Calculator
C=0 Sample Size Calculator
The basic formula for sample size based on the desired Confidence level and Reliability is:
\begin{equation}\large n=\frac{\ln (1-\text {confidence})}{\ln (\text {reliability})} \end{equation}
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Dye Penetration Testing is an effective and widely used method of locating defects in pouch and tray seals. Defects and leaks in the seal area are observed by the test operator as a accept/reject criteria; zero defects are allowed.
For a sterile barrier test with 99% confidence and 95% reliability, a sample size of 90 pouches to be dye tested would be necessary.
When dealing with attributes, we often need a sampling plan that ensures zero defects in the sample, or C=0. Determining the minimum sample size needed to ensure a certain level of reliability at a given confidence level is based on the binomial distribution.
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