Apr 01, 2021 General

Bioburden Testing for Medical Device Review

Bioburden is the people of viable Microorganisms on or in a product. Bioburden test determine the amount of those microorganism’s present, reported as colony forming units. A knowledge of bioburden can be used in a number of scenario as a part of.

  • Validation and revalidation of sterilization procedures
  • Routine Monitoring for management of manufacturing processes
  • Monitoring of raw materials, packaging or components
  • Assessment of the efficacy of cleaning processes
  • An overall environmental monitoring programs

ISO 11737-1 define requirement and Provided guidance for the enumeration and microbial characterization of the populace of viable microorganism on medical devices. The ISO 11737-2 document explain detail process in conducting bioburden testing on medical devices from choice of merchandise samples and proper way of bioburden determination to microbial characterization of bioburden. Additionally, it describe the validation of the bioburden method emphasizing on the extraction efficiency correction factor determination either by repetitive extraction or inoculation procedures. Samples of merchandise to be tested should be representative of production batches. The number of samples required to provide a reliable bioburden estimate BE will be based on the aim of the bioburden enumeration. Generally, for regular bioburden test for QC monitoring requires between 3-10 samples chosen randomly.

Bioburden Testing

For sterilization validation, gamma sterilization need 10 samples from 3 distinct batches for a total of 30 samples, while for EO sterilization, 10 samples have been analysed. For large samples, sample in percentage SIP may be use where representative areas of the apparatus are taken in parts and the SIP ratio is calculated and utilize in the final calculation of ordinary BE. Various techniques of Dislodging the viable microorganisms in the samples may be utilized including stomaching, ultrasonication, mechanical vibration, vortex mixing, flushing as well as mixing if possible. The options of extracting fluids can also be recommended from sterile water to sterilized solution of surfactants such as polysorbates. There should be a balance between extracting the germs aggressively without killing the viable microbes. The efficacy of extracting the microbes in the medical device may be determined as part of the validation protocol in bioburden test. Repetitive recovery or repetitive extraction ought to be conducted to obtain the correction factor that is used to compensate for the extraction efficiency.