Our validation process includes comprehensive IQ/OQ/PQ testing using NIST-traceable calibrated instruments, detailed documentation, and thorough data analysis. We provide complete validation protocols and summary reports that meet FDA and GMP requirements, supported by our experienced validation engineers.
Validation frequency typically ranges from 1 to 3 years, depending on your specific risk assessment and the criticality of stored materials. Most of our customers operate on 2-3 year validation cycles, while some opt for annual validation when storing highly critical materials or when their risk assessment requires it.
Regardless of the chosen cycle, validation should also be performed after any major repairs, relocations, or significant modifications to the freezer or supporting infrastructure and utilities.
A standard temperature mapping validation includes multiple studies, with the loaded chamber study typically running for 24 hours. The entire validation process, including empty chamber, door opening, and power failure studies, usually takes 2-3 days to complete.
This ensures thorough documentation of your freezer's performance under various conditions. After completion of onsite services, final QA-reviewed validation reports are delivered within 2 weeks.
For initial IQ/OQ/PQ validation, please have your simulated load ready but not loaded until our engineers arrive onsite. For re-qualification studies (performed 1-3 years after initial validation), the freezer should already be loaded with your typical products or simulated loads.
In all cases, ensure your freezer is operating at its specified temperature and has completed any required maintenance. Our team will provide a detailed checklist during project planning.
What documentation do I receive after the temperature mapping is complete? A: You'll receive a comprehensive validation package including:
- Executed protocol with raw data and detailed analysis
- Summary reports and calibration certificates
- Graphical representations of temperature fluctuations throughout time-based studies
- 3-D rendering of the chamber showing sensor placement
- Photographic documentation of actual sensor placement, empty chamber, and loaded chamber configurations
- Any non-conformance documentation and resolution
The package provides visual mapping of hot and cold spots within your chamber, making it easy to understand temperature distribution patterns. This complete documentation package is designed to meet regulatory requirements and support audit readiness.
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