EU GMP | New Annex 1 | Contamination control strategy
A concise and clear summary of the key issues and contexts for developing an effective contamination control strategy (CCS) in accordance with the new Annex 1 of the EU GMP guidelines.
Sustainability of air filtration
How can you use air filters to improve your environmental footprint and save costs without compromising on air quality? Benefit from expert tips on planning efficient and environmentally friendly air filter solutions that meet these requirements. Protect people, manufacture clean products and create pleasant working conditions Reduce life cycle costs and CO₂ emissions Avoid negative effects on the environment
Efficiency and consistency through clever monitoring
Economic efficiency and consistency through clever monitoring - contemporary analytics instead of flying blind Use of modern online measurement technology for consistent data, contemporary measuring instruments enable economical operation (adapted water treatment, reduced operating costs), online TOC measurements as an important indicator of water quality. Participants in SWAN's contribution can expect an overview and solution approaches for modern solutions for online monitoring in the areas of pure, [...]
Determination of the bacterial count in pharmaceutical water in real time
The determination of the microbial content in purified water and water for injection purposes was previously based almost exclusively on time-consuming laboratory tests of cultures. The latest technical developments enable precise measurements of contamination by microorganisms and inert particles in pharmaceutical water systems.
Planning process for cleanroom projects
The planning process for cleanroom projects usually follows a structured process that ensures that all relevant aspects are taken into account in order to design and construct a cleanroom according to the specific requirements. The following steps are typically part of the planning process: 1. requirements definition: The first step is to precisely define the requirements for the cleanroom. This [...]
"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.
EU GMP | New Annex 1 | Contamination control strategy
A concise and clear summary of the key issues and contexts for developing an effective contamination control strategy (CCS) in accordance with the new Annex 1 of the EU GMP guidelines.
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.
Impact of the new Annex 1 on cleanroom qualification
Discussion of the changes to the new Annex 1 and its significance with regard to the qualification of cleanrooms and ventilation systems in the pharmaceutical industry. The aim of the presentation is to provide an outlook on the future classification of the requirements of the new Annex, as well as the derivation of measures and suggestions for action.
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.