Cleaning Installations, Sterilization by Steam and VHP

Further more some technical prerequisites must be fulfilled  

The sterilization process consists of three phases, as shown in Fig. 2.46  

Nakahari [2.11] describes, on the basis of his experience with VHP , the advantages of this process a short sterilization time at room temperature, the possibility to update existing plants, VHP does not - compared with ethylenoxide and formaldehyde - affect the health of the operators and can be decomposed to water and 02 without contaminating the atmosphere. 

Steam sterilization is at presenzt the most used method [2.15] for freeze drying plants. It requires a temperature of +121 °C for 10 to 30 min, and thus the plant must be pressure-tight up to 2.5 bar. 

The rules of steam sterilization are well described [2.15], including some guide-lines for the validation of the sterilization process. The special problems with the steam sterilization of closing systems for vial stoppers has been discussed above. Similar problems 

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