From GE Analytical Instruments
Using a process capability approach based on historical or
current total organic carbon (TOC) data for swab and rinse
samples can demonstrate whether the cleaning process
and the limits used for this process are practical, achievable,
and verifiable. Based on the process demonstrated in
Figure 1, both the upstream and downstream processes
use a "default" limit of 1 ppm C. This limit will be used to
determine the capability of the process. However, TOC
samples are typically close to the LOD or LOQ of the TOC
method, so it is a best-practice approach to demonstrate
process capability for one-sided acceptance criteria. For a
one-sided acceptance criteria, the process capability ratio
becomes Cnpk versus the traditional CpK approach.
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