Technical Monitoring of Buildings
Technical monitoring refers to the collection, storage, visualization, and analysis of operational data from building services systems. In most buildings, the monitoring and analysis of technical systems cease after commissioning and handover to the user. Given that lifecycle costs consist of 15% capital costs and 80% operating costs, technical monitoring is a sensible approach. Technical monitoring […]
Contamination control using modern filtration systems
Contamination Control Strategies Using Modern Filter Systems: More Than Just CADR and Ceiling Coverage The design and performance of cleanrooms are often evaluated based on traditional parameters such as the Clean Air Delivery Rate (CADR) or ceiling coverage with Filter Fan Units (FFUs) and terminal housings. However, these metrics alone are not sufficient to ensure robust contamination control and process reliability […]
Practical Contamination Prevention for the Life Sciences
This presentation not only provides theoretical knowledge but also focuses on practical content that can be directly applied in everyday work. The focus is on the fundamentals of GMP regulations, proper conduct in cleanrooms, and hygiene measures to prevent contamination. The training is interactive and offers valuable insights for anyone working in regulated environments. As a special highlight, […]
Rooms with an integrated VHP biodecontamination system
Vaporized hydrogen peroxide (VHP) has been recognized worldwide for over 35 years as the standard method for surface biodecontamination at ambient temperature. By utilizing the sporicidal properties of hydrogen peroxide in the vapor phase, VHP enables highly effective decontamination without thermal stress on sensitive materials and is therefore ideally suited for pharmaceutical and biosafety applications. Originally developed for the biodecontamination of isolators, the […]
Qualification tests / Re-qualification tests
Qualification and Requalification Testing for Cleanrooms: Requirements, Objectives, and Implementation Qualification and requalification testing for cleanrooms is of critical importance for product quality and quality management in industries such as the pharmaceutical, medical, and semiconductor sectors. These tests ensure that cleanrooms meet the required specifications and consistently maintain the prescribed conditions. In this presentation, we will discuss the phases in […]
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 [...]
BIM Method in the Design Process
The BIM Method in the Design Process This presentation on the BIM method in the design process provides a clear overview of the practical implementation of Building Information Modeling. From the perspective of an experienced user, it examines all key aspects—from the initial steps in the pre-project phase through the entire project duration to the processes following project completion. The practical case study […]
GMP Maintenance 4.0 Launched
GMP maintenance is undergoing a transformation: moving away from reactive measures toward a data-driven, proactive strategy. The goal is to detect equipment failures early, reduce unplanned downtime, and increase availability—without compromising on the strict requirements of GMP. This requires a clear maintenance strategy and organizational structure. Modern sensor technology, digital trend analyses, and smart evaluations make it possible to […]
GxP Today: A Look at the Key Challenges
In GxP-regulated environments, companies face a range of recurring challenges that involve both technical and organizational aspects. Issues such as data security and redundancy are particularly critical, as all information must be traceable, protected, and available at all times. At the same time, the integration of a wide variety of systems—from sensor technology and LIMS/MES to cloud and on-premise structures—is becoming increasingly […]