Ampoules Inspection


During the production of an injectable. Is it necessary to do a total visual inspection of a total lot of ampoules? or Do exist a specific number or percentage of ampoules for a visual inspection (Example if I produce 100.000 ampoules; I will inspect just the 30% of the total lot; that is 30.000 ampoules)?. :confused:

Do exist an official monograph where I can find that percentage or number of ampoules that I need to inspect to approve the lot? Right now they are using an automated system but They check the inspection using a visual inspection of 80% of the accepted ampoules .

Thanks in advance

Hi Jhosfe,

You are saying that, the ampoules are already being inspected by a automated system. You can use the AQL guidelines by ISO (table attached), provided - your automated system is adequately qualified for the inspection and challenged before the inspection.

Look at the link here:

Rohit Sattar
Senior Quality Assurance Chemist

Thanks Rohit,

Yes; First, The ampoules had been inspected by an automated system and then they were confirmed by a manual inspection in a specific percentage (the aim is to confirm the result of the automated system during the production). We want to establish a limit of confidence (a number of ampoules that are going to be inspected by a manual inspection after the automated system) independently of the qualification of the machine.

Best regards