Where are you now? Regulatory Basis > 21 CFR Part 11 Issues > Compliant Products > Endotoxin Measurements > PyroLab > PyroTherm
PyroTherm is the core module of PyroLab. The system includes the basic thermal
block with the standard cover and integrating software. An optional cover with venting and gas
inlet manifold for gas purging and fluid mixing will be available soon. The software controls
temperature requirements - either isothermal or programmed -, time intervals, and mechanical
cooling. Sample handling is supported by a sophisticated sample tracking software module.
Standard, supplies, reagents, consumables, and other equipment used in the process can be data
entered for full documentation. EQU Application Integration System enables value added data
management for QC, QA, method development and drug discovery..
- 21 CFR Part 11 compliant software,
- SQL database,
- Upgradeable to network version,
- EQU Decision Support compatibility for application integration,
- DQ-IQ-OQ-PQ integrated system validation protocols,
- 48 or 96 sample tubes of various sizes can be handled in a single block,
- 2 to 4 microplates can be handled in a single block,
- Sample location configuration follows microplate-well-identification scheme,
- Optionally, up to 4 blocks for a total of 192 to 384 sample tubes or 8 to 16 microplates can be managed at the same time,
- Temperature-time programming includes 4°C above ambient to 320°C at 0.1°C intervals with programmable cooling,
- High temperature cleaning of the collection tubes or microplates and cleaning validation are supported,
- Temperatures are monitored up to 8 different points,
- Temperature calibration is built into the system,
- SQC & SPC are supported for quality evaluation & quality improvement decisions.
System Requirements (minimum):
- Intel Pentium 200 MHz or compatible processor
- 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
- CD ROM drive
- SVGA color monitor set to 800x600 graphical resolution with high color
System Requirements (recommended):
- Intel Pentium II 500 MHz or compatible processor
- 128 MB of memory
- 200 MB free hard disk space
- Operating system NT 4.0, 2000 or later
- 1024x768 graphical resolution with True Color
Specification (cooming soon)
- Instrument dimensions
- Electrical power
- Computer interface
- Temperature control
- Heating rate
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 PyroTherm provide significant support to reduce the risk
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 PyroTherm. Documentary proof of DQ
- 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 PyroTherm.
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
- 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
- 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.