fenwayman Posted March 25, 2011 Share Posted March 25, 2011 i need a way to validate the process of using igloo coolers for temporary storage in the operating room. We have been using the coolers for years and perform semiannual QC of each cooler by checking the temperature of units in each cooler. We were recently cited by the FDA for not validating the process. :mad:Anyone have any ideas?? Link to comment Share on other sites More sharing options...
adiescast Posted March 25, 2011 Share Posted March 25, 2011 We packed the coolers the way we expected them to be used and took temperatures and estimated ice volume remaining every hour for 8 hours. This was documented and a summary written and signed off as acceptable. FDA didn't look at that validation when they were here last, so I can't make a claim about the acceptability of our method. Link to comment Share on other sites More sharing options...
Recommended Posts
Create an account or sign in to comment
You need to be a member in order to leave a comment
Create an account
Sign up for a new account in our community. It's easy!
Register a new accountSign in
Already have an account? Sign in here.
Sign In Now