25 years of GMP - developments and milestones
GMP-Verlag celebrates its 25th anniversary in 2025. Thomas Peither, co-founder and long-standing board member of the publishing house, and Dr. Petra Rempe, inspector of the Münster district government, take a look at the developments and milestones of the past 25 years and also venture a look into the future. What level of requirements characterized GMP 25 years ago and where do we stand today? Which [...]
Selecting the right barrier technology in the GMP environment
The use of barrier systems to protect sterile pharmaceutical products is explicitly required in Annex 1 of the EU GMP guidelines. As a result of this requirement, isolators and RABS are coming to the fore over other existing technologies. There are different designs for both systems, which differ in terms of applicability and cost. We talk to Dr. Florian Sieder about important aspects [...]
Contamination Control Strategy is easier than you think
A comprehensive and overarching CCS - this has been a regulatory requirement since last year. Establishing a contamination control strategy in your own company may seem like an impossible task at first glance. This is not least due to a lack of guidelines for implementation. What is the CCS? What are its contents? And how do you succeed [...]
Contamination Control Strategy is easier than you think
A comprehensive and overarching CCS - this has been a regulatory requirement since last year. Establishing a contamination control strategy in your own company may seem like an impossible task at first glance. This is not least due to a lack of guidelines for implementation. What is the CCS? What are its contents? And how do you succeed [...]
Contamination Control Strategy is easier than you think
A comprehensive and overarching CCS - this has been a regulatory requirement since last year. Establishing a contamination control strategy in your own company may seem like an impossible task at first glance. This is not least due to a lack of guidelines for implementation. What is the CCS? What are its contents? And how do you succeed [...]
Operational readiness of aseptic manufacturing areas
Operational readiness is a critical process in the pharmaceutical industry, especially when commissioning new or remodeled aseptic manufacturing areas. This presentation will highlight the key aspects of operational readiness and its importance for efficient and safe production. Operational readiness encompasses the management of all activities necessary for production readiness. This begins with the start of an investment project and [...]
Innovative TOC design prevents unnoticed downtimes
Swan Analytical Instruments AG has optimized the handling and overall performance of online TOC monitoring through incremental, continuous improvements over the years. This presentation will highlight the latest advancements. Significant advances in calibration and fluidics have significantly reduced the total cost of ownership for end users. TOC is an essential component in the monitoring of ultrapure water and [...]
Automation of QC sampling: from the GMP cleanroom to the QC lab
JAG demonstrates how these end-to-end QC processes can now be fully automated, digitized and tracked in real time, from the classified zone product container to the QC lab bench, using state-of-the-art, TRANSVERSE INTEGRATION of mobile robotics, process technology, S88 formulation sampling plan and QC data throughout the cleanroom, building, equipment, lab and product release documentation.
Laboratory automation/robotics in safety cabinets/isolators
Customized special safety cabinets in combination with laboratory automation offer efficient and safe solutions for a wide range of laboratory applications such as bioreactors, Facs devices and liquid handling systems, which must take place in a BSL-2 environment due to increased safety requirements. The safety cabinets, designed in accordance with DIN EN 12469, enable aseptic working under GMP-A conditions and guarantee the necessary personal, product and environmental protection. Aseptic industrial robots can also be used in [...]
Energy management as a success factor in the energy transition
Energy management plays a crucial role in the energy transition, as it can significantly improve the efficiency and operation of systems. By taking targeted measures to optimize energy efficiency, companies can not only reduce their operating costs, but also make a significant contribution to reducing greenhouse gas emissions. This is particularly relevant for the cleanroom industry, where precise and [...]