"Raven states that they have tested the ampoules up to 135oC. The issue that we encountered for the testing of the resomator was the caramelization of the media. Raven proved that the caramelized media still maintains the ability to promote growth, but the color change is not as dramatic as would be observed from a non-caramelized ampoule. Therefore, for caramelized ampoules, the best growth indicator is turbidity or by viewing under a microscope. The tests provided by Raven were based on ampoules exposed to 135oC. We took ours up to 150oC. Raven requested the pictures I took since they have never performed tests at this temperature. Common sense would dictate that exposure at 150oC for an hour, resulting in caramelization, would be indicative of sufficient thermal death time, but there is no statistical evidence to support this."
	"Since, the Raven ampoules have not been tested at the temperature used in the Resomator, approx. 300oF, we do need to be sure that the growth media is still viable. I would suggest that you run a few more cycles (3 - 6) with either spore strips (as presented in the protocol) or ampoules. If you use ampoules, your lab will need to open the ampoules immediately after the treatment cycle and perform a culture test with the treated media to prove its viability. If you use strips, they need to be compatible with the temperature as well, and your lab will need to insert the strips into growth media immediately after the treatment cycle."
	"The time needed to kill the spore challenge is significantly less than the thermal insult required to change the ampoule color to bourbon”. To extrapolate on that statement it is also true that the thermal energy required to change the ampoule color to bourbon is significantly less than that required to destroy the growth media. Therefore it is safe to say that if the growth media is destroyed then the spores have long been destroyed. One thing to consider with the Resomator process is that the spores are directly exposed to the sterilant, as opposed to sitting in the center of a red bag where they may or may not see the required temperature. From the Certificate of Analysis the required kill time is 15.8 minutes @ 121oC. Therefore if Fo >16 all spores will be killed. Using the standard Fo formula at 150oC for 60 minutes, my calculations resulted in a value of 60,000. That is a massive amount of sterility assurance. Regarding the use of spore strips, I do not personally know of any that are designed to be submersed in fluids. Perhaps, with your extensive experience, you might be able to suggest one that is suitable. If you still deem it necessary to run more tests then I would suggest running the ampoules at 132oC for 60 minutes. I have no doubt that this will pass and there won’t be any need to bring a bottle opener to sample the contents. Then, once this temperature has been validated, it should be a no brainer that 150oC will just add an extra degree of sterility assurance."
	"I have three options for you. Please let me know what you decide, so we can have a chance to approve the method, similar to how the protocol was previously approved. 1) Retest with spore ampoules. After the testing, have your lab attempt to grow bacteria in the media. 2) Retest with a vial of spores your lab has prepared (with similar population as Raven) in a saline or low alcohol concentration solution. This will eliminate the carmelization of the pH indicator and other media ingredients. 3) Retest with a spore strip. Can the stainless steel vessel be sealed with Teflon tape, etc., to protect it from the chemical? The spore strip will need to be added to media by your lab and cultured for several days. Either retest shall be accomplished with conditions that simulate actual treatment, i.e., with a cadaver. Your patience with the testing process is appreciated. As a public agency, the Department must be able to defend all testing performed for traditional (steam sterilization) and alternative technology treatment methods. We regularly receive public record requests for our approvals."

Here's a genius suggestion....."Can the stainless steel vessel be sealed with Teflon tape, etc., to protect it from the chemical"?

Who needs terrorists when you can officially create a pipe bomb based on a government agency recommendation? They want us to seal a steel pipe and then expose it to heat so that the air inside the pipe expands. Remember, air is a compressible fluid that will store a tremendous amount of energy as heat is applied to it. Then, at the end of the cycle where the external pressure on the pipe is relieved, but the internal pressure remains, they want us to remove the strip. Well, if the pipe doesn't explode when the door is opened we can count ourselves lucky. If the cap blows off as we are unscrewing it, well I guess that won't hurt as much.

Here's a pictorial of what they are telling us to do. Actually, the bomb is less dangerous since it is triggered under control. The government bomb could go off at any time.

This one one pretty funny too....."If you use ampoules, your lab will need to open the ampoules immediately after the treatment cycle."

The ampoules are hermetically sealed and do not come with a 'screw-on' cap or a cork. So, it appears that the agency in their infinite wisdom are requesting us to break open the glass whilst the contents are under pressure, capture the hot contents and culture them. Where on earth do they get these people from????