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 of achieving this in a scientifically sound and practicable manner is to present it in the form of a risk assessment, from which critical control points for the CCS can then be derived. With a deep understanding of the process, intensive practical experience and a clear focus on the main potential risks, the test procedure can be broken down into a few - but essential - steps, the influence of which is then assessed in detail. The risk assessment created should be seen as a living document and should therefore be reviewed regularly to ensure that it is up to date and that the identified improvement measures are implemented.