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VariClave® Three Phase process was developed to answer multiple issues related to autoclave processing of
Regulated Medical Waste (RMW), particularly treatment efficacy, environmental and workplace safety concerns.
Each Phase of the process addresses one or more of these issues. The variable timers and set points for each Phase
and each Cycle Type have been established by a battery of intensive testing. |
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Phase 1 consists of three parts. The first is a gravity steam portion, whereby steam is introduced into
the chamber by gravity, displacing the air in the chamber and preheating the stainless steel shell and
waste load. This is followed by a steam pressure period, during which the steam pressure in the
vessel is increased to a minimum of 15psig and 250° F. A variable timer maintains this condition for
a period sufficient to kill any airborne pathogens (ABP’s) that may be present. Finally, a vacuum is
drawn on the vessel to remove any tramp air and prepare for Phase 2. This heating and vacuum
regimen is repeated twice for the ‘Red Bag & Sharps’ cycle and three times for the ‘Red Bag &
Suction Canisters’ cycle. These repetitions are necessary in order to effectively compromise the
waste containers allowing for the effective removal of air and subsequent penetration of steam. |
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Phase 2 begins with the processing chamber under vacuum, into which steam is introduced, filling
the chamber and interstitial spaces in the waste. Steam pressure and temperature are maintained at
a minimum of 15psig and 250° F respectively for a residence time sufficient to heat and hold the
waste at 250° F for sterilization. The chamber pressure being vented to atmosphere signals the end
of Phase 2. |
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Phase 3 has been included as part of the cycle to prepare the bins and material to be safely removed
from the chamber. It begins with the operation of the vacuum pump, which removes residual
moisture from the chamber and the waste. After relieving the vacuum, fresh water sprays on the
sides of the bins to cool them for safe removal and eliminate employee related injuries. The cycle
ends with a final operation of the vacuum pump to reset the door seal and remove any moisture
remaining from the cooling water spray. |
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| The Three Phase Cycle with Automatic Variable Parametric Settings results in: treatment of potential airborne
pathogens (ABP’s); effective steam penetration by compromising containment systems; effective sterilization by
varying residence time based on weight and characterization to the load; a cool to the touch bin for safe removal
and elimination of steam plume or odor when the chamber door is opened. |
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