Reply To: Blinded Secondary Packaging with Vials of different sizes / weight
March 31, 2022 at 6:12 amI have never seen any regulations restricting container/closure systems. Justification must be made to ensure the stability and quality of the drug in the packaging used but the components are chosen by the sponsor company. If your vials are different sizes that will not raise any questions as long as there are data demonstrating the safety of the drugs inside.
If there is concern that someone besides the unmasked pharmacist will handle containers and notice a difference is there a way to add additional weight to the lighter carton to equal the difference? I would talk to your packaging group to look for options to adjust the container weight.
Another option could be to restrict handling of the containers at the site. Is it possible to create a site process so that only the unmasked pharmacist is the only person handling the containers?
