How to consider equilibrium time for steam sterilizer (empty chamber or loaded chamber)?
Another main question is equilibrium time observed routine cycle or only for qualification time observed ??
The 30 second equilibration requirement came from EN285 (from Europe, but being adopted world-wide).
The purpose of the requirement is to show that all the air has been removed from the equipment, and that steam has consistent concentration throughout the load.
In case of long tube sterilization,You have a few options here to meet that requirements. (1) Break the load into smaller parts (so steam can effectively get to every nook/cranny), but then you’ll have to aseptically re-assemble the parts under hood or using sterile connects. (2) Replace some of the tubing to have larger diameter. (3) Shorten some of the lengths of tubing.
Another thing to look at to help see if there is adequate steam penetration is temperature uniformity within the autoclave. There are additional requirements in steam sterilization industry standards that all temperatures are uniform or within +/- of the mean.
Also, another thing to consider with tubing assemblies, is that arrangement of the assembly within the sterlizer can have a huge impact on results. A coil of tubing with a low point could cause a puddle to form in the tubing during a run, blocking steam, and therefore causing the sterilization to be ineffective. In this case, something might pass validation then when set-up by someone else, there might be less caution to avoid low points, then the load might not get sterilized, and potentially hurt/kill someone due to microbial contamination.
Equilibrium time is observed during qualification .
Any guidelines availble, only qualification time equilibrium time observed ?
Equilibrium time can be measured by Kaye validator or data logger which is used during autoclave validation.
Autoclave print also consider ??
Guidelines says equilibrium time 15seconds for small chambers and 30seconds for large chamber. Why 30seconds or why 15seconds. Incase in cycle observed 35seconds that cycle is consider failed run. Any formula is there for 30seconds for equilibrium. Any reason is there please tell.