How is indirect integrity testing regulated and what are important issues?
Indirect integrity testing, such as turbidity monitoring and particle counts, is required to act as continuous monitoring of gross integrity failure due to its low sensitivity. The rule specifies that an upper control limit (UCL) of monitored parameters has to be established. Once the UCL is exceeded, it triggers direct integrity testing. The most important issues of indirect integrity testing are the low sensitivity and poor reliability of the methods, which make establishing UCL very difficult under certain circumstances. This FAQ supplied by: Pall Corp.
