IT

Bioburden testing is often achieved employing a number of techniques supported the medium to be tested. However, most of the commonly used methods might not be the simplest fit sensitive products like powders, gels or adhesives like wound dressings. Typically, this is often due to the physical nature of those medical products that traditional extraction or filtration techniques are difficult to perform to realize the specified results. to make sure internal control over such products, another suitable method referred to as Most Probable Number (MPN) is performed. this system is useful in achieving a more sensitive level of bioburden detection because the bioburden is often trapped in areas where it's difficult to get rid of by extraction.

How MPN Method Works?

To remove bioburden from medical products using the MPN method, the merchandise is placed into a liquid growth medium in 10-fold dilutions supported the principle of extinction dilution. The assumptions of the MPN method are that the liquid growth medium will support the expansion of microorganisms and can turn the medium turbid. the extent of the medium’s turbidity can give information about the presence of viable organisms within the sample. All the tube samples are analyzed for turbidity and therefore the trend is measured against a table of values (US Food and Drug Administration’s Bacterial Analytical Manual). A typically used MPN design compares three replicates with a three-log unit. The pattern is then examined through the table to offer the foremost probable number.

Where is it Used?

The MPN method is often utilized in various scenarios where other methods of bioburden testing cannot perform efficiently. MPN is applied in medical devices, delicate adhesives like bandages or gauzes, tissue-based products, pharmaceuticals, powders and gels. As stated in ANSI/AAMI/ISO 11737-1:2006®2011, “The MPN method may have value for the determination of bioburden for liquid medical devices, viscous fluids, powders or in situations where the bioburden is being estimated during a liquid used as an eluent for one product”.

Implementation and Acceptance

The MPN method may be a highly effective technique utilized in bioburden testing by microbiologists. However, it's vitally important to ascertain if the tactic is performed correctly to realize the results from a particular sample. If the MPN method isn't administered correctly, it can't only affect the standard check measures of the merchandise, but also can cause problems for a medical device manufacturer supported the standards of respective regulatory bodies.

There are many other products manufactured by pharmaceutical companies that need the MPN method to see the bioburden levels because these products can't be tested appropriately applying other bioburden testing techniques. At an equivalent time, it's valuable to make sure the presence of knowledgeable microbiologists to carefully observe the test process ranging from initial sampling to achievement of desired results.

By now, we've established the importance of bioburden testing and its various methods that are used for quality check a spread of medical devices and products. to urge the simplest lab testing results for your medical devices, you'll get the services from experienced professionals having appropriate knowledge and every one the fashionable equipment to offer you the simplest results.