Thursday 30 July 2015

Guidance for Aseptic Transfer Processes

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.

A copy is displayed below.

Posted by Tim Sandle

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