Solutions for asept. Processing of obesity products
In addition to therapies for oncological applications, obesity applications are among the products with the strongest forecast market growth in the coming years. In addition to a brief introduction to the general conditions in this therapeutic area, this presentation will provide an overview of the typical challenges involved in aseptic processing and filling of the products. In the third part, fill-finish solutions available on the market and already [...]
Monitoring systems for warehouses & laboratories: what is GMP-compliant?
Precise environmental monitoring is essential for product safety in the pharmaceutical and biotechnology industry. The presentation will highlight the importance of GMP-compliant monitoring systems in warehouses and laboratories and show how they meet the strict regulatory requirements. Key topics such as data integrity, compliance and ensuring resilience in the event of an IT failure or cyberattack will be [...]
The rise of robots in aseptic filling processing
The use of robots is becoming increasingly important in order to reduce or ideally eliminate manual intervention during aseptic filling. The use of robotic systems in the pharmaceutical industry is not a new trend. The first applications were developed and implemented back in the 1990s specifically to support processes relating to fill-finish in cleanrooms. [...]
Sustainability in cleanrooms, a scientific approach
The cleanroom industry is at a crossroads between rising expectations of sustainability and the stringent requirements of the regulatory framework. This presentation will address the legal and scientific challenges that are shaping the industry's path to sustainable practices. As the pharmaceutical sector pushes for greater environmental responsibility, legislation such as the Corporate Sustainability Reporting Directive [...]
Fast/reliable oxygen measurement in pharmaceutical processes
The oxygen content is an important parameter for monitoring processes. Among other things, explosive substances are often used in the production of pharmaceutical intermediates and active ingredients. To avoid explosions or degradation, the oxygen content must be monitored. Laser spectrometry using TDL (Tunable Diode Laser) is a time- and cost-saving measurement technique based on typical processes in [...]
Validation of sterilization processes in accordance with ISO 17665
The validation and requalification of autoclaves and the sterilization processes used in them is a regulatory requirement for all parties involved. This presentation deals with the requirements in accordance with the new ISO 17665. Participants will be able to identify and evaluate the relevant aspects of validation and requalification as well as [...].
Material flow simulation: virtual planning, real successes
Material flow is a key success factor in production, as it enables efficiency increases, cost reductions and optimum utilization of production capacities through smooth processes. But how can an ideal material flow be designed? The answer is simulation. In a world that is changing ever faster and becoming increasingly complex, cost efficiency, process optimization and ensuring [...]
Temperature mapping of storage rooms and cooling units
Whether manufacturer or upstream supplier. Compliance with the cold chain and the specified parameters is required by law for all parties involved. In this presentation, we will look at the country and region-specific regulations and show you step by step how to plan and implement mapping based on the warehouse drawing. We will then point out possible weak points [...]
Improve first-time-right design of aseptic processes
For decades, aseptic process designs for isolators have relied on a combination of 3D CAD tools and physical models made from materials such as wood, cardboard and real components to create realistic models. But advances in digital technologies such as virtual reality (VR), software modeling, spatial recognition tools and 3D printing have ushered in a new era of precision and flexibility. XR (Extended Reality) solutions set [...]
Best practice: Safety and quality in steam applications
Steam as a heat transfer medium in the process industry has many advantages. Without pumps, steam with a high energy density supplies heat to the process. This saves investment costs and space. During heat transfer, the temperature can be precisely controlled via the pressure. The high heat transfer rate enables fast processes. Steam has a sterilizing effect and the starting material, water, is safe. Regardless of the process, [...]