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ental ssessment October 2010 Dental Sterilization Solutions y Avi Cohen – Head of Medical Solutions, Objet Geometries Ltd Abstract • hemical sterilization This whitepaper describes the different sterilization • adiation sterilization methods and technologies currently available in today’s dental equipment sterilization market with Common High Temperature Sterilization observation to apid rototype models ocus is A. Steam Autoclave given to the more common sterilization methods team autoclave is the oldest safest and most used or available for dental equipment in hospitals cost effective method of sterilization in the medical and clinics today t the end of the paper there equipment industry The steam reaches 1211° is a conclusion and table which summarizes the 2000° in the pressure chamber at 1 The common sterilization methods i sterilization sterilization period is dependent on the temperature methodsproducts were isolated and ranked and size of load and can range from 100 minutes based on their sterile efficacy and applicability to medical instruments and apid prototype models onfigurable cycles allow the user to customize the sterilization cycle for items such as hard items terilization means the use of a physical or chemical wrapped items liquids in vented containers waste procedure to destroy all microbial life including highly and glassware resistant bacterial spores The fastest steam sterilization used is flash sterilization acterial spores are the most resistant of all living and it can be accomplished using either gravity organisms because their capability to withstand displacement or prevacuum cycles t is generally destructive agents lthough the chemical or physical a highspeed steam sterilization of an unwrapped process used to destroy all pathogenic microorganisms instrument or device for to 10 minutes in 12° including spores is not absolute when all parameters saturated steam of the sterilization process have been met instruments This type of sterilization is only intended for use supplies and equipment are thought to be sterile in hospital operating rooms for urgently needed equipment n obect should be sterilized depending on its intended use ritical obects those that enter sterile tissues or the n the steam autoclave process microorganisms are vascular system or through which blood flows such as killed by heat and this is accelerated by the addition of implanted medical devices require sterilization before moisture team by itself is not sufficient for sterilization atmospheric is needed use and pressure that is greater than tems that touch mucous membranes or no intact skin to increase the temperature of steam for thermal destruction like endoscopes respiratory therapy equipment of microbial life and diaphragms require highlevel disinfection Solutions: which would not be discussed in this whitepaper team autoclave is used mostly for surgical instruments terilization falls into the following three categories This method is not well suited for heat sensitive materials • igh temperaturepressure sterilization and instruments any surgical instruments are not designed to withstand sterilization safest fastest and least epensive and tO prolonged heat and moisture of the steam sterilization gas sterilization which leaves toic residuals t is a low process This leads to alternative sterilization categories temperature nontoic but fairly epensive sterilization chemical sterilization and radiation sterilization which method n this process hydrogen peroide is activated allow heat and moisture sensitive materials to be sterilized to create a reactive plasma or vapor The terrad system is a ydrogen eroide as lasma Common Chemical Sterilization terilization system with an operating temperature range A. Ethylene Oxie EtO as of 0° Operating cycle times range from 0 minutes depending on size of system thylene Oide gas was introduced in the 10’s and This sterilization system uses a combination of hydrogen it is an effective low temperature chemical sterilization peroide and low temperature gas plasma to quickly method t also takes longer than steam sterilization sterilize most medical instruments and materials without typically 11 hours for a complete cycle Temperatures leaving any toic residues terilization by this method reached during sterilization are usually in the 00° occurs in a low moisture environment range The ydrogen eroide lasma rocess using terrad thylene oide tO is a chemical agent that kills The process consists of two consecutive and equal microorganisms including spores tO gas must have sterilization phases direct contact with microorganisms on the items to be sterilized ue to tO being highly flammable and ¡acuum replasma tage eplosive in air it must be used in an eplosionproof • ¢hen a low pressure is achieved in the vacuum stage sterilizing chamber in a controlled environment low temperature air plasma is generated This helps in tems sterilized by this process must be packaged with removing residual moisture from the chamber The system wraps and be aerated The aeration time may be long is then vented to atmospheric pressure at the end of this and is needed to make sterilized items safe for handling stage and patient use terilization tage • ressure in chamber is reduced and an aqueous n general tO gas is a reliable and safe agent for solution of hydrogen peroide is inected and vaporized sterilization when handled properly into chamber Solutions: • The hydrogen peroide diffuses throughout the chamber surrounds the items to be sterilized and starts tO is used to sterilize items that are heat or moisture the inactivation of the microorganisms sensitive isadvantages of tO gas are that it can leave • fter the pressure is reduced applying radio frequency toic residues on sterilized items and it possesses several energy creates an electric field and thus forms low physical and health hazards to personnel and patients that temperature plasma merit special attention • ree radicals are generated in the plasma by breaking ince tO poses several health hazards there are apart the hydrogen peroide vapor Once the activated currently two alternative technologies that are currently components react with the organisms available terrad a plasma phase hydrogen peroide and kill them they lose their high energy and recombine based sterilizing agent and teris a per acetic acid based to form oygen water vapor and nontoic byproducts technology • This is half of the total sterilization process The other half of the cycle is completed by repeating the above . Sterra o Temperature Hyrogen eroxie sterilization steps lasma • t the completion of the second half cycle the source ow temperature plasma sterilization was introduced to of energy is turned off vacuum is released and fill the gap between autoclave high temperature steam chamber is returned back to atmospheric pressure by introduction of filtered air toicity concerns olutions This system is best suited to sterilize heat sensitive medical Solutions: equipment such as endoscopic equipment ¢ith two This solution is frequently used on surgical cameras systems terrad provides sterilization solutions for both endoscopes The item to be disinfected must be smaller and larger olutions thoroughly cleaned and dried before immersion fter immersion the item must be rinsed thoroughly with sterile C. Steris System Sterile rocessing System water prior to use The teris ystem is another more common low .. Common aiation Sterilization temperature sterile processing system t uses the teris A. amma eta Sterilization 20 terilant oncentrate that combines peracetic acid a rradiation is an effective sterilization method but it chemical biocidal agent and a proprietary anticorrosion is limited to commercial use only The product to be formulation to kill microorganisms at low temperature The sterilized is eposed to radiation for 10 to 20 hours process is achieved at a temperature of depending on the strength of the source The highest 0° temperatures reached in gamma sterilization are usually The teris 20 terilant oncentrate is mied with sterile 00° amma radiation is popular for sterilizing water to create the solution that flows into the sterilization before shipment and it can be done through the chamber The sterilization time is 12 minutes packaging This is followed by repetitive sterile water rinses to complete the process The entire process is completed in The principal sources of ionizing radiation are beta less than 0 minutes for a standard cycle particles and gamma rays eracetic acid by itself is an oidant and disinfecting eta particles free electrons are transmitted through a agent for liquid immersion highvoltage electron beam from a linear accelerator These highenergy free electrons will penetrate into matter t maintains its effectiveness when high levels of organic before being stopped by collisions with other atoms This debris are present t is an acetic acid plus an etra means their usefulness in sterilizing an obect is limited by oygen atom that reacts with most cellular components to the density thickness of the obect destroy cells and by the energy of the electrons These free electrons produce their effect by ionizing the atoms they hit Solutions: producing secondary electrons that kill microorganisms Only immersible instruments can be used with this method obalt 0 is a radioactive isotope capable of breaking and only a few instruments can be sterilized at one time down to produce gamma rays amma rays are £o packaging required electromagnetic waves that have the ability to penetrate a much greater distance than beta rays before losing ide O olution – lternative to lutaraldehyde their energy from collision ecause they travel with ide® O olution is a igh evel isinfectant the speed of light they must pass through a thickness for use in reprocessing heat sensitive medical devices measuring several feet before making sufficient collisions ide O olution provides highlevel disinfection in 12 to lose all of their energy minutes at room temperature 20o and is particularly active against mycobacteria olutions ¥ O olution has the broad materials compatibility The radiation can change the properties of some of glutaraldehyde requires no activation and has minimal materials like plastics and have adverse affects on glues odor The ide O or adhesives olution is replacing ide and ide lus due to their s you can see each of the si common methods ¡ eries discussed above have their advantages and ¡ ¡aporized ydrogen eroide eries disadvantages terilization ystem for edical evices is yet another low temperature sterilization system t is different from Other terilization ethods the terrad system in that it only uses hydrogen peroide n this section the other less common sterilization methods in vaporized form for sterilization while the terrad are described These methods are either eisting being system uses replaced by new sterilization or are still in development vaporized hydrogen peroide to initiate the sterilization 1 Other igh Temperature terilization and then plasma to complete the sterilization process ry eat n the ¡ process hydrogen peroide vapor is inected into the chamber via a series of pulses to sterilize This process is conducted at 1010° for a minimum of packaged medical and diagnostic devices The cycle two hours ue to its high temperatures its applicable use time is 2 hours and the operating temperature ranges is limited from 00° ry heat in the form of hot air is used primarily to sterilize £ote This system is large capital equipment that uses anhydrous oils petroleum products and bulk powders hydrogen peroide On the other hand that steam and ethylene oide gas cannot penetrate n teris orporation’s other product the teris ystem 1 is the absence of moisture higher temperatures are required a portable tabletop system that than when moisture is present because microorganisms uses peracetic acid as the sterilant and it is used to are destroyed through a very slow process of heat sterilize equipment right before use absorption by conduction 2 Other hemical terilization hlorine ioide lutaraldehyde ide lus¦ and ide¦ hlorine ioide is a chemical liquid sterilization • ide lus olution is a disinfectant that is used to process The best operating temperature range for this disinfect medical instruments process is 20° while using low concentrations of lO2 The process requires hours of contact time to t is a § alkaline glutaraldehyde solution which has achieve sterilization The presence of organic matter tuberculocidal and highlevel disinfection capabilities t reduces activity processor converts a compound of achieves highlevel disinfection in 20 minutes at dilute chlorine gas with sodium chlorite to form lO2 2° and has up to a 2day reuse life gas and this gas is then eposed to the equipment in a • ide ctivated ialdehyde olution is used to disinfect sterilizing chamber medical instruments and endoscopes This solution can Ozone also be used in an automated reprocessor glutaraldehyde Ozone sterilizes by oidation a process that destroys solution which has tuberculocidal and highlevel organic and inorganic matter t penetrates membrane disinfection capabilities t achieves highlevel disinfection of cells causing them to eplode n this process a in minutes at 2° and has up to a 1day reuse life generator is used to convert oygen to ozone as a oth have been used as a cold liquid highlevel to 12 percent concentration of ozone continuously disinfectant for heat sensitive equipment flows through the chamber Ozone penetration is £ote ide glutaraldehyde products are being controlled by vacuum pressure or by adding humidity withdrawn from the uropean market due to concerns fter the process is complete oygen is allowed to that it is toic and harmful to health care staff in hospitals flow through the chamber to purge the ozone The lso the ¨ market is requiring glutaraldehydefree cycle time may be up to 0 minutes depending on the chemical solutions which led to the formulation of the size of the chamber or load of items to be sterilized ide O solution ue to ozone gas being corrosive and it being able to damage moisture sensitive equipment or models there
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