Not having specific information as to the type of product and the product description and packaging, I can only provide guidance on what should happen during the transition from clinical to commercial sterilization.

First, unless your two products are of a similar weight and can withstand the same amount of maximum dose delivered to the final product, the two products cannot be “sterilized at one time.” This is because if they are different weights, i.e., density, then a different cycle time in the irradiator would be necessary to deliver the same dose to the two products. In addition, it is not best practice to mix densities within the same irradiation container during routine production, in that certification of the final absorbed dose will not be accurate unless special monitoring and prior validation has occurred. However, if the two products are of similar density and minimum/maximum dose specification, then irradiating together is the best way to go.

Typically, when the manufacturer is producing clinical trial batches, the individual batches are submitted for release using a batch-release process, which is defined in AAMI/ANSI/ISO 11137-2 for both Method 1 and VDmax. The validation of the sterilization dose is only performed on 100 to 10 samples (depending on the method selected) so therefore a Process Validation Dose Map has not been performed, nor is the product subjected to the radiation source in a final carton package. It is typically a much smaller size in order to obtain the tight and low dose required of the dose validation. The product configuration during radiation-dose setting only applies to the dose-setting experiment, and not to routine processing loads. Now, if one is performing a batch release, the product configuration or loading configuration in the irradiator would be validated to that specific batch  if subsequent batches were in the same configuration. The data resulting from the dose-validation irradiation (certification of dose and dosimeter placement) will be expected to be submitted with your FDA submission as well as the loading configuration, dose received, and dose-map validation from irradiation of the clinical batch.

If after clinical trials, the final product carton is not changed, routine sterilization may continue with the dose-monitoring positions resulting from the dose-map validation performed during the clinical batch releases. If the product carton changes when the product goes to routine production, then the dose-mapping exercise at the irradiator would have to be repeated. Changing the final carton size, weight, etc., of the product does not require resubmission to FDA for your product. However, you must retain records of the product carton changes, subsequent dose-mapping results, and sterilization load configuration in your master file.