Highly efficient MWFI system with heat recovery
Join us for an insightful 10-minute Tech Talk on our stand, where we will showcase the latest advances in high-efficiency MWFI ) systems with integrated heat recovery. This session will highlight how these innovative systems are designed to maximize energy efficiency and minimize operating costs. We will explore the key features that make it [...]
Understanding cleanroom garments as a system
Although cleanroom garments are part of so-called workwear, unlike personal protective equipment, cleanroom garments are designed to protect the product or process under controlled conditions from contamination caused by employees or their personal clothing. Cleanroom garments are therefore the only filter between people (the largest source of contamination in the cleanroom) and the product to be protected. From [...]
Pioneering systems for oligonucleotides
Discover how you can successfully meet current trends and challenges in the planning of your production facilities for oligonucleotides. This TechTalk will cover key aspects of facility design and optimization to meet the unique requirements of oligonucleotide manufacturing. Learn more about the latest technologies, regulatory innovations and best practices to ensure efficient [...]
What you always wanted to know about pharmaceutical water
Basic Session - what you always wanted to know about pharmaceutical water. ISPE has the answers. "Best Practices for Pharmaceutical Water Systems" - Information and exchange on best practices in the planning, operation and monitoring of pharmaceutical water systems Focus of the presentation: - ISPE Baseline Water and Steam System - ISPE Good Practice Guide Critical Utilities [...]
Revision - ISPE Good Practice Guide for ozonization
New revision of the ISPE Good Practice Guide for ozonation of pharmaceutical water storage and distribution systems In this presentation, the new ISPE Ozone Guide will be presented with a special focus on the main changes compared to the previous version. Focus of the presentation: - Increased use of ozone in cold WFI systems - Risk from residual ozone in the biotechnological manufacturing process - Reduced [...]
ANNEX1 and new WFI monograph in the ChP2025
The presentation provides an overview of the main changes and their impact on the planning of WFI systems. Key topics include: - Is membrane-based WFI generation replacing the PW generator? - Turbulent flow in DTS shell and tube heat exchangers - Particulate impurities and PFAS in WFI - Process steps in WFI generation
Sustainability: regulations, standards and evaluation schemes
1. standards and regulations and their impact on plant manufacturers, planners and producers e.g. CSRD, ratings e.g. Ecovadis, voluntary commitment e.g. SBTi CSRD, ratings e.g. Ecovadis, voluntary commitment e.g. SBTi 2. explanation of the scopes (focus on plant/machine) 3. scheme for determining the machine-relevant CO2 values and focus analysis using the industrial example of Syntegon in relation to WFI production 4. what solutions are available and how can plant manufacturers, planners and producers make a contribution [...]?
Digital twin - curse or blessing
Digital twin - curse or blessing / Opportunities for project planning and ongoing operation - What is a digital twin? - Areas of application / Project planning, simulation and real operation - Example from the pharmaceutical industry Using the example of a digital twin in the pharmaceutical industry for a storage/distribution system, the topics of design, project planning, simulation and [...]...
Cleanroom GMP vs. containment
Cleanroom GMP vs. considerations regarding cleanroom and containment requirements - different requirements of GMP (e.g. also Annex 1) vs. containment - air locks in negative pressure vs. positive pressure (sink & bubble) - pressure and air losses in rooms and air locks (airtight vs. particle-tight - practical assumptions based on construction methods) - operator protection always takes precedence
ISPE Good Practice Guide "SMEPAC" 3rd edition
The presentation will give an overview of the new edition of the ISPE Good Practice Guide ""SMEPAC"" (formerly known as "Assessing the Particulate Containment Performance of Pharmaceutical Equipment APCPPE"). What does the guide cover and what is new in the third edition?"