LabLogic Systems Limited

A universal solution for PET/SPECT radiotracer quality control

The Tracer-QC is an automated solution for reporting QC tests associated with PET and SPECT radiotracers.

Ease of compliance

• No chance of missing a process, record or signature.
• Objective measurements traceable to standards, without any human interaction.
• Data flow from measurement to batch record.
• Automated.
• Uneditable.
• Completely traceable.
• Regular, automated suitability testing with a permanent record.
• Enables FDA 21 CFR Part 11 (Electronic Signatures) and Part 212 (GMP) compliance.
• No cross-contamination with Tracer-QC, as the sample never leaves the disposable kits. 
• Ease of (regulatory or internal) audits with instantaneous data retrieval.

Cost reduction

• Cumulative annual QC cost reduction of 30% or more.
• Fewer and less skilled personnel required.
• Faster and cheaper training.
• Faster and cheaper audits.
• Electronic access/auditing of records.
• Minimise the cost of addressing 483’s.
• Reduce risk of 483’s by around 84%.
• One analytical instrument to maintain.

Improved safety

• Reduced risk of radioactive spills and contamination.
• Reduced personnel exposure. 
• Single sample.
• Minimal sample handling with the use of a shielded pig.
• Attenuated exposure.

Improved efficiency

• 1 electronic report with all QC results, automatically generated. 
• Run QC unattended from sample to report.
• Increased throughput to enable scale-up. 
• No cleaning or equilibration required with Tracer-QC due to the use of a disposable kit.
• Inventory reduction, eliminating the need to track individual expiry dates of multiple supplies/standards.
• Process standardisation across sites and/or products. 
• Single sample injection for all analyses.

Logi-CHROM ONE integrated all-in-one radio-HPLC system

Logi-CHROM ONE has been developed specifically for PET/SPECT quality control which requires a small footprint and simple to use solution for radiochemical purity testing.

We have used our experience and expertise in supplying radio-HPLC systems to nuclear medicine environments to develop a simple solution with a significantly reduced footprint.

We have combined the most common HPLC modules into one compact system including a Low Pressure Gradient Quaternary Pump, a UV Detector and the Flow-RAM radio detector.

Minimal footprint

Compared to a traditional HPLC system, Logi-CHROM ONE significantly reduces the bench space required for a radio-HPLC unit by 50%.

Cost effective maintenance

Ongoing maintenance costs are reduced − due to fewer parts being used − whilst retaining the same level of functionality as a traditional equivalent system.

Simple set up

Due to its simple design, Logi-CHROM ONE is much easier to set up with limited connections. A smaller, lightweight system also allows for easier changes around a facility compared to a typical HPLC tower.

Integrated into the LabLogic range

Logi-CHROM ONE is part of LabLogic’s expanding range of market leading Radiopharmacy Quality Control solutions. It is fully compatible with Tracer-QC, SPECTra/PETra LIMS and is controlled by Laura for PET radiochromatography software.

The innovative, flexible and compliant radio-TLC scanner

The Scan-RAM™ PET/SPECT radio-TLC scanner is available in two configurations, either with a single interchangeable detector, or connecting both 1" NaI and Plastic Scintillation detectors simultaneously, thus providing the best possible performance for PET and SPECT radionuclides. Fully controlled by the market leading radiochromatography software Laura for PET™, the Scan-RAM produces accurate and reproducible results for radiochemical purity measurements.

Compliance

As with all LabLogic products, the Scan-RAM™ has been designed to exceed regulatory requirements. The instrument’s front panel only has a power button and display so all detector parameters are controlled via the software method. Used with our industry standard Laura for PET™ software, the Scan-RAM™ ensures regulatory compliance via controlled access and audit-trail.

Flexibility

The Scan-RAM™ is available in three different models: Scan-RAM™, Dual Scan-RAM™, and Scan-RAM MCA™. A wide range of detectors are available for the various Scan-RAM™ models, making the system suitable for both low and high levels of radioactivity.

Innovation

LabLogic developed the Scan-RAM™ specifically for PET/SPECT applications, with a range of truly innovative features aimed at ensuring the system is compliant, safe and reliable.

Dual Scan-RAM™

A combined PET/SPECT radio-TLC scanner and radio-HPLC detector, designed to meet the ever increasing demands of the modern radiopharmacy.

It works simultaneously and independently offering ultimate flexibility, as well as saving valuable bench space.

Scan-RAM MCA™

A combined PET/SPECT radio-TLC scanner and Multichannel Analyser designed to save laboratory space and speed up QC testing.

Users can run both Radiochemical Purity and Radionuclidic Identity tests in one combined run.

MCA options are available on all models of the Scan-RAM™.

Scan-RAM™ is controlled by the industry standard radiochromatography software

Scan-RAM™ control, digital data collection, analysis and reporting is provided by Laura for PET™, the industry standard radiochromatography data system developed by LabLogic.

The ideal solution for PET/SPECT facilities

Laura for PET is the industry standard single point control and data analysis software. It supports over 350 r-HPLC detectors, r-TLC scanners, MCA, GC and HPLC modules from leading manufacturers.

Whether you work within a regulated or academic environment, you will only need to learn one software system for the complete suite of PET/SPECT QC instruments.

A dedicated Laboratory Information Management System, successfully implemented in PET Facilities around the world

PETra is a true PET Laboratory Information Management System (LIMS), designed specifically for use within PET production facilities in order to improve efficiency and compliance.

Since it’s introduction to the market PETra has quickly become an industry favourite following successful installations in some of the world’s most prestigious and regulated PET facilities including Mallinckrodt Institute of Radiology (Washington University, St Louis, USA), Herlev Hospital PET Centre (Copenhagen, Denmark), Memorial Sloan Kettering Cancer Research Centre (New York, USA) and a multi-site deployment at Triad Isotopes (USA).