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

PyroSolution 21 CFR Part 11 Compliant



Endotoxin monitoring and control are critical quality criteria in the pharmaceutical, biotechnology and medical device industries. Unfortunately, quantitative LAL-Endotoxin testing has its own quality problems, such as frequent repeat testing and OOS burden. Up to now, the root of these problems has been ignored by software developers. If raw data quality can be improved, then frequent retesting can be significantly reduced. The primary technique for this improvement is signal processing. PyroSolution is the ONLY endotoxin measuring software product on the market, which integrates sophisticated signal processing for best raw data acquisition practices. PyroSolution is a lot more, than a collection of glamorous tools to solve your problems.

PyroSolution is the first total solution product in endotoxin contamination measurement, control, and tracking, which provides Total Compliance & Quality Management for the users.

Key Features

  • 21 CFR Part 11 Compliance - no buts and ifs,
  • High Throughput Instrumentation - multiple instruments can run in parallel at the same using the same SQL database,
  • Wizard Technology with integrated HTML - 3F-interface, form-function-fulfilment with zero-learning-burden and multiple language option,
  • Sample Tracking & Management - you can assign over 30 properties to your samples for extensive tracking & management,
  • OOS Database with OOS Executive Management - Non-compliant OOS investigations & deficient OOS resolutions are frequent cause of Warning Letters. PyroSolution offers significant support to avoid both OOS problems,
  • Signal processing - in PyroSolution you will be able to apply cutting-edge signal processing technology to improve the quality of your raw data,
  • Robust kinetics - if kinetic turbidimetric gives you problems, then improve the accuracy & reproducibility of your results by applying variable kinetic-scan & averaging algorithm,
  • Smart Kinetics Termination (SKT) - Stopping the reaction at the wrong time or the wrong place can be the cause of OOS. SKT algorithm evaluates the kinetic pattern continuously and determines with high probability when the reaction should be stopped,
  • Smart Method Validation & Uncertainty of Measurement Determination - every single-value measurement result is true within limits of certainty. The accuracy of each analytical process is dependent upon the process conditions, such as equipment used, temperature, extractions, etc. In PyroSolution you can model your method and determine the worst-case-scenario conditions and how to improve the outcome in the most cost effective way,
  • EndotogramsTM & EndotographsTM - PyroSolution provides unique capability for interpretation of the kinetic data; - by using EndotogramsTM & EndotographsTM you can evaluate the shape of the kinetic curves relative to “standard” criteria.
  • Extended calculations - the widely used calculation method of LAL-kinetic testing is differential optical density. Extensive analysis of over 10,000 measurements indicate that calculation algorithms, such as inflection point & rising edge, are more robust and accurate. PyroSolution includes all 3 options.
  • Sample load utility - 96-well microplate challenges the analyst for accurate assignment of the samples into the wells during sample loading. PyroSolution is capable to print multi-colour or grey-scale load-pattern of the microplate to guide the analysts to make certain that the samples are pipetted into the correct wells .
  • EQUAL - Decision Support Subsystem - trend analysis had become a vogue expression with the competitors. In addition of the “traditional” trend analysis, we had enhanced PyroSolution with several SQC (Statistical Quality Control) & SPC (Statistical Process Control) models.
  • 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


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

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

System requirements

  • Intel 200 MHz Pentium compatible CPU
  • 64 MB of memory
  • 150 MB free hard disk space
  • Windows 98, ME or NT 4.0 SP6+ or 2000 SP1 or XP operating system
  • Internet Explorer 5.5 or later
  • CD ROM drive
  • SVGA color monitor set to 800x600 graphical resolution with high color

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 PyroSolution 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 PyroSolution. 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 PyroSolution. 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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