EFHSS Questions and Answers - Question Q00619

I am working with a pharmaceutical company having about 1600ltr.capacity dryheat sterilizer and operated at 200 degree cel for 120min.For taking care of the above parameters we set the sterilization temperature at 210degree cel.
Will somebody help me decide whether the sterilization cycle to be considered right from the temperature reaches to 200 degree cel.or it has to be considered from after getting equilibrium phase and temperature of 210 degree.

Hi.
The sterilization parameters (Temperature & time) shall be based on an accepted Pharmacopea (India, European, American, etc.)

Such a Dryheat Sterilizer must be equipped with a fan which is responsible to provide an homogenous temperature in the sterilization space.
The temperature sensor, or Thermostat bulb must be located in a place that present the most appropriate temperature.

Now, prepare a Table that compares: The set point / Thermometer temperature / Measured temperature in the Sterilizer. Example: When the Thermostat knob is set to 210 (not degree, just 210), and the Thermometer shows 207, the actual temperature in the Sterilizer is 200C (degrees)

You can use of course the Australian Standart AS 2487, American ANSI/AAMI ST-50, UK's HTM 2010 and others as Guidance.

miki