From Vision to Machine: Concrete AI & CCIT Solutions for Challenging ATMPs
EducationalTACKLING PRODUCTION CONTROL CHALLENGES IN PHARMA
2026-05-27 | 04:20 PM - 04:35 PM | TPD Room
Abstract
The rapid emergence of Advanced Therapy Medicinal Products (ATMPs) and complex blood-derived therapies has fundamentally shifted quality control paradigms in the pharmaceutical industry. Unlike traditional parenterals in rigid containers, these high-value treatments are often housed in flexible IV bags and present unique challenges - such as product turbidity and container deformation - that categorize them as "Difficult-to-Inspect".
This presentation examines the regulatory and technical evolution from standard Automated Visual Inspection (AVI) for rigid containers to next-generation solutions powered by Artificial Intelligence (AI). We will explore how AI technology has moved beyond the limitations of rule-based systems to provide robust, reliable defect detection in non-traditional and flexible packaging.
The core of the session focuses on practical applications for IV bags, showcasing real-world case studies and performance metrics where AI, combined with an advanced imaging technology, efficiently handles dense, opaque blood products as well as ultra-precise, small-volume CAR-T cell therapy batches.
Furthermore, we will introduce a specialized automated inspection machine specifically engineered for the inspection of IV bags containing ATMPs, highlighting its ability to balance operational flexibility with stringent regulatory compliance.
To complete the quality framework, the presentation addresses Container Closure Integrity Testing (CCIT) for IV bags. A comparison of primary methodologies highlights the pros and cons crucial for guaranteeing product sterility and patient safety.
Attendees will gain actionable insights into how the synergy between AI and CCIT mitigates risks, minimize false rejects, and ensure the integrity of the most challenging products in today’s biotech landscape.
