Ryan Waldhart and Simon Côté present a joint study by Grand River Aseptic Manufacturing, West Pharmaceutical Services, and Corning that quantifies how premium components—coated vials and high-quality stoppers—affect final drug product quality and the bottom line. With regulatory pressure from Annex 1 and global contamination control strategies, this session shows hard metrics on rejected vials, yield improvement, operational efficiencies, and total cost of ownership. Attendees will learn how modest increases in component cost can drive reductions in rejects, investigations, and manufacturing downtime. For quality assurance, manufacturing, and procurement leaders, this talk provides a practical framework to evaluate supplier offerings and to justify investments in upgraded primary packaging.
Colleen O’Brien of Gerresheimer shares design of experiments results that follow up on prior supplier case work to reduce particle burden in RTU and RTF components. Her presentation shows controlled data on production variables, sterilization effects, and shipping and handling impacts. Expect concrete mitigation strategies for suppliers and customers alike: changes to production parameters, packaging and cushioning approaches for transit, and sterilization choices that balance particulate control with bioburden reduction. Importantly, O’Brien links supplier process improvements to filling equipment and facility requirements so that manufacturers can close the loop between incoming component quality and in-plant contamination control.
Federica Baldin, PhD, and Valerio Ravazzolo bring a sustainability and innovation lens with a case study on sterilizing RTU cartridges and syringes using vaporized hydrogen peroxide under high vacuum. Their collaboration between De Lama SpA and Stevanato Group demonstrates laboratory verification of sterilant penetration through secondary packaging and successful sterility testing using biological indicators. The session describes the technical approach, test results, and regulatory considerations, and it evaluates potential environmental benefits such as reduced energy and water use, lower CO2 emissions, and elimination of toxic agents like ethylene oxide. For those responsible for process innovation, environmental impact reduction, or validation strategy, this presentation will challenge assumptions about what sterilization modalities can achieve at industrial scale.
Why These Sessions Matter Together
Taken as a track, these three presentations map a complete pathway from supplier development through logistics, sterilization, and in-plant use. Attendees will gain evidence to negotiate better specifications with suppliers, to design filling lines that respect component vulnerabilities, and to pilot sterilization alternatives that meet both quality and sustainability goals. Each session offers practical takeaways: design of experiment outputs for control priorities, shipping and sterilization mitigations for risk reduction, and templates for translating technical findings into procurement and validation language.
Who Should Attend
This track is designed for quality and regulatory professionals, manufacturing and process engineers, procurement and supply chain managers, and technical leaders evaluating RTU/RTF adoption or upgrades. Bring audit issues, recent investigation experiences, and supplier questions—presenters will welcome real examples towards the end of each session.
Register and Come Prepared
The Component Quality track at 2026 ISPE Aseptic Conference is important for anyone looking to make smarter packaging decisions, reduce recalls, and align contamination control with cost and sustainability objectives. Register for the conference, set time aside for the track sessions, and
Whether evaluating a transition to RTU/RTF formats, negotiating supplier contracts, or planning capital investments in filling lines, evidence in this track will sharpen risk assessments and support business cases. Sessions include a question-and-answer portion and networking opportunities to connect with speakers and peers. Join ISPE in Washington, D.C.: come ready to change how sterile products are packaged.
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