Can some guide me to fix the WFI loop sanitation temperature range with relevant guidelines?
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A temperature of 80ĖC is very āforgivingā of cooler locations which can still be sanitized even with a 10-15ĖC temperature loss as it penetrates throughout the system by convection and conduction, so it is very effective. Cooler temperatures (down to 65ĖC) can also be used but is āunforgivingā of yet cooler locations such as outlet valves off of the main loop. So such cooler locations must be flushed with this slightly cooler hot water in order to assure that all surfaces reach sanitizing temperatures greater than 60ĖC. Unless systems are specifically designed for this, temperatures hotter than 80ĖC can impact the longevity of system materials (e.g. gaskets and diaphragms). A temperature of 80ĖC is well hot enough to kill the most heat resistant biofilm organisms that will colonize a water system
In the new USP 1231 the recommended temperature in hot sanitizing has changed. The previous recommendation of at least 80Ā°C has been lowered to 65-80Ā°C.
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Since thermal or ozone sanitization of WFI systems is typically no less frequent than weekly, that is not enough time for biofilm (with its endotoxin) to develop in the system and be released by periodic sanitization. If the systems are much less frequently sanitized, there is a chance that developing biofilm could release detectable endotoxin when killed by periodic sanitization.
Ok. But we are running our loop at 81-85 always. Some times in ambient temperature( 2-3 hrs operation) . Then again it will be changed to 81-85. In this case what will be the sanitation temperature and itās frequency of perform ?
Do weekly sanitization at 65-80Ā°C.
basically WFI loop temperature is maintain 80 to 98 C during operation then 100 C its in vapor so during WFI loop sanitization maintain temperature 121 to 135 Cā¦