Risk minimization in cold WFI production
This presentation is about cold WFI production, the risks and how these can be reduced with the help of sanitization measures.
Climate conditioning of highly toxic APIs
Biopharmaceuticals offer numerous innovative possibilities for combating complex diseases. A key function is the ability of the active ingredients to influence the immune system in a targeted manner. These biotechnologically produced and modified active ingredients are highly potent and require safe protection of personnel during production. The manufacturing process for these products is very complex, as the active ingredients are usually produced under constant and sometimes [...]
Furnishing cleanrooms correctly: Choice of materials and design
The installation of personnel airlocks and cleanrooms offers a wide range of possibilities while at the same time numerous guidelines and specifications must be observed. The presentation will examine the special requirements placed on the furnishing of cleanrooms and personnel airlocks by both authorities and users and how these can be met. It will be shown which materials are usually [...]
DryClean-CAPE® - Flexible, lightweight dry cleaning room
Together with Cellforce Group, a research team from Fraunhofer IPA has developed a mobile dry cleaning tent. The so-called DryClean-CAPE® not only creates a clean production environment, but also one with low humidity. This factor plays a decisive role in product quality, particularly in battery cell and automotive production, but also in the aerospace industry. Together with Cellforce Group [...]
Hygienic Design: Bactus and his buddies
Introduction to the basic principles of hygienic design using a case study from Food and Pharma and Bactus and its buddies.
Primary validation of an RMM
The key to using an RMM (Rapid Microbiological Method) to monitor pharmaceutical water production is validation. The AQU@Sense MB is the first commercially available device that has successfully undergone primary validation. This presentation summarizes the methods and results of the validation.
Risk analysis
What does a risk analysis for an aseptic packaging line look like? What is expected by the health authority, how do you meet the requirements? Which standards are considered and are relevant in a risk analysis for aseptic filling machinesWho should be in the team? When is the best time for a risk analysis and how long does it take? What does such a document [...]
Automation of packaging processes in the cleanroom
Packaging processes in the cleanroom must meet the specific cleanroom requirements.
Cleaning systems for infeed into the cleanroom
What are the current challenges when introducing production systems? This is linked to a solution approach of a modular method for cleanroom-compatible cleaning. And the validation of cleaning effectiveness with regard to particulate and film-chemical residues
Efficient electric steam generation with HT heat pumps
Electric steam generation works efficiently with heat pumps and vapor recompressors with steam temperatures from +120°C to +200°C. Depending on the heat source and steam temperatures, coefficients of performance of up to 3 can be achieved. This means that they are three times more efficient than steam generators with electric heating, and for particularly high efficiency, steam networks can also be set to lower temperature levels with pressure boosting stations or several [...]