4.2 Operation
4.2.1 Starting the Cycle
4.2.1.1 Start the freeze drying cycle using the appropriate program or settings as per the protocol.
4.2.1.2 Monitor the process parameters such as temperature and vacuum level throughout the cycle.
4.2.1.3 Observe the progress of freeze drying through the viewing window or monitoring system.

4.2.2 Safety Precautions
4.2.2.1 Do not open the freeze dryer door during operation unless necessary for emergency shutdown.
4.2.2.2 Handle frozen samples with care to prevent damage or contamination.
4.2.2.3 Ensure proper ventilation in the freeze drying area to manage vapor release.

4.3 Post-operation
4.3.1 Unloading Samples
4.3.1.1 Once the freeze drying cycle is complete, wait for the shelves or trays to reach room temperature.
4.3.1.2 Remove dried samples carefully from the shelves or trays, avoiding physical stress.
4.3.1.3 Transfer dried samples to appropriate storage containers or packaging.

4.3.2 Cleaning and Maintenance
4.3.2.1 Clean the interior surfaces of the freeze dryer and shelves after each use to remove any residues.
4.3.2.2 Inspect and clean the condenser coils and vacuum lines regularly to maintain efficiency.
4.3.2.3 Schedule preventive maintenance and lubrication of moving parts as recommended by the manufacturer.

5) Abbreviations, if any

QC: Quality Control
SOP: Standard Operating Procedure

6) Documents, if any

Freeze dryer log
Maintenance log

7) Reference, if any

Manufacturer’s manual for the freeze dryer
Pharmacopeial guidelines for freeze drying processes in pharmaceutical manufacturing

8) SOP Version

Version 1.0