GAMP 5 Second Edition - Specify requirements
The presentation provides an introduction to GAMP 5 Second Edition in general and then goes into requirements management. Finally, GAMP relies on agile methods and the traditional separation into user requirements, functional requirements and other requirements is no longer present in the guide. However, some things have not changed. Bad requirements are still [...]
Ultrasonic clamp-on for utilities and energy management
The non-invasive measuring technology with ultrasonic clamp-on has a significant advantage: no contact with the medium. This means 100% hygienic flow measurement without the risk of contamination. In addition, the documentation effort is reduced due to the principle, as no certificates for material, surfaces, seals etc. are required. With the new FLUXUS 532 series, FLEXIM has developed a compact solution for utilities and energy management [...]
Robotic solutions in aseptic production
Practical example of robots in pharmaceutical production in cleanroom class A. Three case studies show examples of ongoing customer processes and the experience behind them. All projects are running with different robot manufacturers and processes.
Contamination Control (CCS) and Now?
With the contamination control strategy, potential risks of product contamination are continuously identified, assessed and controlled. To assess the risks, a contamination control strategy is a prerequisite for the process and system. This includes a process for assessing, detecting and eliminating contamination risks from potential foreign sources of endotoxins/pyrogens, particles and microbiological contaminants. It also supports [...]
Cleanroom technology - Efficient measuring methods
Reduce costs and set new standards in cleanroom measurement technology with practical and efficient measurement methods - an overview and outlook.
GDP-compliant transformation of a warehouse
The presentation describes the progress of a joint project between Simon Hegele Gesellschaft für Logistik & Service mbH and Testo Industrial Services GmbH in 2022. The aim was to transform an existing warehouse into an airfreight-safe area for the deep-freeze storage and global distribution of pharmaceutical products. Central to this was compliance with all GDP-relevant requirements, which [...]
Safety cabinets - solutions for demanding tasks
Highly specialized applications in biological and pharmaceutical laboratories require flexibility and adaptability in the design of safety cabinets. Nevertheless, individualized devices must also meet the requirements for safe operation. These requirements are defined by various international and national standards (e.g. DIN EN 12469, NSF/ANSI 49, DIN 12980). However, the standard test methods described there do not take into account the [...]
What will the future ATMP systems look like?
The ATMP boom since 2019 with the approval of Kymriah and Yescarta, followed by Zolgensma and other therapeutic products, has quickly brought ATMPs to the public's attention. Facilities have been redesigned, adapted and rebuilt at a rapid pace, in some cases adapting typical laboratory procedures to a GMP environment. The pandemic also finally opened up the [...]
TechTransfer - Fast data exchange between R&D and production
Error-prone, incomplete and slow transfer of process information between research and manufacturing or production and CMDOs can be eliminated or optimized with TechTransfer It is too time-consuming and labor-intensive to use traditional methods and tools for technology transfer that are based on manual processes or paper. - Spreadsheets and documents are difficult to manage and share across organizations.
GMP in the manufacture of patient-specific preparations
The requirements for the production of patient-specific medicines in pharmacies are increasing. Even if these are initially subject to the Pharmacy Operating Regulations, requirements from the EU GMP guidelines are increasingly being used for inspections. In this presentation, the differences and similarities will be worked out and explained using examples.