FDA guideline on aseptic processing states that " Endotoxin on equipment
surfaces is inactivated by high-temperature dry heat, or removed from
equipment surfaces by validated cleaning procedures."
Does this imply the requirement of performing a formal cleaning validation
by sampling surfaces and look for endotoxin ? Which is a typical recovery
rate using swabbing/rinsing methods ? Should this recovery used in
calculations and setting of acceptance criteria (as per chemical residues) ?
Thanks in advance,
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