Here is my response from your post. On our sister site:
What is the saline solution used for? There are many uses, some of which might require a change validation (intravenous use or eye drops) and some that might not. The basic ‘problem’ to look for is contamination and perhaps salt concentration.
Is this an off-the-shelf part that would certify conformance to certain specifications or is it a custom order?
This is out of my area of expertise, but would it be prudent to breakdown contamination into chemical contamination and biological (non-sterile) contamination? Thinking of the recent issues with non-sterile eye drops.
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