11.5.5.2 requirements for "other gases"
We recently got a non-conformance for not testing equipment that dispenses nitrogen into bottles for oxygen removal. With the update to Edition 8, "other gases" were added. Does anyone have any recommendations on how to comply with this? I have obtained a Certificate of Conformance from the supplier guaranteeing purity. Thanks in advance!
The issue with these sorts of systems is not just the gas, but also the delivery method into the container.
So; do you have a PM plan for the connections/hoses/nozzles?
You can get test kits from any good accredited lab (but they are NOT cheap)
Alternatively, you can flush sterile solution through the fittings et all and plate that for growth
I would contact your most credible local lab and speak to them about your testing options
The certificate is good. However you need to find a neogen tester (lab, kit, etc) that will test your delivery equipment. Better to use a lab and they can issue a current certificate - suggest twice a year unless something is found.
Thank you everyone!