Risk Assessment - Chemical

Milas

Involved In Discussions
Hi

Can anyone advise as to how I would go about carrying a risk assessment, if I want to change from one supplier to another for a Saline solution.

Not sure what what I should be looking for or what such a risk assessment should look like,

Thank you
 

Bev D

Heretical Statistician
Leader
Super Moderator
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?
 

Miner

Forum Moderator
Leader
Admin
The basic ‘problem’ to look for is contamination and perhaps salt concentration.
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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