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This ITG will give attention to the importance and interpretation of pyrogen/endotoxin tests. Also resources and ways of depyrogenation are going to be mentioned. The restrictions of the rabbit pyrogen exam must be regarded when examining methods through inspections of sterile drug and device companies.

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For instance, if a product is formulated and filtered ahead of a closing sterilization, microbiological testing of the Bio-load immediately after filtration will present some beneficial information with the dedication of your adequacy of the sterilization process. Having said that, it is going to give very little, if any, details pertaining into the adequacy of the process with regard to reducing endotoxin contamination. Considering that endotoxins outcome from superior levels of microorganisms, and therefore are not taken off by sterilizing or microbiological filters, the next reduction of a significant microbiological amount won't be connected with the same reduction of higher endotoxin stage.

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Given that RO filters aren't complete, it might be important to have them in sequence in order to manufacture pyrogen-no cost WFI. Whichever system is employed, superior follow would include the opportunity to isolate and evaluate every bit of equipment in a very WFI program. Confer with ITG No. 36, dated ten/21/80, for the dialogue of Reverse Osmosis.

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