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FASTlab Cassette Automated Vision System for GE Healthcare: Ensuring Quality and Compliance in PET Radiochemistry

Fastlab cassette automated vision system 3

Overview

Client
GE Healthcare – a global leader in medical technologies, operating in over 100 countries

FASTlab™ is an advanced automated PET (positron emission tomography) radiochemistry synthesizer developed by GE Healthcare, widely used in medical or research facilities globally. It enables the efficient and consistent production of a wide range of PET tracers and various radio-metal-based tracers. The company approached us with a challenge of creating a system that would support its components testing process with computer vision.

The Background: The Role of Automated Radiochemistry Systems

In modern nuclear medicine, demand for PET imaging is rising rapidly, driven by growing numbers of cancer and Alzheimer’s cases, aging populations, and the push for precision diagnostics and treatment monitoring. One of the biggest challenges is ensuring a steady and reliable supply of PET tracers.

Such radiotracers can be ordered ready-made from the manufacturer, but this creates logistical challenges due to their instability and short shelf life. Alternatively, institutions such as hospitals can produce them in-house using automated cassette- or kit-based systems, like our client’s FASTlab™.

These cassette-based systems increase daily production capacity, minimize human error, and ensure reproducibility – all while complying with strict GMP standards. For patients, that translates into more reliable access to life-changing scans and treatments.

FASTlab™ by GE Healthcare

One of the world’s healthcare giants, GE Healthcare, has a device answering the above challenges. FASTlab™ is an advanced, automated PET radiochemistry synthesizer automating the synthesis of a wide range of PET and radio-metal-based tracers.

It allows tracers to be produced in-house, eliminating the need to order them from a manufacturer located elsewhere in the world just 72 hours or less before they must be administered to a patient.

In the broader industry, it allows PET centers to operate more efficiently, safely, and in compliance with regulatory standards, accelerating both clinical and research applications.

Significance of Cassette-Based Systems

The key feature of FASTlab™ is its cassette-based system. Each pre-loaded, plug-and-play cassette contains reagents and components for tracer synthesis. The only component that must be produced on site is the radioactive isotope, which is generated separately in a cyclotron and then connected to the FASTLab system. This design simplifies setup, reduces contamination risks, and ensures consistent, reproducible results.

The challenge arises when a cassette or its reagent positions are faulty. If assembled incorrectly, the cassette must be discarded entirely – a highly costly outcome. It may also go unnoticed, and if, for example, certain vials are swapped – and the synthesis process will not proceed correctly, potentially putting the patient at risk.

To prevent such threats, we developed the FASTlab Cassette Automated Vision System. It is designed to assist factory workers in inspecting assembled cassettes, ensuring that no incorrect units leave the facility or reach hospitals.

Combining Hardware and Software

The FASTlab Cassette Automated Vision System is a dedicated workstation designed to test the completeness, quality, and correct assembly of FASTlab cassettes. It combines software with hardware – including two cameras, three illuminators, RFID tag reader, touchscreen, and a computing unit.

Using computer vision, the system inspects each cassette by analyzing and comparing images against predefined test specifications for its type.

Beyond cassette testing, the system also offers a full suite of administrative features, including user management, storage of inspection histories and production batches, batch reporting, creation and modification of inspection profiles, audit trails, and secure data archiving and backup. It is compliant with GMP and 21 CFR Part 11 regulations.

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Testing Process

  • Cassette testing is organized in batches. The operator logs in using the touchscreen with their individual access credentials, then creates or selects the active batch and places the cassette in the inspection station.
  • The system automatically reads the cassette’s information using built-in sensors, verifying its association with the selected batch and validating data from the label, barcode, and RFID tag.
  • The system captures images of the cassette, analyzes them according to the predefined test specifications for that cassette type, clearly visualizes the test results, and highlights any incorrect elements.
  • If the cassette passes all tests, the operator removes it from the station and sends it for packaging. If a defect is detected, the operator can perform corrective actions and re-test the cassette. Re-tests can be done immediately or later within the same batch. A cassette may only be tested twice; if it fails again, it is discarded as scrap.
  • The system records all inspection data, including photographs, and stores it until archiving. Once a batch is completed, administrators can generate a Batch Report. All user actions are also logged as part of the Audit Trail, ensuring full traceability.
  • The system enables customers to create their own inspection profiles – i.e., test specifications for specific cassette types – and independently modify existing ones.
Fastlab cassette automated vision system 4

Testing Process in Numbers

The system:

  • Supports 5 cassette types, with the option for customers to define additional configurations and inspection profiles.
  • Allows for over 100 tests per cassette.
  • Completes all tests for a single cassette in under 5 seconds.
  • Achieves a full cycle time – including cassette replacement and test execution – in under 30 seconds.
  • Includes 40 pre-defined, configurable tests.

Inspection Station Connectivity

The inspection station is a self-contained, standalone unit with its own computing resources, database, and storage. Standard operations do not require any external network connection or Internet access.

It supports optional integration with an internal network, allowing remote access to system resources and administrative functions through a web interface. When connected, authorized users can access the system from any computer on the network via a web browser. Network integration requires specific infrastructure setup, including proper firewall rules and DNS configurations.

For improved efficiency and usability, certain administrative tasks are best performed on a desktop or laptop, which provides better input precision and display capabilities. These tasks include:

  • Analyzing historical records
  • Examining the audit trail
  • Exporting data
  • Retrieving batch reports
  • Managing user accounts
  • Creating and modifying system settings

System Validation in Accordance with GAMP-5

What Is GAMP-5?

GAMP-5 (Good Automated Manufacturing Practice) is a globally recognized framework providing guidance for ensuring that computerized systems used in regulated environments (are fit for their intended use, reliable, and compliant with data integrity and product quality requirements.

It involves:

  • Documented risk assessment
  • Verified and approved validation plan
  • Execution of test scripts
  • Audit trail and security testing to confirm data integrity
  • Controlled change management and periodic review procedures
  • Comprehensive validation report summarizing outcomes and approval for use

FASTlab Cassette Automated Vision System Validation

The system was fully validated in accordance with GAMP-5, a critical milestone for the project. This extensive effort involved generating comprehensive documentation and meticulously reviewing 1,500 pages of test protocols. Our team produced 2,450 pages of test evidence, rigorously confirming that all tests were performed correctly and that the results met the required standards. This thorough validation underscores both the complexity of the system and our commitment to compliance and quality.

Fastlab cassette automated vision system 2

Summary

The FASTlab Cassette Automated Vision System designed for GE Healthcare ensures the correct assembly and integrity of cassette-based PET tracers using an advanced computer vision system.

Key features and results include:

  • Cassette support: 5 pre-defined types, with the option for custom configurations and inspection profiles.
  • High-throughput testing: Over 100 checks per cassette, completed in under 5 seconds, with full cycle time under 30 seconds.
  • Automated quality control: Detects assembly or reagent faults, allows re-testing, and ensures only compliant cassettes are used.
  • Comprehensive administration: Tracks inspection history, batch records, user actions, and audit trails; supports reporting, data export, and profile management.
  • Flexible operation: Standalone unit with optional network integration for remote access and administration.

The system supports operators during the cassette testing process, streamlining workflows, increasing daily production capacity, and – most importantly – ensuring that no incorrect units leave the facility or reach hospitals.

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