glove disinfection validation Contribution from Th Mikosch written on 10/1/2005 at 10:27
In a production facility for a biopharmaceutical API "open" manipulations are performed with gloved hands. Do the agencies expect firms to demonstrate efficacy (validation) of EtOH used for glove disinfection. The gloves used are packed sterile . Would validation require same strategy and acceptance criteria as for surface disinfection (USP 1072)? Answers to this contribution:
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19-20 June 2013 