Following a series of patient deaths in 2014 linked with Bacillus cereus infections (MHRA, 2014)
and observations of practice and microbiological monitoring made during audit processes; a reconsideration of aseptic transfer processes became necessary. This guidance aims to review
some of the current incremental changes to the standards relating to the transfer disinfection process
for aseptic preparation or manufacture.In particular, to address the key issues that relate to the introduction of an addition step and the routine use of sporicidal agents.
The use of operator dependent wipe-spray transfer disinfection techniques has been recognised as one of the weakest links in the aseptic process. In response to this, a number of amendments have been proposed by the MHRA in their Guidance for Specials Manufacturers, January 2015 (commonly referred to as the MHRA Q&As).