US FDA inspections: Typical pitfalls
About Dr. Ralf AubeckDr. Ralf Aubeck works as Principal Consultant and Industry Certified GMP Auditor for gempex GmbH worldwide. He studied chemistry at the Ludwig-Maximilians-University in Munich (LMU) and received his doctorate in 1991 as Dr. rer. nat. on chemical-pharmaceutical biosensors.More than 25 years of experience in responsible positions in quality management of German and American smaller and [...]
Cleanroom personnel
Examples from the cleanroom industry will be used to demonstrate the types of contamination that can be avoided by humans.
Improving mobile particle monitoring
Mobile particle monitoring is characterized by many repetitive activities, which are very time-consuming on the one hand, but also pose the risk of compromising data quality, e.g. due to transmission errors. The presentation shows how digitization solutions can be used to optimize mobile particle monitoring in terms of time, quality, costs and sustainability.
Plastics and packaging in insulators
The packaging materials used and the product make a fundamental contribution to the loading of the isolator. When developing and implementing a robust and functional decontamination cycle using H2O2, the user should be aware of the nature of these materials. The possibilities of determining the material and product behavior towards H2O2, including individual process parameters, are [...]
GxP-relevant applications in the cloud
About Dr. Peter SchoberDr. Peter Schober has more than 23 years of experience from projects in the pharmaceutical industry, medical technology and in-vitro diagnostics in quality assurance, IT and in the CSV environment. After completing his doctorate in chemistry and a research stay in the USA, Dr. Schober started his career in a medium-sized IT consultancy. In addition to the Y2K conversion, his field of work was [...]
Retrofit of sterility test isolators and filling lines
Retrofitting existing and usually well-maintained glass and steel structures appears to be an attractive and cost-saving alternative. This lecture will focus on the possibilities and limitations of integrating modern, state-of-the-art solutions
Cleanroom troubleshooting 4.0 in building technology
We want to show you the options for recording measurement data and storing it for carrying out fault analyses with historical data. The integration of conscious data collection makes fault analysis more complex, but also clearer. Which systems will make our work easier in the future by collecting and processing all relevant data and then displaying it at a glance?
Data-based cleanroom optimization
In addition to the obligation to monitor a cleanroom in order to meet regulatory requirements, cleanroom operators are increasingly intrinsically motivated to operate an environmental monitoring system that enables data-based monitoring and optimization of status and processes. How GMP-compliant cleanroom monitoring can be combined with other data sources and what possibilities arise from this is part of this presentation. Generating added value by combining [...]
Effects of the pandemic
The primacy of mRNA and viral vector-based vaccines in the COVID-19 pandemic has permanently reshaped the global pharmaceutical manufacturing infrastructure. The speed and scale of investment in manufacturing capacity for these life-saving COVID-19 vaccines has brought these new processes to market in a magnificent way, but has led to a large supply - with huge implications for [...]
Ban on fluorescent tubes : New light or retrofit ?
Ban on fluorescent tubes : new luminaire or retrofit ? 1. the three main points of lighting 2. the renovation A. THE OBJECTIVES a. Renovate the lighting and adapt it to today's visual tasks. b. Ensure the safety of the luminaire. c. Ensure the integrity of the clean room. d. Reduce consumption e. Limit costs. B. SOLUTIONS a. Fixing points [...]