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Where are you now? Intelligence Services > Endotoxin > Products > PyroGel

PyroGel 21 CFR Part 11 Compliant



PyroGel is the first computer-aided gel-clot testing system for endotoxin contamination measurement, control, and tracking, which provides Total Compliance & Quality Management for the users.

Gel-clot procedure is the reference technique in LAL-endotoxin testing. On the one hand it is the pillar of BET, while on the other-hand it has many inherent weaknesses that increased the value of alternate determinations. PyroGel brings new capabilities to gel-clot procedure and bring its value closer to alternate quantitative techniques.

Key Features

  • 21 CFR Part 11 Compliance - no buts and ifs,
  • Wizard Technology with integrated HTML - 3F-interface, form-function-fulfilment with zero-learning-burden and multiple language option,
  • PyroTherm - is a computer integrated heating block with multitube ( 4 x 12 or 8 x 12) capability. Temperature range is from room temperature + 4C to 250 C with programmable cooling & timing control,
  • PyroTherm calibration - integrated temperature calibration assures temperature compliance requirement,
  • PyroTherm validation - depyrogenation validation is supported through integrated challenge studies
  • Multi-point temperature monitoring - PyroGel monitors temperature conditions at 8 different points. Real-time visualization and documentation provides meaningful support to temperature compliance,
  • Reagent Performance - lysate related stability characteriscs are documented and monitored,
  • Standard Performance - multiple reconstitution of Endotoxin standard is monitored and its stability characteristics can be evaluated,
  • Depyrogenation - reaction & dilution tubes can be depyrogenated within the block; depyrogenation conditions are documentated and stored in the database,
  • Challenge - specific protocol supports challenge studies. Automatic calculation provides final results,
  • Sensitivity-Limit-Assay - all gel-clot test protocols are supported by PyroGel,
  • Sample loading - PyroGel wizard supports automatic & manual loading of the samples,
  • Supplies & Equipment - each item used during testing can be registered in the database for later evaluation including vendor qualification,
  • Smart Method Validation - you can model the method development process to support your validation,
  • Automatic calculation - after data entry the program automatically calculates qualification requirements and finished results,
  • SQL database - your information is stored in SQL database for security and effective query capability,
  • SQC - Statistical Quality Control models are integrated into PyroGel. You will be able to establish an effective quality control and quality assurance program, which will assist you to maintain a compliant system.
  • Upgrading to PyroSuite - Integrate PyroSolution, PyroGel, PyroDoQ, Epsilon, and LAL competency training to solve all your endotoxin testing requirements, including:
    • Gel-clot, kinetics, and end-point testing results can be reviewed, modelled, correlated by integrating SQL databases,
    • Add PyroGel to improve your gel-clot testing with in-situ depyrogenation, multi-point temperature monitoring, 21 CFR Part 11 documentation,
    • Design Qualify (DQ) your kinetic testing to reduce OOS,
    • Add competency training courses to meet compliance & improve performance of your analysts.
    • Rapid OOS Investigation (ROI) - ROI also means Return-On-Investment, which is the bottom line for using PyroSuite. Just think, you can get the with the click of the mouse:
      • All batch numbers related to the specific OOS
      • All SOPs related to the OOS with full SOP analysis for deviations
      • All employees’ competencies with their training records & training results,
      • Relevant listings of the trouble making equipment, employee, and/or process steps.


PyroGel offers flexible environment & tools for number of applications, including:

  • Pharmaceutical & biotechnology,
  • Medical device,
  • Clinical, and
  • Environmental.

System requirements

  • Intel Pentium 200 MHz processor
  • 64 MB memory
  • CD ROM drive
  • 150 MB free hard disk space
  • Internet Explorer 5.5 or later
  • SVGA color monitor set to 800x600 with high color
  • Windows ME, NT 4.0 SP6+ or 2000 SP1 or XP operating system

DQ-IQ-OQ-PQ and 21 CFR part 11

Regulatory compliance in the pharmaceutical, biotechnology, and medical device, industries is the foundation of good business practices. DQ-IQ-OQ-PQ documents for PyroGel provide significant support to reduce the risk of non-compliance.

DQ (Design Qualification) - is the foundation of good science & good compliance practices. You cannot get more out of a system that has been built into it. DQ is the tool & methodology to make the evaluation of suitability for specific requirements, including worst-case-scenario. DQ also provides the baseline for meaningful Performance Qualification (PQ) monitoring; without DQ, PQ flounders, it does not exist. 21 CFR Part 11 compliance is a major functionality relative to Design Qualification.
In the first part let us consider what may be the most important questions to ask relative to 21 CFR Part 11 DQ. STOP

DQ supports the functional & quality specifications designed into PyroGel. Documentary proof of DQ compliance includes:

  1. Software Validation Plan,
  2. Software Validation Summary,
  3. 21 CFR Part 11 Validation Summary,
  4. Measurement Performance Design Summary, and
  5. Measurement Compliance Summary.

IQ (Installation Qualification) - IQ supports the requirement for proper installation and acceptance qualification for PyroGel. Documentary proof of IQ compliance includes:

  1. Receipt & acceptance checklist,
  2. Physical & electrical compliance checklist,
  3. Environmental compliance checklist,
  4. Training compliance checklist, and
  5. Final IQ Summary.

OQ (Operational Qualification) - OQ supports the specification compliant functioning of the system. Documentary proof of OQ compliance includes:

  1. 21 CFR Part 11 operational specification checklist,
  2. Software operational specification checklist,
  3. Instrument interface operational specification checklist,
  4. Instrument operational specification checklist, and
  5. Final OQ Summary.

PQ (Performance Qualification) - PQ supports quality evaluation & quality compliance management of the system. PQ compliance models include:

  1. 21 CFR Part 11 compliance models,
  2. SQC models for instrument qualification review,
  3. SQC models for method qualification review,
  4. SQC models for vendor qualification review, and
  5. SQC models for OOS investigations.
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