Standard Operating Procedure for Setup and Calibration of Lyophilizer Equipment
1) Purpose
This SOP outlines the procedure for setting up and calibrating lyophilizer equipment to ensure that all lyophilization cycles are conducted accurately and consistently.
2) Scope
This SOP applies to all maintenance personnel, operators, and QA staff responsible for setting up, calibrating, and verifying lyophilizer performance prior to use in manufacturing.
3) Responsibilities
- Maintenance Personnel: Responsible for the setup, calibration, and routine maintenance of lyophilizers.
- Operators: Responsible for assisting in the setup and verifying lyophilizer parameters before each batch.
- QA Personnel: Responsible for ensuring the calibration documentation is accurate and verifying that the lyophilizer is functioning within acceptable parameters.
4) Procedure
4.1 Setup of the Lyophilizer
4.1.1 Initial Setup
- 4.1.1.1 Ensure that the lyophilizer is positioned in a clean, dry area with adequate ventilation and that all power connections are secure.
- 4.1.1.2 Verify that the condenser, refrigeration unit, and vacuum pump are operational and functioning properly.
4.2 Calibration
4.2.1 Calibration of Temperature and Vacuum Sensors
- 4.2.1.1 Calibrate temperature sensors at different points within the chamber to ensure uniform temperature distribution.
- 4.2.1.2 Verify the accuracy of the vacuum sensor by comparing its readings against a certified vacuum gauge. Adjust calibration settings as necessary to achieve an
accurate reading.
4.3 Performance Verification
- 4.3.1 Conduct a dry-run test cycle to verify the accuracy of temperature and vacuum parameters during a simulated lyophilization cycle.
- 4.3.2 Record all parameters and compare them against the equipment’s specification limits. Ensure all readings fall within acceptable ranges.
4.4 Documentation
All calibration results and test cycles should be recorded in the Lyophilizer Calibration Logbook, including any adjustments made to equipment settings. QA should review and verify the calibration documentation.
5) Abbreviations
- QA: Quality Assurance
6) Documents
- Lyophilizer Calibration Logbook
7) References
- Manufacturer’s guidelines for lyophilizer setup and calibration
8) SOP Version
Version 1.0
Annexure
Lyophilizer Calibration Logbook Template
| Date | Lyophilizer ID | Temperature Calibration Results | Vacuum Calibration Results | Operator Initials | QA Verification |
|---|---|---|---|---|---|
| DD/MM/YYYY | Lyophilizer ID | Pass/Fail | Pass/Fail | Operator Name | QA Initials |