Minimum Calibration Requirements for Externally Calibrated Equipment
Effective Date: 11/01
Point of Contact: Quality Engineer for Regulatory Programs
| Equipment or Technique | Calibration Requirements | Criteria | Frequency | Corrective Actions |
|---|---|---|---|---|
| Thermogravimetric analysis | Calibration performed by manufacturer | Confirm acceptability using performance check (temperature and balance checks) | Upon failure of performance check | Recalibrate when performance cannot be re-established |
| Differential thermal analysis and thermal gravimetry | Calibration performed by manufacturer | Confirm acceptability using performance check (temperature and balance checks) | Upon failure of performance check | Recalibrate when performance cannot be re-established |
| Differential scanning calorimetry | Calibration performed by manufacturer | Confirm acceptability using performance check (temperature and enthalpy checks) | Upon failure of performance check | Recalibrate when performance cannot be reestablished |
| Particle size analysis | Calibration performed by manufacturer | Confirm acceptability using performance check | Upon failure of performance check | Recalibrate to manufacturer's recommendations |
| Rheology | Calibration performed by manufacturer | Confirm acceptability using performance check | Upon failure of performance check | Repair or replace |
| Analytical balances | Calibration performed by external organization | Confirm acceptability using performance check | Annually or upon failure of performance check | Recalibrate at specified interval or when performance cannot be reestablished |
| Digital Thermometers | Certified by external organization | Confirm acceptability using performance check | Upon failure of performance check or annually | Replace or repair |
| Thermometers (for critical temperature measurements) | Certified by external organization prior to receipt | Confirm acceptability using performance check | Annually, at ice point | Replace or recertify |
| Pre-calibrated glassware | Calibration performed by manufacturer | Manufacturer's specifications meet analytical needs | Not applicable | Replace when out of specifications or contaminated |
| Conductivity meter | N/A | Confirm acceptability using performance check | Upon failure of performance check | Repair or replace |
| Density meter | N/A | Confirm acceptability using performance check | Upon failure of performance check | Repair or replace |
| Manometer | Calibration performed by manufacturer | Confirm acceptability using performance check | Annually | Replace or have externally recertified |