Quality, Safety & Regulatory Compliance for Elastomeric Closures

Aptar Pharma, a leader in the manufacturing of vial stoppers and Pre-Filled Syringe plungers, introduced PremiumFill^® to address these concerns. This updated solution leverages ISO-classified cleanrooms to reduce particulate and fiber contamination, ensuring safer drug delivery for injectable. PremiumFill also support manufacturers in adhering to the Annex 1 revision by playing a central role in the supply chain element of the Contamination Control Strategy. Furthermore, through a case study performed at on a customer’s filling line, Aptar Pharma demonstrated a 20%+ reduction in scrap rate obtained by switching from a standard product to a PremiumFill equivalent, which did not require any process adaptation.

To complement their Annex 1 adherence strategy, customers may also choose Aptar Pharma’s Ready-to-Use gamma-sterilized solutions, which further reduce contamination risks while guaranteeing sterility at the time of use. As the industry faces challenges in patient safety and regulatory compliance, Aptar Pharma’s parenteral solutions aim to boost operational efficiency while meeting the stringent regulatory standards and their evolution.