USP 71 - Sterility Testing of Pharmaceutical Products

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USP 71 Sterility Testing

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• For sterile pharmaceutical formulations, medical
  devices, and radiopharmaceuticals, USP 71 is a
  crucial GMP Microbiology testing requirement.
  When sterile materials are used on patients, this
  sterility test is used to make sure that they are
  free of any living organisms.
• When bacteria, viruses, yeasts, and fungus are
  completely absent from a sample, it is said to be
  sterile. Products are sterilized during the
  production process to preserve product quality
  and prevent microbiological contamination.
• For patient safety, sterility testing of
  pharmaceutical and biopharmaceutical products is
  crucial. Products are not deemed sterile if they
  promote microbial development in any way. Hence,
  USP 71 aims to encourage effectiveness and
  creativity in the creation of sterile products.