Depyrogenation devices, such as tunnels, are used in the pharmaceutical industry to prepare components for aseptic filling. To qualify such devices, various pharmacopoeias require depyrogenation devices to be periodically challenged with high levels of bacterial endotoxin. Although the pharmacopoeias state the acceptance criteria, little consideration is given to the practical approach.
What will you learn
In this course, we will learn about the qualification of tunnel sterilizing machine in pharmaceutical production.
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