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This ITG will concentrate on the importance and interpretation of pyrogen/endotoxin testing. Also sources and ways of depyrogenation will be talked about. The limitations from the rabbit pyrogen examination needs to be regarded when examining units throughout inspections of sterile drug and unit manufacturers.
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For physical factors, for instance stoppers and tubing, rinsing or dilution with pyrogen-free drinking water techniques is most frequent. Some manufacturers, including LVP producers, are using dilution to eliminate endotoxin from glass containers which can be then sterilized by other usually means. As with validation for sterility, validation for endotoxin reduction should involve a knowledge of the endotoxin burden as well as a satisfactory endotoxin challenge.
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There is certainly some concern that there can be some pathogenic gram negative organisms, for example Legionella pneumophilia, that can endure and increase at fifty seven C. There may be considerable information on the existence of L. pneumophilia in hospital hot drinking water units. Literature has proven that periodically boosting the temperature of these very hot h2o methods to seventy five - eighty C has eliminated the organism.
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Some companies have occasionally resorted to fewer satisfactory solutions including washing or rinsing the crystal or powder with a solvent in an effort to remove endotoxins.}