Risk Management in Pharmaceutical CAPEX Projects
Pharmaceutical investment projects are subject to strict regulatory requirements. EU GMP Annex 15 requires a risk-based approach to qualification and validation. ICH Q9(R1) defines the principles of Quality Risk Management and requires systematic, documented risk assessments throughout the entire product lifecycle. ICH Q10 integrates risk management into the Pharmaceutical Quality System. For project managers, the question arises: How do we implement these […]
Gas emissions resulting from equipment maintenance and repair
During the maintenance, cleaning, and repair of process plants and equipment, numerous particles and chemicals are released into the environment. Reactions with the ambient air (e.g., oxygen, moisture, carbon dioxide) produce gaseous, liquid, and solid chemicals that are not documented in any safety data sheet or manual. This release has significant implications for environmental, health, and safety (EHS), which […]
Commissioning Management as the Basis for Qualification
Even after completion and commissioning, a pharmaceutical interior fit-out with its associated utility infrastructure is not yet a GMP cleanroom. The successful transition begins early in the project phase in collaboration with the qualification team. For building services engineering, following the guidelines of VDI 6039 can be one possible approach. Ensuring the successful completion of mechanical work and the subsequent commissioning, […]
The Future of Locking Systems
This digital locking system provides modern, secure, and efficient access through biometric identification such as Face ID and fingerprint recognition. Attendees will gain a concise overview of features such as self-booking, fixed or dynamic locker assignments, intelligent space allocation, and transparent occupancy and cleaning processes. The presentation is particularly relevant for professionals in engineering, laboratory, and cleanroom environments who wish to gain practical insight into modern locking solutions.
Why Industry 4.0 products matter now
Industry 4.0 has been a familiar concept for several years, but today it is becoming increasingly tangible and effective thanks to the rapid commercialization of artificial intelligence and smart technologies. The key question for many companies is: Should we get on board now, or can we wait a little longer? If we continue to work with analog connections, without monitoring or integration into […]
Sustainability in Cleanrooms: Impact on Filter Technology
The development of filters in cleanroom technology is increasingly shaped by sustainability requirements and regulatory standards. This presentation will demonstrate how current regulations influence material selection, production processes, and product labeling. The focus will be on Environmental Product Declarations (EPDs) as a tool for transparent environmental assessment, the transition to PFAS-free materials to avoid persistent pollutants, and the implementation of […]
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 […]