Membrane Filtration Membrane filtration is preferred over direct inoculation for several reasons. The method does not depend on product type, container volume or concentration of microorganisms to provide a statistically valid sample. With membrane filtration the entire volume can be filtered, which captures all the microorganisms present, removes product components that could cause the growth medium to appear turbid and can decrease the inhibition of microorganism growth due to anti-microbial agents in the product since they are filtered away during this method. The nature of the membrane filter method reduces operator handling, which decreases the likelihood of accidental contamination. Please refer to that chapter for specific details.
Prevention demands strict aseptic procedures and conditions.
Detection of breakdowns in the aseptic process requires a valid method of sampling and testing the prepared products. Corrections are actions taken based on a preset plan, which depends upon the results of the detection portion of your program. Before you can detect product contamination through sample testing, you need to determine which samples to test and how many to test. Recent guidelines may dictate a fixed number to test, but that number may not have statistical significance to your own production. A statistically valid sampling plan confirms the level of quality you want to achieve.