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Hello there!
A) I wonder what it is the max allowed limit for glove 5 fingers test cfu/glove for microbial contamination in facility producing medical device products with ETO terminal sterilization. The ISO 13408 has not limit mentioned for grade D facility. How this test should not conducted ? based on what recommendations?
B) the standard recommend the time fro settle plates 4 hours. how we should consider how results if we made our tests for only one hour. has a linear just multiply by four or which else meaning?
Thanks for any clarifications
Eric
A) I wonder what it is the max allowed limit for glove 5 fingers test cfu/glove for microbial contamination in facility producing medical device products with ETO terminal sterilization. The ISO 13408 has not limit mentioned for grade D facility. How this test should not conducted ? based on what recommendations?
B) the standard recommend the time fro settle plates 4 hours. how we should consider how results if we made our tests for only one hour. has a linear just multiply by four or which else meaning?
Thanks for any clarifications
Eric
