Best practice cleanroom monitoring system
What does implementation look like in practice? What is the system structure? How are the measuring devices installed in practice? What do processes such as alerting or reporting look like in practice? Experience a practical overview of the topic of monitoring. The basis for this is an implemented project, into which we provide exclusive insights.
"From onboarding to the spacing effect" - effective learning concepts
"From onboarding to the spacing effect" - how to increase efficiency with a coherent learning concept With blended learning, a combination of classroom training and various forms of online learning, you can create a coherent, contemporary learning concept. The presentation highlights the features and benefits of such a concept in employee development and provides ideas for implementation.
Single-use: the future of bioprocess technology?
According to surveys conducted by Reuters in 2022, more than three quarters of all respondents want to ban single-use plastic from their daily lives. In bioprocess engineering and pharmaceutical production, we are currently experiencing an opposite trend towards single-use technology. But is this development at all compatible with the concept of sustainability? This question is answered in more detail using the example of the "bioreactor" [...].
Innovative concept for aseptic-toxic filling
An innovative, aseptic-toxic filling concept is presented in which the filling line merges with the isolator and is viewed as a single unit. Optimum operability, employee protection and cleanability were at the forefront of the development.
QRM according to GAMP 5
Both GAMP® 5 (Second Edition) and ICH Q9 (Revision 1) have recently been updated. The presentation outlines the current risk management procedures, presents the changes and additions and highlights similarities and differences. Participants will learn what is new and what has changed and what modern quality risk management looks like.
GAMP®5 - 2nd Edition - Application of the key principles
GAMP®5 - 2nd Edition - Applying the Key Principles to Enable Innovation The presentation provides an introduction to the key principles of GAMP 5 Second Edition and how they are applied in an ever-changing world. In addition, the new GAMP Guides will be briefly introduced and categorized. Key challenges arise from the topics of Critical Thinking/CSA/ RBA, [...]
SaaS, cloud, edge and deep learning in the pharmaceutical industry
Deep learning is becoming increasingly important in the pharmaceutical industry. AI products differ from previous software systems because deep learning models learn from data. This poses new challenges for regulation in the pharmaceutical industry. InspectifAI has developed a validation concept for a modern product consisting of SaaS, cloud and edge computing and deep learning that meets the compliance requirements from the perspective of [...]
GAMP 5 Second Edition - Specify requirements
The presentation provides an introduction to GAMP 5 Second Edition in general and then goes into requirements management. Finally, GAMP relies on agile methods and the traditional separation into user requirements, functional requirements and other requirements is no longer present in the guide. However, some things have not changed. Bad requirements are still [...]
Ultrasonic clamp-on for utilities and energy management
The non-invasive measuring technology with ultrasonic clamp-on has a significant advantage: no contact with the medium. This means 100% hygienic flow measurement without the risk of contamination. In addition, the documentation effort is reduced due to the principle, as no certificates for material, surfaces, seals etc. are required. With the new FLUXUS 532 series, FLEXIM has developed a compact solution for utilities and energy management [...]
Robotic solutions in aseptic production
Practical example of robots in pharmaceutical production in cleanroom class A. Three case studies show examples of ongoing customer processes and the experience behind them. All projects are running with different robot manufacturers and processes.