Hi all,
I work for a Class 1 sterile medical device company in the field of dentistry. I was asked to provide defined process for sampling and keeping samples of sterile products from each batch in the company's warehouse. I'm talking about defined sample of each batch of sterile product is stored internally in accordance with the specifications for the event of non-conformities/notifications/incident case, we can use the stored product samples to analyze the deviation etc. and for carry out sterility tests on these samples as part of the next product file review in order to prove the shelf life or sterility for the defined period.
We have specified all controlled environment parameters and storage areas for finished sterile products for this purpose.
My question is-
How can I determine the sample size of the amount of finished products I need to keep from each batch?
The size of the batches in each production is about 5000 units, sometimes even more.
Thank you very much for your help.
I work for a Class 1 sterile medical device company in the field of dentistry. I was asked to provide defined process for sampling and keeping samples of sterile products from each batch in the company's warehouse. I'm talking about defined sample of each batch of sterile product is stored internally in accordance with the specifications for the event of non-conformities/notifications/incident case, we can use the stored product samples to analyze the deviation etc. and for carry out sterility tests on these samples as part of the next product file review in order to prove the shelf life or sterility for the defined period.
We have specified all controlled environment parameters and storage areas for finished sterile products for this purpose.
My question is-
How can I determine the sample size of the amount of finished products I need to keep from each batch?
The size of the batches in each production is about 5000 units, sometimes even more.
Thank you very much for your help.
