Moist Heat Sterilization

Moist Heat Sterilization

Steam Sterilization

Similar to EO validation studies, appropriate biological indicators can be seeded within medical device or pharmaceutical article samples and exposed to steam for a period of time one-half that which is expected to be used for routine processing. Biological indicators are removed from the samples following exposure and tested for sterility. Negative sterility test results (no survivors) indicate an acceptable routine (full) sterilization cycle with a defined sterility assurance level. Bioburden and Fo –based cycle validation approaches can also be utilized.

Study Outline

These Studies are consistent with ISO 11134 and ISO draft standard 17665.

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