Life cycle management in plant service
Service and maintenance are not the end of the GMP consideration of the pharmaceutical water system, but the beginning of the operator's life cycle management. We discuss how risk analyses and the evaluation of critical influencing factors can be used to implement the safest possible plant operation and continuous availability.
claire® neo - safety cabinets for the laboratory of the future
Safety cabinets provide a highly clean, controlled working environment in which products can be examined, processed or manufactured virtually free of particulate contamination. They are therefore primarily used for the sterile preparation and testing of pharmaceuticals and for handling sensitive biological or genetically modified substances. As safety equipment, they also make a significant contribution [...]
Modular ATMP Production - Case Study Planning & Realization
Case study: Design and implementation of a new flexible (modular) ATMP production plant: A large German biotech company has expanded its CMO capacity for ATMPs and vaccines at its site in eastern Germany with a new, highly flexible biotech plant. The case study provides an overview of the project development from the initiation phase through the concept planning and further engineering phases, based on "almost [...]
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 [...]