Examples of USP in a sentence
This CRM may be used in connection with EPA Methods 6010, 6020 (all versions), Standard Methods 3120 B and USP <232> / ICH Q3D.
During processing devices such as Sterile Sodium Chloride 0.9%, USP and Sterile Water, USP both for wound irrigation various compounding tanks can be used.
For example, your validation for Sterile Sodium Chloride 0.9%, USP (b)(4) used only the (b)(4)L compounding tank, and lot/batch number ANR/F11110 used the (b)(4)L compounding tank.
We note that two of your compounding tanks use air sparging and one compounding tank uses an agitator for compounding the Sodium Chloride 0.9% USP.
USP <797> states “All high-risk level CSP’s, except those for inhalation and ophthalmic administration, that are prepared in groups of more than 25 identical individual single-dose packages (e.g., ampuls, bags, syringes, vials) or in MDVs for administration to multiple patients or that are exposed longer than 12 hours at 2° to 8° and longer than 6 hours warmer than 8°before they are sterilized shall be tested to ensure that they do not contain excessivebacterial endotoxins.