We are currently looking for Container Closure Integrity Testing using the Microbial Immersion/Challenge Test.
I am unable to determine the sample size for the test that would represent the whole batch or give us an assurance that the container/closure system will be integral and sterile post-capping.
I was asked to determine the sample size using statistical approach. I looked online for determining sample size based on confidence level and confidence interval but I am getting confused if I am approaching the right way.
Any help would be greatly appreciated.