CSPT Sterilization
Tyvek
A brand of flashspun high-density polyethylene fibers, a synthetic material. The name is a registered trademark of DuPont. The material is very strong, it is difficult to tear but can easily be cut with scissors or a knife.
Ethylene chlorohydrin
A byproduct produced when EO reacts with saline or body fluids.
Ethylene glycol (antifreeze)
A byproduct produced when EO reacts with water. Characterized by the presence of a brown oily film that is poisonous and toxic.
Table-top steam sterilizer
A compact steam sterilizer with a chamber volume no more than two cubic feet that generates its own steam when distilled or deionized water is added by the user.
Maximum, small
A failed ___-load test indicates the sterilization process was not adequate, a failed ___-load test indicates inadequate steam penetration or air removal.
Exception form
A form documenting the premature release of implants before the BI result is known.
Maximum-load test
A test that assesses the sterilizer's ability to sterilize under actual use conditions. Two test containers are placed on each shelf of the sterilizer cart along with other containers or packaged items.
Polyethylene
A tough, light, flexible synthetic resin made by polymerizing ethylene, chiefly used for plastic bags, food containers, and other packaging.
Lot control number
Enables each sterilized device to be tracked, and includes the sterilizer number, the cycle or load number, and the date of sterilization.
Process challenge device (PCD)
Formerly called a "test pack", designed for sterilization monitoring. It contains a BI and/or CI and is designed to be representative of a load.
Neoprene, butyl rubber, nitrile rubber
Glove materials that are EO resistant.
EO
Hydrochlorofluorocarbon (HCFC) and carbon dioxide (CO2) are often mixed with ___ to reduce it's potential for fire or explosion.
Upper, lower
In a mixed load of textile items and metal goods, textile packs or paper-plastic pouches should be placed on the ___ shelfs while metal instruments, basins, and other metal items should be placed on the ___ shelves.
131-140, 24
Incubation of a BI for LTGP and LTHP is at ___°F for at least ___ hours.
Specific test indicators Class 2
Indicators used in certain test procedures, such as the Bowie-Dick test for air-removal performance of prevacuum sterilizers.
Steam sterilization
Sterilization as a product of heat plus moisture, where heat is given up by the process of condensation.
Dynamic-air-removal cycle
Sterilization cycle used in prevacuum and SFPP sterilizers.
Gravity-displacement cycle
Sterilization cycle where incoming steam displaces residual air through the drain at the bottom of the sterilizer chamber. No mechanical air removal.
Immediate-use steam sterilization (IUSS)
Sterilization method used in emergency situations, formerly known as "flash sterilization".
Gravity-displacement
Table-top sterilizers usually have a limited number of cycles, most with "locked-in" cycles, using ___ steam sterilization.
PCD with conventional BI
The BI in this PCD must be incubated for 48 hours after sterilization. Used with 270-275°F dynamic-air-removal and 250°F gravity-displacement cycles.
Permissible exposure limit (PEL)
The amount of airborne EO or H2O2 which personnel are exposed to may not exceed 1ppm as an 8 hour TWA.
Sterilizer access area
The area behind the steam (and sometimes EO) sterilizers, needed by service representatives to gain access to the equipment for repairs.
Time-weighted average (TWA)
The average exposure level over an entire shift of an employee.
Drain line
The coolest part of the steam sterilizer chamber, also where the thermometer is located.
4, 270, 28-30, 3, 275, 28-30
The minimum parameters for dynamic-air-removal cycles: ___ minutes, ___°F and ___psi, or ___ minutes, ___°F and ___psi.
Exhaust phase
The phase of a steam sterilization cycle where steam is exhausted from the sterilizer through the drain.
75-85, 10
The recommended temperature range of the sterilizer access area is ___°F, with recommended ventilation at ___ air exchanges per minute under negative air pressure.
Time, temperature, hydrogen peroxide gas plasma
The three parameters for LTGP sterilization.
Wick
To absorb or draw off liquid by capillary action.
Wet load
When multiple wet packs are found in the same load. May be cause for recalling entire load.
Small-load test
A test that assesses the steam sterilizer's ability to sterilize under worst-case conditions. One test container is placed on the sterilization cart over the drain with no other additional items.
Process indicators Class 1
Also referred to as external CIs. Indicators used to differentiate between packages that have and have not been sterilized. Contains a chemical that reacts to the sterilization process with a color change (e.g. indicator tape).
System 1E liquid chemical sterilant processing
An automated, table-top, microcomputer-controlled device designed to maintain process parameters necessary for standardized and effective liquid chemical sterilization.
97-100%
Ideal range of incoming steam's relative dryness.
Bacillus atrophaeus
The spore used in BI monitoring of EO and dry heat sterilization.
Geobacillus stearothermophilus
The spore used in the BI monitoring of large and table-top steam sterilizers, as well as LTGP, LTHP, and ozone sterilizers.
Dry heat
The sterilization method used mainly for sterilizing powders, oils, and petroleum-based items. It is not widely used otherwise because of it's high temperatures and long exposure times, which can damage devices and packaging materials.
Convection-type dry heat
The sterilization process using a fan to move heat around the chamber, providing for even heating.
Gravity-type dry heat
The sterilization process using gravity to lower heat from the top of the sterilizer to the bottom. Produces greater temperature variations within the chamber.
99
The temperature for incubation of EO BIs is typically ___°F.
68-73, 30-60, 50, 35-60, 50, 10
The temperature of the sterilization area should be between ___°F with relative humidity at ___%, ideally at ___%. If sterilization is performed within the prep & pack area, then humidity range should be ___% with ideal at ___%. ___ air exchanges per hour.
Oxidation
To combine chemically with oxygen. The process used by LTHP, ozone, and dry heat sterilization to kill microorganisms.
Superheated steam
Saturated steam subjected to higher temperatures, occurring when heat is added to dry steam in the absence of water. The steam is "dried out".
Denaturing/coagulating
Saturated steam under pressure kills microorganisms by ___ the protein.
Bowie-Dick test
Used to detect air leaks, inadequate air removal, inadequate steam penetration, and the presence of non-condensable gases. Performed daily for dynamic-air-removal cycles of prevacuum sterilizers.
18, 273, 60, 250
When processing instruments used on suspected CJD patients, AAMI recommends a minimum prevacuum cycle of ___ minutes at ___°F, or a gravity-displacement cycle of ___ minutes at ___°F.
Peracetic acid
A liquid chemical sterilant used in the System 1E system for immersible items at point-of-use.
Implant load
A load that requires a BI PCD containing a Class 5 integrating indicator and that is quarantined until the BI test results are known.
Ozone
A low-temperature sterilization method for heat, pressure, and moisture-sensitive items. A form of oxygen with an extra atom to form O3. Electricity is added to create a higher energy level, giving it an oxidative action.
Wet pack
A package that has visible moisture on the outside, inside, on the instruments, or visible water in the set. It must be completely reprocessed.
Low-temperature gas plasma (LTGP)
A quick, low-temperature process using a combination of hydrogen peroxide vapor and gas plasma to sterilize packaged devices. An alternative to EO gas without the hazards or extended aeration times. A.k.a. STERRAD sterilizers.
Low-temperature hydrogen peroxide (LTHP)
A quick, low-temperature sterilization process that uses vaporized hydrogen peroxide without plasma. It is an oxidizing agent that can be corrosive to device surfaces.
S40
A single-use chemistry labeled exclusively for use in the System 1E system. It's active ingredient is peracetic acid in the inner cup, with dry-powder inert ingredients in the outer cup to minimize corrosion or degradation of the processed devices.
Control BI
An unsterilized BI that is tested in an incubator. Used to verify that the spores are viable before being sterilized, that the incubator can promote growth of test spores, that storage conditions are correct, and that the proper temperature was used for incubation.
Humidity level
Because microorganisms must be hydrated for EO to penetrate the cell walls, the ___ is critical in EO sterilization.
LTGP, LTHP
CIs change from red to yellow for ___ sterilization, and purple to yellow for ___ sterilization.
700ppm
Concentration of EO in the air where it can be detected by odor.
48-72, 4
Conventional BI indicators for EO require ___ hours while enzyme-based early-readout indicators require ___ hours for incubation.
113-131
Depending on the model, cycle temperatures for LTGP sterilizers range from ___°F.
Chemical indicator (CI)
Device used to monitor one or more of the sterilization parameters required for the sterilization process.
3
During a recall, if the sterilization process failure was caused by a sterilizer, it should be rechallenged with a BI PCD in ___ consecutive empty-chamber cycles in the shortest cycle time. Repeat with a Bowie-Dick test afterwards for prevacuum sterilizers.
Prevacuum sterilizer
Dynamic-air-removal sterilizer that removes air by drawing a series of vacuums with an injection of steam between each vacuum pull.
Steam-flush pressure-pulse (SFPP) sterilizer
Dynamic-air-removal sterilizer that uses a sequence of steam injections and pressure at or above atmospheric pressure to remove air. No vacuum required.
Negative, positive
If the color of a BI is unchanged or shown no fluorescence after testing, it is considered a ___ test. If it is yellow or shows fluorescence it is a ___ test.
Higher, shorter
In a steam sterilizer; the higher the temperature, the ___ the pressure. The higher the temperature, the ___ the time.
131-140, 24, 48
Incubation of BIs for ozone are at ___°F for ___ hours at the first reading and ___ hours at the second.
Emulating indicators Class 6
Indicators designed to react to all critical variables of a specified sterilization cycle (e.g. an indicator labeled for use in only prevacuum, express, 270°F, 4-minute cycles).
Integrating indicators Class 5
Indicators designed to react to all of the critical variables of the sterilization process. These parallel the performance of BIs, but should not be used as a substitute.
Multi-variable indicators Class 4
Indicators designed to react to two or more variables of the sterilization process. Most show an acceptable endpoint by a color change.
Single-variable indicators Class 3
Indicators designed to respond to only one variable of the sterilization process (e.g. glass ampule containing a chemical that melts when sterilization temperature is achieved).
LTGP
Items sterilized in ___ sterilizers must be packaged in non-cellulose materials. Cloth, paper-plastic pouches, and cotton can not be used. Tyvek all-plastic pouches and polypropylene-based wraps are compatible materials.
68-79, 4
Ozone sterilization cycles run at ___°F for ___ hours.
Injection phase
Phase in a LTGP cycle where a premeasured amount of concentrated (59%) H2O2 is pumped from the cassette into the vaporizer bowl, then vaporized into the chamber.
Vacuum phase
Phase in a LTGP cycle where air is removed from the chamber until the pressure is reduced below atmospheric pressure.
Vent phase
Phase in a LTGP cycle where radiofrequency energy is turned off and air is vented into the chamber through HEPA filters, returning it to atmospheric pressure.
Plasma phase
Phase in a LTGP cycle where the chamber pressure is reduced by vacuum and radiofrequency energy is radiated within the chamber from the electrode screen. H2O2 is ionized into gas plasma, leading to the formation of oxygen and water.
Diffusion phase
Phase in a LTGP cycle where the chamber returns to atmospheric pressure and H2O2 vapor is driven into the small crevices and lumens of the devices. Inactivation of microorganisms is initiated.
EO
Polyester, polyvinylchloride (PVC), styrofoam, and nylon packaging materials are not recommended for ___ sterilization.
Action level
Set at 0.5ppm as an 8 hour TWA. The level at which additional monitoring and/or other actions must be taken regarding EO exposure.
Excursion limit (EL)
Set at 5ppm as a 15 minute TWA. EO levels measured over 15 minute periods while performing specific activities.
Gravity-displacement liquids cycle
Steam cycle used to sterilize liquids. Uses a slow exhaust to prevent rupture of the liquid container.
Physical monitoring
Sterilization monitoring process involving the observation of charts, gauges, and printouts.
Chemical monitoring
Sterilization monitoring process involving the use of external and internal chemical indicators, and for prevacuum sterilizers, a Bowie-Dick test pack.
Biological monitoring
Sterilization monitoring process used to verify that the sterilization conditions in the load are adequate to kill bacterial spores.
Administrative monitoring
Sterilization monitoring process using policies and procedures.
Biological indicator (BI)
Sterilization process monitoring device consisting of a standardized, viable population of microorganisms (10-6 or one million spores) known to be resistant to the mode of sterilization being monitored.
Ozone
The advantages of ___ sterilization are low cost, no toxic fumes or hazardous byproducts, no disposal costs, low cost per cubic foot of space, and aeration is unnecessary because it uses only oxygen, water, and electricity. The disadvantages are limited penetration and metal corrosion.
PCD with enzyme-based early-readout BI
The original version of this BI PCD provides a final reading 3 hours after sterilization, based on the detection of fluorescence. A new type uses the same technology with a final reading only 1 hour after sterilization. Used with 270-275°F dynamic-air-removal and 250°F gravity-displacement cycles.
Steam jacket
The component of a steam sterilizer that insulates the chamber, provides heat to prevent condensation on the walls, and holds the steam until cycle initiation.
Fluorescence
The emission of radiation, especially of visible light, by a substance during exposure to external radiation, as light or x-rays.
Vacuum, injection, diffusion, plasma, vent
The five phases of a LTGP sterilizer (phases 2-4 are repeated a second time).
Gas concentration, exposure time, humidity, temperature, (pressure)
The four (or five for EO mixtures) parameters of EO sterilization.
Condition, exposure, exhaust, dry
The four phases of a steam sterilization cycle.
Administrative, physical, chemical, biological
The four types of monitoring of the sterilization process.
Sterility assurance level (SAL)
The level of sterility defined by log reduction, i.e. 10-6 equals a 99.9999 % reduction of bacteria, or a one-in-a-million chance a viable microorganism survived.
30, 250, 15, 15-25, 270, 27, 10, 275, 30
The minimum parameters for gravity-displacement cycles: ___ minutes, ___°F and ___psi, ___ minutes, ___°F and ___psi, or ___ minutes, ___°F and ___psi.
Ethylene oxide (EO)
The most stable low-temperature sterilant for heat, pressure, and moisture-sensitive items. It has no restrictions on its use with lumens, complex devices, or packaging materials. Kills microorganisms by an alkylation process.
Dry heat
The packaging material of choice for ___ sterilization is aluminum foil. Glass and metal containers can also be used.
Sterilization phase
The phase in a LTHP cycle consisting of four pulses. A vacuum pulled to a set point, sterilant vapor drawn into chamber, exposure period, filtered air introduced to a set point, another exposure, then a deep vacuum.
Conditioning phase
The phase in a LTHP cycle where the reservoir fills with sterilant and a vacuum pulse removes air and moisture from the chamber. When the set point is reached, the load is tested for moisture content and then dry air is introduced.
Aeration phase
The phase in a LTHP cycle where the system pulls a vacuum and continues to evacuate the chamber for the programmed time until the pressure is at an atmospheric level.
Conditioning phase
The phase of a steam sterilization cycle where air is removed from the chamber and steam is injected, and the packs in the sterilizer are gradually heated by steam.
Drying phase
The phase of a steam sterilization cycle where filtered air is drawn into the chamber, or the chamber walls are heated in order to evaporate the moisture.
Sterilization/exposure phase
The phase of a steam sterilization cycle where the exposure temperature is maintained for the prescribed amount of time.
60-80 psi
The pressure range required in a steam sterilizer.
Alkylation
The removal of hydrogen from the chemical structure of a microorganism. The process used by EO sterilization.
Time, temperature, hydrogen peroxide
The three parameters for LTHP sterilization.
Time, temperature, sterilant concentration
The three parameters for System 1E sterilization.
Saturated steam under pressure, time, temperature
The three parameters for steam sterilization.
Time, temperature, ozone concentration
The three parameters of ozone sterilization.
Conditioning, sterilization, aeration
The three phases of LTHP sterilization.
Routinely, implant loads, qualification testing
The three times a BI should be used in monitoring steam sterilization.
PEL, action level, EL
The three types of limits on employee exposure to EO.
Gravity, convection
The two types of dry heat sterilizers.
Qualification testing
The type of testing performed when a sterilizer is installed, relocated, malfunctions, or when the sterilizer or its utilities have a major repair.
6
There are ___ classes of chemical indicators.
1
There should be a ___ inch space between each container as well as the chamber wall to permit air removal and steam penetration, and to prevent scorching of packaging material.
270-275, 3, 4, 3, 10
Typical IUSS cycles are ___°F and either ___ or ___ minutes for dynamic-air-removal or ___ or ___ for gravity-displacement.
122, 12, 130, 10, 140, 8
Typical minimum aeration times and temperatures for EO sterilization are ___°F for ___ hours, ___°F for ___ hours, or ___°F for ___ hours.
131-140
Typical temperature range (Fahrenheit) for incubation of BIs.
