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phloQS
Dear all,
hope anyone can give me good advise with this one:
We need a shelf-life validation for our new packaging system for sterile medical packaging. Previous designs have been validated on a sample base of 5 samples for each test. As most of the test (peel, dye, burst etc.) are destructive and prices for transportsimulation, accelerated aging and real time aging depend on volume a large sample size is very expensive. The testlab which we chose gave us the advise to test five samples again but they have no rationale on what they decide so. They only say it is common use. our daily production rate differs from day to day and we produce some very small batches of one product, so i can not find any samplesize based on batchsize. My question is: Does FDA accept shelf-life validaion reports based on the five samples or do they want to see larger sample sizes? As the project manager form our lab told us, they never had any problems with their reports but many customers ask them for the rationale.
Regards
phloQS
hope anyone can give me good advise with this one:
We need a shelf-life validation for our new packaging system for sterile medical packaging. Previous designs have been validated on a sample base of 5 samples for each test. As most of the test (peel, dye, burst etc.) are destructive and prices for transportsimulation, accelerated aging and real time aging depend on volume a large sample size is very expensive. The testlab which we chose gave us the advise to test five samples again but they have no rationale on what they decide so. They only say it is common use. our daily production rate differs from day to day and we produce some very small batches of one product, so i can not find any samplesize based on batchsize. My question is: Does FDA accept shelf-life validaion reports based on the five samples or do they want to see larger sample sizes? As the project manager form our lab told us, they never had any problems with their reports but many customers ask them for the rationale.
Regards
phloQS