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The Importance Of Bioburden Testing

Liquid dropping from pipette into test tube lineup.

Bioburden testing is a critical component for medical device manufacturing to ensure the safety of the product and the user.

Why Is Bioburden Testing Important?

Bioburden testing occurs just before the final sterilization process for a medical device or product and measures the level of contaminants present on the piece.

Bioburden testing is of the utmost importance because it provides insight into the level and intensity of sterilization needed and informs the choice of sterilization method. The final sterilization process is the last barrier of protection before the device reaches patients and users and is the most critical step in keeping unwanted contaminants from causing harm. Bioburden testing and proper sterilization are especially important in the medical industry, where patients are vulnerable to infection or illness.

Infographic provided by Technical Safety Services

What Does Bioburden Testing Tell Us?

The results of bioburden testing provide key information for a number of different uses and applications. These include:

Bioburden testing can be used for a broad cross-section of contaminant types, including:

What Is the Bioburden Testing Process?

The bioburden testing process involves several steps, each of which must be followed in order to ensure the accuracy, validity, and effectiveness of the process. These steps are:

Bioburden testing may also be carried out via the most probable number (MPN) method, where the sample is monitored in a controlled environment for a seven-day incubation period and contaminant growth levels are measured.

It is also important to note that while bioburden testing should always be carried out as the last step before the terminal sterilization process, it can also occur at any other point in the manufacturing process—for example, if the integrity of the manufacturing setting is called into question.

Bioburden testing can be useful in several different areas of the medical device manufacturing process, including:

See the accompanying resource for even more details about bioburden testing applications and procedures.

ANAB Laboratory Related Accreditation

Please note that the information included in this resource and in this post does not reflect the requirements for ANAB accreditation. To learn more about various laboratory related accreditation programs, please see below:

ANAB Laboratory Accreditation

ANAB Accreditation for ISO/IEC 17043 Proficiency Test Providers

ANAB Accreditation for ISO 17034 Reference Material Producers

Contributing Author: Steve Gonzales, CEO, Technical Safety Services

Steve Gonzales is CEO of Technical Safety Services, which provides testing, certification and calibration of equipment and controlled environment crucial to the success of the biopharma, medical device, academic research and food production industries.

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