Microbial identification in cleanroom qualification
Environmental Monitoring Performance Qualification (EMPQ) is critical to maintaining cleanroom integrity, ensuring product quality and minimizing the risk of contamination. Accurate microbial identification at the species level is required to meet EU GMP Annex 1 standards. This presentation will cover a wide range of theory and practical application using [...]
Added value for the supply chain through RMMs
In today's dynamic and interconnected marketplace, supply chains are increasingly impacted by a complex network of forces, including evolving regulatory requirements, technological advances and heightened consumer expectations. Amidst these challenges, Smart Quality is emerging as a potential solution to increase efficiency, reliability and value. This presentation will explore how rapid microbiological methods can serve as a cornerstone for [...]
New VDI 2083-4.2: Energy efficiency in cleanroom technology
Cleanroom technology is particularly energy-intensive. In order to create controlled environmental conditions such as particle concentration, temperature, humidity, pressure, etc., large quantities of air of high treatment quality are often required. The energy requirements of cleanrooms are correspondingly high. The energy requirements of cleanroom technology systems exceed those of residential and administrative buildings many times over. However, while regulations have been drawn up for residential and administrative buildings that [...]
Climate monitoring for temperature, humidity and differential pressure
Hardly any other sector is as strictly regulated and monitored as the life science sector. Our comprehensive solutions for monitoring environmental conditions such as temperature, humidity and differential pressure provide reliable support to meet the demanding regulatory requirements at all times. In our presentation, we will discuss the benefits as well as our range of services: [...]
GAP analysis as preparation for an (FDA) audit
As part of an audit preparation, a detailed gap analysis helps to identify weaknesses in the QM system and in the implementation in the company (for example, the maintenance of log books). The presentation shows the biggest challenges that we were able to identify in the context of gap analyses. Furthermore, the topic of audit implementation from the [...]
Cleanroom excellence: sustainable PPE solutions for you
Discover how our company sets standards for PPE and cleanroom solutions with a diverse portfolio. With extensive industry knowledge, we support companies in contamination control and regulatory compliance. Our commitment to a sustainable future drives innovation, while our global network guarantees reliable supply chains. We offer customized solutions and a collaborative approach that ensures safety [...]
Warehouse qualification with consideration of risk analysis
In addition to the regulations that define that a qualification in the GMP and GDP environment is essential, the presentation includes the general content of quality risk management and the importance of risk analysis in the pharmaceutical environment. The application example illustrates how a risk analysis in the warehouse can be used to identify hazards at an early stage in order to avoid or reduce them. The aim is [...]
Modular design framework in pharmaceutical production
In the increasingly demanding field of pharmaceutical production, the need for improved functionality, flexibility and compliance has never been greater. To meet this need, this presentation will focus on the implementation of modular design frameworks - for hardware and especially for software - as advanced control strategies. The design frameworks and the symbiotic [...]
Energy-efficient production, storage & distribution of WFI
Distillation plants are predominantly used to produce water for injection (WFI). This energy-intensive process, which is powered by steam and therefore by burning fossil fuels, is neither environmentally friendly nor cost-efficient. The membrane-based cold production of WFI causes less CO2 emissions and has lower operating costs. In this presentation, in addition to comparing hot and cold [...]
Shell and tube heat exchanger solutions in GMP environments
The presentation provides an insight into the NEUMO Ehrenberg Group. The thermodynamic principles of heat transfer and the relevant parameters are explained below. In the main part of the presentation, the NEUMO-specific aseptic shell and tube heat exchangers and their mode of operation will be explained in detail. Particular attention is paid to customer-specific design and dimensioning. Special structural features, the bandwidth [...]