The Harmonized Microbial Limits Test (MLT) is used in The United States, Europe and Japan as the primary biological release test for non-sterile solid oral products intended for human use. This standardization has largely improved the work flow of products in a global market, and made it easier for laboratory specialists in different countries to resolve compliance issues when they arise Key wordsīioburden, bacteria, fungi, compendia, non-sterile Introduction Prior to 2009, there were variations of the test in different countries which required re-testing when a given product was sold in a country different from the country that the product was originally tested in. The test was “harmonized” in 2009 and as such certain aspects of the procedure were changed to accommodate a global testing requirement.
This test has its origins in the middle part of the 20 th century when final product coatings and manufacturing facility controls were being recognized as important in the pharmaceutical industry, but were in their infancy in terms of sophistication. These products are manufactured and sold worldwide as non-sterile formulations. The Harmonized Microbial Limits Test is a compendia method used by commercial and clinical/developmental laboratories to evaluate the bioburden of solid oral dosage formulations such as pills and tablets.
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