Bioburden Testing

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Bioburden Testing

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• Counts of bacteria, fungi, viruses, and microbial
  residues can be used for various purposes. A
  proper Bioburden Test has several key aspects. It
  is important to understand the Limit of detection
  required to determine the presence of bioburden.
  Sample methods should also be determined, as well
  as the Labor-intensive and cost-effective
  methods. Trending of the data obtained during
  Bioburden testing can be helpful in determining
  the true level of contamination.

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Limit of detection needed for bioburden testing

• Whether the products are used in a manufacturing
  process is subject to bioburden tests. These
  tests determine the presence of aerobic and
  anaerobic bacteria ,mold, spore-forming
  organisms, and yeast. The limits of detection in
  bioburden tests are determined by measuring the
  amount of Gram-stained bacteria or mold in the
  samples. USP 60-62 provides the primary guidance
  for bioburden testing. The cornerstone techniques
  are membrane filtration and pour-plate methods,
  while surface-spread and most probable-number
  methods are also used.

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Methods of obtaining samples for bioburden testing

• Bioburden testing is a critical part of the
  in-process monitoring of pharmaceuticals. It
  detects aerobic mesophilic bacteria and fungi,
  providing a preliminary indication of the final
  product's quality. The data obtained from
  bioburden tests can be used to verify that the
  final product is safe for consumption and reacts
  as it's intended. But how do we obtain samples
  for bioburden testing?

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Labor intensive method for bioburden testing

• In order to protect consumers from contamination,
  food manufacturers are increasingly focusing on
  efficient and reliable bioburden testing.
  Membrane filtration methods have become the
  standard for liquid bioburden testing since they
  minimize sample residue and allow testing of the
  entire volume. Bioburden testing requires
  microbiological recovery. The recovery of
  microbes requires a rigorous process. This
  article will discuss the key steps in the
  bioburden testing process.

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Trending of data is useful

• For example, in the process of bioburden testing,
  it is sometimes useful to look at the trends in
  the results. This can help in detecting changes
  before they become a problem and improving
  manufacturing practices. For instance, if you
  regularly see the same genus and species in the
  data, this would mean a certain pattern in the
  bioburden levels. Trending can also help you
  determine whether your bioburden testing program
  is ineffective or needs to be improved.

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Inexact science of bioburden testing

• Bioburden testing is an inexact science, but some
  methods of the process can still yield accurate
  results. One way to measure how much an organism
  is present is by choosing the appropriate
  parameters for each sample. In most cases,
  bioburden tests require the removal and culture
  of viable organisms, so the results can be only
  as accurate as of the technician's ability to
  collect them. The results of bioburden tests can
  be used to determine the level of a variety of
  organisms on a product, which can include both
  naturally occurring and artificially-introduced
  organisms.

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Importance of Bioburden testing to quality
assurance

• The Importance of Bioburden Testing to Quality
  Assurance is crucial for a number of reasons.
  Bioburden testing is a useful tool for
  determining the microbiological load of a given
  medical device, raw material, or process.
  Bioburden excursions can help pinpoint the source
  of contamination and pinpoint step changes in
  processes or materials that can lead to microbial
  growth. If not conducted properly, bioburden
  excursions can cause serious manufacturing supply
  problems and damage customer confidence.