Is Aseptic Processing at Risk? Navigating New Demands
This Year’s Trends Are Different
For over a decade, the aseptic processing industry has pushed boundaries with increasingly advanced techniques—driven by factors that will take center stage at the upcoming 2026 ISPE Aseptic Conference.
But this year feels different. Questions are challenging long-held assumptions, as the industry seeks to understand, plan, and respond:
- What is the right approach for each business: Isolator or restricted access barrier systems (RABs)?
- Why are some early adopters of isolator technology actively exploring a return to RABs?
- Why was vaporized hydrogen peroxide (VHP) a trusted component in bio-decontamination for so long, and why is it now falling under scrutiny?
- Should there be increased gowning protocols for isolated filling lines set up?
- Aseptic process simulations media fills—how many do we really need to perform?
- What role will science and engineering play in the future of facility and equipment design?
- What role will the “risk-based approach” play in future design and procedures?
The upcoming Sterile Processing track, organized and moderated by Paul Valerio, Senior Director of Process Technology at IPS, will spotlight these questions, the factors affecting them, and other relevant trends.
The goal is to bring clarity to topics that appear increasingly complex.
Attendees will hear from representatives of owner-companies, contract development and manufacturing organizations (CDMOs), facility and equipment experts, and professionals who work with both RABS and isolator filling lines. Each brings a different perspective to help evaluate and discuss how the landscape has shifted.
Session 1: “Are Isolators the Future or the Past?”
First, attendees will hear from Norman Nickolas, Manufacturing Quality Manager at Amgen, and Oscar Perez Villatoro, Global Strategy and Technical Director at IPS. Together they’ll tackle one of the industry’s biggest questions: “Are isolators the future or the past?”
Key Questions and Current Challenges
The session starts with an overview of filling isolator designs and setups. Topics will examine how industry is still navigating the relationship between “sterile products” and “aseptic manufacturing”—and how regulations and guidance are being interpreted and implemented.
This session will explore new risk concerns around isolator technology—processes that were once on track to become the industry standard. Topics include:
- The robustness of VHP
- Glove integrity and contamination risk
- Indirect contact parts
- First air principles
- Setup procedures and intervention protocols
The Risk-Based Approach Under Pressure
Risked based approaches have allowed innovation to flourish. The program committee let the owners, original equipment manufacturers, and consultants help define and design to ensure quality. The committee pointed to a compilation of factors intended to reduce risk to patients and products, reduce costs and complexity of facility and equipment design, simplify gowning and setup processes, and achieve more reliable, repeatable, controlled environments.
Today companies are receiving much more prescriptive direction with regards to isolators and RABs lines
The Annex 1 Impact
Over time, a few key “events” and “milestones” increased regulatory pressure. Each event led to ever more significant investments to improve “perceived quality.”
Those events have compounded on each other and now culminated with the impacts of EU Annex 1 and are having global impacts due to increased international collaboration between regulatory bodies.
Evaluating Industry Reactions
The intent of this session is to examine the appropriateness of the industry’s reactions. The goal is to use real market data to evaluate the frameworks being considered and discuss the real costs to mitigate risks.
The impacts include capital and operational expenditures (capital expenditures and operational expenditures), which translate into cost of goods, product supply, and total market capacity—all of which could affect the potential and severity of drug shortages.
Villatoro and Nickolas will digest their findings and share actionable suggestions on how our industry should proceed.
Session 2: “Life as a Fill-Finish CDMO in a Post-Annex 1 World”
While Session 1 examines the why behind industry shifts, Session 2 explores the how—showing what leading CDMOs are actually doing in response.
This session, “Life as a Fill-Finish CDMO in a Post-Annex 1 World,” examines how several leading CDMOs have responded to both industry trends and their clients’ individual demands.
Vetter Pharma’s Approach
Jörg Zimmermann, Vice President of External Affairs at Vetter Pharma Fertigung GmbH & Co KG, will speak to his company’s journey and how they’re addressing a matrix of regulatory frameworks and client expectations.
He’ll describe critical components of the Vetter process and present data illustrating the effectiveness of their unique approach which is a combination of facility design, RABS filling lines, and rigorous setup and operational practices.
Zimmermann will outline steps Vetter has implemented recently to ensure they exceed regulatory and industry-agreed quality standards.
Grand River Aseptic Manufacturing’s (GRAM) Experience
Ryan Waldhart, GRAM’s Director of Manufacturing Science and Technology, will share insights on their facility layout, key equipment and aseptic considerations. These will include GRAM’s strategy and process for:
- Ready-to-use glass introductions across two separate filling lines including no-touch transfers and debagging and de-lidding
- Indirect product contact part set-up
- Smoke studies strategy to demonstrate the isolator set up
INCOG BioPharma Services’ Strategy
Dennis West, Principal of Manufacturing Science and Technology at INCOG BioPharma Services, will discuss the feedback they’ve been receiving from regulators and clients as they implement additional filling lines.
Dennis will address these key topics:
- Their equipment setup procedures, what is considered sterile, and what is bio decontaminated and the first air considerations they have implemented.
- The INCOG approach to continuous improvement and how they are balancing industry trends and customer expectations while considering flexibility, robustness, speed, and compliance.
- Training and cultivating a quality culture
Session 3: “Fireside Chat – Trends and Industry Responses”
The final session, “Fireside Chat – Trends and Industry Responses,” brings together Waldhart, Valerio, West, Zimmerman, and Christa Myers, Senior Fellow of Aseptic Processing at CRB.
Together, they’ll summarize the sessions, discuss the future of aseptic processing, and tackle the questions the industry is buzzing about—plus other topics that emerge during the conference.
This conversation will be a natural transition before sessions featuring regulators from the US Food and Drug Administration begin. The program committee expects it to be an excellent opportunity for the entire industry to come together.
Join the Conversation
Whether grappling with isolator vs. RABS decisions, navigating Annex 1 compliance, feeling overwhelmed by how many media fills may be needed to perform or plan a future aseptic facility, this track offers data-driven insights and real-world perspectives that can’t be found anywhere else.
