Validating a filter for microbiology
Reliability implies definition of the principle variables affecting sterilization.
Predictability suggests the ability to forecast assurance of sterility.
Allison holds a Bachelor's of Art degree in English from the University of Nebraska Lincoln, and will be pursuing her MBA this upcoming fall at the University of North Carolina Wilmington.
Additionally, we have an advantage in that we are supporting filter validations for our internal drug products.The test objective of a most severe bacterial challenge to the filter is met by the challenge conditions which include high pressure, high flow rates and a high bacterial concentration per cm of EFA (effective filtration area).The growth parameters, temperatures and media are adapted from the ASTM and HIMA methods.This test allows manufacturers to determine membrane pore sizes and is an excellent lot release test.Test data can also be used as an effective marketing tool.
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In other words, it’s when you have a drug product that it is sterilized by means of a filter.