new perspective on sustainable further education. A central goal of any learning solution lies in the transfer of learning, which bridges the gap between theoretical knowledge and practical application. This article focuses on the design of a learning journey that goes beyond the "classic" training framework and thus [...]
Filter systems and their role in contamination control
The presentation deals with the basics of filtration in cleanroom technology. It discusses the structure of modern cleanrooms and presents possible designs of cleanrooms with different filter systems. The right choice and dimensioning of the systems is the success criterion for a clean and safe environment as well as high production reliability. Topics such as sustainability, energy consumption and compliance with the required [...]
Release of gases during the cleaning of process tools
The maintenance and cleaning of process tools are essential. The opening of the process chamber to the cleanroom air and the mechanical and chemical treatment of the process chamber surfaces release a number of chemicals that are not included in the list of chemicals. This generally increases the level of contamination in cleanrooms and presents cleanroom operators with major challenges. Through the use of [...]