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.
Detection and removal of disinfectant residues in
Detecting & Removing Disinfectant Residues in GMP Environments The new EudraLex Vol.4 Annex 1 has resulted in an increased regulatory focus on the residues associated with cleaning and disinfection agents. This presentation highlights the importance of detecting, proactively controlling and removing residues, as well as the visual and chemical impact of residues if not effectively [...]
From product development to agile manufacturing
The increasing need for cost efficiency in pharmaceutical manufacturing, combined with the new urgency to secure national supply chains and achieve net zero emissions, is leading to a renaissance of manufacturing in the pharmaceutical industry. These new and demanding requirements, from research and development to production at different locations, can be met with innovations in digitalization and [...]
Online TOC analysis according to USP and EP 2.2.44
The monograph "Water for Injection" of the European Pharmacopoeia Ph. Eur. has been revised and no longer requires the production of WFI by distillation. WFI may now also be produced cold using alternative methods (RO, EDI). The advantages for operators of pharmaceutical water production, storage and distribution systems are significantly lower operating costs. Cold production, storage and distribution [...]
High-quality measurements through field calibration of sensors
Handheld instruments are typically used for direct measurement of environmental or process conditions or as reference instruments for spot-checking or calibrating a stationary instrument in the field. This presentation will discuss basic principles for instrument calibration, factors that influence the need for calibration, and practices to ensure accurate and reliable measurement results. Calibration of sensors is [...]
Aseptic sampling - practical tips for modern processes
Find out in this presentation how a conventional component has been completely rethought and optimized. You will also receive practical tips on correct installation and modern sampling in clean processes. (Presentation also available in English) The main area of application is aseptic process engineering in bio-fermenters or WFI production and distribution. There will also be a computer animation of a "perfect" aseptic sampling process [...].
Integrated Continuous Processing - a sustainable solution?
Sustainability is an important and defining topic in all areas today. There are also solutions and ways to produce bio-pharmaceutical products more sustainably. The implementation of integrated and continuous production processes (Integrated Continuous Biomanufacturing - ICB) could be an option that not only makes processes more sustainable, but also brings about a general paradigm shift in the [...]
Risk-based optimization of calibration intervals
There is no general answer as to when exactly the right time has come to calibrate the device. Even the relevant regulations do not provide sufficient information on this. Due to the existing uncertainties, calibration intervals are often set at one year for lack of better knowledge, but this does not do justice to the heterogeneity of the various measuring points. So while one measuring point is far from being [...]
Basics of water chemistry
The presentation deals with the properties of water and its chemical and microbiological ingredients. The critical parameters for the design and layout of a pharmaceutical water treatment system are emphasized.
Integrated real-time production planning
Real-time planning directly integrated into the production software enables the manufacturing industry in the pharmaceutical, biotech and specialty chemicals sectors to gain far better and more detailed insights into the production process. This makes it possible to react directly to delays and deviations from planning and evaluate the impact on delivery data. Production, planning and management have direct and [...]