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Sterile Filtration

Meaning

Sterile filtration is a critical pharmaceutical manufacturing process that involves passing a liquid preparation through a membrane filter with a defined pore size, typically 0.22 micrometers or smaller, to physically remove all microorganisms and particulate matter. This technique is used to sterilize heat-labile compounded hormone solutions, such as certain injectable peptides or hormone solutions, which cannot withstand terminal sterilization by heat. It is a method of choice for preparing compounded sterile preparations where the active pharmaceutical ingredient would be degraded by autoclaving. The integrity of the filter must be verified before and after the process to ensure absolute sterility.