LabLogic Systems Limited

Sheffield,  S. YORKSHIRE 
United Kingdom
http://www.lablogic.com
  • Booth: 927


Welcome to the LabLogic Systems booth.

LabLogic are a manufacturer of instruments and software to the Life Science, PET/Nuclear Medicine and Radiation Safety sectors. We have over 35 years’ experience and expertise in providing solutions within highly regulated environments.

Within PET and Nuclear Medicine, LabLogic have a range of market leading products which can be found in some of the world’s most prestigious laboratories. Our products include a range of QC equipment including innovative r-TLC, r-HPLC instruments and a single point of control radiochromatography software package – Laura for PET. The complete QC package is also available from LabLogic, just ask about the QC solution.

Furthermore Lablogic offer PETra, a purpose built PET LIMS system designed to improve efficiency and compliance. What’s unique about PETra is that it directly captures data from all the equipment used. It acts as a central repository all information within PET production including batch record management, QMS, trending, inventory, instrument maintenance etc.

LabLogic will be showcasing its Tracer QC system at SNMMI 2019. Utilising an instrument smaller than a desktop PC to perform the essential PET QC tests with just single touch operation, this system is already creating a great deal of interest across the nuclear medicine community. For further information please contact our office or visit booth #927 at the show to see it demonstrated.

Brands: Tracer QC Flow-RAM Scan-RAM Dual Scan-RAM Scan-RAM MCA PETra SPECTra Laura Laura for PET Bubble Point EC Detector Posi-RAM


 Products

  • Tracer-QC
    A universal new solution for PET/SPECT radiotracer quality control. The Tracer-QC is an automated solution that utilises only an optical plate reader, a pipetting robot and single-use consumable kits for release testing of PET/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.

    QC Tests

    • Colour.
    • Clarity.
    • pH.
    • Kryptofix concentration.
    • Endotoxin concentration.
    • Residual solvents.
    • Radionuclidic identity (half-life).
    • Radioactivity concentration.
    • Radiochemical identity.
    • Radiochemical purity.
    • Chemical purity and specific activity.

  • Scan-RAM
    The innovative, flexible and compliant radio-TLC scanner...

  • LabLogic’s PET/SPECT radio-TLC canner, the innovative Scan-RAM™, is designed to meet the ever increasing demands of the modern laboratory. Versatile and compact, the instrument is fully controlled by the market leading radiochromatography software Laura for PET™, providing 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 now available in four different models:

    • Scan-RAM™
    • Dual Scan-RAM™
    • Scan-RAM MCA™
    • Dual Scan-RAM MCA™

    A wide range of detectors are available for the various Scan-RAM™ models, allowing the system to be 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™.

    Laura for PET™

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

  • Flow-RAM
    The innovative, flexible and compliant flow-through detector...

  • LabLogic’s PET/SPECT radio-HPLC Detector, the innovative Flow-RAM™, is designed to meet the ever increasing demands of the modern nuclear medicine laboratory.

    Flexibility

    The Flow-RAM™ is available in a single or dual detector configuration. In the latter configuration, each of the detectors can be set up independent of each other and used for different applications, if required.

    With a wide range of detectors suitable for both low and high levels of radioactivity, the Flow-RAM™ is an ideal quality control and research instrument.

    Compliance

    As with all LabLogic products, the Flow-RAM™ has been designed to exceed regulatory requirements. The instrument contains only 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 Flow-RAM™ ensures regulatory compliance via controlled access and audit-trail.

    Controlled by Laura for PET™

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

  • Posi-RAM
    Unsurpassed performance for PET metabolite profiling....

  • Designed specifically for the detection and quantification of low-level PET metabolites in the presence of higher levels of a single substance, therapeutic agent, test compound, or substrate.

    Posi-RAM™ utilises two bismuth germanate (BGO) crystals mounted on matched photomultiplier tubes with a flow cell in between to achieve the highest possible sensitivity. Using fast coincidence electronics, an event is only registered when each of the detector assemblies detects an event within the coincidence resolving time.

    The results are a low background and unmatched signal-to-noise ratio, enabling detection and quantification of low-level PET metabolites.

    Flexibility

    Although the primary intended use is detection and quantification of low level PET metabolites, the Posi-RAM™ has been designed with flexibility in mind. The coincidence counting circuitry can be switched off to enable gross gamma counting. Under those settings, the Posi-RAM™ can be used for radiochemical purity checks.

    Resolution and sensitivity

    To achieve the desired resolution and sensitivity, a range of high performance flow cells are available for the Posi-RAM™ with fixed volumes from 5 μL to 500 μL.

    Controlled by Laura for PET™

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

  • PETra
    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....

  • Improved Efficicency

    By managing data electronically, PETra significantly improves workflow efficiency in the following areas;

    • Pre-production checks.
    • Direct capture from equipment, thus eliminating transcription errors.
    • Dose Requirements; storing site, customer and dose information in one manageable place.
    • Barcode driven inventory management, providing you with up to date stock levels and allowing use of accepted raw material only.
    • Quality Management System; SOP, CAPA, Deviation, Change Control, OOS and Trending.
    • Instrument Maintenance / Calibration; ensuring equipment is maintained in accordance with your SOPs.
    • Labels and shipping documents.
    • Notifications for efficient communications and reminders of any tasks.
    • Training / User Records.
    • Audit Trail.
    • Sub-batches / Drug Stability Testing.
    • Security Access in accordance with regulatory requirements.
    • Electronic signatures; no more missing manual signatures.

    Improved Compliance

    PETra is a closed system that ensures compliance with regulatory demands.

    User access is managed via a unique login ID that is linked to users’ training and skill set. Electronic signatures and audit trails are configurable and in line with the FDA 21 CFR part 11 requirements in sections 11.50 and 11.10, respectively. These functionalities ensure that you don’t miss signatures where required and that retrieving audit trails for review is the effort of a few mouse clicks.

    LabLogic have decades of experience creating systems within highly regulated environments. We are confident that our
    systems will improve compliance within your facility.

    Direct Data Capture

    During the various phases of PET production, facilities have to manage data from a range of equipment and software packages, resulting in multiple outputs and reports. What’s unique about PETra, is that it captures data directly from equipment used in the process.

    Eliminates Transcription Errors

    As a result of direct data capture, PETra completely eliminates manual transcription  and the likelihood of any errors.

    Interfaces to all Equipment

    PETra captures data from all the equipment either directly or by interfacing to the respective software.

    Standardised Production

    Multi-site facilities can standardise production of their radiopharmaceuticals with PETra.

    Each site can be configured to ensure the same processes are being routinely carried out, removing inconsistencies.

    A modular system aimed at improving workflow efficiency whilst ensuring regulatory compliance.

    PETra is modular system which can be configured to suit the needs of any PET production facility. It is designed to improve efficiency whilst maintaining regulatory compliance at all stages of the PET production workflow.

    Dispensing Requirements

    Dispensing requirements can be entered manually, collected from on-line data systems or from bespoke in-house systems.

    Using that information PETra then automatically calculates the required activity.

    Customer and Site information can also be maintained within PETra.

    Pre-Production Checks

    Often Pre-Production checks are done by completing printed check sheets where errors can occur.

    In PETra there are logical step-by-step prompts ensuring pre-production checks fall in line with your SOPs.

    PETra can also be installed on a tablet which can be carried around the facility.

    Production

    PETra interfaces to all the leading Cyclotron systems and integrates the key information directly into the batch report. Beam current, LOB, EOB, etc., – all directly transferred into the batch report at the touch of a button.

    With the Synthesis process, PETra integrates key data directly from the manufacturers’ system, no manual transcription, no data errors.

    Quality Control

    PETra captures data directly from all QC instrumentation used within PET production, bringing it directly into the batch report.

    As some QC tests are done manually PETra allows for manual data entry with a full audit trail.

    For customers wanting to streamline control of their radiochromatography equipment, we have a dedicated single point of control software package called ‘Laura for PET.’

    Product Release

    Throughout the whole production and QC process, PETra provides a simple and logical way of reviewing batch progress. This information is available to review from any workstation allowing technicians and quality personnel maximum visibility.

    Once all the required test have been completed successfully, the responsible person can electronically sign off the release.

    Batch Reports

    All data is consolidated in a single, central repository. This can be printed to a user defined batch report.

  • SPECTra
    SPECTra is a true Radiopharmacy Laboratory Information Management System (LIMS), designed specifically to improve efficiency and compliance.
    ...

  • Improved Efficiency

    By managing data electronically, SPECTra significantly improves workflow efficiency in the following areas;

    • Customer orders with consolidated invoicing information.
    • Pre-production checks and worksheets.
    • Direct capture from equipment, thus eliminating transcription errors.
    • Dose Requirements; storing site, customer and dose information in one manageable place.
    • Barcode driven inventory management, providing you with up to date stock levels and allowing use of accepted raw material only.
    • Quality Management System; SOP, CAPA, Deviation, Change Control, OOS and Trending.
    • Instrument Maintenance / Calibration; ensuring equipment is maintained in accordance with your SOPs.
    • Labels and shipping documents.
    • Notifications for efficient communications and reminders of any tasks.
    • Training / User Records.
    • Audit Trail.
    • Sub-batches / Drug Stability Testing.
    • Security Access in accordance with regulatory requirements.
    • Electronic signatures; no more missing manual signatures.

    Improved Compliance

    SPECTra is a closed system that ensures compliance with regulatory demands.

    User access is managed via a unique login ID that is linked to users’ training and skill set. Electronic signatures and audit trails are configurable and in line with the FDA 21 CFR part 11 requirements in sections 11.50 and 11.10, respectively. These functionalities ensure that you don’t miss signatures where required and that retrieving audit trails for review is the effort of a few mouse clicks.

    LabLogic have decades of experience creating systems within highly regulated environments. We are confident that our systems will improve compliance within your facility.

    Direct Data Capture

    During the various phases of the workflow, facilities have to manage data from a range of equipment and software packages, resulting in multiple outputs and reports. What’s unique about SPECTra, is that it captures data directly from equipment used in the process.

    Eliminates Transcription Errors

    As a result of direct data capture, SPECTra completely eliminates manual transcription and the likelihood of any errors.

    Interfaces to all Equipment

    SPECTra captures data from all the equipment either directly or by interfacing to the respective software.

    Standardised Production

    Multi-site facilities can standardise production of their radiopharmaceuticals with SPECTra. Each site can be configured to ensure the same processes are being routinely carried out, removing inconsistencies.

    Implementing SPECTra enables LabLogic experts, alongside end user QA, to review and challenge current practices, building improvements and industry best practice into existing processes.

    A modular system that improves workflow efficiency whilst ensuring regulatory compliance

    SPECTra is a modular system which can be configured to suit the needs of any Radiopharmacy. It is designed to improve efficiency whilst maintaining regulatory compliance at all stages of the SPECT production workflow.

    Orders

    Both internal and external orders can be taken manually, with a full audit trail, or automatically via SPECTra’s On-line Ordering Module.

    Customer information including delivery addresses, unique pricing details and customised product information can be stored in the customer explorer section to ensure efficient data management.

    The Invoicing Module seamlessly integrates with customer orders so they are tracked automatically and can be generated in just a few mouse click’s.

    Preparation

    SPECTra automatically calculates the required activity for a production session.

    Worksheets are automatically generated to ensure your production session fulfils all orders efficiently.

    The barcode driven Inventory Management Module ensures materials are available and are in date ahead of each production session.

    Production

    SPECTra’s allows you to select the generators you want to elute for a particular session.

    Activity measurements are captured directly from the Dose Calibrator and logged against server date/time.

    Calibrator daily checks are recorded directly in SPECTra − results can be reviewed in the Trending Module.

    Activity dilutions/vial split’s are calculated automatically – saving on operator time and avoiding errors in manual calculations.

    Quality Control

    SPECTra captures data directly from all QC instrumentation used within SPECT production, bringing it directly into the batch report.

    As some QC tests are done manually SPECTra allows for manual data entry with a full audit trail.

    For customers wanting to streamline control of their radiochromatography equipment, we have a dedicated single point of control software package called ‘Laura for PET.’

    Dispensing

    Individual patient doses will be automatically calculated in-line with each customer’s predefined criteria.

    Direct data capture with Dose Calibrator and Balance ensure final product activity and volume are within an acceptable limit.

    Product and transportation labels/documents are automatically generated and available for printing.

    Product Release

    Throughout the whole production and QC process, SPECTra provides a simple and logical way of reviewing batch progress. This information is available to review from any workstation allowing technicians and quality personnel maximum visibility.

    Once all the required tests have been completed successfully, the responsible person can electronically sign off the release.

    Batch Reports

    All data is consolidated in a single, central repository. This can be printed to a user defined batch report.

  • Laura for PET
    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....

  • 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.

    Easy to use

    Laura for PET uses recognisable formats and wizards for multi-function tasks to make it simple to use by multiple users with different levels of experience with the system.

    A single software solution for the range of disciplines needed in the QC department makes the learning process easy and the day to day use effective.

    Compliant

    Laura for PET can be installed and configured to meet the most rigorous regulatory compliance requirements. Featuring configurable audit trail, multi level security, e-signatures and data storage into a secure database environment Laura for PET is the PET/SPECT industry’s answer for regulatory compliance.

    Connectivity

    Laura for PET provides connectivity to the widest range of detectors and chromatography systems, including the Flow-RAM and Scan-RAM for radioactivity detection along with chromatography systems for HPLC, GC as well as MCA.

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