A
new edition of Pharmeuropa 27.3 (July 2015) has been issued. Pharmeuropa is a
free online EDQM publication. Draft monographs are published in Pharmeuropa for
public enquiry, which lasts for three months.
There
is one update of importance:
Chapter
5.1.2 Biological indicators and related microbial
preparations used in the manufacture of sterile products, and indicators for
depyrogenation processes
Revision
of the chapter was proposed because the current text was considered to be
outdated and contained a number of technical shortcomings. The chapter was
completely rewritten and numerous modifications were proposed and the revised
chapter was published for public comment in Pharmeuropa 24.1.
A
position paper on this topic was also published in Pharmeuropa Bio &
Scientific Notes 2011-2.3.
The
Pharmeuropa enquiry generated a large volume of comments on the proposed text
and the Group of Experts with responsibility for the chapter have undertaken to
redraft the chapter to address relevant comments.
The
general changes are:
BIs for sterilisation processes: this section
gives guidance on how BIs are selected and how
they
are used to characterise sterilisation processes. A description is provided of
4 types of BIs for terminal sterilisation processes: inoculated carriers, self-contained
BIs, characterised spore suspensions and custom-made BIs.
Information
regarding the quality requirements for BIs and user requirement specifications
are introduced.
BIs for heat sterilisation: the parameters
of biological indicators for heat sterilisation are
described
and how a validation cycle is established. Further information on biological
validation with reduced sterilisation cycles is included.
BIs for moist heat sterilisation: it is
recognised that Geobacillus
stearothermophilus may not be suitable for sterilisation processes
delivering an F0 between 8 and 15, therefore a different test micro-organism
may be used.
BIs for dry heat sterilisation: description of
the reference conditions and an example of how survivor rates of typical BIs
are affected by temperature variations are given.
BIs for gas sterilisation: this section
sets out that the use of gas sterilisation for disinfection is outside the
scope of the chapter. There are a number of different types of gas
sterilisation process and no reference cycles, therefore no criteria to which
the BIs shall comply have been defined. Suitable micro-organisms for ethylene
oxide sterilisation and an example are given. It is, however, the
responsibility of the user to define the cycle and the suitability of any
biological indicator used.
BIs for ionising radiation sterilisation: this was
deleted from the previous draft (in Pharmeuropa 24.1) but has been reinstated.
Although it is recognised that BIs are not considered to be necessary for
defining the suitability of radiation sterilising cycles, their use may be
required for the development and validation of ionising radiation sterilisation
in specific cases. Information on test micro-organisms is given.
BIs for sterilisation grade filtration: information on
test micro-organisms is now given for the validation of retention of
micro-organisms using a membrane.
Posted by Tim Sandle
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