Bioburden Testing

What it is
Bioburden testing is performed to determine the number and nature of microorganisms on a product prior to sterilization.

Why you need it
Any sterilization process can kill only a finite number or organisms. Monitoring the bioburden in advance ensures that the challenge to the sterilization process is not too great to maintain an assurance of sterilization efficiency.

Bioburden testing can also assist in monitoring the entire manufacturing process, from raw materials through clean room procedures.

How it is done
In most cases, bioburden is removed from a sample by rinsing with a sterile liquid in a controlled environment. Microorganisms are then retrieved from the liquid and incubated on a growth medium.

Several bioburden testing options are available from SteriPro® Labs. Choosing the one most suitable for a precise need is determined by a number of factors:

  • raw materials
  • components
  • manufacturing environment
  • processes involved
  • intended use of the finished product