Standard Operating Procedure for Preparation of Lyophilizer Chambers
1) Purpose
The purpose of this SOP is to outline the steps required to clean, set up, and verify the readiness of lyophilizer chambers prior to the freeze-drying process. This ensures that the chambers are free of contaminants and that all equipment functions are prepared for a successful lyophilization cycle.
2) Scope
This SOP applies to operators, maintenance staff, and QA personnel involved in the preparation of lyophilizer chambers for product loading and lyophilization.
3) Responsibilities
- Operators: Responsible for chamber cleaning, disinfection, and setup as outlined in the Batch Manufacturing Record (BMR).
- Maintenance Personnel: Responsible for inspecting and verifying the proper operation of sensors, refrigeration, and vacuum systems.
- QA Personnel: Responsible for verifying cleanliness and setup prior to initiating the lyophilization cycle.
4) Procedure
4.1 Cleaning and Disinfection
4.1.1 Cleaning Frequency
- 4.1.1.1 Clean and disinfect the lyophilizer chamber before every batch to ensure sterile conditions and prevent contamination.
4.1.2 Cleaning Procedure
- 4.1.2.1 Use a cleaning solution suitable for sterile environments to wipe down internal surfaces, including shelves, walls, and door seals.
- 4.1.2.2 Inspect for and remove any residue from previous batches.
- 4.1.2.3 Allow surfaces to air dry before proceeding to equipment setup.
4.2 Chamber Setup
4.2.1 Temperature and Pressure Checks
- 4.2.1.1 Verify that temperature and pressure
sensors are properly calibrated and functioning within specified limits.
4.2.2 Shelving Configuration
- 4.2.2.1 Set up the shelves according to the product’s lyophilization parameters, ensuring that vials have adequate spacing for uniform freeze-drying.
4.2.3 Chamber Sealing
- 4.2.3.1 Ensure that the chamber door seals properly. Perform a vacuum test to confirm no leaks before starting the lyophilization process.
4.3 Documentation
Record all cleaning and setup tasks in the Lyophilizer Chamber Preparation Logbook. Ensure both operator and QA personnel sign off before proceeding with the freeze-drying process.
5) Abbreviations
- BMR: Batch Manufacturing Record
6) Documents
- Lyophilizer Chamber Preparation Logbook
7) References
- Manufacturer’s guidelines for lyophilizer chamber preparation
8) SOP Version
Version 1.1
Annexure
Lyophilizer Chamber Preparation Logbook Template
| Date | Chamber ID | Cleaning Performed | Shelving Setup | Operator Initials | QA Verification |
|---|---|---|---|---|---|
| DD/MM/YYYY | Chamber Number | Pass/Fail | Pass/Fail | Operator Name | QA Initials |