Requirements for insulators - Basics & Annex 1 points
Isolators are used to enclose aseptic processes (filling, loading and unloading of freeze dryers). Product protection is achieved by a barrier (handling unit and plenum) between the operator and the product. The laminar air flow system reduces the turbulence of existing particles, which are discharged by the downward air flow. The infeed and outfeed of products and [...]
Rapid Microbial Methods for process and data optimization
Access to fast, accurate and secure microbiological data can enable early detection of contamination, provide actionable insights and improve production flexibility. The availability of such data in near real-time to monitor the effectiveness of contamination in ultrapure water and other manufacturing processes leads to better process understanding for implementing better risk management strategies. With the new RMM from [...]
EXERGY ZERO-WASTE WFI POINT-OF-USE COOLING SYSTEMS
Exergy-Purex point-of-use cooling systems are highly efficient and sterile WFI point-of-use cooling systems designed to meet the challenges of staff safety during sampling while keeping the WFI circuit free from contamination. Through the safety, flexibility and efficiency of our compact, fully sterile point-of-use systems, we can help achieve optimal sterility that facilitates the development of [...]
IPS: Provision of first-class facilities
Welcome to our presentation on IPS-Integrated Project Services, LLC, where we address the core aspects that make us a leader in the Architecture, Engineering and Construction (A/E/C) industry. This presentation is designed to provide a comprehensive understanding of our diverse approach to engineering and construction and to emphasize our commitment to excellence, innovation and sustainability. Our [...]
Dynamic airflow visualization - Wind protects products
The presentation will highlight industry best practices in performing dynamic airflow visualizations to achieve a robust and compliant representation of your aseptic process. The importance of airflow visualizations to demonstrate aseptic compliance will be explained. The increasing importance of airflow visualizations in Appendix 1 is discussed and the resulting link between aseptic training and airflow visualizations [...].
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 [...].