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State Of Illinois Radiation Machine Registration Form Demand Assistance

one and welcome to part one of our tech.team webinar series on the basics of.gamma irradiation today's webinar.focuses on the language of sterilization.my name is Sarah Crowell and I'm the.marketing manager at stereo supplied.sterilization technologies I'll be the.host for today's event.Betty Howard is for today's webinar.Betty is the gamma tech team manager.force Terris ASP managing technical.support and validation activities for.gamma sterilization Betty has over 20.years experience in biotechnology.research applications and technical.support relating to drug discovery.analytic instrumentation microbiology.biochemistry and sterilization.technology we would like to encourage.everyone to submit questions at any time.during the webinar today once the.presentation is completed Betty will.answer the questions in the order they.were received you can submit your.questions by typing them in the.questions field on your GoToWebinar.control panel if you have a question.that we don't answer in the time.allotted we will address it separately.in an email following the webinar.today's presentation will be recorded.and we will email all participants a.link to view the recording on our.youtube channel please note that.continuing education credits are not.provided as part of this webinar series.and now I'd like to turn the phone over.to Betty to begin the presentation thank.you all for attending today's webinar.our basic overview Sara gave you of what.we're trying to achieve but what we're.really going to talk to you today this.is the first of a three-part series that.we wanted to gradually bring people who.are new to the radiation field up to the.level of understanding the key pieces.that they need to know almost.immediately which are dose setting and.studies of those distribution many times.very very smart people use very very.complex ways of explaining stuff that.somebody who's very new to something.they don't necessarily understand the.actual words they're using or the words.may mean something completely different.to them so what we're going to start out.with.this week's seminar which will be very.low-key you know you won't be stressed.mentally what we're going to do is we're.going to talk a lot about the words we.use when we're describing all of the key.features of the process and of the dough.setting and testing that's done with.radiated products on the floor first.seminar today we're going to do a lot of.all the words so there may not be a lot.of questions but any questions you have.please feel free to do them and we're.going to set you up so that when we're.doing dose setting next week which there.will probably a lot of questions we're.all going to be talking with the same.words and we can pass through some of.the slides very quickly so that we can.get more information done okay now we're.going to start off with the dry part but.the really important one we're going to.start talking about all the letter.acronyms we use some of the terminology.we use and give you a flavor for where.we're coming from and why these things.are important to you I'll start off the.first slide the main reason you're doing.this in most cases is because you are.required to do it there are regulatory.agencies there are standards there are.guidelines you're required to follow.let's start off with some of the names.of those groups and organizations that.become critical to what we do and why we.do it.the FDA Food and Drug Administration is.a u.s. organization there are similar.agencies just like them that exist in.every country their purpose is to assure.that products are safe and effective for.their intended use and since.sterilization is such a critical.component of any health care product.oversight by agencies such as these.assures that the process is carried out.properly and it's documented you're.going to find that word documented used.many many times because that's critical.to you have a product out there that has.an ongoing process there has to be.records for why things were done and how.they were done so that you always know.if you are meeting the expectations of.all of your regulations and requirements.the second acronym we use is the letters.AAMI which we pronounce as Amy.frequently say Amy.says this or Amy says that many of you.may if you're not familiar with Amy.might you know have a friend named Amy.or know somebody you work with and.wonder why Amy is requiring you to do.things but in this case amy stands for.the Association for the Advancement of.medical instrumentation they develop and.publish guidance documents Amy.standards in the radiation field for.Dell setting and such are the most.frequently reference documents worldwide.they provide not only those setting.information but a great deal of.information on microbiological testing.materials guidance and they do this in.many different healthcare fields not.just the radiation process ISO.international standards organization.refines and reviews guidance in these.documents for international use and.provides the assurance that what we're.doing in the u.s. is also what is being.done in other countries as well so.between Amy and I so you'll find the.standards we're going to refer to in.great varieties are almost always listed.as both an ISO and an Amy document.because it is the same document okay Oh.what sorry about that people the next.one is ASTM American Society for testing.materials provide critical standards on.calibration use testing to assure the.measurement of absorbed dose at least.for our purposes they also do many other.things these preceding organizations.also and there are additional codes out.there and regulatory groups that are at.the national or local level that is sure.that your sterilization process is.carried out properly to assure that your.product is being delivered and.documented to an end-user with the right.and safe expectations it is always going.to be critical to know and stay current.with all the regulatory requirements of.your product your industry and each of.the specific regulatory agencies that.govern your product and how it's being.used okay.additional of the alphabet soup of.letters that we we tend to just drop.when we're talking on the NRC the.Nuclear Regulatory Commission in the US.the IAEA the International Atomic Energy.Commission OSHA for safety of our.operations and the EPA sometimes we.forget about these but whatever we're.doing just as when you're making a.product all of these requirements exist.for how we run our business in addition.to the naturally high level of.operational excellence and focus on.safety in the irradiation industry as a.whole these additional agencies provide.oversight to assure we're operating.safely consistently and can deliver.appropriate doses when needed for.sterile products let's start out with.what actually is doing the sterilization.when we're talking about irradiation for.the vast majority worldwide of products.that are gamma radiated the source.material used is something called cobalt.60 cobalt 60 is the radioactive is a.radioactive isotope used to provide the.gamma rays needed to sterilize your.product for the sake of what we're.talking about we want to say that a.gamma ray is also sometimes called a.photon so whenever if I use either terms.assume I'm talking about gamma radiation.on your product cobalt-60 the symbol for.it when you see it in publications will.be that little 6e little oh it's a.little sixty above it the reason it has.60 is that it contains in its nucleus.thirty-three neutrons and twenty-seven.protons and if you add those two.together you get sixty cobalt 60 is very.interesting material how we get it and.how we get enough of it to use for.industrial applications is that it is.sourced in most cases as cobalt 59 which.is naturally-occurring.the ore of it is refined to produce a.metal that can be exposed to a severe.bombardment with neutrons requiring.specialized equipment to do that for the.purpose of trying to get an additional.Neutron shoved into the nucleus of that.cobalt 59.when you do that you change that number.of particles in the nucleus and it then.becomes cobalt 60 cobalt 59 is very.stable cobalt 60 is not but we like the.fact that it's unstable because the end.result of it being unstable is that in.nature everything wants to move to.stability the act of that cobalt 60.going to a more stable state gives us.what we need those gamma rays or photons.so that we can sterilize your product.specifically the end process you start.out with cobalt 60 and what we'll end by.the time it's not in a steady state and.stable again it will be nickel which is.normal the normal atomic number for.nicholas 60 an electron will be emitted.and most importantly for our discussion.to separate energies levels photons of.gamma rays one at 1.17 and the other at.1.33 MeV and MeV is a measure of the.energy that they have in those photons.the other nice thing about cobalt 60 is.it has a reasonably long half-life of.5.26 years I have life we mean the.amount of time that that radioactive.energy will decay to half its normal.amount so it will take five and five and.a quarter years that have half as much.activity on our source over time it's.also a nice predictable number which.means we're pretty much losing the.activity on it about one percent per.year we use that information to always.have a good idea of how much activity we.have at any given time and predict how.long your product is going to need to be.in the irradiated.it's very important to mention here.because sometimes when you're working.with radioactivity people are afraid of.it because they're afraid some however.the radioactivity will be on their.product or their products will become.radioactive it is important to note that.the energy of a mission from the Cobalt.at one point one seven and one point.three three MeV is too low an energy.level to create a radioactive material.but it's plenty of energy in order to.sterilize your product.so your product cannot become.radioactive as a result of a gamma.radiation process somewhere in early.science classes you probably saw.something called the electromagnetic.spectrum it gives you the different.energy levels of things that occur in.your life the most common place that you.probably focus is that visible range in.the middle the different wavelengths of.light were set into color but if you.start looking to either direction from.visible you start realizing that there.are energies that are that can be.obtained or created that have either.longer or shorter wavelengths than.visible spectrum and as a result of that.have lower high energy the reason we.care about that is when you go off to.the left side of the spectrum the things.with the longer energy seems like you're.my voice.that's that serves a purpose but it's.relatively low energy so on the right.side you have things have very short.very high energy levels and the reason.we care about that is because that.allows them these short wavelength.high-energy particles or processes to.give us the ability to have ionizing.radiation ionization is a simple.chemistry term it says that it means.that you can either act it will cause.the emission the addition or the.subtraction of an electron it will free.and create charged particles that is one.of them that is the major mechanism.involved in sterilizing need that.ionization process to create the.activity we need now let's start looking.at each of these things so that we.understand what these words actually.mean a photon or gamma ray is.electromagnetic energy they have no mass.and no charge just a lot of energy being.emitted they create these ionization.events that we need for sterilization by.creating damage to biological molecules.in effect making the molecules no longer.capable of doing their function and as a.result killing the organism that was.carrying them.they have very short wavelengths they're.very energetic and those properties not.only can they kill things in your.product that we want to kill they can.also deeply penetrate the product from.all the way through its package its.carton through the actual object itself.through other objects sitting on top of.it so it makes it an excellent method or.technology or component to actually.sterilize a product the other.terminology in this photon area that we.mentioned a great deal as will sake tila.raised the little symbol for it will be.little k big G little Y and when we talk.about kilogram we're talking about how.much dose or how much absorb energy is.being given to your product it will be.the unit of the met when we're trying to.determine if your product got the amount.of energy was supposed to get to be.sterile that unit of measure will be.integrate how we know we've given it the.right number of kilograms is by using.devices that are called those senators a.dosimeter is actually measuring that.device it's a calibrated device so that.we're assured that the act of the.accuracy of the dose we're delivering to.your product we're going to start.talking about the actual physical unit.that we call in a radiator cobalt is.wonderful stuff it's out there but on.its own it would be of no use to us what.we need is the ability to put it in.equipment and have established processes.that allow us to use it safely and.effectively for sterilization so the.Arabia tour itself is an assembly of.equipment needed to either convey.product or to convey the product safely.to where the cobalt is to deliver the.product in a position or in an.orientation that will allow the cobalt.to effectively do its job and do it such.that we can get it in there and it will.spend the right amount of time safely in.the process and can be removed safely so.that no people or product or ever.damaged there are.lot of components to this overall system.the cobalt-60 is of course there to.provide the photon we have to get the.photon source into some format that we.can manipulate so that we can decide.where it is and know where it is on a.predictable basis we call those units.pencils and we're going to actually I'm.going to show you what one looks like.that's going to hold the Cobalt.we're going to have something called a.source rack which can hold many pencils.and also gives us the ability to move.the pencils as we need to because in a.radioactive system you can never turn.off the energy once the isotope is.created and it's unstable it is on so.every time we would need to for example.get in in the radiator we would have to.have a way to move the source pencils so.that they weren't it's being exposed to.people when we bring product into the.field photons are we have to transport.them in some way there are many ways to.do this you will hear the terms carriers.totes turntables.all of them are ways of presenting the.product to the source for our purposes.today assume a carrier tilt are the same.thing they are the way the product in.your cartons for example will get to the.Cobalt there has to be a conveyance.system of some sort these carriers don't.walk in there they have to be carried in.and they also have to be moved around.the source in a predictable timed manner.that's how we guarantee that the dose.delivered is appropriate and then of.course because it can't be on it can't.be turned off we have to have ability.ability to contain it safely so that no.additional dose is being given to your.product when it's not needed but also so.that one can go in there and do.maintenance and such on the originator.those similars we want to talk to you.about a little more they not only are.measuring the device but when they're.divine we are irradiated they actually.exhibit a quantifiable change in some.property that 10.measured and that measurement of change.can be equated to a dose so they are the.actual measurement of your dose you're.looking when you see them there are many.different types of dosimeter x' on the.market they will have some physical.change that can be seen or measured with.some form of equipment for example they.may have a change in optical density.where they get darker they may have a.change in the electron spin resonance of.for example an amino acid like alanine.and there are many others but whatever.one you use they must be calibrated to.assure the dose delivered to a product.is accurate and you must have the.appropriate equipment to read them the.pictures you have surrounding here are.at least are different types of.dosimeter is the ones we most commonly.see are these red ones at the top that's.a red per spekt and the ones in the.lower left hand corner are tape tabs.there an alanine pellet when we talk.about a carrier or conveyance system.here is an example of one these aluminum.boxes on the left actually turn around.and open them they would look like the.one on the right they have the ability.to carry your boxes into the radiator.there are large aluminum boxes.relatively simple but they can be.conveyed on a system such as this rack.system you see underneath carriers we.are talking that you had a pencil a.pencil looks like this it's a long.stainless steel rod about 18 inches long.double encapsulated in stainless steel.and they're actually very traceable we.know how much energy was in them when we.got them so that we can predict the.decay times how much energy we have at.any given time but they are also.numbered for traceability so every one.we put in our radiator we know which one.was there and we know where it is the.reason we know that is so we can.characterize how our radiator will.perform but diabetes in a pencil they.are now in a form that we can manipulate.and design our radiators to be very.effective for the processing we need on.the right you have.if you had many pencils put in little.ticket sense style here you have a.module and you can stack together many.modules to create a source rack.a source rack can be done in many.orientations could be very large could.be very small it could be very uniform.but it's designed and set up for its.intended use but when it looks like this.in this picture this lovely blue that.means this source rack this picture was.taken when this source rack was sitting.in a pool of water water is how these.things are stored for containment and.the color is only visible when they are.stored in the water it is not visible if.that rack was standing up in air before.it sorry about that.technical difficulty let's turn this.there John okay when you take components.that are in Anna radiator they will all.be enclosed in a large concrete bunker.almost a small room with very very large.thick reinforced concrete walls within.that concrete room will be your source.rack so mech the pool will be under it.for storage you will have hydraulic.systems to be able to lift the source.rack out of the water to expose your.product to the photon and you will have.the wave a way in and a way out for the.carriers or whatever mechanism is.bringing them in to bring this the.carriers with your product around the.source rack so that they get irradiated.as they need to now there are different.ways you can present product to a source.and take them out and those are defined.by different types of radiators but.we're not going to go into the different.types today just know that whatever type.of radiator you have has to have a.mechanism by which this product can be.proof.disseminate defined orderly fashion at.timed intervals so that we know how long.it's in there all of the mechanism.surrounding it any ventilation that's.needed so that you can out gas whatever.you need to anything you need to keep.the water at temperatures that you.needed to be for safety all of the.mechanisms will be surrounding or part.of this overall complex that we call the.radiator now think of your product your.product will be presented to a source.rack in from one of these carriers of.some sort if you think of the Purple.Line as the source rack the photons are.coming off of that you're going to have.product that would be put would have.been put into this.sorry there's I it's kind of like.jumping on me so sorry it's making it.jumpy for you guys if you have the.source rack doing the photons if they.were moving in a straight linear line.fashion your products would get.irradiated but it's also not a very.productive way to do a lot of throughput.and it's also kind of wasteful because a.radioactive source that's unstable right.it's just shooting out energy it doesn't.know that you want the photons to go on.a particular direction so it is.considered isotropic it's shooting.energy in every direction off of the.source much like you can equate the.visual to a light bulb when a light bulb.is you take the lampshade off of it you.can see the light from any position you.are around there that's that light.energy coming off of the bulb in the.case of a radioactive source those.photons are coming off in every.direction it presents a really.interesting problem slash advantage.though because those photons are coming.in all directions we can take advantage.of all those lovely photons and we can.actually design a radiators so that they.can have multiple layers of carriers.coming in or that they can be.continuously moving around the source.all of them at any position around the.source are getting from dose the amount.they're getting we can predict by the.work we do when what we qualify in a.radiator so that as carriers come in to.Ana radiator we can time how long they.have to stay at different positions and.as they come out of the radiator or are.taken out of the irradiated.they will have by the time they come out.the amount of dose you need them to have.to make your product serum we decide how.your products being run to assure your.dose is being delivered by taking the.information you give us on your cartons.how heavy they are how big they are we.then take the information we have on our.radiator qualification what we know.about.it behaves and we determine how many of.those cartons and in what orientation.they will best fit in our system then we.take the additional detail of which a.radiator specifically it's going to run.up the sizes of that carrier your.product details so your box size weights.on doses your dose required and with.that we develop something called a load.specification specific to your product.in that ax radiator you will also be an.approver on that so you'll know how.we're going to load your product this is.an example of a load spec to read on the.screen but notice it will have a picture.so somebody can see exactly how to load.your boxes and there how many will fit.in a carrier at one time it will have on.it the information on what product it is.who your company is but I'll wear this.on this left side it will have all those.critical details to assuring that the.product is accurately delivered the.dosage means when you put this part.together you have how many shippers.you're going to have you'll have them.pack the way you pack them so that it's.consistent on that then we load them.into these carriers and we run them at.the time needed image in the radiator to.deliver the dose that you requested some.of the processing terms we use is we.will say it is an anterior process or an.austere process on carrier is what we've.been talking about so far where you're.saying that the product is going to use.some kind of conveyance system to get.the carriers so with your product boxes.into and then out of the irradiated but.you can also present product in other.ways for example on a turntable where.you may be doing one box at a time.so it's not in a conveyor and it's not.in a carrier it's being run near the.source on something or some other device.either a turntable of some sort the best.example of that will be when you're.doing validations you will do something.called verification doses or dose audits.does that require your.precise doses most radiators will have a.system somewhere in their organization.are many of them that have the ability.to have specialized equipment built.specifically for delivering very low and.tight doses and when you do that you.generally do them off carrier on.turntables we're going to talk much more.in detail about that process a little.bit later in this seminar but.extensively in next week when we start.talking about those settings.and when I hit the thing it's been.jumping two or three okay when you set a.dose a dose is not just a minimum dose.it's not a single number it's always a.range because you're going to have a lot.of product processed at one time and.it's not a pinpoint source so you have.you will have some distribution of your.dose delivered because of that you have.to make sure you know not only the.amount of dose that will sterilize your.product but you have to have a number a.higher number of the maximum dose you.will allow the product to see and know.that the product will still keep all of.its properties that you require it to.have as opposed to just getting adults.because you're sterilizing it there is.not there's never going to be one dose.maximum for every product product doses.are all specific to your product and its.components so your maximum dose is the.maximum the highest dose you allow your.product receive it is based on the.effects of the sterilization process on.your product it is known that a.radiation processes because of the.ionization process can damage or change.your product or its materials so if.these changes could do nothing but they.could also affect the performance the.safety or the appearance of the product.so it must be checked and it must be.documented it is to your advantage to do.this kind of evaluation early so that.you can best pick the methods for.setting the minimum sterilization dose.and know what is possible you may find.in this testing that you can't go very.high on your maximum dose that will.restrict you on what your minimum will.have to be that may impact other.decisions you make like how well you.clean your product before it's.sterilized or how much product you can.process at one time so it's useful.information to know and it is also.required to be document.so the maximum allowable dose is product.specific not type of product meaning for.example all catheters get the same dose.range the maximum allowable dose is.material source and production process.specific meaning if you use polyethylene.and somebody in another state uses.polyethylene to make their product those.are different processes for making the.product and they also may be completely.different resins of polyethylene that.means the maximum dose could be.different your production process could.also impact the performance of the.plastic combined with the dose to it so.you always have to check real product.preferably final product and final.package when you start looking at.maximum allowable dose it is all.documented solely by knowing what the.minimum dose is there are ranges you'll.see quite commonly in publication.probably the most common one is 25 to 40.kilogram but when you validate to prove.that the 25 is your minimum dose that.does not mean that without further.evaluation that 40 automatically is a.given some products may not be able to.tolerate it.others may be able to tolerate much more.it also needs to have data to support it.you cannot just look up the type of.material in literature and say the.literature says it's stable to.irradiation because the literature only.tests certain parameters they are.probably not testing the ones that are.important to your product then in dose.setting the terminology we use.frequently we start out with we are.trying to achieve a sterility assurance.level also called SAF probability of a.single viable organism remaining on your.product after it went through a.sterilization process the most this is.most commonly applied as a ten to the.minus six sterility assurance level.there are times when that is not needed.but for the vast majority of.applications worldwide in a healthcare.product you're going to have a ten to.the minus six drill the.pterence level what that means is when.your product comes out of a.sterilization process the probability of.your product or one unit of your product.having a single viable organism.remaining on it is one in a million.you can never prove zero but one in a.million is acceptable for labeling your.products zero when you're setting a dose.adults will have a minimum that will be.the lowest dose required in Killa grace.to make your product test sterile and.assure that the sterility assurance.level needed has been met you must do.certain tests on the microbiological.side to achieve and document that dose.doe setting methods are how you set that.dose range they define the minimum dose.and the maximum dose allowed to assure.your product is both safe and effective.for its intended use and this is what.the entire subject of next week's.seminars webinars okay now we want to.start looking at some of the.microbiological words because we're.going to talk a lot about these tests.next week in microbiological terms we.are to looking at your product is made.as a result of being made it's got.certain organisms on it through handling.through the materials that came in.through equipment through air that.measure of the population of viable.organisms on your product or what's.inside your sterile barrier system is.called bio bird it's a way to quantify.how contaminated your product is that.bio burden is measured in units called.colonies.Oh Sara hey Betty you you wouldn't blink.for a minute there but you came back.okay.I'm sorry people this is it they measure.the unit of measure of bioburden is.called the colony forming unit or CFU it.is the reason they use the word colony.forming unit is that if a single.bacteria was to land somewhere it will.create more of its kind and they will.pile up on each other and make little.mounds like these little pictures that.are at the bottom of your screen since.once you have these little circular.colonies formed you really don't know if.they were the art they originated from a.single organism or a few but what you.can do is count how many colonies you.have so what you're doing is you're not.counting counting exactly how many.organisms you have you're counting how.many colonies you have when you're.testing a product sometimes the product.is very small other times it is very.very big so you have to know how much of.the product is included in the test and.that's called the sample item portion or.you'll hear it referred to as sip if the.entire product is tested which is ideal.that means you're testing a fifth of 1.0.if for example the product is too big to.be able to test it is tested in its.entirety and a portion of it is tested.then you have a fraction of one as your.sip.the test you do the two critical tests.but tell you a lot about your product.are your bio burden and your sterility.since those tests are so critical.each one has method tests to qualify it.to make sure we have a good test to.accurately represent the test that's.really important so you have things.called validation of methods so you have.validation of the bioburden test method.which is this first one called the.recovery efficiency what it really is is.a measure of how effectively you are.removing bioburden or organisms from.your product so they can be counted how.good that extraction process is will.affect whether or not how accurate your.dose setting is because you're going to.use bioburden in most cases to set your.minimum dose you want to make sure.you're getting that number as accurate.as possible so that you don't forget the.product only to find out at the end of.the testing that you have to start your.testing over because your process was.not very good what you get out of a.recovery efficiency is something called.a correction factor.it's a numerical value that's based on.the results of that bioburden recovery.test that can be used to adjust the.natural bioburden number you get from.your product to give you a more accurate.count so that the dose used is also more.accurate and more representative of your.product we're going to talk more about.how some of these are done a little bit.today and a little more next week a.product for biological or.microbiological purposes will be what.are we actually testing sometimes you.test just the fluid path of the top.products sometimes you test the entire.thing sometimes you test everything in.the sterile barrier sometimes you test.everything except for example an inner.pouch or a holder so the product has to.be defined how it was tested sometimes.you have products that are many.different versions of the same thing or.heavily related in some way those can.time's be called the product family the.advantage of a product family is that if.the products are truly related.microbiologically and materials and both.types of things they can be represented.by one product rather than having to do.dull setting on every product in the.family.the standards are very explicit on.giving guidance on how you assess if a.product can be in a family it is not.just because they're all used for the.same function they have to follow and.have to be evaluated for certain.criterias which we're going to list.later.just a quick crude overview of what a.bioburden test is you take your product.represented by these little blue squares.on irradiated so finished goods but they.have not been sterilized in any way they.get placed in media and then they're.agitated shaped vortex whatever is.appropriate for that kind of product to.cause the bugs to get knocked off the.product and get into the media then that.media has to be either filtered so that.we collect all the organisms in it or.some other method where they end up on.these culture plates at the bottom.they're allowed to grow incubated for a.certain period of time and then somebody.has to physically go there and count how.many colonies were created as a result.of that extraction now while during.recovery is required it is done to.assure the accuracy of that population.count and is the value you get is.directly related to what your minimum.dose will be so it is critical that it.be done well this test avoids.underestimation and it makes sure that.the method because of that we have to.make sure the method that will be used.is effective you have options and the.lab that a microbiology lab will have a.great deal of experience on deciding.what might be ideal but also there may.be preferences based on what they know.about the products or extraction.processes but the two most common.approaches are either exhaustive rims or.inoculated recovery exhaustive rinse.directly what it says you take your.product you put it in media you shake it.around in some way you extract that.media then you take that same unit you.just washed and rinsed and you do it.again multiple times then you compare.the first rinse so the total extracted.unit numbers and that gives you a.percentage number to use for correction.inoculated recovery is also sometimes.called spore inoculation because in that.case you are actually going to irradiate.or treat the product in some way to kill.off the vast majority of the bioburden.and you are going to then inoculate that.product with a sixth number a known.count of a spore forming organisms so.you know now how many we're on there and.then you do an extraction process to see.how many of the ones you put on you get.off so you have a before and after.number the goal here is to try to find.out a correction factor because if you.just took your product and extracted it.you would get a number it would be the.number you extract it but it would not.reflect how many you left behind which.could be significant or could be quite.small but you need some way to bring.back the quantity total versus the.quantity released I told you we talked a.little more about families families are.grouped by number and type of organisms.present in the bioburden.some of the things you have to consider.but all of them that you consider our.issues related to the impact on.bioburden type and quantity not just.quantity the nature of those sources.nature and sources of the raw materials.you use to make your product more than.one source of the same material could.have completely different bioburden the.components of your product maybe you.make one product that has tubes five.tubes on it you make the same thing with.only two tubes sticking out of it one.may have a dozen clamps on it another.one may not it could be all very related.but one may have many more parts than.the others.but each of the components you have to.make a judgement which of these are the.most complex are they truly related the.design and the size of the product can.also impact your by Auburn say you have.something simple like a gauze pad and.you cut it in multiple different sizes.clearly they're identical in components.and process but they are different in.size if you assume that the bio burden.is proportionally spread throughout the.product equivalently on every inch.obviously the bigger one would have more.violet but the things that are less.obvious are your manufacturing process.how it touches your product how it's.clean how it's maintained the actual.helmet how long it spends through each.component of it the environment that.that manufacturing is done in and the.actual physical location all could.change if not the total number of.bioburden colony forming units but it.could change the organisms that are.present an individual living thing very.different tolerances to a rate based.sterilization process including.radiation so you want to have as much.consistency of your manufacturing.process as possible and have an idea of.how your process impacts all the members.that you're considering putting in the.family these families you are required.to assess these effects before defining.the product and you have to be able to.support your decision you have to say.why they belong together you may require.actual data to support that it may be.more than a paper evaluation once.they're defined you have to select in.the family who you're going to test to.represent it remember that the product.you test will now represent every member.of the family so the family stands.together or they all fall together so if.there's a problem every member of your.family will be affected by it you may.choose to use a master product meaning.you pick a member of your family that.has the greatest challenge as determined.in your assessment to be the worst case.source of bioburden.not.the one that has the greatest challenge.to the delivery of the dose that's.handled in the dose mapping parts where.we're talking about now is which one.you're going to actually test to set.your dose for the entire family it has.to be the one that would be expected to.have the worst by over you may have a.products or you may have several.products in the family that are.considered equivalent in which case you.can use either one or several of them to.do the same test the third option.sometimes your product is made in very.very small quantities very complex or.expensive or something and using the.actual product is not ideal for testing.if you don't use the actual product you.have to create a simulated product that.is similar to the actual product in.terms of materials size surface area.subject to the same production process.so that and it may be a combination the.products to do it but it has to.accurately represent what would be on.the real final product to test it now.what do I do with all this bio burn data.the first thing you do is you use it to.determine a very specialized dose called.the verification dose and the.verification though is a low-level dose.sub-lethal that gives you a sterility.assurance level of either ten to the.minus one or ten to the minus two and.that number will depend on how you set.your dose what methods you use that dose.is never used for sterilizing product.that will be used by people it is so can.never be sold as labeled sterile it is.used only for testing purposes so that.you can assure that when you do your.minimum sterilization dose whatever that.number becomes that you have the.sterility insurance level you need it is.used for routine monitoring as well as.validation purposes when we talk about.sterility testing we do that after we.set a dose we set the dose based on the.bio verb you said.that verification does the sterility.test invalidation of adults will be done.at the verification dose this is just as.important a test as bioburden so you.have to have a method development test.here as well so just as you had a.validation of the bioburden test method.you have a validation of the sterility.test method the specific test that is.done is called bacterial stasis and.Fundy stasis or B / F for short this.test you use product that has been.irradiated so you've killed off the.naturally occurring organisms and you.will inoculate them not with just once.for you're not getting with different.kinds of organisms one unit will get a.bacteria one will get a yeast one will.get a mold and this is used to show that.in the conditions you intend to do the.sterility test that your product will.not impact anything to the media that.could inhibit growth the worst thing.that could happen is you could have a.product that had living organisms on it.that just weren't happy in the.conditions that they were sitting in but.they were not killed if they don't grow.they would not be seen easily in a.sterility test and you could assume.falsely that your product is sterile.then when the product was used and it.was removed from those conditions it.might actively grow because it was not.it was never really sterile what a BNF.test does is it ensures that the.conditions will allow a living bubble to.grow the reason you do that is because.you're going to do a test of sterility.as part of your validation process and.as part of your monitoring at that.verification dose and you want to give.the bugs if present a chance to grow.quick look at the sterility test which.is a very simple test now your little.blue squares have already been.irradiated they just could put into.sterile media that will look clear well.not clear white but clear so you can see.through it you can read through it as.they sit there they're required to.incubate for at least 14 days if.anything grows we don't care what or how.much that is considered a sterility.positive test means something group.in other words that would count against.your sorority test so you look at how.many units you incubated and how many.grew something within 14 days and it's.an easy test to look at easy there is.turbid and cloudy or it's clear when.you're validating your testing does not.stop that's what we're going to talk.about even in more detail next week but.what is this testing you do it's called.the don't sod it it's a series of tests.and steps you do periodically to.substantiate the results of your.validation it's ongoing monitoring it's.your biological monitoring of your.process to assure you stay in process.control it's required and the intervals.are defined in the same standards that.you've got all the information for the.DOE setting you're going to do as part.of that a repeat of bioburden justing.and a repeat of sterility testing but.using the same methods and the same unit.numbers you did in validation but now.only for the lab that's current at the.time you have to do the tests when you.finally have doses you have adults range.and then in the max you're going to.process it in bulk.many many boxes of your product now your.consideration is can the dose range I.need be delivered to every unit in my.box.that means we're concerned about the.distribution of dose within the box and.we determine that through a process.called dose mapping which is the.measurement of that distribution and.it's variability within a product mix.mix or step it's specific to the divine.defined conditions and the facility used.it confirms that your dose range that.you're saying you need can be delivered.in the configuration it's going to be.presented to the source you're going to.get a lot of detail on how that can be.done in the third part of the seminar.series when you do these studies you.will possibly use your actual product.you may use your actual product load but.there will be times where you may use.surrogate or simulated product to.perform these studies in that case that.surrogate or simulated product has to be.device or material that represents an.equivalent challenge to.the distribution we're no longer talking.about the bioburden anymore so the.distribution of dose throughout a.product as it would really be packed you.can use rejected product you can use.these simulated products you could use.products of Simpson materials of similar.density that would pack the same way in.your in your boxes but it's got to.represent an equivalent challenge to the.dose distribution but your product would.to be used when you qualify in a.radiator when we call finery we do dose.mapping we look at a variety of.densities of materials for products to.show what the distribution would be we.can use that information to translate.your product information to know how we.need to load the product to achieve your.dose we do these types of studies every.time we modify the irradiated would mean.every time we put cobalt in there it has.to be done prior to processing any real.product because we have to know the.characteristics of the irradiated first.most of the time customers aren't aware.this is being done but it is required.that's how we are able to deliver your.dose very specialized products unique.packaging may require very more.additional studies done or specialized.forms of mapping and that you'll hear.more about an internal reference mapping.now what can affect the distribution of.your dose when it's processed the.package configuration how you put the.product into those actual shippers the.load configuration how we stack those.shippers in a carrier the source.configuration from one radiator to.another could be different so the.distribution could be different and then.the fact that we are going to have to.replenish the cobalt occasionally so.we're going to do two source loading.because the radio is decaying if we let.it continue to decay it would keep.taking longer and longer to process your.products so we have to be able to put.more cobalt in there that's why every.time we add cobalt we do another study.to make sure we know what the.distribution is.you bring a lot of this together what do.we really have we have a product you.selected you've made it you've proven.that it's a reproducible process you can.make it in that means you've got a.process that's in control you're testing.it for tolerance to the effects of the.sterilization process in this case gamma.radiation or what effect a known allowed.worst-case number of Killa grades of.radiation it will come out of and still.meet all your specifications we note we.learned something about the product.contamination level that's coming out of.the process we've measured it that's our.by Oberg we've confirmed that the method.used for both bio burn and sterility are.effective that's our BNF test and our.bioburden recovery test we've confirmed.that our predicted minimum dose will.sterilize the product we do that with.our sterility test the only test here.that the pass/fail is the sterility test.if you pass your sterility test based on.the rules for passing in the standards.you can now document a min dose a max.dose and support a sterility assurance.level you document that minimum and.maximum dose that they can be delivered.to your product through dose mapping so.it's a process that flows through.one-step builds on the other but you.look at this and at first you go why.would somebody do all of this well.there's a thin reads they're good.reasons why you may select to a radiator.product to sterilize it one is that it.doesn't add moisture to your product.there's no excessive or constant heat.added to with the to the load when it's.run there are published recognized.easy-to-follow steps and standards that.are recognized worldwide for.establishing that it is sterile.it's an adaptable process to smaller.large loads and you can sometimes.overcome issues that might make other.methods hard to do for example say your.product cannot be filter sterilized and.it allows for very high throughput.because we can do a lot of steps on.this whole talk what you did today which.is why we're used up somewhat to the.hour is just to get the words in your.head so that when we talk next week.about the really critical features which.are setting adults and making sure it's.accurate and then measuring and then.documenting that does distribution in.the next two weeks you we are also very.passionate at sarah AST about resources.and education to help our customers.achieve what they need to do as a result.of that we have online on our website.and stuff you'll have access to previous.webinars there will be additional.webinars on different topics throughout.the year we also have on our website a.number of tech tips that look at.individual topics we also in addition to.the webinars where we can have more time.and go into much more depth of detail on.not just a radiation but other parts of.sterilizations specifically athlean.oxide sterilization cleaning processes.packaging some of these lab tests and.just materials consideration for.selecting the appropriate things we do.this is live seminars throughout the.year and our next one is scheduled to be.at in September in Mundelein Illinois.and in part of that is also a tour of.the actual facility I work ok and as to.find out more information about this you.can find all of that on our website ok I.want to thank you for listening I.apologize for the some of the technical.difficulties in this today but I want.you to know that the tech team and all.our members are only a phone call or.email message away we are always here to.help with any questions and services you.may need assistance with as part of.developing or maintaining your.sterilization program.there was one more slide but I guess.there is not I'm going to try the best.we get to say goodbye well Betty I sense.the first question over to you can you.confirm which I received it I did not.okay then I will read it off to you so.the first question is if there's a few.questions within one here it's I.recently heard about electron beam.sterilization how is this different are.there other types of radiation.sterilization and what are their.advantages or disadvantages okay there.is something called electron beam.irradiation all we've talked about today.is gamma radiation in many respects the.well first off the standards are the.same for all the forms of radiation but.there are differences your actual.question is could be on in and of itself.an entire seminar to compare the two but.so I'm not going to address the actual.advantages and disadvantages directly.now but if you would like to talk over.some of the details so you know what the.differences are I'd be glad to do that.as a separate offline discussion but the.three types are x-ray a beam and gamma.that are the most common irradiation.steps okay the next question says are.bioburden efficiency and recovery test.methods the same for ethylene oxide.sterilization well whenever you're.measuring bioburden independent of what.you're going to do with it after you've.measured it those recovery efficiencies.are the same it's the same test how you.use them may be different but that is.the same test.all right we've another a multiple part.question.I'll read the entire thing to you does.the material type often relate to the.use of either exhaustive rinse versus.inoculated recovery for example.stainless steel has few natural CF use.thus we need to give it some thus we.need to give it some verses prick which.could have many and thus exhaustive.rinse is a better option okay I know.where it's going okay.one's a physical material itself.can definitely impact the results of a.recovery test some products uh materials.and reports than others others are not.but the second part which is that you.got to in the question which was really.good is that when you're just trying to.decide whether you do exhaustive rents.or inoculated there are times when one.or the other is definitely the preferred.way to go for example if you have a.product known to have very very low.bioburden counts such as what you.mentioned with a metal metals generally.are treated in such ways that they the.process of making the metal is pretty.much antibacterial it just kills.everything in the process if you have a.product that has maybe one or two CSU's.at best on it if you try to do.exhaustive rinse you would never get a.number because you get all zeroes all.the way through so in those cases you do.default to inoculated recovery as the.preferred way to do it so you would put.a number that you can actually see on.the product test your extraction.efficiency with the process the test.method you plan to use and then get a.more realistic number so it's very good.question the next question says if any.growth is observed is that an automatic.sterility failure not in a me in in an.ami sterility test method when you're.doing validation that last ability test.remember you're testing products that.only got a sterility assurance level of.ten to the minus one or ten to minus two.that means you only tested either ten or.hundred samples so standards give you.cut-offs for pass and fail if for.example you had a ten to the minus one.sterility assurance level and you have.one positive that would mean you have.proven the sterility assurance level so.you don't fail the validation by having.one positive if you were to get three.positives out of the ten that would be a.failure that would mean that method did.not work for you when you test a hundred.samples with something called method one.or method two validations you are now.allowed two positives in your sterility.test and that will hold true also when.you do those tests again in your.auditing.all right next question says this does.scaris do bioburden testing.yes tariffs are they large the greater.Cirrus ast organization includes within.our abilities not only a L e beam and.gamma sterilization processes but we.also have within us a group called the.bio test laboratories in Minneapolis or.outside of Minneapolis that is capable.of doing any of the microbiological.testing ok next question says you.mentioned no excessive or constant heat.does this mean there is a short term or.limited heat due to the irradiation okay.you have to assume that there is we're.not adding heat as part of the process.but you are ionizing things you're.breaking bonds so you are potentially.creating in your product at least some.heat it is a very well insulated chamber.that is holding in it a great deal of.energy as a result the while the product.is in process one would expect it to at.least get warmer than ambient in many.cases but not at such high levels like.you would see in say a steam or a heat.sterilizing process so it's and it also.is running for a period of time usually.in hours so you're not getting a.localized heat you're also allowing for.time for dissipation so it's not a fixed.amount for a fixed amount of time but it.should be expected that that temperature.that your product sees at some point.during the process will be above ambient.all right just a couple questions left.here Betty first one is to use different.dis emitters for different dose ranges.the way our system specifically is.calibrated we we don't need to we're.using a dosimeter that is calibrated.over the range at which we test but.physically on the market there are many.different types of dosimeter z' that are.each optimized and calibrated for.different ranges any dosimeter that's.calibrated to a dose range as long as.you're within that dose range you can.use.okay the next one says can you please.elaborate on how the validation of.method process works for example.bioburden okay okay we're going to talk.a lot about that next week but I'll give.you a little sneak peek here basically.what you're going to do let's talk about.let's talk about inoculated recovery as.an example you're going to take a.product an honest-to-goodness product.finish good and you're going to probably.irradiated so that it doesn't have or.wouldn't be expected to have living.organisms on it you're going to take.that product and inoculate it throughout.its space with a known amount of.organisms usually about a hundred cf use.of a known marker organism or less you.take that product that you've put these.organisms on and then you say okay this.product I look at it based on my.expertise as a microbiologist what would.be the best way for me to extract those.bugs from that product and I will.perform that test I will use media on it.I will shake them.I will filter them whatever I'd have to.do to try to get those organisms back I.now know how many I put on initially.because I counted them before I put them.there and now I know I can take whatever.I extract off and count how many.organisms are in it so I have a first.number of say 100g of us say in my.extract when I'm done with this test I.only have 50 that means I have 50 out of.a hundred that were recovered and as a.result I have a 50 percent efficiency.that means that I have a correction.factor for my natural bioburden so I now.take my product on irradiated I extract.it with the same method and I count up.how many bugs I got in my bioburden I.now take this correction factor from the.50 percent which means I have a.correction factor of 2 I double my bio.burn to assure the accuracy of it all.right and just two more here we get.another one that came in so do the.bioburden test method.and bf testing have to be revalidated.periodically it is recommended because.of the fact that products do change.source materials to change.I will admit not it isn't often done but.it is recommended that it be repeated.periodically alright and the last.question is it recommended to validate.your sterilization process for double.cycle or single cycle what would be the.advantage of single versus double cycle.validation for gamma okay.in gamma it's rarely done because of a.very important characteristic of.irradiated products the effect of.radiation is cumulative so if you've.done something to a product it doesn't.sell correct itself over time as if it.didn't happen damage was done the first.time if you do it again it will get.twice as much dose and twice as much.effect so but there are products that.are done that way good examples of where.it's is a useful advantage if the.products materials can tolerate it would.be say you had to make a minor change to.a product that was already on the shelf.sterile and you needed to you took all.the product into a clean room and you.swapped out the piece or maybe maybe.just the insert because there was a rule.change somewhere and you have to take.that paper I'll put a different one in.many times you would then repack it so.there's no question about the packaging.being going through two cycles but the.product is the only way you would be.able to reprocess it at the same that.you use the first time would be to know.that the product could tolerate twice.the dose you gave it before so that that.would be why you do a 2x to show that it.can be tolerated but the other.interpretation of 2x sometimes is two.times the minimum to be your maximum so.for example if your projected minimum.dose is 25 kilogram many times people.will test at 50 to be.two times and that still becomes one a.radiation process that could be run.between twenty-five and fifty so that.two times those can be interpreted.different ways but it is possible it's.just done less often with the radiation.than it is for example with a deal.process where you would do something.over because of the cumulative effect.and potential damage to the product but.if you test it and it tolerates twice.the dose you absolutely can do it great.Thank You Betty and thanks to everyone.for attending our webinar today we.appreciate you taking the time to learn.with us and hope you found this session.beneficial our gamma webinar series.continues next week with part 2 the.gamma a radiation dose setting process.if you haven't already done so you'll.need to register separately for next.week's presentation and we'll include a.link to register in a follow-up email.that will send out later today we had a.lot of people submitting questions.asking if they could get copies of the.slides from today's webinar we don't.provide the slides from our webinars but.we will send a link to view the.recording on YouTube and that will be.sent just a little bit later today once.our recording is downloaded thanks again.for joining us today we look forward to.learning with you again next week this.concludes today's webinar.you.

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Are you assuming that the browser will send the email? That is not the way it is typically done. You include in your registration form a <input type=submit> and use PHP or whatever on the server to send the email. In PHP it is PHP: mail - Manual But if you are already on the server it seems illogical to send an email. Just register the user immediately.

Can I fill out the CPT form and the registration in ICAI before the examination of 12th class? How?

SORRY to say but now you can't appear for CPT anymore. You have to appear for CA FOUNDATION and for that you can register anytime after your 10th exam but you can appear in the FOUNDATION exam after clearing your 12th exam. All the BEST

How to decide my bank name city and state if filling out a form, if the bank is a national bank?

If your bank is national but has a branch in your town/city you can enter your town/city as the bank's address. Your employer is not relying on the bank's address you enter on the form.

How can I fill out Google's intern host matching form to optimize my chances of receiving a match?

I was selected for a summer internship 2016. I tried to be very open while filling the preference form: I choose many products as my favorite products and I said I'm open about the team I want to join. I even was very open in the location and start date to get host matching interviews (I negotiated the start date in the interview until both me and my host were happy.) You could ask your recruiter to review your form (there are very cool and could help you a lot since they have a bigger experience). Do a search on the potential team. Before the interviews, try to find smart question that you are Continue Reading

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