A
aramono
Hello,
It's my first post and before every thing I’m so sorry for my bad English.
I need to develop a SOP for calibration of temperature and pressure of the autoclave's chamber when machine is working (during machine working on) But I didn’t find any guideline to do this.
I read many related standard ( because in time I develop a non complete sop for validation according to EN17665) such as: EN 285, EN 13060, EN 17665, HTM2010, PDA tr no.1,
And also I can’t find the scope that I need, in some temperature calibration standard (that are specially for testing Environmental & climatic chambers) such as IEC 60068 ( I review approx. all parts) afnor nfx 15-140, dkd-r 5-7. Because all of them need to stable condition for temperature recording and also need to calibrate at atmospheric pressure.
Unfortunately the validation process that explained in these standards (EN 285, EN17665) had many critical parameters like how to measuring equilibration time, fluctuation, variances, and more item but didn’t focus how to calibration.
I need to calibrate for example 8 points of sterilizer chamber in 2 temperature points 121C and 134C, and also for pressure.
I need a guideline that explained a procedure for calibration temperature, in pressure about 3300 mbar absolute and also another one to calibration pressure, in 134C.
Thanks for your cooperation.
It's my first post and before every thing I’m so sorry for my bad English.
I need to develop a SOP for calibration of temperature and pressure of the autoclave's chamber when machine is working (during machine working on) But I didn’t find any guideline to do this.
I read many related standard ( because in time I develop a non complete sop for validation according to EN17665) such as: EN 285, EN 13060, EN 17665, HTM2010, PDA tr no.1,
And also I can’t find the scope that I need, in some temperature calibration standard (that are specially for testing Environmental & climatic chambers) such as IEC 60068 ( I review approx. all parts) afnor nfx 15-140, dkd-r 5-7. Because all of them need to stable condition for temperature recording and also need to calibrate at atmospheric pressure.
Unfortunately the validation process that explained in these standards (EN 285, EN17665) had many critical parameters like how to measuring equilibration time, fluctuation, variances, and more item but didn’t focus how to calibration.
I need to calibrate for example 8 points of sterilizer chamber in 2 temperature points 121C and 134C, and also for pressure.
I need a guideline that explained a procedure for calibration temperature, in pressure about 3300 mbar absolute and also another one to calibration pressure, in 134C.
Thanks for your cooperation.
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