Critical Process Filtration Blog

Extractables and Leachables, these terms are a part of the manufacturing process of new medicines and other areas of such. These terms are very commonly misunderstood by one another and they both gave their distinct characteristics, which can be traced through the whole supply chain.  The definitions of these are not balanced. They overlap and have different utilization, and situations in the manufacturing process must be categorized to highlight the weight and necessity of both extractables and leachables.

DEVELOPMENT, SCALE-UP, AND VALIDATION OF PHARMACEUTICAL FILTRATION PROCESSES Our Technical Service Team performs application testing for a wide variety of fluids from water to complex chemical solutions. No matter what industry the customer is part of, we carefully document our test results and make recommendations based on those results. We get it right the first time.  For pharmaceutical applications, whether removing particles from ingredients entering the plant or sterilizing parenteral products, the testing and documentation we routinely create help show the consistent performance required for validation of the process.

While filter ratings are an important indication of how well the filter will remove particles of varying sizes from a fluid or gas, it is important to note that nominally rated filters from different manufacturers can have the same rating, but yield different results. The opposite is also true – nominally rated filters from different suppliers can have different ratings, yet yield the same result. Naturally, this can create confusion and impact your filter buying decisions. When these situations arise, we recommend that focusing on achieving the targeted performance of a filter over the rating will yield the best results. With that in mind, let’s start with differentiating between the two types of ratings that indicate pore size and efficiency in removing particulates -- Nominal and Absolute ratings.