Overview

The document presents the Radiopharmaceutical Quality Control (QC) Analysis Station developed by Zhejiang Tailin Bioengineering Co., Ltd. It highlights the system's key features, compliance with regulatory standards, innovative technologies, and technical specifications related to radiopharmaceutical testing.

Quality Control Functions and Compliance

• The QC station supports compliance testing methods aligned with Chapter 1401 of the Chinese Pharmacopoeia.
• It emphasizes minimizing radiation exposure to personnel during testing procedures.
• The system limits the consumption of mother liquor to no more than 1 ml, reducing waste and exposure.

Key Innovations

• High-Precision Sample Dispensing: Ensures accurate and consistent sample handling.
• High-Precision Camera Imaging: Utilizes a fixed light source for reliable imaging quality.
• AI Algorithm Interpretation: Automated data analysis enhances accuracy and efficiency.
• Enhanced Data Integrity: Robust data management ensures reliable results.

Advanced Detection Materials and Methods

• New Detection Material: Incorporates cadmium zinc telluride (CdZnTe) with 2% energy resolution, operating at room temperature in a compact form factor.
• Chromatographic Development: Employs a dynamic chromogenic method with automatic sampling and dilution, consuming as little as 5 μL of mother liquor and completing detection within 15-20 minutes.
• Automatic Sample Spotting and Plate Development: Ensures stable and reproducible development results.

Radiation Protection and Efficiency

• The system is designed to minimize radiation exposure to operators during testing.
• Low mother liquor consumption further reduces potential hazards and resource use.

Summary

This Radiopharmaceutical QC Analysis Station integrates advanced materials, automated processes, and AI-driven interpretation to provide precise, efficient, and safe quality control testing. It complies with national pharmacopoeia standards while innovating in sample handling, detection sensitivity, and radiation safety.