PETra™

Complete Process Management System for PET Facilities

PETra is an innovative PET LIMS (Laboratory Information Management System) from LabLogic that is specifically designed for PET facilities. PETra compiles all the relevant information into a single batch report is by interfacing to all of the equipment in PET facilities including:

  • Environmental monitoring system
  • Dose dispensing system
  • Cyclotron
  • Synthesis units
  • HPLC/GC instrumentation
  • Radio HPLC/TLC systems
  • Dose Calibrator, pH meter, Balances, Charles River Endosafe PTS spectrophotometer etc

LabLogic has used its 25 years of expertise in LIMS development to produce a system that is ideally suited to facilities operating in the regulated environment while being sufficiently flexible to be used in less regulated investigational and research PET environments. Wherever possible, critical data is captured directly from key instruments, thus reducing the need for manual data transcription. The system also includes multi-level security, full audit trails and electronic signatures to facilitate compliance with GxP, FDA and other applicable regulations.

A barcode-driven inventory and stock-control system provides a user friendly and time-efficient system for stock control of raw materials and reagents.

PETra interfaces with various Chromatography Systems and facilitates a seamless interface with our Laura radiochromatography system allowing chromatograms and associated metadata to be stored, displayed and reported in PETra.

By implementing PETra, facilities will eliminate the need for paper records of the production processes. Production method for each PET radiotracer can be designed and stored in PETra so that anyone, with the appropriate access rights, can log into PETra and follow the process to produce any PET radiotracers such as [18F]FLT, [18F]FDG, [18F]FDOPA, [18F]fluorodopamine, [11C]acetate, [11C]Choline, [11C]flumazenil, etc

Features

  • Inventory system to track components, materials and supplies.
    • Chain of custody; from point of order through to its use in a batch
    • Automatic expiration and dating
    • Quality Control data is linked to each raw material
    • Automated re-ordering when materials reach critical stock level
    • Label generation with barcodes
  • Standard Operating Procedure management via the PETra Document Management system
  • Instrument performance reports - to enable early diagnosis of any potential requirement for maintenance work and ability to look at yield etc
  • Pre-production checks prompts to ensure that certain actions such as cleaning of the synthesis apparatus, checking of the tubing, reaction vessels, purification columns and other materials have been undertaken as recommended by the FDA
  • Different security levels based upon qualifications/levels of expertise
  • Double signature of all processes as recommended by the FDA part 211
  • Multi site deployment - ideal for PET Manufacturing facilities that have multiple sites

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