Single lot release for sterile packaging

[shimonv]

Hi everyone,
I have a question for you. One company I work for intends to do a clinical trial with a sterile disposable instrument.
By way of sterilisation, they will do EtO single lot release. The question is what about packaging. They did do some feasibility tests of dye and peal but not PQ. How do companies go about this? Is there a "single lot release" allowance in packaging standards? and how would you handle the shelf life statement in the labelling.

Thanks a lot,
Shimon

 

[planB]

Shimonv,

to my knowledge, the governing standard ISO 11607-1 is silent about "single lot release". ISO 11135:2014/Amd 1:2018, Annex E section gives two tiny hints what could be done:

E.2.4 A representative number of samples taken from the manufacturing batch shall be selected for [...] packaging tests, [...]
and
E2.14 Other test samples should also be removed at an appropriate time after the process (e.g. samples for [...] packaging integrity tests, [...].

So you would add an appropriate dedicated packaging-testing samples to your single sterilisation lot and test them afterwards according to the same or similar acceptance criteria that you apply during a packaging validation.

Another option would be to aim at packaging the product into an existing validated sterile barrier system, e.g. provided by packaging contractors. This would also allow you to establish a shelf life based on already existing validation activities.

Hope this helps,

 

[shimonv]

Hi PlanB,
It is also my understanding that there is no process for a "single lot" packaging release. That is the problem. A colleague of mine suggested that I can get away with it by using ANZI AQL release with peel and dye tests. He also suggested using chevron pouch for an added mitigation. Not sure what else can be done and how to handle shelf life.

 

[chris1price]

I would agree, either base sample size on a AQL or as a binomial. For the packaging test, you may not have to use real product, just empty pouches or trays may be ok.

I would expect most clinical trials to use the samples quickly, so a short shelf-life test would be ok. You could do it as a basic accelerated test, 6 months in 3 weeks.