Pulsating vacuum sterilizer is strictly designed and manufactured in accord with GMP technical Standard. has been certified compliant with the ISO 9001 standard and the ISO 13485 standard. Moreover, the sterilizers presented here are designed and manufactured in compliance with China Pressure Equipment Directive – GB150.
Sterilization, i.e., the exposure of the product to a constant temperature, is the most critical phase of the entire process and is adjusted on the basis of the pressure of the pure steam measured inside the chamber by a pressure transducer, with constant monitoring of the temperature.This type of control is based on the principle that the pressure of water steam, in saturation conditions, has a one-to-one correlation to its temperature, according to the values stored inside the process controller.The advantage of this control principle is that while the pressure inside a closed vessel, such as the chamber of a sterilizer, is always uniform and therefore pressure measurement is independent of the location of the sensor, the temperature, depending on various conditions and characteristics of the machine, may vary over a relatively wide real tolerance range (although this is not always noticeable by analyzing the process documentation).Another advantage of pressure-control is that, thanks to the features of the process controller software, the appropriate programming of the controller allows to immediately detect abnormal operating conditions, if the steam is not in saturation conditions. The sterilization process adjusted in this manner is therefore monitored by Pt 100 (RTD), one of which is installed in a fixed position at the drain trap of the chamber, which is theoretically the coldest point of the chamber.
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