Maurizio Colombo Good point. To my knowledge there is no standard giving an acceptable failure rate value. It is up to the manufacturer's risk acceptance policy. I would say that 1/1,000,000 could be a "low" occurrence rate for sterility failure, since it is the same as the sterility assurance level granted by sterilization processes. Whether the risk will be acceptable depends on how severe you judge the consequence of sterility loss.

Dr. Patrick Druggan The is not standard on this. Both ISO 11607 and EN 868-5 say nothing on it. However there are limits on strength of the seal 1.5 N per 15 mm for steam sterilisation. Based on the requirement for a six log Assurance for commercial sterility this would mean that this would be the lower limit for acceptability - as Maurizio has already stated it would need to be 1 in a million failing to meet the 1.5 N limit for steam sterilisation or 1.2 N for EO. I did some work on this a few years ago and found that paper to paper using a Hawo sealer set up correctly would easily meet a failure rate of one in a billion for the 1.5 N limit. Paper to film I got one in ten million failure rate. This was on five samples from forty bags in a design space map. It was a lot of work, but it gave us true assurance for the process.

Brian Matthews Has anyone looked at EN 556-1 and EN 556-2?

Mike Helmus depends on the kill value required. If it's an implantable it's 1 in a million, and less for external and disposables.

Thank you all for valuable comments and thoughts.

In this case, it is disposable and not implanted. 556 reflects sterility, and in the example shared by Dr. Patrick Druggan the challenge of the sterility is the seal strength. But by the end user the product has been transported, which also may have an impact. So sterility at roll-out from EtO is one case, but by the nurse on a different continent may be another. True (?).

Maurizio Colombo I agree that the concern is not merely on seal strength, which is fundamental but cannot be the only acceptance parameter. Ageing too is important, so accelerated ageing shall be performed, and transport is of chief importance. For transport there is an ASTM standard (cannot remember the number) for testing package resistance to shipment stresses. Probability for all of these failure modes shall be lower than one in a million.

Merav Shefer you can look at the package integrity standard ISO 11607-1 amendment, it states all relevant test to conduct in order to prove your package maintains its sterility through shipping and over time (real and accelerated). good luck.

The ASTM transport simulation test is D4169-14

Sri Vishnubhotla 95/95 is used commonly

Raymond Alley That’s an excellent question. The question I have is where would I go to get disposable products sterilized?

Interesting discussion; consider also the kind and quantity of evidences You will have to give, on the producer's side, when the producer will be sued or charged on criminal side for that 1/1.000.000 problem.

Maurizio Colombo @Alessandro. In my opinion in such case the manufacturer will need to provide evidence that risks were reduced as far as possible. This can be accomplished by providing evidence of having fulfilled pertinent harmonized standards, through risk analysis report and all pertaining test reports.

Maurizio Colombo @Raymond. Depends on where you are based, in general I suggest you to search for contract sterilization facilities (google search may be of help)