Publications, Pharmaceutical

Quality, Safety & Regulatory Compliance for Elastomeric Closures

The pharmaceutical industry places utmost importance on the safety and efficacy of injectable drugs. Particulate contamination and sterility are major concerns that led to numerous recalls by the FDA over the past years. In addition to increasingly stringent regulatory standards, manufacturers are developing highly sensitive biologics and biosimilars that require utmost protection, from the manufacturing stage through to delivery. These two factors put the pharma industry under increasing pressure for guaranteeing the cleanliness and safety of their products.

Recently, the European Medicines Agency (EMA) revised Annex 1 of Good Manufacturing Practices (GMP), emphasizing contamination control not just in operations but also in the upstream supply chain. In addition to requiring manufacturers to implement a comprehensive Contamination Control Strategy (CCS), they must provide assurance of sterility for their products, which may require further process and supply adjustments.

Download the Quality, Safety and Regulatory Compliance for Elastomeric Closures Publication
Author(s): Estelle Verger
14 Sep 2023

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.

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