USP : New Standards Related to Sterilization and Bioburden Control

The 1229.x-series of general chapters are intended to provide valuable information and guidance about processes for sterilization. Of these chapters, three will be official in 1S to USP 36 (August 2013):

<1229>Sterilization of Compendial Articles,
<1229.1>Steam Sterilization by Direct Contact
<1229.2>Moist heat Sterilization of Aqueous Liquids
While <1229.3> Bioburden Monitoring
is currently proposed in PF (Pharmacopeial Forum), several more are being proposed in PF for public comments:

<1229.4> Sterilizing Filtration of Liquids
<1229.7>Gaseous Sterilization
<1229.8>Dry Heat Sterilization
<1229.10>Radiation Sterilization
<1229.4>Sterilizing Filtration of Liquids

Vapor phase sterilization is a complex process with chemical and physical attributes that make validation a ‘not so simple’ activity. Along with the development of a new USP chapter about vapor phase sterilization,<1229.11>.