Statistical Process Control SPC with PartSens 4.0
By implementing a Statistical Process Control (SCP) system on the shop floor, organizations can effectively monitor, control and improve the quality objective of cleanliness. SPC provides a data-driven approach to consistently maintain cleanliness levels within specified limits, reduce the risk of product defects, ensure customer satisfaction and improve overall process efficiency. The PartSens 4.0 [...]
Monitoring system: implementation options, findings
ISO 14644-2 prescribes regular verification of the cleanroom's compliance with the requirements of ISO 14644-1. One way of doing this is to install a permanent monitoring system for particles and environmental parameters. In this presentation, we will provide you with approaches and solutions, show you real data from our production and invite you to join the discussion. - [...]
Maintenance cleaning - how do I go about it safely
Every construction project is contaminated with dust and particles. These are undesirable in cleanrooms. We clean every cleanroom system so that it complies with the legal regulations of the respective RR class from day one, both in terms of particles and microbiology. We explain how to plan your cleanroom system correctly from the outset and how to approach a tender [...]
Modular planning for active pharmaceutical ingredient synthesis factories
The pharmaceutical industry is developing new and more efficient active pharmaceutical ingredients (APIs) in its research and development centers. Time-to-market is one of the most important requirements for new pharmaceutical products, especially for new APIs. Fast and reliable scale-up methods from laboratory to pilot scale to commercial production are crucial for the successful introduction and [...]
Spring cleaning: activity-based process planning applied
Do I still need this or can it go? When changes are imminent (at home or in production), there is an opportunity to tidy up. So how can synergies be exploited, production and laboratory processes made more efficient and the available space used in the best possible way? It is important to recognize these opportunities and derive the right measures. Activity-based process planning helps to optimize the [...]
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 [...].