Specified—Ordered—Confirmed—Delivered… right?
Everyone is familiar with the process of shopping. For example, you go to an electronics store to buy a new washing machine. You seek advice from a salesperson who, hopefully, knows their stuff. You decide on a model and place your order. Once that’s done, you assume that the right appliance will arrive at the right time at the right […]
Clean by Smart Testing: Balanced Garment Qualification
The technical presentation “Clean by Smart Testing: Balanced Garment Qualification” provides a comprehensive overview of what matters when testing cleanroom textiles. It explains which testing methods are available, which standards, guidelines, and custom specifications can be applied, and how to determine which tests are essential and which may be considered optional. Using a structured approach […]
Clean by Design: The Right Approach to the RR Apparel Concept
The technical presentation “Clean by Design: The Right Approach to Your Cleanroom Garment Concept” demonstrates how cleanroom personnel—as the primary source of contamination in the cleanroom—can be effectively controlled. Drawing on the latest research, the presentation highlights the most important factors related to human activity. The focus is on garment systems, including individual components, as well as an efficient donning process. The Right Path to Your Customized Final […]
Focus on Sustainability
Sustainability is an integral part of the cleanroom industry. Since sustainability began to be given greater consideration in corporate strategies and implemented through a wide variety of initiatives within the industry, pressing questions have arisen for every market participant: Do sustainability and economic efficiency conflict with one another, or do they reinforce each other? How can regulatory requirements be best addressed? Is it possible to […]
The TOC meter with the easiest maintenance in the world
Through continuous, incremental improvements, Swan Analytical Instruments has optimized the handling and overall performance of online TOC monitoring in recent years. The Swan instrument’s well-thought-out design makes any service intervention a breeze, whether planned or unplanned. This presentation will feature both a live demonstration using actual equipment and an overview of the benefits for customers. TOC is indispensable for monitoring […]
Is a safety cabinet Annex 1 compliant?
Given the wording in the current Annex 1 of the EU GMP Guidelines, the question arises as to what extent safety cabinets may continue to be used for aseptic manufacturing—such as for the patient-specific preparation of antineoplastic agents. In this presentation, Andreas Nuhn (GMP compliance consultant) and Thomas Hinrichs (Managing Director of Berner International) will discuss this topic to provide the audience with insight […]
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.