USP <1229> - Sterilization of Compendial Articles

What it says

This general information chapter introduces the principles of sterilization of compendial articles, including the concepts of a sterility assurance level and the use of biological and physical indicators, and points to a series of related chapters covering specific methods such as moist heat, dry heat, gas and radiation.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It gives a common vocabulary for how a sterilization process is defined and shown to be effective.
• Sterility is shown through validated process lethality and routine control, not through finished product sterility testing alone.
• It sits beside USP <1211>, which addresses sterility assurance more broadly.

What inspectors look for

• Whether sterilization processes are validated with appropriate biological and physical evidence.
• Whether routine cycle records show the process stays within its validated parameters.
• Whether revalidation occurs after changes to loads, equipment or cycle parameters.

Related regulations