The
NHS Pharmaceutical Micro Protocols Group has produced some very detailed and
careful piece of work, led by Tim Sizer and Mark Oldcorne, in relation to the Aseptic
Transfer Processes and the use of sporicidal disinfectants.
From
the findings of the work of the Micro Protocols Group, the most important thing
to note is that the presence of any viable organisms in the Grade A
environment, and bacterial spores in particular, poses a very real risk of
contamination for aseptically prepared products and a significant potential for
patient harm.
In
practice, with the diligence of operators, the use of ‘closed systems’ and the
application of good technique, the likelihood of product contamination is low,
but the consequences can be severe.
The
Micro Protocols Group has concluded that it is necessary for all NHS aseptic
units to heed the warnings and apply the MHRA Guidance, improve technique and
incorporate additional measures to enhance the sterility assurance of aseptic
preparation.
The
key points are:
The
main document is “Guidance for Aseptic Transfer Processes in the NHS:
Addressing Sporicidal Issues”. This Yellow Cover Document explains the need,
outlines the risks and points the way to best practice. There are also tables
of the available products, stability considerations and health and safety
issues. The chemistry is also explained.
Posted by Tim Sandle
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Pharmaceutical Microbiology Resources