autoclave qualification

Hi, I want to qualify autoclave. For biological challenge in liquid product, I want to use spore strip as indicator. Because I’ve heard that indicator in ampules type can influence heat penetration as barrier. Could I put the spore strip into the liquid product? If I put it into the empty chamber, could it represent the condition? Because I think air is the worst heat conductor. So if it can be success in the worst condition, it will be applied in common usage, isn’t it? Thank’s before.

Best regards,

Felisia

Hello
The liquid loaqd you are probably talking abiout the filled product load.
This can be done by adding the biological indicator ( Spore suspension) in the product itseld to the concentration of 10^6. Also you have to chek the recovery of the same in the product. If you can demonstatrate the sufficient recovery then it can be successfully.

Dear Anil and Osama,

Thanks for your attention. That’s really helpfull.
But, any recommendation for usage spore strip that contact with the liquid test material?
Any information is willing to impart would be greatly appreciated!

Dear Felisia,
Can you please let me know why exactly you want to use the spore strip only So that it will be easier for me to shao a better alternative.

Anil

Dear Anil,

It’s about contradiction of usage spore strip and ampules type. Some said thet glass material inhibit the heat penetration and reducing the “power of heat”, so it can’t represent the real condition in sterilization. That’s why I try to find reccomendation about it. Do you have any opinion about this problem? May it can make us sure that the contradiction is unreasonable.

Thanks.

Best regards,

Felisia

See
You are interested in the heat load which is given to the product not the container. The load of interest is the material inside the glass container. By using the ampoules you can best demonstrate that. Your product is in the glass container and similarly your BI is also in the glass container which mimics the actual load of interest.
If you want to use similar container put the BI suspension in the product.
Please feel free to communicate if you have furthr things to discuss.
Anil

I faced one problems during qualification of tunnel ,I got 300OC & above temperature in 3 out of 12 selected location and say after 5 min next 4 location I got 300 OC + temperature but same time all other 8 location showed less then 275 OC, after that I checked diff. Pressure & aif flow and fond ok , can anybody suggest me from where I will take hold time and what is the probable cause for that.

Regrds
Hiamnshu

[quote=himanshumb]I faced one problems during qualification of tunnel ,I got 300OC & above temperature in 3 out of 12 selected location and say after 5 min next 4 location I got 300 OC + temperature but same time all other 8 location showed less then 275 OC, after that I checked diff. Pressure & aif flow and fond ok , can anybody suggest me from where I will take hold time and what is the probable cause for that.

Regrds
Hiamnshu[/quote]

Dear Himanshu,

Calculate Fh value and endotoxin 3 log reduction test, as far as diference in temperature with in sterilization zone , you must check air pattern , air velocity. also check the HEPA filters condition.

thanks

Dear Shahnawaz

thanks for your suggestion Thanks for your suggestion, I checked all the test what you were mention i.e. air velocity , air flow pattern and Diff. pressure and I got everything as per design criteria , my problem is from where I will start to calculate hold time &fh Value as I mention in my earlier mail I got different temperature range in same time say for example at time x I got in Channel1 – 256, ch-2-272, Ch3-248, ch-4-287, ch-5-291,ch-6-301,ch-7-310, and my acceptance criteria is 300 for 3 minutes , can I pass my validation test only base on FH value & 3 log reduction? Please help me on this issue.

[quote=himanshumb]Dear Shahnawaz

thanks for your suggestion Thanks for your suggestion, I checked all the test what you were mention i.e. air velocity , air flow pattern and Diff. pressure and I got everything as per design criteria , my problem is from where I will start to calculate hold time &fh Value as I mention in my earlier mail I got different temperature range in same time say for example at time x I got in Channel1 – 256, ch-2-272, Ch3-248, ch-4-287, ch-5-291,ch-6-301,ch-7-310, and my acceptance criteria is 300 for 3 minutes , can I pass my validation test only base on FH value & 3 log reduction? Please help me on this issue.[/quote]

Dear Himanshumb,

The real concern in sterilzation/ depyrogenation is to achieve SAL, if your tunnel can acchieve 3 log reduction of CSE (Control Standard Endotoxin) and required Fh value then you can declair pass this tunnel.

At 250°C, the time required to disintegrate pyrogenes 1-log cycle, is 5
minutes (D-value). Empirically has been determined that for every 46.4°C.
increase in temperature, the D-value will be reduced by 1-log cycle.
In other words, at a temperature of 296.4°C, a 1-log pyrogene reduction is
accomplished after 30 seconds.
At a temperature of 342.8°C., a 1-log
pyrogene reduction is accomplished after 3 seconds.

        1-log cycle 2-log cycle  3-log cycle    4-log cycle

Z250 → D5min. D10min. D15min. D20min.
Z296.4 → D30sec. D60sec. D90sec. D120sec.
Z342.8 → D3sec. D6sec. D9sec. D12sec.

I think this will help you,

Thanks

hanks Shahnawaz

Dear all,
Any exact value for Fh and Fo?
Or it depend on our policy?
For my study, I use term that Fo must be > 12 and Fh must > 750.
Is it right or not?
Because, I can’t find any literature abuot it.

Thanks,
Felisia :wink: