if you don't uh that's 30 degrees fahrenheit if you don't like fahrenheit
it's about -1 degrees celsius it's it's a little sunny with some clouds on the sky so it's a beautiful
day we want to welcome you to the validating optimizing and monitoring your ethylene
oxide sterilization process webinar we we're going to be covering different aspects of this sterilization
process using ethylene oxide and we are going to emphasize some certain activities that
are hoping to help you um to optimize your cycles or to develop new
inefficient cycles um i have courtney with me so we're gonna go together on this
down this path and and try to help answer as many questions as you
might have at the end of the webinar um this webinar is is a two-day webinar
today and this is the agenda today we're going to focus on on on different activities that can be
performed before a cycle has been validated in fact they will need to be performed before a cycle has been
validated if the cycle already has invalidated that doesn't mean that you can change
certain things and still be within that initial validation but if you are just about to develop a
new cycle day one is for you and if you already have validated a cycle
and you're looking to optimize that optimize that our stereogenics experts mike dylan and ross grockowski
are going to help with that on day two they're gonna talk about cycle optimization next thursday
on day two of this webinar so if you haven't registered just take a minute to do so and don't
miss on this opportunity again they're going to talk about how to optimize a current cycle
now i do i do want to take a couple of minutes to to for us to understand where in the
process the contents of this webinar are taking place so on the slide you are looking at um
and um going to get my pointer here um you're looking at the different stages different steps
that you have to take to validate a sterilization process and it everything starts with
the manufacturing your own facility and it goes all the way to after validation and after you have
defined the cycle at the end you are end up monitoring and maintaining your process efficiency
and effectiveness so um what are we gonna the the things that we're gonna talk about today
are taking place on mainly on these two phases of your validation road
that is on the process definition this is where you select your pcbs this is where you establish your load
a little bit on the product definition right but pcd selection is really important and and that's that's at this step and
then we'll move on to the validation phase um this is where we'll talk about the alternative ways of validating the
cycle um other than the overkill cycle and this and that's this too
so um this is again just a big overview of where we're going to be focusing on
today now um let's start here we're going to start on on on a little bit on on product
development and the process development and that we're going to start on on selecting the best packaging and the
best effective load configuration so when you're moving down the road you you don't have
any issues with these two aspects believe it or not they do
tend to affect the effectiveness of the gas penetration so for that courtney is going to she's our
resident expert on pcds and in different packaging aspects as well so she's going
to take us about that about packaging loading configuration and pcd selection
all right thank you dania um before we get too far i just want to put in a little plug and just a reminder
that optimizing your sterilization cycle starts as soon as you begin to design your product
if you keep sterilization in mind as you're designing your product your packaging etc etc
you can make informed decisions that will help you create the most optimal cycle for your product today
we'll start off by discussing some key items to consider when designing your device packaging building your
sterilization load when considering your package remember
that product packaging should be selected in a way to facilitate the sterilization we're keeping the
sterilization in mind all the way at the beginning of the design packaging needs not only to be
able to stand up to the conditions of a sterilization process such as the vacuum and injection phases temperature
humidity you want to ensure that it can that the packaging is
permeable to humidity and gas humidity is important it acts as a catalyst for the gas to inactivate the
microorganisms and is a critical factor in the process
when designing your test your packaging keep in mind that you also want to ensure that the packaging can withstand multiple
exposures to a sterilization process because it's not an if but a when you'll
need to re-sterilize your load for one reason or another
once you've defined your packaging the next step is to define what your sterilization load will look like
what is the loading configuration that you intend to validate there are a couple of options when it
comes to um to this uh you could validate a
standard loading configuration range for example um 100
shipper boxes distributed over four pallets or a loading configuration range might be an example of this might
look like 25 shipper boxes on one pallet as your minimum loading configuration
to 100 boxes distributed over four pallets as your maximum loading
configuration you might be asking yourself is it more work to validate a range
than it is to validate a standard loading configuration and the short answer is yes however
doing so does provide flexibility for routine production as the sterilization cycles can fluctuate
with production needs and can be of great benefit to your sterilization program while we're on the
topic of a validation range it is important to remember that the maximum load is not always the
appropriate load to use for validation when evaluating a range the primary
validation activities are based on the load that provides the maximum challenge to sterilization
the maximum challenge or worst case loading configuration is determined by performing a subweasel
or a half cycle on both the minimum and maximum loading configurations
these loads are monitored with both bi and temperature and rh sensors the microbial inactivation and
thermodynamic properties of the load are compared to each other to determine the worst case loading configuration
after that's been determined then you would move forward with your validation activities
with this worst case or maximum challenge load when building your load there are
several things to keep in mind especially when we're trying to always have our sterilization
in mind you don't want to have your loading configuration create unnecessary challenges for the
process but result in longer than desired cycle times some of those things include permeable
wrapping material the way your load is secured can have significant impact on the overall
resistance of the load for example if you use standard stretch wrap
to secure your load you may add several layers of a less permeable barrier to the load and this barrier is going to
prevent heat transfer rh transfer eo transfer
into the load and create a harder to sterilize situation a better solution might be to use a net
wrap where their penetration ability does not change uh isn't changed by this and maybe even
the best solution would be to use banding i just take a minute to see how those
options can impact the penetrability of the load and create or remove inefficiencies
within the sterilization process another option is reducing low density
does this mean you have to sterilize less product no not necessarily but you can look at other ways of
reducing density like removing paper ifus the industry is getting creative with
this using dvds or qr codes to communicate instructions could be a great way to reduce the
density of your of your load some other things to consider is
layers adding many layers to a pallet can add resistance to those boxes that
are in the central locations it's harder for eo to get to those locations as it has to travel through
through many many boxes so in the opti if you have options to create chimneys or
things like that within your palette to maximize product contact with contact with the stereolint you're
setting yourself up for some success with this
now that we've covered the product packaging and loading configurations let's jump into the pre-validation work
developing a process challenge device also known as a pcd
just a quick refresher for any of you that aren't familiar with the pcd essentially it is a surrogate product
that has demonstrated to be equal or greater in resistance to sterilization
than the product that is being sterilized iso 11135 states that the resistance of
your pcd must be equal to or greater than the resistance of the natural bioburden
in the most difficult to sterilize locations of the device as we move through the rest of this
section we'll look at different ways of demonstrating the resistance hierarchy between the pcds and the products
before we can talk about alternative methods let's refresh on the method that has been traditionally used to determine
a pcb a device is inoculated with at least one million spores
in all the hardest to sterilize locations we are specifically looking for locations of the device that the
steroid may have a hard time reaching such as mated surfaces where the gas has to penetrate
through material to get to us to a location a long lumen that the gas would have to
travel through to get to a central or a distal location the inoculated devices and then the
candidate pcds are exposed side by side to compare the resistance of the bi and the product
to the resistance of the bi in given pcbs these results are then used to select an
appropriate pcb again we're looking for a pcd that is equal to or greater in resistance than the
hardest to sterilize location of the device what is missing from that
last statement remember the requirement from iso the resistance of your pcd must equal
must be equal to or greater than the resistance of the natural bio burden in the most difficult
to sterilize locations of your device the alternate methods that we will be
discussing today ensure that we're focusing on that on just that then the resistance of the
natural bio burden one of the alternate methods is making
sure that the microbial load on the bi during the inoculation phase represents
the overall microbial load of the product so then so rather than inoculating each
of those hard to sterilize locations with one million spores you select a
microbial load that best represents the natural bio burden there may
even be instances where it may be appropriate to not inoculate the device at all and only evaluate the resistance of
the nice naturally occurring bio burden on the device now you may be saying this this girl is crazy and i tell you
daniel will attest to that most of the time but not today these
types of things should be considered when you're looking at your your pcb selection options
this option may be most appropriate when a device is very simple in nature a device that is surface
sterilization and the only way you could inoculate inoculate it is to put a
bi in the packaging adjacent to the product this would be a good candidate for for
not doing an inoculated product and so in these cases since there isn't
really a hardest to sterilize location an evaluation of the entire device may be justified
there are some considerations that you want to make i'm sorry when opting for either of the
methods we discussed first of all you will want to ensure that you have a good grasp on the bio
burn on your device what this means is that you know what types of organisms
and you know how many of them are on an average device this includes looking at the control of
the manufacturing process making sure that you understand what's being put onto the device and that
you're regularly monitoring your routine bio burden when spikes occur it may be necessary to
do some additional testing to confirm pcd appropriateness the pcd that's used to monitor the loads
for validation or routine processing must meet the requirements of iso 11135
with regards to devalue and population but for pre-validation work justifications can
be made to ensure that we're really doing the best that we can to mimic
the conditions of our product in this slide we're going to take a look
at a worst case method for a pcb development so this would be something that's traditionally done in this example the
device is inoculated with a million spores in the syringe that is attached to the device this is done to represent a worst
case challenge however configuration like this is going to
very likely make the pcd much harder to sterilize than it actually is in turn will have will require a much
more robust cycle to kill this pcb this is just compounded by the fact that it's very unlikely that this device
actually has a microbial load even close to that of the bi so we're really really making ourselves
a hard to sterilize pcd when it comes when we're comparing it to our actual product and pro
file burden in this next example an alternate we're taking an alternate
approach to developing this pcd it shows a more appropriate means for inoculation we're not making the device
artificially harder to sterilize than it needs to be by choosing a very representative
location for our bi in addition to that we are taking consideration of
what our microbial load on this device is and picking a a microbial load for our bi
that is representative of our product this pcd is a better representation of
the device and would yield a much more efficient cycle
as you can see in this slide it helps us to see how these alternative methods can
can impact the efficiency of the sterilization process this graph depicts what a lethality
curve might look like using a gas concentration of let's say 700 milligrams per liter
the blue line out here shows a scenario like we saw in the first example we have
a pcd inoculated in the hardest to sterilize location with the standard bi of at least 1
million spores as we change our approach to the pcd
take a look here at the green line which represents a pcd that has a bi that more
closely represents the bio burn on the device and then the red line indicates the
resistance of the natural occurring bio burn on the device as you can see we are
getting closer and closer to really representing our product as we really take a look at
how these pcbs are designed
as you can see from that graph choosing or designing the most appropriate pcd for the job can significantly impact
the lethality obtained from a given cycle but how does this contribute to the overall effort of optimizing a cycle and
reducing gas consumption to answer this question let's refresh on the critical parameters of an eo cycle
time temperature rh and gas concentration so with less resistant pcd we can target
any one or combination of those parameters to optimize a cycle since there is an industry since there
is an industry push to reduce eo concentrations let's focus our attention there
as you can see from this altered graph we are looking at a gas concentration of 250 milligrams per liter
we have the same pcds and product that we had in our first graph when using a pcd that most closely
represents the product there is potential to re reach the same 10 to the minus 6
sal in the same exposure time that we did with when validating a pcb that is
harder to sterilize using traditional methods
in conclusion we have learned that although these are alternative methods for pcd development require more bio
burden control and monitoring designing or finding the pcd that most closely represents the product will
contribute significantly to the greater efforts of eo reduction in cycle optimization
once the pcts are determined the next step is to validate a cycle here to talk to you about the different
validation approaches and some ideas on how to create the most effective sterilization parameters let
me turn the time back over to our sterilization expert dania cortez
thank you courtney um up to this point we we've learned the importance of having the appropriate pcd
and we'll put it all together at the end but just keep that in mind as we're talking about on how to validate the
cycle either by the overkill method or using alternative approaches in this webinar we want to walk you
through a couple of examples using an a different approach than overkill
and that's we're going to focus our attention on today we're not gonna talk about the half cycle overkill a lot um as
this is well characterized we feel that it's it's important for us the better use of
our time to talk about how to do one using a cycle calculation approach or a
bi by a burden combined method approach so with that said
if you are unfamiliar and you want to get yourself more familiarized with this different
approaches iso 11 135 the 2014 version annex amv gives a good content on these
different approaches um in just as a quick summary just as a refresher
there's this standard talks about the overkill and the bi bio burden combined
method the overkill you can do it two ways you can do it through a psycho
calculation approach or you can do it through a half cycle approach if you remember right your your half
cycle approach you perform three half cycles after you have determined the time and you just you are just confirming
this this process parameters that you already have established previously cycle calculation is pretty
similar in the sense that you still have to show a 12 spore log reduction
that is that's why it's call overkill because you still have to show that much that you have to travel
that much to get to a good stability assurance level now the bi by vernon method it's
actually it's based on the same concept you still have to show unnecessarily assurance
level or 10 to the minus six nevertheless the difference is that this method allows you to start at
a different starting point instead of studying at a population of a million you are
going to start a population that is representative of your product this method can be used either using
graded bi population bis or it can be used by grading the the time by changing the
the time of your cycle exposures aka by performing fractional cycles
there is an alternate method as well it's just the absolute bio burden this one is described on amy tir16
however if you are going to [Music] distribute product in a different
country that it's not united states you might want to check with your regulatory body if this is accepted over there
as well but it it's out there if you if you are wanting to do even a shorter
cycle or wanted to not use avi as a monitor this one is definitely harder and i
don't know of many companies that use an absolute bio burden method so just just for your information
just talk about it now just real quickly this is a comparison of the different
approaches again you have your half cycle approach the first two are still overkill believe
it or not um half cycle and cycle calculation are described again in 11 135
the difference is that your cycle calculation it will it might give you a
significantly shorter cycle if the difference here too is that your
bio burden becomes more significant on your cycle calculation and even most
significant on your bi by overland approaches and and how do you accomplish this well
you're going to have to understand what's in your product you have to characterize the bio burden
load over time not just a one-time point where you're validating your product but you're going to have to
do it more often as minimal as quarterly or as often as monthly depending on which method you use that's
why it's more expensive because you'll have to do more testing on the vibrant
load it can also be more expensive because you might have to do more fractional cycles than just the
three half cycles or four half cycles that you're required to do on the half cycle approach so
that's that's the main difference amongst all all of them now why is overkill so widely used
well this one has been the the method that has it's it's been the top choice in in
the industry and that's because it's the easiest one you don't have to perform
different cycles to estimate your time you can just estimate your time in different ways based on the loading
configuration or based on the pcd that you're using
it doesn't require much vibrant information because you're you're aiming for killing everything
it's well understood it's accepted by almost everybody in fact up to a few a few years ago two
to three years ago you would still have to face scrutination
or you will have to justify on why you're doing a different cycle approach that it was in the half
cycle approach just again because it wasn't so understood and it wasn't so accepted
now because of the challenges that we're facing with with watching our epilen oxide
consumption we we need to be more responsible and and we need to understand this more um
different approaches and i have seen an increased acceptance from the regulatory bodies when
by doing a different one so that's the good news there um and then again three half cycles you
have to use a a pcd that's uh at least 10 to the sixth
now whoa why did it pop
let's go over the cycle calculation approach um so the the way that this is please don't
feel i hope you're not feeling overwhelmed when when we when we say uh when we talk about these
alternative alternative approaches they they are really based on the same principle so let's go through
them you have any questions type them in or chat hopefully we'll we'll get to them all but um it's it's it might be daunting at
first and the concept might be hard to understand at first nevertheless um
it's i i promise it's it's it gets easier as you apply these concepts
so psycho-calculation approach the way that you do this is you are going to take your load and you're going to expose it at
different cycles you can also use different vi's with different populations if you'd
rather keep the cycle time constant you can do so as well i personally like
performing different varying the time on on my on my cycle calculation instead of the
population but then again you can do either one um so the reason why you do this is you want
to build your microbial decay curve you want to you want to build that curve that courtney you showed earlier and we're
going to show you one more a little in in a couple minutes here but that's the purpose of that you want to
build your microbial decay curve right you don't want to just assume a straight line with the half cycle
approach now once you have run those fractional cycles
then you determine the value of the load now here you can do it in you can take
two different approaches here as well you can use you can use the of different um calculations
that are aimed to give you the value on the fraction negative of the curve or you can use a different
calculation and that's direct enumeration and that's aimed to give you data on the positive side of
the curve or on the on the direct enumeration that's the direct enumeration approach
now how many bis are you going to use in your load that depends on which method you used to you want to choose
for instance if you want to use the holcomb experiment carver method you have to do a minimum of five
exposures and you have to show that one of those exposures have all bis
growing you want to show two fractional with growth and two would all know growth right and you have to use a minimum of
20 bis per cycle on the contrary if you want to use the stumbo murphy cochrane
then you use a minimum of 50 bis per run but you only need to have three runs in
the fractional negative range some people get lucky and get it right on the first three fractional cycles and
then you're done um but some people would like the the would like to have the additional
confidence that the whole time experiment covered method gives you by giving you a confidence interval
that's the main difference between the two that you get a confidence interval with one you can get a confidence interval
with the other but you're required to do a little bit more math there um and and also with the other one
you get to have less cycles if needed so so you run your cycles uh you calculated
the deep value and now you get to take that and extrapolate
to get your routine cycle time the way that you do that is by multiplying and or really by
adding the summing that's the sum really that's the right mathematical term you sum it to your um sporolog reduction
so i have um i have a few [Music] formulas here for um
for the different the value calculation methods this is in 11 138 as you get familiar
with the valley calculation methods you just pull the standard and it goes through the derivation of all
these formulas and it gives you the number bis it it gives you everything you need to
select the correct value calculation approach so all right let's let's go through an
example and let's go through step by step method so you're you want to use the the psycho calculation approach
first step you perform your fractional cycles with your ipcd you build your decay curve and the
number of bis will depend on the method that you selected of the devalue once you run those you
take you calculated the value and after that you will you need to
calculate the minimum as poorly log reduction because this is overkill
you will always have to do a a 12 a spoiler sport log reduction of 12
because you are looking at ten to the minus six right for any sterility um claim
will have to show us the reassurance level of ten to the minus six which is a probability of one survivor
organism in a million right so that's that's that's based on the standard um we'll we'll go from there
now don't get me started on where did that come from where did the one in a million uh come
from right but that that's that's a different topic um is it appropriate is it too much
i'm on the on the less conservative side of the list at 10 to the minus 60
relations level is too much however that's what we do in the industry for sterilization so because
you have to go down there to the 10 to the minus six zone on your kill curve um
we you end up with an ester with a spore lock reduction of 12 and that's because you're starting with
a population of one in a million um you take okay so you calculated your
the value and then you calculate your minimum steady sport log reduction which in this case is 12.
now you will take that the value from step two and you're gonna sum it with step three
and that would be the minimum exposure time for your full cycle now that you have
the time you are to run a confirmatory cycle that's your full cycle that's where you
prove your your ppq on your validation that's this is where you get your residuals this is where you
get your temperature humidity data um and all all the stuff that we need to use so i have an example here
um in this case we chose the standard murphy cochrane the valley calculation we exposed the
load at the two different cycle times and each one of them had a different
result on on the ice growing and no growing the value calculation using that formula
that i just showed you it was a 12 11 13. um if um i i think i got the wrong numbers
here but just picture here that is 12 11 and 13 and then you get the average of that your average d value comes out to be at
about um 12. so you take that 12
the value and multiply it by your score log reduction that gives you a cycle
time of 144 minutes so that's very simple
i know it sounds simpler than it will be because getting fractional cycle
fractional growth sometimes is a challenge but on the math end it's it's not more complicated than than that you're
just multiplying the the slr by the d value by the average the value and you're there now some
people um they they want to include an additional confidence interval so they
actually calculate the standard deviation and then just add it to this calculation um to you to the
cycle time and that's doable as well i've seen as much as three standard deviations added to this time
so that's again somebody that wants to be more uh more conservative
all right now let's talk about the bi bioware and approach really this this is really based on the
same principle um you will the difference is that you will start
on your curve at a different population meaning you don't get you don't have to come all the way and show your
10 to the minus sixth relations level from a starting population of a million
you actually start at a hundred or a thousand depending on where you buy a burden is
the main concept for this approach is is that you have to understand your bio berlin you have to
have uh levels and you have to have controls as you're manufacturing your devices um
vibrating control is crucial right because this is not a this approach is not meant
for a manufacturer to just do the testing a one-time point right before the
validation it's meant for manufacturers that understand the vibration over time that they know how it changes seasonally
um and and this this is pretty pretty important to understand
so if you are at this level you understand you buy a burden the next step for this validation
approach is is to do pretty much the same thing that you did on the cycle calculation approach
you are going to you can either use different times for your fractional cycles or you can use different bi titers
for for those cycles and then this is this is what i was talking about earlier your slr you still have to show a 10 to
the minus six the real issuance level nevertheless because you're starting at a different point because you're
starting at a hundred by version you only need a sport log reduction of paid instead of a 12.
um that's that's the difference and that's the beauty of this of this approach all right i hope i hope
you're all following um we'll go through a step-by-step uh method same thing step number one you run your cycles on
your ipcd you choose the value calculation method once you have it
you're going to sum it to the only additional step here is that you're going to get the log of your buy
burden and you're going to sum it to the log of your studio assurance level and you multiply the value from step
two with that from step one to the step two from that calculation that you just did
and you get your time and you just run a confirmatory cycle it's another example your d value was
after you run all three cycles thermomurphy cochrane you got a 5.5
d value um your vibration is a thousand so the log of that thousand you're gonna
you're gonna sum that to your sterility assurance level or your log reduction which is a ten to the minus six
so that gives you a positive six um and i'm i'll call it right here um so that that
gives you a a sport log reduction of nine then you take that four log reduction
multiply it by your d value and this is your exposure cycle time um
yep and that's that's as simple as simple as that um this table just shows you
as just a comparison approach the number of cycles that you have to do the number of bis um one thing that i
like to point out here is that you don't think half cycle on on these three different approaches
the only time that you think half cycle is in your overkill half cycle approach i get questions from
clients sometimes and say okay so now i have my time from the fractional cycle so now i run a
half cycle right like no no you go straight to your full cycle to your p to show your ppq
um parameters that you need to show for the validations just remember that
all right this is my favorite slides of all this is what i was talking about earlier if you choose a bi bio burden you get to
start at a different point of the curve to show your curve decay to get to a 10
to the minus six daily assurance level right so your your log reduction is going to
be your six that are on your negative side of the curve seven and eight that's your your your log
uh reduction right as opposed to the half cycle where you have to assume
a million organisms in your device right so then you're starting over here then your log reduction is a whole
12 log decay um that's that's a lot right so that this is this is where i
highlight the bi vibrant method now let's talk about the cycle calculation
so this one is a cycle enumeration this d value was calculated based on the
positive side of the curve right because you're you're dealing with survival organisms this one is on the fraction negative
side of the curve because you are dealing with probabilities you're on the quantum zone right here
for your d value calculation the slope of your line is going to be different and this is what the d
value is telling you right so your your cycle calculation is giving you
this slope that is the resistance this is how quickly your organisms are
going to die so by having a more accurate devalue a more accurate slope of this curve
then you don't end up with a very long slide this picture is like when you go to the park and and you have
like the longest more a stretchy slide in the park you take forever
to go down i don't know what's happened there you take forever to go down on a slide
on the part that is that the slope is so long right but you have a more inclined slow
a shorter slide boom you're there it's the exact same concept um and yeah that that that's what the
value gives us um on on this approaches
all right so for just to conclude on this and this uh on this on the validation
approaches um by having a different and half cycle approach we will we might
we will increase the cycle efficiency i i i don't want to say my i don't want to say will either but
i'm pretty sure and data shows that you may have a shorter amount cycle and a better efficient cycle um in order for
you to to reach this level you have to have more knowledge on the bible then and by knowing these two cycle reduction
will be significant um and then again putting it all together this is why
having a right the right pcd is crucial right because it doesn't matter if you calculate
a great cycle on on on bi by burden or you calculate a good on
an amazing cycle and psycho calculation approach if your pc is all the way over here right next to your
overkill it doesn't really matter you won't be able to kill your pcd if you once you calculate a time that is
shorter than what you did so again apply to to do different alternatives to chose your
pc all right i hope that that wasn't too much um
for for us to grasp now um this next section um
it's um we wanted to talk about a little bit on sterilization parameters
and and really we wanted to do this to set the stage for our next
um day webinar that's next week on thursday where uh mike and ross are gonna take us
a little bit more on how to optimize a cycle that is already there and they're gonna touch more on this on
how to to change certain parameters to get us a good um
reliable cycle so we'll talk a little bit more about that next week what i did wanted to mention this week
and just again to set the stage is that um just just to remind you to
to bring us back to the basics of this right your main parameters uh just go back to
remember what the main parameters what the intention of the combination of these main parameters
are and that's your gas concentration your relative humidity temperature and time all these together
aim to help the eo the ethylene oxide molecules to reach
and have a better contact with your product right so um and there's lots of literature out there
on how gas concentration and temperature plateaus at certain after a certain time and
after a certain concentration and a certain um
degrees because really more doesn't mean better um so yeah so you go back to your
main parameters you have a product that it's temperature sensitive or is humidity sensitive
and you cannot really do much with this or if you have already maximized these
four there are additional parameters that can help you and can can actually increase the yo
penetration to the device for a better contact and that's that's what we're going to be talking
about and doing more of this but this additional parameters you can use to your advantage
and help create different dynamics in the cycle to help with an additional
microbial destruction so as an example of those are you're doing
dynamic conditioning as opposed to a static dwell time or doing some actual dynamic
evacuation as well some sterilizers have the capability to add steam or our water molecules at the end
of the cycle during the dry inauration phase um and we have a on the slides we have a
couple of a few parameters again that that can help you there if you're going to do preconditioning
you know are you are you doing a cold start are you um are you looking in
viewpoints and condensation on your load making sure that it doesn't get too wet right so it better penetrates
so eo better attaches to the molecules when it's in the chamber again temperature temperature is a big a
big win if you are running low and your temperature and your device is not temperature sensitive we
this is the first time or this is where we the first thing we look at different temperatures are used for
different phases your initial evacuation deeper vacuums are going to
give give better performance because it's going to help the eo molecules to reach your difficulty
difficult to sterilize location uh conditioning dynamic conditioning this is i'm a big
fan of this one water molecules are an excellent catalyzer for your molecules to
to help facilitate and facilitate their diffusion um again if you are able to do combine
these two some dynamic vacuums and air flushes in this in this
phase that we're going to give you a good and efficient cycle uh ghost concentrate gas concentration i
know it seems continually iconic intuitive but but more gas is not always proportional to more lethality
and we'll talk about that next week a little more same with time um this this is this came back
came from all the validation work that you did earlier right from the different approaches
instead of having a 700 minute cycle you are now have a very efficient uh lower amount of time on this cycle so
so this is what it's going to pay off and again post vacuum you can use some dynamic vacuums there um
and that is it hopefully you're endured through all that and now you can feel that you're
able to understand these concepts a little more you can go back to your co-workers and tell them you learn all about different approaches for
validation other than half cycle and um i believe uh mike are you

Speech Record: Validating, Optimizing And Monitoring EO Sterilization Processes

Publish Time：2023-12-28