Automated Visual Inspection for Clinical Trials in Pharma: The EVO CAX Advantages

Clinical trials demand precision, flexibility, and absolute reliability. With batch sizes too small for traditional automated inline inspection, manufacturers face the challenge of ensuring 100% visual inspection without compromising efficiency. EVO CAX is designed to bridge this gap, offering automated, human-like inspection that adapts to the dynamic needs of clinical trial production. From rapid format changes to reproducible results, the EVO provides an automated solution for small batches.

Ensuring quality control in clinical trials presents significant challenges for pharmaceutical manufacturers. Unlike large-scale commercial production, clinical trial batches are small, often highly variable, and require strict adherence to evolving regulatory requirements. Traditional inline inspection systems are impractical for these settings, as their high setup costs and rigid processes are not suited for small batch inspections.

Furthermore, regulatory agencies such as the FDA and EMA mandate 100% visual inspection for injectable drugs, ensuring that all vials meet stringent safety and quality standards before they reach patients. This requires inspection systems that offer full traceability, reproducibility, and compliance with Good Manufacturing Practices (GMP). In clinical trials, where formulations, packaging, and inspection specifications can change from batch to batch, manufacturers need an inspection solution that can adapt quickly without compromising accuracy.

Clinical trial batches differ significantly from commercial production in both size and inspection requirements. Key challenges include:

• Small batch sizes – Inline inspection machines are designed for high-throughput production and are inefficient for clinical trial volumes.
• Frequent specification changes – As clinical trials progress, inspection requirements can shift from batch to batch.
• High-value products – Many clinical trial drugs are expensive and sensitive, requiring gentle handling to avoid negative impact on the product.
• Regulatory compliance – Full traceability and repeatability are essential for regulatory approval.

For these reasons, a flexible, human-like automated visual inspection system is essential.

EVO CAX addresses these challenges by providing a flexible, automated solution that mimics the precision of manual inspection while maintaining the efficiency of automation. Its rapid format change and recipe development cycle allow manufacturers to quickly adapt to shifting requirements while ensuring reproducible, operator-independent results. This ensures not only compliance with regulatory expectations but also reduces the burden on manual inspectors, increasing overall process efficiency.

Rapid Format Changes and Recipe Development

Specifications and formulations frequently change in clinical trials.  The EVO does not require any adjustments to the visual setup to change the format of vials between 2R to 30R. Only minor guiding components need to be replaced tool-free. This results in less downtime and a more efficient transition between batches.

Reproducible, Operator-Independent Results

With its recipe memory feature, EVO CAX ensures reproducible and consistent inspections without operator variability. Every batch, regardless of its size, receives the same level of quality control, guaranteeing accurate and reliable results.

Gentle Handling for High-Value Products

Many clinical trial drugs, especially Advanced Therapy Medicinal Products, are extremely valuable and sensitive. EVO CAX uses human-like robotic movements to gently handle vials, reducing the risk of damage while ensuring thorough inspection.

Ideal for Early Commercial Ramp-Up

Before an inline inspection setup becomes efficient, EVO CAX provides the perfect transition, allowing manufacturers to inspect early commercial batches without committing to large-scale automation prematurely. This ensures high-quality control during the critical phase of scaling up production.

As personalized medicine and advanced therapies continue to grow, pharmaceutical manufacturers need flexible, scalable, and precise inspection solutions for clinical trials. EVO CAX delivers exactly that—a human-like automated visual inspection system designed to handle small batches with the efficiency of automation and the adaptability of manual inspection.

If you’re looking for a flexible, and cost-effective solution for clinical trial batch inspections, EVO CAX is the answer.