Risk Assessment and CCS for Sterility Testing
For aseptically manufactured medicinal products, the sterility test is an essential criterion for batch release. As part of quality control, the test must be linked to the manufacturing process, resulting in the regulatory requirement to integrate it into a Contamination Control Strategy (CCS) in accordance with Annex 1 of the EU GMP Guidelines.
A scientifically sound and practical approach is to conduct a risk assessment to identify critical control points relevant to the CCS. Based on an in-depth understanding of the process, practical experience, and a clear focus on the most relevant potential risks, the testing procedure can be broken down into a limited number of essential steps. The influence of each step is then evaluated in detail.
The risk assessment should be considered a living document and regularly reviewed to ensure it remains current. Identified improvement measures should be implemented accordingly.1
About SKAN
We don’t sell isolators. We deliver Grade A.
Since 1968, we have combined Swiss pioneering spirit with global technological leadership. As the world’s leading provider of isolators, cleanroom equipment, and decontamination systems, we set standards where regulatory requirements, process reliability, and performance allow no compromises.
Our technologies are used across Europe, North America, Japan, South Korea, and Singapore, where the highest regulatory standards apply. Based on our insights, one in three vaccines in our core markets is manufactured in a SKAN isolator. This trust is a commitment for us: we not only deliver equipment but also take responsibility for reliable performance in daily production from process consulting and qualification strategies to digital solutions across the entire lifecycle.
