Sensors with IO-Link: Opportunities for Modern Maintenance
Equipment availability and operational reliability are key drivers of modern maintenance. Automation and digitalization serve as essential tools for simplifying maintenance tasks, reducing costs, and ensuring traceability of the work performed. ifm electronic and Thomas Rücker Consulting & Engineering would like to jointly demonstrate […] how intelligent sensor technology and IO-Link technology can be used to optimize processes, ensure quality, and significantly reduce downtime.
Temperature mapping of storage rooms and cooling units
In this presentation, you will receive a structured introduction to temperature mapping as a key element in the qualification of temperature-critical systems and processes. We will provide an overview of the most important regulations and guidelines, and explain the conceptual approach—from risk assessment and the definition of critical zones to sensor placement. Finally, we will demonstrate an example of how a mapping is carried out, including […]
Barrier technology and GMP-compliant transfer systems
In pharmaceutical manufacturing, barrier technologies are used to consistently minimize the risk of microbial, particulate, and pyrogenic contamination. EU GMP Annex 1 sets forth clear requirements for this purpose, particularly with regard to the safe transfer of materials into and out of such protected areas. A key principle is to maintain the integrity of the barrier at all times and to ensure that […]
From URS to Go-Live: Automated Cold Storage Facility
The qualification of fully automated deep-freeze storage systems poses unique challenges for the pharmaceutical industry. In this presentation, we will use a real-world project to demonstrate how we successfully qualified a highly automated logistics facility—featuring over 16 high-bay warehouses, 35 deep-freeze and ultra-low-temperature freezers, and GMP-compliant sampling booths—in collaboration with a global life sciences company. What made this project unique was that neither the customer […]
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. […]