#1: "Bioburden" is determined on NONsterile solutions and suspensions.
STERILE solutions have sterility tests done on them, which tend to take 2
#2: For the solutions BEFORE they are filtered and filled, or filled and
sterilized, or whatever, I have used membrane filtration methods, with or
without rinses (0.1% Peptone water or PBS)- the MilliFlex system is one
we have used successfully, or simple manifold methods. The direct
pour-plate method is also done for un-filterable suspensions. All of
these provide an answer in 3-5 days. There are "rapid" methods out there,
many of which have been validated for specific applications by companies,
which will provide answers in hours, but validation is the key to these.
Hope this helps some.
M. Carroll ([log in to unmask])
On Wed, 30 May 2001 10:35:59 +0200 Clare MacLeod <[log in to unmask]>
> I would like to benchmark bioburden (total viable count)
> methods (specifically methodologies and equipment) used in the
> pharmaceutical industry for sterile solutions and suspensions in
> containers eg bags, vials and ampoules.
> Relating to the equipment I am looking for information on where
> equipment can be purchased and how rapid the bioburden results are
> available as well as the accuracy of these determinations.
> Thanx Clare MacLeod
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