Discontinuation of a critical dispensing device or component from the supply chain can lead to costly stock out situations for product owners and negative health impacts for patients.
This case describes how Aptar Pharma was able to rapidly help a customer transition to an optimal off-the-shelf gel dispensing device, Airless+ ES, that seamlessly replaced their discontinued dispensing system, providing equivalent dosing precision with the original product formulation. Aptar Pharma quickly identified an Airless+ ES dermal dispensing system that met their specific product’s dose weight, fill volume parameters and regulatory requirements.
Combined with Aptar Pharma’s unique Extended Support (ES) offering that included compatibility and functionality testing (FAPT), product specific performance data studies, relevant USP/ISO testing and material selection data, Aptar Pharma provided complete services all backed by comprehensive regulatory support compliant with drug-device combination regulations (European MDR 2017/745 and U.S. FDA 21CFR820.30).
Aptar Pharma was able to derisk the customer’s transition to a new gel dispensing solution, that offered secure device supply, and comprehensive development and support services that allowed Aptar Pharma to meet critical customer timelines and avoid costly product stock-outs.
