Planning, building and operating cleanrooms sustainably - 10 tips
Hardly any other term has developed as much in recent years as the term "sustainability". But what does sustainability actually mean and what does it have to do with cleanroom technology? First and foremost, it means using existing resources sparingly and reducing the CO2 footprint, especially with regard to climate change. The presentation will [...]
Advanced Pharmaceutical Manufacturing
Advanced manufacturing involves the integrated production of pharmaceuticals and the use of artificial intelligence (AI) in such process environments. What are the advantages and challenges compared to a batch-to-batch process? What functions must an integrated production line support? What are the main known regulatory expectations for the use of AI in pharmaceutical production? And [...]
Effective qualification of laboratory heating & cooling appliances
Find out how you can make the qualification of laboratory heating and cooling appliances even more efficient today. We take a look at the comparison between the previous and current approaches and answer the question of whether the increased effort offers more safety. You will gain in-depth knowledge of the qualification phases (IO/OQ and PQ) and learn how [...]
Possible sources of error in and around the cleanroom
In this lecture, we would like to show you which sources of error can lead to a malfunction or failure of a cleanroom. In order to make this as practical as possible, we will explain the various problems to you using pictures. Because it is often minor causes that can have major consequences in such a complex system. The focus of the [...]
Successfully implementing sustainability in the laboratory
The integration of sustainability in laboratories is becoming increasingly important, as laboratory work consumes large amounts of energy, water and chemicals and at the same time generates large amounts of waste. Therefore, implementing sustainable practices in laboratories makes sense from both an environmental and economic perspective. It helps to conserve resources, minimize waste and [...]
Qualification measurements - requalification measurements
Qualification measurements for cleanrooms are a decisive factor in quality management in sectors such as the pharmaceutical, medical and semiconductor industries. They ensure that cleanrooms meet the required specifications and consistently maintain the prescribed conditions. In this presentation, we will talk about the phases in which we should test the cleanroom and how we can avoid problems that [...]
Qualification of cleanroom systems
The presentation will explain the difference between qualification and validation. The qualification of a cleanroom system is explained. The User Requirement Specification (URS), the Qualification Master Plan (QMP), the Design Qualification (DQ), the Installation Qualification (IQ), the Operational Qualification (OQ) and the Performance Qualification (PQ) will be discussed. The relevant standards and guidelines are presented, as well as the determination of all [...]
Reading Annex 1 with green glasses
Implementing the requirements of Annex 1 (EU GMP guidelines) for sterile manufacturing not only requires compliance with regulatory standards, but also offers opportunities to integrate sustainability into pharmaceutical production. This presentation examines approaches on how ecological responsibility can be combined with the strict requirements for sterile production processes. The focus is on increasing energy efficiency in cleanrooms, [...]
Project planning - structure of an efficient planning process
The presentation on project planning describes the structure of an efficient planning process. The following is an explanation of the successive project phases, taking into account the BIM method used in the planning process. It is explained how project planning can ensure that the project budget is adhered to throughout the entire project. In this respect, the update of the cost calculation, cost estimate, cost calculation, [...]
Communication in a cleanroom environment
Cleanroom loudspeakers should be of extremely high quality and durability, absolutely maintenance-free, installable in various ways and encapsulated in order to exclude any contamination of the clean environments by the acoustic system and to withstand various pressure influences in cleanroom environments. A typical application in such an environment is gassing with H2O2 for disinfection. In this case it is of [...]