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AssigneeAustrialian Biotechnologies PTY. Limited
InventorsSimon Jonothan Berry, Sharon Bryce, Jerome Alon Goldberg
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A Method Validation Unit (MVU) for the evaluation of the level of sterilisation in a sterilisation method involving the use of a fluid at or near the supercritical pressure and temperature for that fluid, wherein the MVU comprises a sterilisation indicator housed within a gas-permeable container, wherein the sterilisation indicator comprises an indicator medium and a population of one or more colony forming units (CFUs), and wherein the indicator medium comprises one or more structural features representative of the internal structure of a material to be sterilised in the sterilisation method.
A Method Validation Unit (MVU) for the evaluation of the level of sterilisation in a sterilisation method involving the use of a fluid at or near the supercritical pressure and temperature for that fluid, wherein the MVU comprises:
A MVU kit for use in the evaluation of a sterilisation method, the kit comprising:
A sterilisation method comprising bringing a MVU and a material in need of sterilisation into contact with a sterilant fluid, the sterilant fluid comprising a fluid at or near the supercritical pressure and temperature for that fluid, and wherein the MVU is useful in evaluating the level of the sterilisation in the sterilisation method.
A pre-treatment method, wherein a material in need of sterilisation is pre-treated with a SCF, or wherein the material in need of sterilisation is pre-treated with a SCF and wherein that SCF is SCCD.
Dependencies are inferred from the claim text.