800.777.1198

Located in Sycamore, IL

Brandi

Jack

Dear Old Iaq

If your assessor wants to see the calibration certificate or calibration by third party, they actually means it and probably it will be difficult to negotiate down them to rather a simple solution (although in most of the cases and for most of the assessors it is acceptable) of using a maximum autoclave thermometers. Be ready for the “trouble” during assessment or closing an NCR. First let me explain what actually assessor wants to know and see in case of an autoclave.

·          Autoclave is the main microbiology laboratory equipment and reliability in sterility at right temperature and for a right period of time is the key for reliable results; because this either lead to incomplete sterilization or overheating that may affect the performance of media or other items.

·          Calibration is required for time and heat or pressure. Timer verification can be achieved with a calibrated clock or comparison with national speaking clock. You can perform this annually or after each modification or repair and keep the record.  As pressure and temperature only one is enough for calibration because both correlates with each other; if one changes other will also change in proportionality. I (and most of the assessors) will prefer to have a calibrated temperature device, autoclave fitted thermocouple or externally used calibrated maximum registering thermometer traceable to NIST to record the temperature for each run.

·          But when assessors says they want to see the calibration certificate; most of the laboratories consider they want to see calibration record of thermometer/ thermocouple or pressure; but for calibration of autoclave it means little more. Calibration of autoclave actually includes;   establishing its functional properties initially at the time of installation in the laboratory, e.g. heat distribution characteristics with respect to typical uses. This process must be repeated after significant repair or modification (e.g. replacement of thermo-regulator probe or programmer, loading arrangements, operating cycle) or when performance is questionable and after a repeated frequency let’s says two years. The sterilization/decontamination cycle must take account of the heating profile of the load. Clear operating instructions shall be available based on the heating profiles determined for typical uses and you should have records of these multipoint calibration studies. This is a job of expert but you may do your self; generate such data and develop particular instructions based on this study.

With the performance evaluation record as above, preventive maintenance record, performance evaluation and preventive maintenance schedules, use of calibrated thermometer (autoclave fitted or maximum registering) to keep the record of each run, use of chemical or preferably biological indicators with suitable frequency, I hope you will be able to satisfy any “hard” assessor.

I hope this helps

sabir

By the way we have two Market Forge Sterilmatics that are old but still work like champs    

Mark Wyzalek
Manager, Laboratory / Environmental Compliance
Macon Water Authority
478 464-5678
www.maconwater.org

http://hbinstrument.thomasnet.com/viewitems/thermometers-special-application/autoclave-thermometer?&plpver=10&forward=1#

sabir

The need is for the ability to measure the temp of an autoclave run so as to ensure that the required minimum temp is maintained during it. Std Methods wants the max/min recorded once a week. 

Mark Wyzalek
Manager, Laboratory / Environmental Compliance
Macon Water Authority
478 464-5678
www.maconwater.org

Market Forge sells a continuous temperature recorder for the SterilMatic part no. 95-2606 (120 V).  I installed one for the autoclave here in the micro lab after ELAP recommended one.  You can view Market Forge's Price List PDF on this particular autoclave:

http://www.mfii.com/products/healthcare/sterilimatic/sellsheet/PDF/s3220.pdf