Some terminologies are not so commonly heard among the general public although they have a rather important application in our daily lives. Bioburden testing is one of these terms. So what exactly is bioburden testing and why do we need to know about it? Bioburden testing is an important practice that is applied to almost every field of life having a direct link with living beings. It is a process in which levels of microorganisms like bacteria or fungi are measured on or inside a product to ensure quality control. Without its application, germs and harmful bacteria can spread and cause illness leading to severe infections.
Why is Bioburden Testing Used?
Bioburden test serves a variety of purposes and the relevance of its outcomes can vary from insignificant to critical depending on the type of product or device to be tested for quality assurance. It is important to mention here that a bioburden test alone may not serve as the solution but it determines the types and levels of viable microorganisms that can be traced on a particular device. Some situations in which bioburden testing is effectively applied and used include determining the efficiency of cleaning processes, environmental monitoring and evaluation, quality control of raw materials, components and packaging materials, routine quality control check of manufacturing processes and validating sterilization processes.
After the test is carried out, the appropriate method for the removal of viable microorganisms is applied. The method used to obtain the samples for the bioburden test is also an influencing factor in the process. The most commonly preferred method is to get random samples because these samples can be selected from the routine production of products or devices. The selected batch of samples should undergo all the steps involved in the manufacturing process except sterilization. An important tip while choosing the right sample is to remain as clean as possible to save any false interpretations during the test.
There are several removal methods that are used for this purpose under different environments and parameters. Some of the removal techniques are listed below:
Total Aerobic Count
Total Yeast and Mold count
Spore-forming Colony Count
Most Probable Number method
Vortex mixing method
Agar overlay technique
Where is it Applied?
Bioburden testing is most commonly used in medical devices and products, pharmaceuticals, laboratory equipment, and other instruments which require sterility from microorganisms. The testing method can vary depending upon the device or equipment to be tested. Before the bioburden test is carried out, a suitability test is performed to see if the parameters to be applied in the actual test are suitable for efficient results. A recovery factor is taken into consideration based on the outcome of the suitability test to ensure a successful bioburden test.
Bioburden testing is vitally important as it falls under the laws of quality control bodies and compliant with ISO 11737 standards. If you are a manufacturer or have frequent interaction with medical devices, you can seek the services of a professional testing lab for bioburden testing and sterilization of the manufactured products.