Metallic 3D printing: New possibilities for process valves
The presentation Metallic 3D Printing: New Opportunities for Process Valves by SISTO Armaturen S.A. will highlight the innovative approaches and advantages of metallic 3D printing in the production of process valves for the pharmaceutical and biotechnology industries. The presentation will explain the technical aspects of the 3D printing process, including the possible materials and printing technology used to produce high quality and resilient valve bodies [...].
Unexplored Potential of Radial Flow Column Chromatography
Radial flow chromatography is a chromatographic separation process that has developed into an effective method for separating biomolecules such as proteins, antibodies and nucleic acids since its development in the 1970s. In radial flow chromatography (RFC), the cylindrical column is flowed through radially from the outer radius to the inner radius or from the inner to the outer. For comparison, in […]
Capacity and efficiency of filling lines
An optimal filling and packaging system for the pharmaceutical industry can be achieved in any building. However, if the type of building has a lot of load-bearing walls, low ceiling heights and narrow spaces in an existing room layout, the project faces major hurdles. The real difficulty is not in obtaining the necessary machines with the appropriate equipment features. On the part of the [...]
Fast-track realization of a SiC wafer production factory
STMicroelectronics' (ST) competence center for power semiconductors is located in Catania, Sicily. It combines research, development and production of silicon carbide (SiC) substrates in collaboration with research institutes, universities and suppliers. Valtria is currently supporting ST in the rapid establishment of an integrated clean room production facility for the manufacture of SiC-based raw and epitaxial wafers, with the aim of increasing ST's supply [...]
Measurement uncertainty considerations according to GUM versus MSA
The Measurement System Analysis (MSA) approach is not only widely used in the life sciences industry and GMP consulting to estimate, determine or evaluate measurement uncertainties, measurement errors or measurement accuracies. However, MSA also has limits in its applicability when, for example, only individual verification tasks arise or a detailed look is necessary. This can be remedied by [...]
Development of an agile documentation structure
Suppliers, e.g. of machines or software, who supply customers in the regulated environment of the life sciences industry often have the problem that the requirements are set at very different levels of detail. In addition, the implementation of projects is often handled very differently by the customer. When working on these projects, there is often a lack of clarity as to which documentation should be supplied and to what level of detail [...]
GMP project management - basic stumbling blocks
The lecture will present numerous experiences from the reality of GXP projects in companies of all sizes. In practice, projects are often not easy and are often underestimated. Common mistakes and problem areas are addressed as well as strategies to avoid and minimize such stumbling blocks. The presentation includes practical tips and advice on how to make GXP projects more successful. The [...]
FDA Warning Letter - Lessons learned for GMP manufacturers
The presentation deals with the escalation of an investigative US FDA inspection in the form of the warning letter. It addresses common mistakes that are often made. In addition, there are misunderstandings that can often result from a lack of knowledge about the products that are sold on the US market. The presentation is based on a large number of supervised inspections in various roles. These include [...]
Centralized vs. decentralized dust extraction/containment dedusting
The choice between centralized and decentralized dust extraction is crucial for containment, GMP compliance and dust control. In addition to efficiency, energy consumption, sustainability and the avoidance of cross-contamination also play a role. The presentation will highlight the advantages and disadvantages of both systems and their impact on production, maintenance and costs. It will also discuss how malfunctions affect operational safety and which factors play a role in [...]
JAG: three projects in filling (pharmaceutical industry)
In this presentation, we present three projects, all of which were carried out in the areas of sterile filtration, filling and bottle handling. The aim of all projects was to increase the capacity and productivity of the production plant in order to achieve the highest possible degree of automation and digitalization. The projects were completely planned and implemented by JAG [...]