Autoclave validation

Hi all,

Just a quick question regarding the equilibration phase of a autoclave cycle.

Why is it that the equilibration time shall not exceed 15 s for sterilizer chambers up to 800 l usable space and 30 s for larger sterilizer chambers?

If the equilibration time does take longer than the maximum allowed time, is it an indication that the chamber is overloaded?

Thanking you in advance!

Jayo

[quote=Jayo]Hi all,

Just a quick question regarding the equilibration phase of a autoclave cycle.

Why is it that the equilibration time shall not exceed 15 s for sterilizer chambers up to 800 l usable space and 30 s for larger sterilizer chambers?

If the equilibration time does take longer than the maximum allowed time, is it an indication that the chamber is overloaded?

Thanking you in advance!

Jayo[/quote]

The 15 second for small sterilizer and 30 second for larger sterilizer is as per sHTM guidelines.

Yes, This may be one reason for not achieving the equilibration time within the specified limit that the chamber is overloaded. To achieve 15 or 30 sec. equilibration time you can arrange the load in such a way that the steam can easily penetrate in every part of load. Also you can achieve the equilibration time by making slow heatup or by keeping the spare (exhaust) ON during heatup to achieve uniform heat distribution. Also you can check the accuracy of each sensor used in cycle. Off coarse all this requires many trials

Hope this may satisfy your question

Thanks Sandip!
I think we’ll start with increasing the vacuum and steam pulses. Not only are we having trouble with equilibration times, but we are also struggling to reach temperatures inside long pieces of flexible tubing with 3 pulses.

Thanks again!

In my experience it is not possible to get consistent steam penetration in tubings greater than 10’ no matter what settings you use.

If you have variable equilibration times the first place to look is vacuum pulses. Three pulses to 300mbar is a good starting point.

Jason

[quote=Jayo]Thanks Sandip!
I think we’ll start with increasing the vacuum and steam pulses. Not only are we having trouble with equilibration times, but we are also struggling to reach temperatures inside long pieces of flexible tubing with 3 pulses.

Thanks again![/quote]

It has been my experience, with large pre-vacuum sterilizers, with loads containing stoppers and tubing, that a minimum of 5 pulses will do the trick. Also, during the charge, try staying below atmosphere. We run (based off of the advise from industry experts), vacuum to about 1.5PSIA (assuming the unit can achieve a deep enough vacuum) and charge to 12PSIA. Repeat for a total of 5 pulses. I have also done it while increasing pressure during each purge, from about atmosphere to 30PSIA, incrementing during each pulse.