Hi everyone-

What is the typical lead time for a quarterly dose audit of a gamma sterilized device?

My packaging/sterilization vendor is claiming that it takes 8 weeks, and they need to hold the entire lot of product for those 8 weeks post sterilization. There has been no significant change in product or manufacturing since the last dose audit.

However, our in-house sterilization "expert" says the test only takes 2 days.

This doesn't make sense to me - why would anyone use gamma if 4 times a year their shipments are delayed by 8 weeks?

Thanks very much for any input!

Is there anyone here in the Cove that are subject matter experts on this subject?

I wouldn't call myself a subject matter expert, but:

What test are they doing over that eight weeks? That's a long time for lethality testing.

Are they also running testing for ISO 10993 biocompatibility, i.e. pyrogenicity of your materials at the designated dose? I assume that was tested and cleared during your original process validation. If your specific materials haven't changed and the dose hasn't changed, I wouldn't be clear on why new pyrogenicity testing would be required.

You must have asked for more information. What explanation have they offered you?

Hi

Our quartly dose audits (for VDMax25) only take a few weeks. Probably a week for bioburden and 2 for sterility testing. Pyrogen testing normally only takes 2 weeks. As this is all part of a routine, historically well controlled process, we don't hold up production waiting for the results.

You may want to check, but I believe if you have 12 months of good information and reliable bioburden data, you can reduce the sterility testing to once a year, but keep quarterly bioburden. Have a look at 11137-1 Section 12.1.3.2 and see if it applies to your process.

Chris

I agree with Chris, the dose audit testing can be done on samples taken from the batch and certainly does not require the retention of the whole batch while the testing is being done. Its purpose is to demonstrate that the orginal dose validation versus your finished product bioburden remains valid, it is intended to pick up changes in the resistance and composition of the bioburden, and, as a result, is an ongoing commitment to verify the original dose choice was appropriate. Tell your irradiator to stop messing about, take the samples they need and then release the batch as normal.

Your in house expert is right in that the testing only requires two days, however it requires a further 14 days incubation time, and may require some dose sensitivity analysis which can take a further few days. Still no reason to sit on the batch though.

Jimmy