Review on Bioburden Studies on Medical Devices

  • Dhruti Mehta Geetanjali Institute of Pharmacy, Geetanjali University, Udaipur-313002, India
  • Devender Sharma Goenka College of Pharmacy, Sikar, Rajasthan-332315, India

Abstract

Producing safe products is a core goal of all medical device manufacturers and sterility assurance is a key component in achieving that goal.  Many single use medical devices are terminally sterilized by ethylene oxide or radiation methods such as gamma or e-beam.  The FDA and other regulatory bodies requiring that the sterilization process be validated and these validations typically require a bioburden and sterility testing.  Sterility testing and bioburden testing are also performed on devices as part of routine quality control. By conducting this test on medical device we can assure the in-house sterility; during production, packaging (primary and secondary) and dispatch. To avoid the any error or contamination attacks on the product.


Keywords: Bioburden, Medical Device, IUD, Sterility

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How to Cite
1.
Mehta D, Sharma D. Review on Bioburden Studies on Medical Devices. JDDT [Internet]. 18Dec.2019 [cited 24Oct.2020];9(4-A):887-96. Available from: http://www.jddtonline.info/index.php/jddt/article/view/3774