The term bioburden is used to describe the concentration of microorganisms in a material; this may be either a total number of organisms per millilitre or per gram, regardless of type, or a breakdown into such categories as aerobic bacteria or yeasts and moulds.
BIOBURDEN
DETERMINATIONS
The term bioburden
is used to describe the concentration
of microorganisms in a material; this may be either a total
number of organisms
per millilitre or per gram,
regardless of type, or a breakdown into such categories as aerobic bacteria or yeasts
and moulds. Bioburden determinations are normally
undertaken by the supplier
of the raw material,
whose responsibility it is to ensure
that the material supplied conforms to the agreed
specification, but they
may also be checked by the recipient. The maximum permitted
concentrations of contaminants may be those specified
in various pharmacopoeias or the levels established by the manufacturer
during product development.
The level of sterility assurance that is achieved in a
terminally sterilized product
is dependent on the design of the sterilization process
itself and on the bioburden immediately prior
to sterilization. However,
the adoption of high standards for the quality of the raw materials is not, in itself, a strategy that will
ensure that the product
has an acceptably low bioburden immediately
prior to sterilization. It is necessary also to ensure that
the opportunities for microbial contamination during manufacture are restricted (see
below), and that those
organisms that are present initially do not normally find themselves in
conditions conducive to growth. It is for these reasons that manufacturing processes are designed to utilize adverse
temperatures, extreme pH values and
organic solvent exposures in order to prevent an increase in the microbial load. For example, water
is the most common, and potentially the most
significant, source of contamination in the manufactured product, and maintenance of water at elevated
temperatures is commonly employed
as a means of limiting the growth of organisms such as Pseudomonas
spp., which
can proliferate during
storage, even in distilled or deionized
water. Precautions such as these
ensure that
chemically synthesized raw materials have bioburdens
that are generally much lower than those
found in ‘natural’
products of animal, vegetable or mineral origin.
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