Physical Testing Quality Control (Differential Scanning Calorimetry, Thermogravimetric Analysis, and Differential Thermal Analysis/Thermogravimetric Analysis)
Effective Date: 11/01
Point of Contact: Quality Engineer for Regulatory Programs
| Quality Control Requirements | Frequency | Acceptance Criteria | Failure Action |
|---|---|---|---|
Differential Scanning Calorimetry |
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| Continuing calibration verification (performance check) temperature characteristics | Each time the temperature ramp rate is changed | Standard(s) which is within the range of analysis and thermogravi-metric analysis standard (material of known thermal properties) shall conform to known physical constants. | Investigate. Correct and restart. Recalibrate if necessary. |
Thermogravimetric Analysis, Differential Thermal Analysis/Thermogravimetric Analysis |
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| Continuing calibration verification (performance check) mass/weight characteristics | Periodically, not to exceed quarterly | Check balance performance using material of known mass or of known mass loss as a function of temper-a-ture properties | Investigate. Correct. Restart. Recalibrate if necessary. |
Rheology |
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| Continuing calibration verification | Monthly or within 30 days of measurement | ± 15% at viscosities <10CP ± 10% at viscosities >10CP | Repair or Replace |
Particle Size Analysis |
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| Control Check Standard | Daily | ± 10% of expected value | Rerun standard. If fails again, then investigate and correct. |