whats the acceptable no. of vials containing particle in a batch size(150000 vials)?
At one company I worked, we used the AQL tables. The number of samples is based on quite a few things including How critical the failure is, what the batch size is, etc. This was just one model to determine how many samples you’ll need (and also how many failures you’ll accept). For particles in a vial (probably an injectible) I would think that particles could really hurt/kill someone, and so there would be zero allowable defects.
Look up AQL for this approach. But please know that there are other statistical methods to do this, and that AQL is considered somewhat archaic. There might be alpha/beta tables as well. I’m not a statistician at all, but used the input from statisticians I worked with to validate processes (including particles in finished product).
Re-reading your question. I don’t think any particles is acceptable (depending on your product/application). The AQL tables can tie together the batch size, number of samples required to be inspected, and failure rate (assume zero, unless otherwise discussed with your QA department).