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Autoclave Qualification

Can anybody help me in this isuue (Autoclave Validation). We have Autocleve (heaters). I performed 3 runs heat distrbuion (empty load) & three runs (full load). and it passed . during the penetration studay, the internal temperature didn/t reached the 121 C so i increased the temperature set point to be 123 C with the time, to get 121 +/- 1 c insdie the bottelss and to acheive 6 log reduction. My quasion is: Should I repeat the studies distribtion forfull and empty loads, or i directly go to penetration study (3 runs)?

jalal

HEAD OF VALIDATION

Hi Jajal,

As you increased the temp to 123C, this temperature provides the same lethality as as 2.45 minutes at 121.1C.

As you fulfilled the requirements for (empty load) & three runs (full load), my opinion would be that it would be fine to carry on with the penetration study.

Below is a link to a white paper released by ISPE in 2002 which gives a detailed practicle approach to autoclave validation, which I think you find both interesting and informative.

http://www.idc-ch2m.com/Papers/IDC2002%20autoclave.pdf

Regards

Let me see if I understand this correctly. You did an empty chamber test and a full load test with a setpoint of 121°C and they both passed? What is the acceptance criteria for “passed”? Uniformity? of load? Control? Drain?

I have yet to see an autoclave that can maintain temperature uniformity within the chamber, when the chamber controlling setpoint is the same as the target temperature. Typically, there is an offset of 2-3°C required between the controlling temperature and the chamber temperature.

Now as far as going forward with penetration studies…I would say that the you haven’t really developed a cycle yet. Wouldn’t it be more prudent to develop a cycle before moving into penetration.

Dear sear

As you know, the controler is calibrated befor the heat distribution study (empty, full) and all the three run’s for empty load and full load were successed. the problem is when performing the heat penetration study, the temperature insde the bottels couldn’t be reached to 121 C, so I increased the set point at 123 C to get 121C INSDIE THE BOTTEL. MY QUASION IS, sholud I repeat the empty and full runs for the new set point.

many thanks

jalal

I don’t know if I would repeat the empty chambers. I would probably do 1, just to have data to support the equivalence between the different set points. I like to have data on hand and to guess auditor’s questions before they are asked.

I wouldn’t call it repeating the full load. In my book, you were doing cycle development. I would look at the AC for the test. Was the AC just to reach a temperature of greater than 121, or were you looking for an Fo value? Typically bottles ramp up/down slow and there for may meet your Fo requirements. What about spore strips and determining edge of failure? Do you know your failing point? Do you have a correlation between drain temperature and load temperature? Hopefully you don’t intend on using load thermocouples.

our AC IS (6 LOG REDUCTION X 1.8 m BI’s AC)= 10.8min (F0) at 121 C
+/- (1 C).

WE TRIED THE FOLLWING RUNS:

1- 121 C FOR 15 min THE FO=7min & the resultes of BI’s (+ev) — fail

2- 123 C For 15 Min / the Fo= 8 min & the resultes of BI’s (+ev) — fail

3- 123 C FOR 25 min / the fo= 25 & the resultes of BI’s (-ev) — pass

Note: for theis run we have tested the Media & ther was degredation &
        it passed

There is no correlation between the drain temp. & load temp. since the controling sensore is located nearest the elctriac heaters and far away from the drain. durin the empty and full load studies, the drain was the coldest point, and during my load configiration there is nothing to be located at this point (drain)

I was expecting a heat liable liquid run. Those are not so easy to do. It is hard to apply wrapped goods methodology to them. It’s been a awhile.

The primary objective in sterilizing heat labile materials is to provide the amount of heat that will result in an acceptably low probability of non-sterility yet not adversely affect the product.

From what I recall, you need to determine the Fo where the media is degraded. Once this is known, you will need to determine the level of bioburden occurring in your media. Finally, do comparable studies to determine if you can use water to simulate the media (cheaper for development). Then find a cycle that is less than the degradation Fo but enough to assure that there is a high probability that the naturally occurring bioburden has be rendered sterile.

Dear Sir,

We will calculate the minimum Fo value, but is there any guidlines for maximum Fo value.

not certain of your question, why would you want to know the maximum Fo?

your target should be acchieve at least minimum F subo, to attain lethel temperature, which is most suitable 12 minutes at coldest point.

Mr. jalal you have to repeat the whole validation exercise (Empty mapping, distribution& penetration without BIS and Distribution & penetration with BIs) on same parameters for example 123°C, so you have to qualify steam sterilizer on at least 3 runs on each parameters.over all 9 runs, and u have to be calculate different mass configuration studies also.

Mr. Jalal

You have to repeat your all cycle.
first of all you have take a trial with maximum load ( penetration cycle ) at 121 set point for 30 min. & calculate the Fo value. if u achived above 10.8 min Fo value then u can set your parameter and run all the cycles.

[quote=jalal29]our AC IS (6 LOG REDUCTION X 1.8 m BI’s AC)= 10.8min (F0) at 121 C
+/- (1 C).

WE TRIED THE FOLLWING RUNS:

1- 121 C FOR 15 min THE FO=7min & the resultes of BI’s (+ev) — fail

2- 123 C For 15 Min / the Fo= 8 min & the resultes of BI’s (+ev) — fail

3- 123 C FOR 25 min / the fo= 25 & the resultes of BI’s (-ev) — pass

Note: for theis run we have tested the Media & ther was degredation &
        it passed

There is no correlation between the drain temp. & load temp. since the controling sensore is located nearest the elctriac heaters and far away from the drain. durin the empty and full load studies, the drain was the coldest point, and during my load configiration there is nothing to be located at this point (drain)[/quote]

Dear Mahak,
how can u say that, F subo value is more than 10.8 min, i think it should be greater than 12 minutes at coldest piont.
Please comment on it.

I m waiting for your reply
Thanks

This might help

http://www.askaboutvalidation.com/fe...ded.php?uid=16
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