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Where are you now? Intelligence Services > Endotoxin > Products > PyroSolution
PyroSolution
Introduction
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
Applications
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.
DQ supports the functional
& quality specifications designed into PyroSolution. Documentary proof of DQ
compliance includes:
- Software Validation Plan,
- Software Validation Summary,
- 21 CFR Part 11 Validation Summary,
- Measurement Performance Design Summary, and
- Measurement Compliance Summary
IQ (Installation Qualification) - IQ supports the
requirement for proper installation and acceptance qualification for
PyroSolution. Documentary proof of IQ compliance includes:
- Receipt & acceptance checklist,
- Physical & electrical compliance checklist,
- Environmental compliance checklist,
- Training compliance checklist, and
- Final IQ Summary
OQ (Operational Qualification) - OQ supports the
specification compliant functioning of the system. Documentary proof of OQ
compliance includes:
- 21 CFR Part 11 operational specification checklist,
- Software operational specification checklist,
- Instrument interface operational specification checklist,
- Instrument operational specification checklist, and
- Final OQ Summary
PQ (Performance Qualification) - PQ supports quality
evaluation & quality compliance management of the system. PQ compliance
models include:
- 21 CFR Part 11 compliance models,
- SQC models for instrument qualification review,
- SQC models for method qualification review,
- SQC models for vendor qualification review, and
- SQC models for OOS investigations
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