Contamination Control in Radiation Safety
The implementation of a contamination control strategy (CCS) in accordance with Annex 1 provides significant added value for radiopharmaceutical products while also establishing clear regulatory requirements. The CCS ensures rigorous control over the entire manufacturing process, thereby enhancing safety and product quality and ensuring compliance with regulatory standards. In radiopharmaceutical manufacturing processes, the performance of classic GMP controls […]
Operator Readiness: Ready for Production with VR
Pharmaceutical manufacturing demands the highest standards of process safety, efficiency, and regulatory compliance. A central element of GMP Annex 1 is the qualification of operating personnel based on clearly defined Standard Operating Procedures (SOPs). VR training is particularly effective when the underlying SOPs realistically replicate the specific customer equipment. At the same time, VR offers the advantage of realistic training […]
From the market environment to a complete cleanroom solution!
This technical presentation details the implementation of a brownfield cleanroom project by the NETZER GROUP as general contractor, with a particular focus on the market environment, project development, modular construction, and energy-efficient ventilation systems. The project involved the implementation of cleanrooms in an existing facility while operations continued. The cleanrooms ensure the centralized handling and cleaning of specialized containers in pharmaceutical, semiconductor, and food processing companies. The planning was based on […]
Design and Qualification of HVAC Systems in Accordance with Annex 1
The planning and design of HVAC systems for cleanroom facilities compliant with EU GMP Annex 1 remain a core element of new construction and renovation projects. This presentation will examine relevant aspects from the perspectives of technical planning and GMP, drawing on various viewpoints and practical experience, and will discuss potential solutions. The intended use of pharmaceutical cleanroom facilities can significantly influence the technical planning. To ensure a […]
Unit Dose in Cleanroom Environments: Vindur Turnkey Solution
From concept to implementation of unit-dose packaging in pharmacies. Design of cleanrooms in compliance with regulations, laws, and guidelines. Requirements and challenges in the design and sizing of rooms and HVAC systems. Targeted airflow and exhaust in critical areas. Collaboration with regulatory authorities, definition of acceptance criteria, and qualification from URS through to release. […]
Efficient and Sustainable Air Filtration in the Life Sciences
The presentation addresses the sustainable design of filter systems in cleanrooms. The focus is on how energy savings can be achieved without reducing efficiency or filter performance. Environmental Product Declarations (EPDs) and Life Cycle Assessments (LCAs) are presented as important decision-making tools for future developments. It is demonstrated that all filter stages—including HEPA filtration—offer potential for energy savings. […]
Brownfield Cleanroom Solutions – Turnkey
In the NETZER GROUP presentation, participants will learn how international cleanroom and plant projects are implemented with a high degree of planning reliability—on a turnkey basis, efficiently, and with clear overall responsibility from an Austrian general and turnkey contractor that provides all services, from planning to handover, from a single source. A particular focus is placed on the NETZER GROUP’s expertise in brownfield projects, i.e., the implementation […]
VDI EE 2083 4.3 Dry Cleanrooms – Expert Recommendation
Special case: dry rooms as controlled process environments. Such dry cleanrooms are necessary because moisture in the air is a critical contaminant, e.g., in the manufacture of lithium batteries, semiconductor production, or when working with other hygroscopic materials. The planning, construction, installation, and operation of dry rooms with extremely low relative humidity (low dew point temperatures) require a special approach. Material selection and design measures. Application and […]
Process reliability through mass spectrometry
How can product quality in pharmaceutical freeze-drying be monitored even more precisely in the future? Mass spectroscopy offers new insights—directly into the process. But how can this technology be efficiently integrated into existing systems without fundamentally altering the production environment? Especially with validated lines, it is essential to balance stability and innovation. Modern analytics should not only […]
GDP Logistics: Efficient Processes and Validation Strategies
The presentation highlights the central importance of GDP (Good Distribution Practice) logistics within the pharmaceutical value chain and is aimed at specialists and executives in the pharmaceutical industry, logistics service providers, and those responsible for quality assurance and regulatory compliance. The goal is to provide participants with practical insights into how to comply with regulatory requirements and ensure product quality throughout the entire […]