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For parenteral products and solutions, inspections have proven that in which pyrogen issues were located in dosage varieties, and when the source was among the Uncooked products, it absolutely was the active drug substance. This was significantly genuine for drug substances wherein approach h2o was applied at some late stage while in the synthesis process.
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Given that RO filters usually are not absolute, it could be needed to have them in sequence to be able to manufacture pyrogen-free WFI. Whichever procedure is utilized, excellent practice would come with the chance to isolate and Assess each bit of equipment in a WFI process. Consult with ITG No. 36, dated ten/21/80, for your discussion of Reverse Osmosis.
There may be quite a few sources of pyrogens in parenteral and medical product merchandise. Typical sources are: the h2o employed given that the solvent or inside the processing; packaging factors; the chemical substances, Uncooked components or machines Utilized in the preparing with the solution.}