Increasing process yield and safety in cleanrooms
The topic of this presentation is the influence of Airborne Molecular Contamination (AMC) on process safety and yield. Cleanrooms are designed to maximize process flow and yield, while the tight conditions of the process window and the serviceability of the process equipment must be maintained. With strict cost and space optimization, AMC interferes with cleanroom design and production by reducing yield. Due to the [...]
Discussion - Pharmaceutical water: Stimulating new paths
The discussion is inspired by the approaches of the presentation by Thomas Herbelssheimer, Roche, ("Reuse of pharmaceutical water"). But what do the audience and the experts think about where the journey towards more sustainable plants and their operation could or should go? What paths can be taken without running into regulatory problems? What needs to be done by the authorities [...]?
What happens when it happens....Disaster Recovery
The rapid digitalization of the pharmaceutical industry is leading to an increased dependency on IT systems and data. The smooth execution of business processes and decision making is essential to the uninterrupted availability of these resources to ensure compliance and efficiency. Criminal activity, political instability and environmental risks underline the need for well thought-out disaster recovery and business continuity planning. Measures such as regular data backups, redundant [...]
Can pharmaceutical water be reused?
Sustainability will be a key issue for us in the coming years. Like many others, Roche Diagnostics has thought about how expensive CIP final rinse water can be reused after it has been used in the process. The presentation provides details and suggestions for replication.
Validation strategies for computer-aided systems
- The role of critical thinking in optimizing CSV strategies - "Records over Documents" and the use of tools in validation - Agile software development in a regulated environment This presentation will provide an overview of modern strategies for validating computer-aided systems, taking into account digitization and in line with GAMP 5. The aim is [...]
Discussion round - CU projects
We will look together at the "do's and don't's" in projects in a panel discussion in which the lessons learned from these projects and possible developments in project management over the next few years will be openly discussed. Topics such as data management, PoU management and AI will be highlighted.
Critical Utilities projects: Exciting and unique
This presentation is dedicated to the fascinating and unique aspects of high-purity media projects. We will address this topic in several steps: 1. content of high-purity media projects: - high-purity media that the ISPE Group deals with - project types and execution scenarios that are typical for the field of high-purity media - project phases that are crucial in [...]
MWFI - Regulatory and technical update
The presentation deals with various aspects of the use of MWFI. - Regulatory conditions: How do manufacturers deal with the restriction of use by the ChP and what are the experiences of Chinese inspections? - Sustainability: Case study on the heating of membrane-based MWFI via a heat recovery system using a heat pump - Market development in MWFI production: MWFI vs. distillation - How often [...]
Errors/traps in the risk assessment of computer systems
Have you already asked your system the question of trust? Most recently with the publication of the 2nd edition of the GAMP®5 guide, "Critical Thinking" is strongly recommended to find and manage the risks associated with operating a computerized system. By involving system suppliers and people with system and process knowledge (Subject Matter Experts) in [...]
ISPE - Good Practice Guide, Process gases
And, do you also want to become CO2-neutral in your pharmaceutical company? The ventilation systems are certainly already well on the way to being reduced, but what can you do with your compressed air and gases? A new ISPE guide has recently been published to make this easier for you and will now be explained in the presentation.