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December 2003

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Subject:
From:
Boschi Francesco <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 17 Dec 2003 11:14:20 -0500
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text/plain
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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,
Francesco
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