Is the staggering of gamma allowed?

It is recommended to gamma irradiate all test items in a single gamma run. The staggering of gamma is when a lot is split up to be gamma irradiated on multiple dates, e.g. the components for T70 days extraction are gamma irradiated on one occasion and the components...

Is inverse staggering of extraction starts allowed?

Inverse staggering of an extraction start is when, for example, the 21 days extraction is started on day 1 and the 24 hours extraction is started on day 20. All samples are then collected at the same time and analyzed on the same occasion. This approach is allowed as...

Is it mandatory to include two lots in a study?

Yes. Preferred is to include two separate extractions from components in the same family manufactured from two different resin lots. If this is not feasible, two separate extractions from two components in the same family manufactured from the same resin lot in two...