Pioneering: GEMÜ innovation for diaphragm valve technology
The future starts now: GEMÜ presents the new generation of diaphragm valves. In this presentation, Product and Application Manager Elena Zuck will introduce the latest developments and highlight their significance for aseptic systems in the pharmaceutical and biotechnology industries. The focus will be on the innovative diaphragm valve with EasyLock technology. It enables maintenance including diaphragm changes in a matter of seconds - a [...]
Simplified documentation for flexible software validation
The FDA's draft on Computer Software Assurance was published in 2022. It describes various methods and test activities to ensure the safety of software. The GAMP®5 was published in the second edition and takes up approaches from the Computer Software Assurance Guidance. This presentation gives an overview of how the guidelines are applied [...]
How mRNA platforms shape vaccination & therapy factories
Since the introduction of mRNA vaccines against COVID-19, significant advances in manufacturing have been made to expand the applications of mRNA vaccines and therapeutics. Improvements in mRNA synthesis and purification, modification and optimization of mRNA sequences, and refinement of lipid nanoparticle (LNP) delivery systems have enabled the development of mRNA for a wide range of therapies, from cancer vaccines to [...]
Measurement data acquisition and evaluation software
Modular software for measurement technology with over 35 years of market presence in many areas of industry. It supports different hardware from different manufacturers. The user-friendly interface is easy to use for the normal end user and makes the acquisition and analysis of measurement tasks effective. From small to extensive monitoring tasks, e.g. for the pharmaceutical industry, test benches, [...]
Harmonized solutions for material handling and cleaning
Efficiency is crucial in pharmaceutical production, especially in the manufacture of tablets (OSD). This presentation will highlight how harmonized solutions for material handling and cleaning can optimize production processes. By minimizing interfaces and integrating lifting systems, cleaning solutions and automation technologies, processes become not only more efficient but also safer. Examples include flexible lifting systems for low-dust [...]
UVC decontamination for material logistics in accordance with GMP Annex-1
The presentation highlights Annex 1-compliant logistics and focuses on hygienic safety at the highest level. It will show in detail how UVC decontamination is integrated as a key technology in comprehensive particle management to achieve maximum purity and decontamination effect in the material flow. The combination of state-of-the-art technologies with strict Annex 1 requirements ensures exceptional quality assurance, which [...]
Mist and wet showers in high-security areas
The presentation highlights the importance of mist and wet showers for laboratory safety in high-security environments, particularly in pharmaceutical production. It will address the strict regulatory requirements to ensure the protection of personnel and the containment of contamination. Mist and wet showers are key applications for the prevention of cross-contamination and help to ensure that [...]
Sustainability: water reduction, recycling and recovery
In pharmaceutical manufacturing, sustainability has become a critical goal driven by environmental imperatives and regulatory requirements. This article focuses on decarbonization through strategic water reduction, recycling and recovery. Key areas include the reassessment of heating requirements, with an emphasis on energy-efficient methods of generating, storing and distributing water for injection (WFI), [...]
Modular vs. cleanroom panels: fast delivery
Cleanrooms are essential in industries such as pharmaceuticals, biotechnology and high-tech manufacturing. The efficient yet uncompromising delivery of cleanrooms is critical to achieving project goals quickly and successfully. This presentation provides an in-depth look at two leading approaches to cleanroom construction: cleanroom panels and modular cleanroom systems. We compare the unique benefits and challenges of both construction methods and [...]
Basics of GMP-compliant calibration
In this technical lecture, the speaker explains what is meant by calibration and why calibration is necessary. He discusses the basic terms and definitions of calibration technology and explains the calibration process. He then goes on to discuss special guidelines, particularly in GMP-regulated industries. He also lists the essential criteria for professional and [...]