The race to develop vaccines and treatments for COVID 19 has re-emphasized the need to de-risk and accelerate packaging development for injectable drugs.
The risk does not just relate to the patient, but also regulatory risk that impacts quality and potentially the bottom line. No company wants to find its drug product listed on the FDA Recalls list due to contamination i.e. the presence of particulates, and yet, 11% of drug recalls in 2018 were due to foreign materials.
As formulations become more sensitive, the selection of elastomeric components that adapt to manufacturing processes as well as meet compatibility expectations, is a critical component in the product lifecycle.
In this webinar, we discuss how high-quality film coated injectable components meet compliance expectations and maintain safety of supply for your drug product. This presentation highlights how a proprietary film coating approach can improve product robustness and facilitate the development of a packaging solution for an injectable drug.
We discuss how elastomeric components are the major contributor to leachables in the drug product and review how a coated stopper solution mitigates the presence of leachables in the formulation, not only preventing compatibility issues but also minimizing toxicity.
We also review the results of a migration study performed over a 12 month period, which evaluated the impact of sterilization methods on the potential leachables from different coated and uncoated stoppers from different suppliers.
We assess the impact of the choice of stopper on other properties such as the vial compatibility and other functional properties, and from a manufacturing standpoint, review how continuous process improvements have been implemented that reduce contamination to achieve a 1.3 PCI specification. In addition, 100% inspection via visual systems helps prevent defects from entering the supply chain.
By introduction of quality through technology, we will demonstrate the attributes of how film coated elastomer components improve managing component selection in a quality risk management environment.
Regional Market Development Manager, North America
Arnaud Fournier is Senior Business Project Manager for Aptar Pharma. A graduate from IPAG Business School Paris, with a specialization in Marketing, he joined Aptar Pharma in 2004 as Marketing Project Manager. Arnaud then moved into Business Support and promotes Aptar Pharma’s range of elastomeric components for vials and Pre-Filled syringes. He is involved in new product development, especially PremiumCoat®, within Aptar Pharma’s coated range of products.
Dr. Julie D. Suman
PhD, President, Next Breath, an Aptar Pharma Company
Julie holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University. Julie is a Past-Chair of the AAPS Inhalation Technology Focus Group. She is also a licensed Maryland pharmacist. Julie has published her research in peer-reviewed journals, has presented during podium sessions at international meetings such as the FDA Visiting Professor Lecture Series, and has been an invited speaker at ANVISA in Brazil. Dr. Suman’s doctoral research, which focused on the relationship between in vitro tests for nasal sprays and in vivo deposition, has been recognized for excellence by a research award presented at the International Society for Aerosols in Medicine, 2001.
Director of Sales and Marketing, Gateway Analytical, an Aptar Pharma Company
Mr. Scatena has been with Gateway Analytical since 2010 and was responsible for helping establish their particulate identification laboratory. He has held the roles of scientist and laboratory manager, responsible for the day-to-day operations of the laboratory and the investigational testing for pharmaceutical clients. Today, Mr. Scatena oversees sales and business development operations and works as a scientific liaison between pharmaceutical clients and the laboratory for particulate matter and container closure investigations and testing. Mr. Scatena holds a Bachelor’s Degree in Biochemistry.