Another method for sterilization is vapor phase. USP <1229.11> addresses this subject, starting out by saying “Sterilization can be accomplished using sporicidal agents suspended in air (i.e., vapor). Sterilizing agents that operate in this fashion include hydrogen peroxide (H2O2), peracetic acid (CH3CO3CH), formaldehyde (CH2O), and glutaraldehyde [CH2(CH2CHO)2] in aqueous solution.” One difference between this method and the others we have discussed is that surfaces must be exposed to the greatest extent possible. Key parameters in for vapor phase sterilization includes: sterilant amount, relative humidity and temperature.
According to UPS, “Efforts to develop a standardized biological indicator for vapor systems have been hampered by the multiphasic nature of these sterilants.” When selecting a biological indicator to use for your system, you must experiment with, and then prove that, the BI selected is appropriate for your use. The concentration, humidity level, temperature, substrate, and phase must be well-define prior to implementation.
The two most common vapor phase sterilizing agents are hydrogen peroxide and peracetic acid. This section goes into further detail on these two agents, as well as validation of vapor sterilization and routine process control.
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