Calibration Procedures

Over time, even the most advanced process control instruments tend to drift. Environmental conditions, mechanical wear, and complex internal structures can cause deviations that compromise performance. Without routine calibration, you simply can’t be sure your process is under control.

IMA’s calibration protocols are aligned with GMP regulatory requirements, which demand:

• Written procedures for routine calibration
• Full documentation for each calibrated instrument
• Defined accuracy and precision limits
• Use of traceable standards
• Remedial actions when deviations are found
• Trained and qualified personnel

Within freeze dryers, the most critical parameters are temperature and pressure – both above and below atmospheric levels. These are measured by instruments whose accuracy directly affects:

Time, while essential, is not calibratable in the strictest sense. Therefore, IMA focuses on the instruments that truly impact control and documentation.

Regulators require not just calibration – but proof of it. IMA provides a complete documentation package, including:

• Standard operating procedures (SOPs)
• Instrument qualification files
• Calibration master lists
• Test sheets and reports
• Exception reports with follow-up actions

This ensures full traceability and compliance with international standards.