ISO 11137 gamma sterilized device dose audit - Lead time?

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engineer0129

Guest
#1
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!
 

MIREGMGR

Inactive Registered Visitor
#3
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?
 

chris1price

Trusted Information Resource
Trusted
#4
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
 
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Jimmy the Brit

Guest
#5
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
 

arrabellaangel

Inactive Registered Visitor
#6
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
i agree with jimmy..our sterilizer only takes 5 days for bioburden and sterility test need 14 days...total lead only 3 - 4 weeks only..
 

Kees Fremery

Inactive Registered Visitor
#7
Indeed a Periodic Dose Audit can be performed within 3-4 weeks. First of all irradiate the samples using the initial varification dose and test for sterility. During those two weeks of incubation the Bioburden test can be performed. No need to do the Bioburden test before the verification experiment because the verification dose already is determined.
 

Aqeel Abbas

Starting to get Involved
#8
We are planning to use gamma radiation for the sterilization of our single use medical device. The materials used in the device are all compatible with gamma radiation. In our country there is only one goverbment organization that offer gamm radaitioon servcies. They have clients like Johnsosn and Johnsons and other big local pharamceutical companies.

This organization however is not certified for ISO 13485.

They do help in process validation to develop a specific process for our devices.

My question is that can we subcontract their services? If the bioburden, sterility and pyrogencity tests performed as part of process validation are clear, can these alone be considered as performance qualification? Do we or the local notified body has to audit this organization? Are there any specific qualification for the auditor who can audit a gamma sterilization plant?

Thanks in advance for help.
 

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