Tom
The sampling frequency will depend on the performance of the filler
and capper. Fill and cap placebo solution and sample very frequently
to determine the variation from bottle to bottle both short term and
throughout the batch. Two or three batches should provide the data
on which you can base your sampling frequency.
Most new machines are very consistent and it should be possible to
sample every 15 minutes or even every 30 minutes.
It might be best to start production with more frequent sampling and
extend the interval as more results become available. Remember that
when you extend the interval the reason for the extension should be
documented and approved by Production and QA.
Alan Newbery
winmail23.dat
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