We understand the challenges our clients face with visual inspection of infusion bags. The flexible material, irregular shape, and risk of particles settling make it difficult to ensure consistent, reliable quality checks. 

To help tackle these issues, eyetec now offers particle-seeded infusion bags designed to enhance your testing and validation processes.  

One of the most critical steps in this process is visual inspection, which aims to detect particulate matter and other defects that could compromise product quality and integrity. At eyetec, we continually innovate to address these challenges. In this blog, we introduce our new particle-seeding service for infusion bags and highlight our expert consultancy services for difficult-to-inspect products (DIP). 

Particle seeding in infusion bags – tackling challenges in Visual Inspection 

Why infusion bags are hard to inspect 

Infusion bags are among the most challenging pharmaceutical products to inspect due to their flexible, often opaque material. Issues like particle settling and the presence of tubing or irregular shapes make it difficult for both manual and automated inspection systems to reliably detect defects. This complexity can result to defects reaching the market or false rejects, impacting both product quality and patient safety. 

Introducing particle-seeded infusion bags by eyetec 

To help our clients validate their visual inspection systems, we’ve developed a new service: particle-seeding for infusion bags. This solution involves introducing controlled particles into the infusion bags, allowing for realistic defect simulation and comprehensive testing of inspection capabilities. 

Particle-seeding in infusion bags 

Our seeding process is designed to closely mimic real-world scenarios, replicating the types of particles commonly found in pharmaceutical production environments. This realistic approach allows manufacturers to thoroughly validate their visual inspection systems. 

To maintain sterility and preserve the physical integrity of the infusion bags, we employ advanced techniques during the seeding process. This careful handling guarantees that the test samples remain suitable for stringent quality control procedures, without risking contamination or compromising the product’s structure. 

By addressing the common challenge of particle settling, our particle-seeded infusion bags provide a realistic testing scenario, allowing manufacturers to optimize their visual inspection processes. This improved testing environment helps both manual and automated inspection systems fine-tune their detection capabilities, enhancing accuracy and reducing the risk of undetected defects or false positives. 

Supporting regulatory compliance 

By providing controlled, defect-containing samples, we help pharmaceutical companies meet regulatory requirements such as those specified in EU Annex 1, Ph.eur 2.9.20 and USP <790>, which emphasize the importance of comprehensive visual inspection for parenteral products. 

Consultancy services for Difficult-to-Inspect products 

In addition to our particle-seeding service, eyetec offers expert consultancy for handling difficult-to-inspect products. These products, which include opaque solutions, colored liquids, or complex container shapes, pose significant challenges in visual inspection. Our consultancy services are led by experienced specialists, who bring a deep understanding of GMP requirements and a strong background in pharmaceutical manufacturing. 

How eyetec supports Difficult-to-Inspect products 

For products classified as difficult to inspect, we develop tailored strategies that address specific characteristics like opacity, turbidity, or complex container design. This customized approach helps manufacturers establish inspection protocols, significantly reducing the risk of undetected defects. Our consultancy team brings strong engineering expertise, conducting focused engineering runs to fine-tune inspection parameters. This process optimizes defect detection while minimizing false rejects, especially valuable for companies transitioning from manual to semi-automated or fully automated inspection systems. Throughout the process, we ensure that all inspection strategies are aligned with the latest regulatory requirements and best practices, including guidelines from EU Annex 1. This commitment to compliance helps clients uphold high-quality standards and confidently meet regulatory audit expectations.