Validation of disinfectants on cleanroom surfaces
Describes the new expectation in Annex 1 for the validation of disinfectants to include the efficacy of disinfectants on cleanroom surfaces. The session will cover available tests, selection of high risk surfaces and sharing test data on ten organisms on ten different surfaces recently collected for two different disinfectants.
Digital commissioning for transparent building technology
Commissioning often takes place silently and behind closed doors, so that hardly anyone has an exact overview of what is actually happening. To resolve this black box-like situation, Drees & Sommer has developed various tools and measures with which commissioning can be carried out completely transparently. Starting with the neutral selection of the building automation manufacturer best suited to the respective project [...]
Integrative processing models in EPCM projects
Implementation projects in the pharmaceutical industry are characterized by a high level of complexity and a large number of stakeholders. This applies equally to new construction projects and existing projects. Clients and EPCM partners alike are faced with the challenge of integrating a wide range of technical experts with sometimes very different ways of thinking and approaches into one team for the duration of the project. Only if [...]
Project Management Office (PMO) - Relevance for major projects
Major projects in the pharmaceutical industry are generally characterized by high complexity and enormous time pressure. In addition to the usual execution models such as EPCM, forms of partnership-based execution from the Anglo-Saxon world are also finding their way into Europe. However, all models pose similar challenges to the client and therefore to project management. Stringent interface management and maximum transparency, [...]
Electromagnetized hydrogen peroxide technology (HPE)
Controlled contamination zones are classified environments that guarantee that the presence of microorganisms and inert particles is below a certain number per unit volume. The microorganisms present on surfaces and in the air can enter the air in the form of bioaerosols through convection movements, attach themselves to dust, liquid particles or other pollutants naturally present in the environment [...].
Axial and radial flow column chromatography
Chromatographic methods are generally used to separate a component into its individual constituents, to obtain a target substance or for qualitative and quantitative analysis. Chromatography is a separation process in which 2 different immiscible phases are brought into equilibrium through different distributions. Common types of column chromatography are axial flow chromatography and radial flow chromatography. [...]
Filter systems for a clean environment
We examine modern cleanrooms with regard to their filter systems. Correct dimensioning is a key factor for production safety. Noise emissions, the required cleanroom classes and energy consumption have a significant influence on a successful application. The flow-optimized design of filter systems is decisive for energy consumption. Investigations in the acoustics laboratory and simulations can be used to take decisive steps.
Digitally optimized qualification of calibration devices
GxP-compliant monitoring systems need to be calibrated regularly, not only because of regulations, but also to maintain accuracy and traceability. In a digital world, M2M communication helps to improve processes, reduce effort and increase data integrity. In the presentation, the digitally optimized qualification of a calibration system for temperature and humidity, as a method to [...]
Lean qualification: a smart approach to the qualification process
The presentation "Lean Qualification: The smart approach to qualification and validation of hardware in cleanrooms" offers an insight into the efficient planning and implementation of qualification processes for hardware in cleanrooms. The focus will be on the lean approach in order to make the qualification process lean and effective at the same time. The presentation begins with a comprehensive explanation of terms and definitions, [...]
Ceiling air circulation systems. Findings from a CFD simulation
Since turbulent cleanrooms have found their way into pharmaceutical companies, there have been differing opinions and, to this day, lively discussions as to whether the classic approach of floor-level return air extraction can be replaced by extraction via the ceiling without negative effects on the quality of the cleanroom. In our presentation, we will look at the two approaches and [...]