The Hospital Pharmacy: A Case Study of a Compact Cleanroom
The specific requirements and characteristics of a hospital pharmacy compared to a standard cleanroom in the pharmaceutical industry are illustrated and explained using case studies.
A new generation of drug manufacturing
This year, we successfully completed the new “Isolator with Incubator” project, for which we received a grant in 2021. This project is funded with government support from the Technology Agency of the Czech Republic and the Czech Ministry of Industry and Trade as part of the TREND program. The aim of the project was to […]
Advantages of the electronic Bowie & Dick test
This presentation provides a structured overview of the advantages of the electronic Bowie & Dick test compared to traditional indicators. Following a brief comparison of the available measurement technologies, we will explain how they impact the quality of results—from objectivity and reproducibility to the precise measurement of temperature and pressure profiles. We will then demonstrate the specific benefits users gain from this: efficient workflows, […]
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 […]