Method of sterilizing a pharmaceutical composition

Details Method of sterilizing a pharmaceutical composition Method of sterilizing a pharmaceutical composition

1994-10-31

1997-02-18

Warden, Robert J.

Chemical apparatus and process disinfecting, deodorizing, preser

Process disinfecting, preserving, deodorizing, or sterilizing

Using direct contact with electrical or electromagnetic...

422 38, 422111, 422308, 426521, 99483, A61L 204, A23L 3005

Patent

active

056038941

ABSTRACT:
The present invention provides a method and apparatus for sterilizing a pharmaceutical composition, the method comprising providing a sterilization system including a heat exchanger for elevating and then lowering the temperature of the fluid in a time period; measuring temperature at an input of the heat exchanger, measuring temperature at an output of the heat exchanger and measuring temperature at least one point in the heat exchanger 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 (F.sub.o) using the coefficient; and adjusting the temperature of the heat exchanger to minimize degradation of the pharmaceutical composition while maintaining an acceptable degree of sterilization.

REFERENCES:
patent: 4534986 (1985-08-01), Hasting
patent: 4990347 (1991-02-01), Rasmussen et al.
patent: 4994291 (1991-02-01), Swartzel et al.

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