Parts Cleanliness Testing

Abstract

PartsCleanlinessTestingIn the medical device industry it is becoming increasingly critical to ensure that parts are clean. Infections or rejections due to inadequate or improper cleaning can result in serious health problems, major litigation, and, in some cases, business failure. While a rigorous cleaning method is important, it is also necessary to quantify that the cleaning method was effective. That is, after being cleaned, parts need to be checked to see if particles remain. While there are particle scanning devices to check the cleanliness of flat surfaces, medical devices are complex in shape and do not lend themselves to this technology. Different particle counting methods need to be used for testing the cleanliness of complex parts. When testing the cleanliness of an irregularly-shaped part (and therefore testing the effectiveness of the cleanliness method), all methods follow two steps:

  1. Extract the particles from the device into a liquid.
  2. Test how many particles the liquid now contains.

This article reviews the common techniques used to measure cleanliness of irregularly-shaped parts and discusses the advantages and disadvantages of each.

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