From Wikipedia,
the free encyclopedia
Bioburden or
microbial limit testing is
performed on
pharmaceutical products and
medical products as a
quality control measure.
Products or components used in the
pharmaceutical or medical field
require control of
microbial levels during
processing and handling. Bioburden
or microbial limit testing on
these products prove that the
requirements are met.
Microbial limit testing of raw
material as well as finished
pharmaceutical products can help
to determine whether the product
complies with the requirements of
the BP, Ph. Eur. or USP. Bioburden
testing of components can show the
use of adequate control measures
during the preparation and
handling.
The University of Rochester
glossary states that bioburden is
the number of microorganisms with
which an object is contaminated.
This unit is measured in CFU
(colony forming units) per a gram
of product. In industry the number
of measured CFU should not exceed
an un-processed bulk action limit.
These limits are required by the
FDA and similar regulatory bodies
to ensure the acceptablility of a
drug product. The drug is also
required to be tested as a bulk
drug substance (bds).
Per the FDAs CGMP REGULATIONS
FOR FINISHED PHARMACEUTICALS, 1987
"Appropriate written procedures,
designed to prevent
microbiological contamination of
drug products purporting to be
sterile, shall be established and
followed. Such procedures shall
include VALIDATION of any
sterilization process." (emphasis
added)
