Discussion round - CU projects
We will look together at the "do's and don't's" in projects in a panel discussion in which the lessons learned from these projects and possible developments in project management over the next few years will be openly discussed. Topics such as data management, PoU management and AI will be highlighted.
Critical Utilities projects: Exciting and unique
This presentation is dedicated to the fascinating and unique aspects of high-purity media projects. We will address this topic in several steps: 1. content of high-purity media projects: - high-purity media that the ISPE Group deals with - project types and execution scenarios that are typical for the field of high-purity media - project phases that are crucial in [...]
MWFI - Regulatory and technical update
The presentation deals with various aspects of the use of MWFI. - Regulatory conditions: How do manufacturers deal with the restriction of use by the ChP and what are the experiences of Chinese inspections? - Sustainability: Case study on the heating of membrane-based MWFI via a heat recovery system using a heat pump - Market development in MWFI production: MWFI vs. distillation - How often [...]
Errors/traps in the risk assessment of computer systems
Have you already asked your system the question of trust? Most recently with the publication of the 2nd edition of the GAMP®5 guide, "Critical Thinking" is strongly recommended to find and manage the risks associated with operating a computerized system. By involving system suppliers and people with system and process knowledge (Subject Matter Experts) in [...]
ISPE - Good Practice Guide, Process gases
And, do you also want to become CO2-neutral in your pharmaceutical company? The ventilation systems are certainly already well on the way to being reduced, but what can you do with your compressed air and gases? A new ISPE guide has recently been published to make this easier for you and will now be explained in the presentation.
Purified Water / Water For Injection - Combination system
PW and WFI share some similarities in terms of water quality requirements, system planning, monitoring and sampling. Typically, both a PW system and a WFI system are considered in the planning for bio-pharmaceutical productions - to supply the individual reference points accordingly. Due to the similarities between the two systems, the question arises whether there is a possibility [...]
Opportunities for the introduction of paperless qualification
The digital transformation has now reached every company and does not stop at qualification/validation. As a result, many companies will have to consider introducing a system that enables paperless qualification/validation in the future. With such a system, many advantages can be exploited while maintaining compliance. With [...]
Visualization of the 3D air flow with STV
Plastic articles for the aseptic fill & finish of sterile pharmaceuticals are increasingly being manufactured in ISO Class 7 cleanrooms to ensure maximum cleanliness. A cleanroom booth equipped and qualified for this purpose was analyzed using the novel Ultrasonic Sensor Tracking Velocimetry method to understand the influence of installations that potentially disturb the airflow. Detailed information on [...]
Safety & efficiency: High containment filter solutions
Avoiding contamination is crucial in pharmaceutical production. High containment technologies play a key role in preventing cross-contamination, increasing workplace safety and reducing environmental impact. This presentation will introduce the latest developments and applications specifically designed to meet the challenges of the pharmaceutical industry. We will highlight innovative strategies for the safe handling of active ingredients, [...]
Certified PPE for handling hazardous substances in cleanrooms
When handling hazardous substances (e.g. CMR drugs), certified protective clothing of the highest category III must also be worn in the cleanroom. The presentation shows the differences between the various garment materials, deals with filtration efficiency and chemical protection, GMP-compliant production and packaging of cleanroom garments and possible recycling of the materials.