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Tuesday, May 2, 2017

What is your risk in increasing endotoxin levels due to the different sanitization methods? FAQ @ USP

  1. Endotoxin levels are typically a concern only for WFI systems. Most WFI systems are sanitized by elevated temperatures (hot water is better than steam since no special engineering is needed for hot water sanitization and it is plenty adequate), though more may employ ozone in the coming years as ambient non-distillation purification technologies become more widespread with EP’s relaxation of the methods of preparing WFI in their WFI monograph. 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 sanitised, there is a chance that developing biofilm could release detectable endotoxin when killed by periodic sanitization.
  2. If chemical sanitizers other than ozone are used (this would be very atypical for a WFI system or an endotoxin-controlled Purified Water system), the sanitizer would have to be rinsed out, which would also rinse out any released endotoxin.

Source: USP
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