Risk minimization through correct glove management
Gloves are currently still the most proven option for manipulation within isolators, barriers and other systems. However, they also pose the greatest risk to the integrity of these applications. Incorrect handling, poor maintenance or inadequate monitoring can result in leaks through which bacteria and germs can enter. It is therefore important to have a suitable glove management program [...]
Stumbling blocks and milestones: Implementation of ISO14644 Part 9
ISO 14644-9 deals with particle contamination on surfaces. It provides limit values, so-called SCP classes, for particle concentrations on walls, floors, work areas and products, for example. It also provides information on testing and test reports. However, there is also a lot that is not considered. In this presentation, we want to take a closer look at this part of ISO 14644 as well as related [...]
Case study: Detailed life cycle analysis (LCA)
WFI production by distillationEnergy-intensive distillation has long been the standard method of choice for the production of water for injection (WFI) in pharmaceutical GMP production. However, the increasing importance of sustainability in pharmaceutical operations and the current turmoil in the energy markets are challenging the status of this method. Many companies are now considering switching to [...]
Filtration technologies for pharmaceutical processes
In the presentation we will discuss contamination control in pharmaceutical cleanrooms. We will highlight the challenges in the different process steps regarding HEPA filtration. Process safety and risk management are the key success factors for efficient processes and product reliability. Product contamination is not only very expensive for the pharmaceutical industry, but also leads to image damage and / or in the worst case [...]
Microbiological monitoring
Microbiological monitoring is one of the key elements of an effective hygiene concept in aseptic production. The current methods for microbiological monitoring and the identification of microorganisms will be explained in more detail during the presentation. In addition, possible courses of action will be outlined on the basis of the available identification results and other methods that can be used to trace contamination paths will be presented.
HOF CryoBlizzard: Innovative charge storage technology
The HOF CryoBlizzard describes a future-proof and natural method of refrigeration specially developed for freeze-drying systems and freezing and thawing technologies. With the exclusive use of air as a refrigerant, this technology is not subject to any official regulations and impresses with its sustainability. The HOF CryoBlizzard is also ideally suited as a central refrigeration system for several freeze-drying systems. For this purpose, a charging accumulator is used to [...]
Fundamentals and development trends of filter fan units (FFU)
The presentation deals with the basics of filtration in cleanroom technology. It discusses the structure of modern cleanrooms and presents possible designs of cleanrooms with filter fan units. The correct dimensioning of the FFU is the success criterion for high production reliability. Issues such as noise emissions, compliance with the required cleanroom classes and energy consumption have a major influence on successful [...]
CryoRoadstar low-temperature trailer from -30 to -110°C
The low-temperature trailer is a standard system, including storage system, safety, loading and unloading concept. The trailer consists of special insulation panels with PU foam, which are mechanically stable enough for extreme temperatures and achieve a sufficient insulating effect for the low temperature range. For the main storage room, we used Mirai Intex's flexible cold air chillers, which can withstand temperatures from -40°C to -110°C (optionally up to [...]
Hard to kill bugs, resistance to irradiation & disinfection
Hard to Kill Bugs - Resistance to irradiation and disinfection in microorganisms There are more microorganisms that survive sterilization and disinfection processes than is generally assumed. This fact is increasingly taken into account in regulatory documents. It must be possible to assess the risk of finding such microorganisms in the manufacturing process. This requires a precise understanding of the bioburden before the [...]
CO2 footprint in cleanroom technology
Cleanroom technology in the classic sense, and thus the entire infrastructure and air technology in focus, is still predominantly built and operated on the basis of traditional regulations and old practices. In times of modern simulation technology, optimized measurement and control technology and pressure to save energy, there is an opportunity to implement energy-optimized cleanroom systems and facilities. For example, [...]