| 摘要 |
<p>The present invention provides a method of sterilizing a pharmaceutical composition, the method comprising providing a sterilization system including heat exchanger means for elevating and then lowering the temperature of the fluid in a time period; measuring temperature at an input of the heat exchanger means, measuring temperature at an output of the heat exchanger means and measuring temperature at least one point in the heat exchanger means intermediate to the input and output; calculating a coefficient of heat transfer for the sterilization system using the temperature measurements; calculating a degree of sterilization (Fo) using the coefficient; and adjusting the temperature of the heat exchanger means to minimize degradation of the pharmaceutical composition while maintaining an acceptable degree of sterilization.</p> |
