Items can be sterilized by either destroying the microorganisms (such as using an Autoclave) or by physically removing them (by filtration). According to USP <1229.4> “The physical removal of microorganisms depends on the bioburden of the solution to be filtered, the properties of the solution, the filtration conditions, and the filter itself.” There are a number of factors that contribute to the effectiveness of using filtration for sterilization: the quantity and type of microorganisms in the liquid, what type of liquid, the type of filter along with the membrane material, as well as the parameters put into place for the filtration process.
This chapter in USP goes into detail on various aspects of the filtration concept, including:
- Sterilizing-grade Filters
- Retention Mechanisms
- Nature of Pores
- Nature of Microorganisms
- Composition and Structure of the Filter Matrix
- Composition of the Filtered Solution
- Filtration Conditions
- Filter Efficacy: Log Reduction Value
- Integrity Testing Principles and Methods
- When to Test Integrity
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