Process development and validation

Release time：2016-12-06

　　In industrial steam sterilization, the overkill method is generally employed for setting and applying the sterilization cycle. The objective of the overkill method is to ensure a specified level of sterility assurance, regardless of the actual bioburden of the load or the thermal resistance of the microorganisms present. It is assumed that the bioburden and thermal resistance are at the following levels:

　　It is rare to find naturally occurring microorganisms with a D121 value exceeding 0.5 minutes. The overkill method assumes a higher bioburden and greater resistance than are actually encountered. In fact, most microorganisms exhibit lower heat resistance, thereby enabling a very high degree of sterility assurance.

　　Even when the overkill method using steam–moist heat is employed, periodic monitoring of the initial microbial load of the product and regular biologic indicator testing are still required.

　　Certain auxiliary materials used in the production of injectable preparations come into direct contact with the drug product during manufacturing and therefore also require sterilization. These include filters, rubber stoppers, elastomeric tubing, workwear, stainless-steel equipment, components of filling machinery, cleaning agents, and the like. Sterilization is typically achieved by direct exposure to saturated steam, with the thermal energy of the moist heat being transferred via conduction or convection. A common approach is to establish a standard sterilization cycle that provides an equivalent assurance level, supplemented by an appropriate safety margin, regardless of the nature of the load.

Pressure steam sterilization is a widely used method.

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