Annex 1: What has changed? How to become compliant
The presentation will explain step-by-step the key updates to Annex 1 and the reasons for the changes. As a subject matter expert in aseptic equipment and compliance, the speaker has nearly four decades of experience in the pharmaceutical industry at the forefront of operations and quality. This is coupled with extensive design and remediation activities to ensure [...]
Design of a continuous cell lysis device for Plasmid Tec
This research project is about the development of a continuous cell lysis device tailored to plasmid technology applications. The overall goal is to develop an efficient, scalable solution for the extraction of plasmid DNA from bacterial cells to enable more optimal processing modalities. This presentation provides a comprehensive overview of the work and highlights the [...]
Traceability matrix in iC&Q projects
Nowadays, traceability matrices are used as an important tool for planning and tracking commissioning and qualification activities. Every quality-relevant requirement for a system or device that is defined in the User Requirement Specification (URS) should be checked and confirmed during qualification. It is advantageous to use the integrated commissioning and qualification (iC&Q) approach [...]
AMC the 3rd source of contamination in cleanroom production
Airborne molecular contaminants, also known as AMC (airborne molecular contamination), have been a threat to cleanroom production for many years. These contaminants can lead to direct product damage in cleanrooms. The problem will be explained in more detail using examples from the pharmaceutical industry, the chip industry and glass production. Sampling will also be discussed. The participants [...]
Large-scale tank exchange project in a pharmaceutical production facility
Experience an exciting presentation by Christina Füting from Expert Institute, project manager of a large-scale, highly complex tank exchange project in a pharmaceutical production plant that took place in 2022, and engineer Dominikus Forsthuber, a renowned expert in cleanroom floor construction who was involved in the aforementioned project. They will provide fascinating insights into their practical experiences, as well as the extraordinary journey of how they achieved the seemingly impossible [...].
Process simulation in the pharmaceutical industry
Process simulation is used for the analysis and optimization of existing and/or new processes (greenfield / existing infrastructure) within the pharmaceutical industry. Various scenarios are simulated in order to investigate the effects of different conditions on processes, systems and production. With the help of process simulation, plants can be customized or planned based on customer-specific requirements. At the same time, the optimization [...]
EU GMP Annex 1 and its significance for ultra-pure media systems
In our presentation, we will examine the new requirements of Annex 1 with a focus on ultra-pure media systems and the potential impact the new revision is likely to have on operators and suppliers. The chapters and requirements relevant for high-purity media systems and the consequences derived from them from our point of view will be discussed. The main focus here is [...]
Membrane systems in pharmaceutical water treatment
This article takes a closer look at and compares the various membrane systems used in pharmaceutical water treatment. We would like to give you an overview of the different membrane technologies - what were the beginnings of membrane technology and where do we stand today? We look at the different design features of reverse osmosis membranes and compare the respective advantages and disadvantages. [...]
The "overlooked" Chapter 3 of the new Annex 1
An effective quality system forms the basis for the development of usable processes and suitable medicines. In this context, the key responsibilities of management, the competent person and quality assurance must be highlighted. By clarifying these roles, clear guidelines for effective implementation should be created. A particular focus is on the question of whether "quality oversight" in the [...]
Proven and new methods of decontamination
Disinfection, decontamination and sterilization are a matter of course in the medical and pharmaceutical environment. For decades, research was mainly concerned with the development of chemicals, substances and active ingredients. More recently, cleanroom technology has focused on application, measurement and simulation techniques. This presentation deals with different modern decontamination techniques and processes and shows alternatives to e.g. [...]