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Superior apply would include nominal managing in the part just after washing and prompt sterilization particularly if sterilized by steam. Storing non-sterile wet stoppers could lead to an increase in microorganisms and possibly endotoxin amounts.
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The necessity to validate the dependability and accuracy from the LAL method for every item analyzed can't be above-emphasized. Manufacturers can reveal this by inoculating the merchandise with reduced amounts of endotoxin and assay for his or her recovery. The endotoxin concentrations used really should be within the decreased array of the lysate sensitivity.
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