Safe Handling of Anticancer Drugs and ATMPs Using Isolator Technology
The handling of cytostatic drugs and the manufacture of ATMPs (Advanced Therapy Medicinal Products) place the highest demands on sterile and aseptic working conditions. Cytostatic drugs are highly effective yet toxic substances whose handling is strictly regulated, as even the smallest amounts can pose a health risk to staff. ATMPs, on the other hand, are extremely sensitive products for which even minimal contamination […]
Greater process reliability through 3D and VR technology
In today’s highly regulated and competitive pharmaceutical and biotech industry, aseptic processing requires precision, reliability, and continuous improvement. Digital transformation offers powerful tools to address these challenges by improving process understanding, operational efficiency, and real-time transparency. This presentation explores how innovative digital solutions are revolutionizing aseptic operations and delivering measurable […]
Annex 1-compliant E-beam transfer with surface sterilization
Given the growing demand for pre-sterilized RTU components such as syringes and vials, e-beam technology is being used more and more frequently. By sterilizing the surfaces, it enables these components to be transferred into Class A cleanrooms, such as isolators. According to the requirements of Annex 1, the transfer of materials into and out of cleanrooms and critical areas is one of the […]
H.U.G.S. Mobile Cleanroom Robotics – Use Cases and Benefits
The presentation features a mobile robotic solution designed for use in Class C and D cleanrooms. The system automates manual, contamination-sensitive tasks involved in microbiological sampling. It is based on the Stäubli Sterimove mobile platform, which carries the HEITEC top module—equipped with a collaborative robotic arm, a gripper, and a particle counter from Particle Measuring […]
In-line instrumentation for the pharmaceutical industry
Given the high standards for quality and product safety in pharmaceutical manufacturing, sterile process engineering plays a key role in ensuring the efficiency and safety of production processes in both upstream and downstream operations. Contamination-free process control remains a critical quality factor throughout the rest of the process chain, including cleaning and sterilization. This requires […]
Water Wars: Challenges and Opportunities of Ultra-Pure Water
The panel discussion provides a comprehensive overview of key issues in ultrapure water treatment, bringing together four key perspectives. The first topic, “Everyone has biofilm. Do you know where yours is growing?”, highlights why modern microbiological monitoring is indispensable. Old methods such as spot-check monitoring are reaching their limits in the face of complex systems. Microorganisms form biofilms that evade even the most advanced disinfection methods, such as ozone […]
Optimizing Energy Consumption in Ultra-Pure Media Systems
The production of ultrapure media—particularly the generation of WFI and ultrapure steam—has historically always been tied to the use of process steam. Consequently, there is a global discussion on how to produce hot media in a more environmentally friendly manner. This presentation offers a brief introduction and overview of the topic by explaining the key features and characteristics of the various technologies […]
Compliant with regulations & future-proof: Mobile measurement solutions
This presentation addresses the critical aspects of mobile particle counting and airborne microbial sampling in controlled environments. We will examine the benefits, challenges, and best practices associated with the use of mobile particle counters and airborne microbial samplers, as well as the specific requirements for these devices and their applications. When companies understand the intricacies of monitoring viable and non-viable […]
Risk Assessment – The Foundation of Every Monitoring Program
The current version of EU-GMP Annex 1 places particular emphasis on risk assessment. This is a strict prerequisite for a monitoring plan and is also useful for practical reasons. A thorough understanding of the process makes it possible to design and monitor production processes optimally and to avoid additional effort in routine monitoring. In risk assessment, critical […]
Cleanroom Qualification and the Impact of Annex 1
This presentation covers the current requirements of Annex 1 of the EU GMP Directive and their implications for sterile manufacturing processes. The focus is on the proper qualification of cleanrooms in accordance with ISO 14644, including particle counting, differential pressure monitoring, filter integrity testing, and microbiological monitoring. In addition, the implementation of a contamination control strategy (CCS) and the integration of quality risk management (QRM) are explained. Practical examples demonstrate how companies identify risks, set limit values […]