Introduction To Ethylene Oxide (EO/EtO) Sterilization
Introduction toEthylene Oxide (EO/EtO) Sterilization
About Ethylene-Oxide EO is a gas that is 1.5 times heavier than air and tends to settle along the floor. At concentrations below 500 ppm, EO is colorless and odorless. At concentrations above 500 ppm, EO has a sweet, ether-like smell. EO vaporizes at 51 F (10.7 C).Common UsesChemical Intermediate (99%)Fumigant/Insecticide6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012Steriliant (0.1%)www.madgetech.com
EO/EtO SterilizationAdvantages DisadvantagesMaterials sterilized with EO are not exposedto damage from excessive heat, moisture, orradiation. Therefore, a wide variation ofmaterials, particularly plastic componentscommonly used in medical devices, are ableto be sterilized with EO.Products that are already packagedfor shipment can be sterilized, sinceEO will permeate sealed films andcartons.EO is highly diffusible and willpenetrate areas not reached byliquid or steam. EO/EtO is considered a carcinogen and can beharmful to people. There are more process variables to controlthan with steam or radiation. Cycle monitoring often requires more attentionthan heat or radiation processing. Residual levels of ethylene oxide and ethylenechlorohydrin may be present after EOsterilization and must be evaluated by thedevice manufacturer to assure they meetpredefined maximum limits. Ethylene oxide is extremely flammable and canprovide its own oxygen in the absence of air.6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
Material CompatibilityMaterialSteam SterilizingResponseRadiation SterilizingResponseEthylene OxideSterilizing ResponseDry Heat GoodGood-Acrylonitrile butadiene styreneVariesGoodVaries-High-density olyethylenePoorGoodGood-Polyglycolic acidNoNoGood-Polymethyl penteneGoodPoorGoodOK, no loadPolypropyleneGoodVariesGoodOK, no loadPolypropylene and polyethylene copolymerGoodGoodGoodOK, no dYesPolyurethanePoorGoodGood-Polyvinyl chlorideVariesVariesGood-Polyvinylidene fluorideGoodGoodGood-SiliconeGoodGoodGoodLow temp.TeflonVariesNoGoodOK6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
Conventional EO Sterilization PhasesEnvironmentalPreconditioningPhase 1EO/EtO ProcessingPhase 26 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012AerationPhase 3www.madgetech.com
Environmental PreconditioningPurposeTo provide the bacteria with an ideal growingenvironment so that endospores will becomeexposed to the ethylene oxide. The endosporeconsists of the bacteriums DNA.Preconditioning Monitoring Requirements Attainment of minimum temperature inpreconditioning room prior to product entry Temperature and Humidity levels in preconditioningroom throughout this phase Length of time product is in preconditioning room Preconditioning room to sterilization chambertransfer timeIntrinsically Safe data loggers are required for monitoring6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
Conventional EO Sterilization PhasesEnvironmentalPreconditioningPhase 1EO/EtO ProcessingPhase 26 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012AerationPhase 3www.madgetech.com
EtO / EO Processing StepsInitialEvacuationAir EtORemovalEO/EtOInjection& Dwell6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
EtO / EO Processing – Steps 1 & 2Initial Evacuation & Nitrogen Dilution Removes at least 97% of the oxygen from thesterilization chamber. There are two methods of accomplishing this: Allows the process to be performed below theflammability limits of EO.Pull a deep vacuum (1-2 inHgA).Perform a series of “shallow” vacuums followed bynitrogen injections (known as nitrogen dilutions ornitrogen washes).8OOxygen15.99The nitrogen dilution consists of injectingnitrogen and immediately removing it from thechamber. This helps in the removal of oxygen.7NNitrogen14.0076 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
EtO / EO Processing – Step 3 & 4Conditioning Heat and humidify the sterilization load Replacing moisture lost during initial evacuation and nitrogen dilution steps.Static Conditioning (most common) Steam is injected and maintained at a predefined pressure.Sterilant (EO/EtO) Injection & Dwell Introduces the validated sterility assurance level of EO to the sterilization load. Sterilant is injected into the sterilization chamber to a pre-determined pressure. The sterilization load dwells(exposure to the sterilant) for a specified amount of time.6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
EtO / EO Processing – Step 5, 6 & 7Sterilant Removal & Nitrogen Washes Removes ethylene oxide from the sterilization chamber andproduct packaging Accomplished by performing a series of post-exposurevacuums, each followed by a nitrogen injectionAir In-bleed Brings the sterilization vessel to atmospheric pressure(so the sterilizer doors can be opened) In-bleed filtered air into the sterilization chamber6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
EtO / EO ProcessingChamber Monitoring Requirements Temperature and Pressure levelsthroughout cycleEvidence of gaseous EO Gas circulation duringexposure Exposure time EO pressure and volumeConditioning Humidity levels RH by pressure or directConditioning Time6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
Conventional EO/EtO Sterilization PhasesEnvironmentalPreconditioningPhase 1EO/EtO ProcessingPhase 26 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012AerationPhase 3www.madgetech.com
AerationHeated AerationHeated air is continuously circulated through theaeration area and residual gases are removed viaan abatement system to eliminate remaining EOfrom the sterilization load.Aeration Monitoring Requirements Temperature levels in Aeration Cell Pressure level changes Operation of the air supply and circulation6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
Variables that Impact LethalityThe four primary variables in the EO/EtO sterilization process are:TemperatureHumidityGasConcentrationGas ExposureTimeThe set points for these variables are established during process, development and validation.6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
Variables that Impact LethalityTemperature The higher the temperature, the higher the lethality of the cycle. Q10 Effect: For every 18 F ( 10 C) increase, lethality doubles. Heat is transferred to the sterilization load duringpreconditioning and conditioning via a controlled steam process. The sterilization vessel temperature setting will also affect theheat transfer to the sterilization load.Common range: 120 F to 135 F( 48 C – 57 C).Humidity Moisture is not only helpful in the transfer of heat to theproduct, but it also aids in the absorption and desorption ofEO/EtO into and out of the product/packaging. Moisture is transferred to the sterilization load duringpreconditioning (if utilized) and conditioning via a controlledsteam process.6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012Common range:30 %RH – 80 %RHwww.madgetech.com
Variables that Impact LethalityEO Gas Concentration The gas concentration should be enough to sterilizethe product, but not enough to create EO and ECHresidual problems. The concentration of gas may be calculated usingthe ideal gas law (PV nRT)Common range:400 – 800 mg / LGas Exposure Time The exposure time should consider the time it takes for the gasto penetrate into all areas of the devices and themicrobiological kill time. The duration is determined at the cycle design/developmentstage. It can be based on a D-value study or on the experience of thesterilization scientist6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012Common range:3 – 5 hourswww.madgetech.com
The MadgeTech SolutionData Loggers and Secure Software for EO/EtO SterilizationThe MadgeTech 4 Secure Software contains criteria suchas electronic signatures, access codes, secure data files, andan audit trail which meet the requirements of 21 CFR Part 11and help provide data integrity. As a requirement forgood manufacturing processes, MadgeTech’s SecureSoftware is an essential tool.MadgeTech provides data logging solutions fortemperature & humidity monitoring. Thesesolutions are intrinsically safe and designedspecifically for use in EO/EtO environments.Free support is provided to ensure users feel comfortableand confident using the MadgeTech system.For a complete EtO data logging system, the following is required: Data loggers such as the RHTemp1000IS and Temp1000IS IFC400 and/or IFC406 Computer MadgeTech 4 Secure Software6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
The MadgeTech SolutionEtO Sterilization Process OverviewUnits are placedthroughout andaround the pallet orload to measurestratification1.Data Loggersare placedwhere theyare needed2.Cycles areRunNo wires – Completelyself-sufficient. Loggerscan record through theentire sterilization cycle3.Data isDownloadedAfter each EO cycle, data is retrieved tovalidate temperature and humidity overtime using MadgeTech 4 Secure Software6 Warner Road, Warner NH 03278 P: (603) 456-2011 F: (603) 456.2012www.madgetech.com
MadgeTech Customer SupportMadgeTech data loggers come with a one year manufacturers warranty.Free support available for the lifetime of the product.Contact Information:Phone: 603-456-2011Fax: 603-456-2012Email: info@madgetech.com
Data Loggers and Secure Software for EO/EtO Sterilization The MadgeTech 4 Secure Software contains criteria such as electronic signatures, access codes, secure data files, and an audit trail which meet the requirements of 21 CFR Part 11 and help provide data integrity. As a requirement for good manufac
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