Steris VHP X10, Operator'S Manual

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Terms, Definitions and Symbols Operator Manual 10087252
2.1 Terms and
Definitions
Aeration – Final phase of a Biodecontamination Cycle. Allows for re-
entry into treated, sealed Enclosures once the Sterilant concentration
levels are at or below permissible levels. Typical H
2
O
2
concentration
≤
1 PPM.
BI – Biological Indicator used for Biodecontamination Cycle
evaluation. Typically E6 Geobacillus stearothermophilus is used.
Biodecontamination 1 – Third phase of the Biodecontamination Cycle
or the obtaining of bioburden reduction targets in a sealed Enclosure.
Biodecontamination Cycle
1
– Represents the complete process
(Biodecontamination) from start to finish which may include
Dehumidify, Condition, Biodecontamination and Aeration phases.
Biodecontamination Unit – STERIS X10 ™ Biodecontamination Unit.
Catalytic Converter – A component of the Biodecontamination Unit
utilizing a catalyst to degrade H
2
O
2
into water vapor and oxygen.
CI – Chemical Indicator used for Biodecontamination Cycle validation
and Sterilant mapping.
Condition – Second phase of the Biodecontamination Cycle. Sterilant
is added to the sealed Enclosure to reach the target concentration
needed for the Biodecontamination phase.
Cup – Vaprox
®
59 Hydrogen Peroxide Sterilant container, 70 mL.
Dehumidify – First phase of the Biodecontamination Cycle. Achieves
temperature and humidity conditions necessary for subsequent
Biodecontamination phases.
Enclosure – Contained area to be Biodecontaminated (e.g., Class II
Type A2 Biosafety Cabinet).
FMP – Fumigation Management Plan. 2
HMI – Human Machine Interface (such as the control display).
H2O2 or H
2
O
2
– Hydrogen peroxide.
I/O – Input/Output.
PLC – Programmable Logic Controller.
1
When using STERIS X10 Biodecontamination Units with Vaprox 59 Hydrogen Peroxide Sterilant in the United States, the term
Biodecontamination referred to in this Operator Manual is defined as Sterilization of exposed porous and non-porous surfaces in a precleaned,
dry, sealed Enclosure. Any reference to Biodecontamination as it relates to the use of this equipment in the United States does not impart
additional claims of effectiveness beyond that approved in the EPA registered labeling of Vaprox 59 Hydrogen Peroxide Sterilant for use on
precleaned, dry, exposed porous and non-porous surfaces in a sealed Enclosure.
2
Guidance for developing a suitable Fumigation Management Plan can be found in STERIS publication (P129383-938) or searching EPA
website (epa.gov) for the key words ’Vaprox Package Insert.’
Continued ...
TERMS, DEFINITIONS AND SYMBOLS
2