Understanding Bioburden Testing

I’m sure you must be wondering, what exactly is bioburden? And why should I understand bioburden testing? Bioburden testing is imperative to many fields and practices and without it, illness can spread and causes severe infections, and even death. [bctt tweet=”Bioburden testing is necessary and critical for many therapeutic and medical devices.” username=”novalabstx”]

What Is Bioburden?

Bioburden is a term used to describe the microbial numbers, or bacteria, present on a surface that has not been sterilized. Bioburden can be found on all surfaces, but medical devices, pharmaceuticals, and other instruments are regulated and rely on bioburden testing in order to save lives.

What is Bioburden Testing Used For?

The bioburden test is used to indicate problems in the manufacturing process that can lead to inadequate sterilization. Bioburden testing is performed on many pharmaceutical and medical products for quality control. In fact, many medical products, as well as new drug products, require this testing in order to measure the total number of micro-organisms before the product is used or ingested. Bioburden testing is used in situations such as:

  • Validation of sterilization process
  • Routine monitoring for control of manufacturing processes
  • Monitoring of raw materials, components, and packaging
  • Assessment of the efficiency of cleaning processes
  • An overall environmental monitoring program

Removing Microorganisms

Once bioburden testing is complete and has been validated, the correct method of removal will be performed. Removal methods include techniques with and without elution, as well as incubation and enumeration, and are determined through the validation process.

Removal techniques by elution include:

  • Ultrasonication
  • Shaking
  • Vortex mixing
  • Flushing
  • Blending

Removal techniques by non-elution include:

  • Contact placing
  • Agar overlay
  • Most probable number (MPN)

Incubation and enumeration techniques include:

  • Total aerobic count
  • Spore-forming colony count
  • Total yeast and mold count

Understanding Bioburden

Bioburden testing helps provide an accurate basis for calculating effective sterilization and provide the number of viable microorganisms on a medical device, or raw material. Bioburden is an important part of quality control and in determining the bioburden of a given device.

To learn more about understanding bioburden testing, Contact Us.

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