Calibration Interval
The minimum requirement for GMP systems is a calibration requalification every 12 months.
Many customers increase this to six-monthly, with calibration support and replacement parts. This depends on the frequency that the system is used.
If there is evidence that a particular instrument is regularly outside its specified limits, we strongly recommend that the frequency of calibration is reviewed and increased as appropriate.
A calibration register should be created, defining instrument range, process range, allowable error and calibration frequency. This has to be maintained as a minimum FDA requirement.
Planned preventive maintenance (PPM)
Some parts are normally replaced regardless of condition, as part of an annual PPM procedure. This enhances the reliability of a system and reduces the risk of failure during production runs. When determining which parts should be replaced, you should consider the following areas:
• Valve diaphragms
• Sanitary seals
• Other seals and O-rings
• Pump seals, check valves and diaphragms
• pH electrodes
• Batteries
Age of systems and other known problems
As systems age, some components may be prone to failure. MAControls holds service records for a large number of process scale Chromatography and UF systems which can be used to identify possible models that might fail.
A risk assessment should be reviewed annually against known failure modes and amended as necessary. Older systems will have a greater risk of failure, or use obsolete components which become difficult to source as spare parts. MAControls have great success sourcing obsolete parts. If not we can provide alternatives.
