FDA guidance requires that filling equipment be calibrated at specific intervals, depending on the type of equipment. Don't forget you need to document all calibration!
Equipment should have annual calibration according to NIST standards, National Institute of Standards and Technology.
Equipment |
Each Fill Day |
Annual |
Recommended Standard |
Vacuum Gauges
|
X | X | NIST |
Thermometer
|
X | NIST | |
High Pressure Gauges
|
X | NIST | |
Servomex (Paramagnetic Oxygen Analyzer)
|
X | X | Manufacturer's Manual |
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