The most probable number bioburden test method can be a Valuable tool for discovering bioburden counts when the normal bioburden test methods are debatable on a specific product or when a test should detect low levels of bioburden. Frequent bioburden determination techniques utilize the elimination of Microorganisms by elution germs are removed from the item through an extraction procedure i.e., an extraction-based bioburden method. The item is immersed in a sterile fluid and expressed using a vibration method. The solution is then filtered through a 0.45-micron filter that is set on agar; the agar is incubated, and the bioburden expansion is counted. Some goods are not easily extracted, or after extraction, the Extraction solution can’t be filtered or plated. Food and cosmetics are great examples of products which frequently require bioburden counts, but extraction-based methods aren’t possible or feasible for them.
For these kinds of products, the most probable number MPN test is an effective way of determining bioburden testing. The MPN test method also works well for medical device, pharmaceutical, and tissue products which are difficult to extract due to the nature of the goods. The MPN method examines the real product, not an eluent of this Product, by putting the item into liquid growth medium, much like a test of sterility. A recovery efficiency determination isn’t applicable, as the MPN dAAS not involve removal of the bioburden by extraction. The suitability of the MPN method is dependent on demonstrating the ability of the test to detect microorganisms in the presence of the goods. In USP <71> that is known as a method suitability evaluation, also popularly called bacteriostasis/fungi stasis B/F. The method suitability test that is used to qualify an MPN evaluation is done in precisely the exact same fashion as a method suitability test used to qualify a sterility test.
There are assumptions built into the MPN test Method for the product being analysed. 1 These assumptions are applicable to testing of health care products as well. The product bioburden is equally or randomly distributed in or on the item. There aren’t isolated regions of high bioburden in or on the item when a sample thing part SIP of <1.0 is used. High bioburden counts spikes aren’t present on individual product units within batches of product. While being immersed in the press, the press gains access to all areas where germs might live. The existence of one microorganism will bring about visible turbidity. Assumptions 1, 2, and 3 above are significant for Healthcare products as there are occasions when only some of the item is used at the MPN test as opposed to the whole product. If these three assumptions aren’t correct for a specific solution, the MPN test provides erroneous results; either lower or higher than the real value depending on which section of the item was tested.