Do you have to perform an autoclave minimum load validation run (3 times), with biological indicators (BI) if you;
Established a temperature mapping with an empty chamber run. (with BIs)
Have performed a worst case maximum load validation run (3 times) with BI.
I question this by looking at the big picture.
• What would a minimum run provide for (in data), that the maximum run has already provided and established as a worst case scenario?
• How would you even determine what your minimum run is, i.e. 1 tube or one part etc?
• If we do consider a minimum load validation run to be a separate validation then a max… are we saying that if an autoclave fails at a minimum load configuration and passes at a max load configuration that the autoclave is only valid to use in maximum run scenarios?
However, that seems not logical, if it fails at any configuration, determines there is a problem with the autoclave. To get this, a worst case approach should be used, not best/easiest configuration.
Examples:
• When other processes are validated take example an aseptic media run, you would not run one container through a production line to show a minimum, it is always maximums.
• If X Car Company produced a car it would not be tested by driving it only slow and straight and then claim it was valid for high speeds and corning.
Please advice, it does not make sense to me.
Thanks for your guidance on this.
In terms of sterilization, the logic is reversed a minimum load is typically perceived as worst case. Why? Ramp rates are typically less sloped with maximum loads, thereby imparting more exposure to the load (think longer cycle).
Your worst case should be your worst case item (slowest to heat) in the cold spot minimum load.
The only reason I would do minimum and max trials is to provide production with the flexibily to run between the extremes. If you plan to validate only the maximum load, then there is no reason to do minimum.
And the question concerning temperature distribution in empty chamber investigation during OQ.
From ISO 17665 it’s obligatory during OQ, but is it necessary to make this 3 replicate times to show reproducibility, as it obligatory for PQ (9.4.6 17665-1)?
Then concerning requalification approaches:
Do we need to perform OQ temperature distribution at all? ISO 17665 doesn’t describe this definitely?
If we have different type of loads (for example, ampules 1 ml, 2 ml, 5 ml, 10 ml and 20 ml the same set temperature and exposition time). During first qualification we have qualified 3 times each ampule’s size and each programm - is it possible during annually requalification to perform only minimum and maximum loads, i.e. 1 ml and 20 ml in a given example (actually minimum and maximum weight)?
Also for the same situation (same load and same set temperature), but with different exposure time, for example 8 and 15 minutes - during requalification if we achieve the lethality at 8 minutes, could we avoid testing 15 minutes program?
[b]In 1980 the USP first formally recognized the now-standard sterility assurace level (SAL) of 10 to power 6 (i.e., assurance of less than one chance in 1,000,000 that a sterilized item is microbiologically contaminated) as alegitimate target for sterilization processes.
However, application of the SAL approach to determining sterilization cycles requires much more microbiological information than the compendial cycle approach or the over kill approach,namely an actual knowledge of the numbers of microorganisms conlamimuing product items.[/b]
FBIO = SLR x D121°C-value (F-value of the process)
D = theoretical (assumed) bioburden resistance of 0.5 min.*
N0 = initial (assumed bioburden) population (102)
SLR = Log N0 − Log (ln a/x)
SLR = spore log reduction (log reduction of the BI population achieved during the cycle)
N0 = initial count of BI’s (control count)
a = number of BI’s tested
x = number of BI’s negative
FBIO = SLR x D121°C-value (F-value of the process)
D = theoretical (assumed) bioburden resistance of 0.5 min.*
N0 = initial (assumed bioburden) population (102)
SLR = Log N0 − Log (ln a/x)
SLR = spore log reduction (log reduction of the BI population achieved during the cycle)
N0 = initial count of BI’s (control count)
a = number of BI’s tested
x = number of BI’s negative[/quote]
Dear all,
I am going to do autoclave validation,Can i get ISO standard reference for it,if anyone has it.
Or any other standard wherein the acceptance criteria is also mentioned.
Thank you in advance.
I am going to do autoclave validation,Can i get ISO standard reference for it,if anyone has it.
Or any other standard wherein the acceptance criteria is also mentioned.
Thank you in advance.
Regards,
Aparna[/quote]
If you have liquid load I suggest you PDA Technical Report 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control.
[quote=joksavs]If you have liquid load I suggest you PDA Technical Report 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control.
If you have porous load then EN 285[/quote]
Thank you very much for your reply.
Can you please mail me the both the copies on aparnajagadale@gmail.com as i didn’t found the same on net