Autoclave Cycle for probes

GOOD MANUFACTURING PRACTICE (cGMP)
1

I was hoping for some help with an autoclave cycle for probes. Has anyone else had to validate pressurized gel filled pH probes in an autoclave cycle?

My company wants one cycle to autoclave DO and pH probes for our one bioreactor. The DO is a solid good, but the pH has a pressurized gel inside.

I would treat this as a liquid cycle because of the gel, but I’m not sure how to measure the temperature of the gel and verify that there is no growth. The manufacture has informed me that the gel is sterile and pressurized, so nothing should flow inward.

I really don’t have the tools (or the spare probes) to drill a hole into the probes and deposit microbes, as suggested by others.

2

Seems to be a bit confusion here. The pH and DO probe sterilization is done (generally) by dipping them in water and plugging the gaps with cotton or other porous material. For effective sterilization, intermediate vacuum run ensures vaporization of hot water. You can challenge the process by keeping challenge organism in water.

Drilling a hole into the probes is a fancy idea (and this doesn’t require sterilization as you have to through it anyway.)