What Is Bioburden Testing

Bioburden is the population of viable microorganisms in or on a product, water, or raw material. Bioburden test determines the number of these microorganisms present, reported as colony forming units (CFU).  

 

Bioburden Testing for Medical Devices at Sanichem Resources

SaniChem offers a few variations of bioburden test methods to suit customers' requirements. These follow the accredited in-house method MB-BIOBURDEN-1 which is based on ISO 11737-1:2018. We conduct medical device tests for customers from all over the world such as Malaysia, Singapore, Thailand, Vietnam, Philippines, Saudi Arabia, United Arab Emirates, Pakistan, Egypt, Kenya and more.

     

Bioburden and Related Tests.​

1. MB102a - Determination of bioburden by membrane filtration (aerobic bacteria + yeast & molds) - 3 parameters

2. MB102b - Total aerobic and anaerobic bioburden by membrane filtration method - 5 parameters

3. MB102c - Total anaerobic bioburden by membrane filtration method

4. MB102d - Determination of bioburden of liquid samples by pour plate method (aerobic bacteria + yeast & mold) - 3 parameters 

5. MB102e - Total aerobic and anaerobic bioburden by pour plate method

6. M102f - Correction Factor determination for bioburden - repetitive extraction

7. MB102g - Correction Factor determination for bioburden - inoculation method

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