Contamination Control Strategy for sterile testing
For aseptically manufactured medicinal products, the result of the sterility test is an essential criterion for the release of a product batch for the market. As part of quality control, the test must be assigned to the manufacturing process, which results in the regulatory requirement for integration into a contamination control strategy in accordance with Annex 1 of the EU GMP guidelines. One way to [...]
Cleaning of insulators
Regulatory requirements such as Annex 1 or Annex 15 describe the requirements for cleaning in the pharmaceutical industry. But what does this mean for the isolator? What aspects must be taken into account and how should a sensible cleaning strategy be developed? What to do if the product is toxic?
AI in GMP use: opportunities and pitfalls
Everyone is talking about AI and it seems that no one can escape the hype surrounding ChatGPT, CoPilot and the like. Hopes are high that the new tools are actually intelligent and can not only make our lives easier, but also take work off our hands. A brief excursion into how AI works will give you the basic understanding you need to [...]
Artificial intelligence (AI) in continuing education
This presentation highlights the potential applications of artificial intelligence (AI) in continuing professional development. Starting with examples of AI in everyday life, it will show how modern technologies enable adaptive learning and increase efficiency through personalized learning paths. Practical examples, such as AI-supported tutors and virtual reality, are used to illustrate the benefits of a customized learning experience. The focus is on the [...]
Energy-efficient operation of cleanrooms
Class C cleanrooms require the largest areas in the aseptic production of pharmaceuticals and therefore also the largest air volumes to maintain air purity. The FDA's Aseptic Guide specifies an air exchange rate of 20/h as "typically acceptable". The extent to which this value ensures compliance with the limit values for particles and colony-forming units (CFU) in accordance with the FDA guideline and [...]
Project audits - a nuisance or an opportunity worth millions?
The problem: delays in the project occur regularly and are tolerated. Especially if the delays are only a few days long. The justification is then: "Nothing can be done", "It's just the way it is", "It's not that bad" or something similar. But how bad is it really? If you look at the costs that just a single [...]
QMS in the age of digitalization
biotechnology and medical technology. At the same time, companies are faced with the challenge of digitizing their processes in order to meet increasing regulatory requirements and work more efficiently. In this presentation, you will learn how an electronic quality management system (eQMS) helps to centralize quality-relevant processes, guarantee data integrity and ensure compliance. The presentation will also highlight current challenges in the industry, [...]
GMP meets Quality Culture
This presentation shows how the principles of Quality Culture can be used in a targeted way to promote sustainable and effective employee training. After an introduction to the essential core elements and the relevance of Quality Culture, concrete examples will be presented that illustrate how these can be integrated into modern training approaches. The focus is on establishing [...]
Green building and cleanroom technology
The technical lecture deals with the topic of green building in general, as well as green building in relation to cleanroom technology. The focus of the lecture is on the presentation of possible recycling models for finishing products in cleanrooms (e.g. ceilings, walls, floors) with examples of the preservation, reuse, processing and recycling of individual components. Furthermore, various recycling models, such as purchase [...]
10 mistakes in cleanroom construction and how to avoid them
The planning and construction of cleanrooms can be compared to the construction of a house: the matter is technically more complex than you might think, as there are a large number of interfaces to consider, the client often only does this once in a lifetime and does not have the technical expertise and: what is not considered beforehand costs [...].