Standard Operating Procedure for Qualification of Automatic Tube Filling Machines
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying automatic tube filling machines used in pharmaceutical manufacturing. This SOP ensures that the tube filling machines are correctly installed, operated according to specifications, and perform effectively under normal production conditions. The qualification process verifies mechanical, electrical, and operational parameters to ensure that the filling process meets the required regulatory and quality standards, including fill accuracy, sealing integrity, and labeling consistency.
2) Scope
This SOP applies to the qualification of automatic tube filling machines used in pharmaceutical manufacturing for filling creams, gels, ointments, and other semi-solid formulations into tubes. The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new tube filling machines and those that have undergone major repairs, upgrades, or relocations. The qualification ensures that the tube filling machine operates effectively, produces consistent results, and meets predefined product specifications.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the automatic tube filling machine is operated according to the qualification protocols and that critical parameters
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the automatic tube filling machine are carried out in compliance with this SOP and meet all regulatory requirements. QA is also responsible for reviewing and approving all qualification reports and documentation.
Production Supervisors: Oversee the qualification processes to ensure that operators follow the protocol and that the machine operates within the specified parameters.
Validation Team: Responsible for developing the qualification protocols, executing the IQ, OQ, and PQ runs, and analyzing the results to ensure the tube filling machine meets all performance criteria.
Maintenance Personnel: Ensures that the automatic tube filling machine is properly installed, maintained, and calibrated, and that all mechanical and electrical systems are functioning correctly during the qualification process.
4) Procedure
The following steps should be followed for the IQ, OQ, and PQ of automatic tube filling machines:
1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the tube filling machine meets the necessary requirements for installation.
1.2 Verify that all required utilities (e.g., electrical power, compressed air, water supply) are available and meet the specifications required for proper machine operation.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, cleanliness, and space.
1.4 Confirm that all mechanical components are correctly installed, including tube feeding systems, filling nozzles, capping mechanisms, and conveyors.
1.5 Ensure that all electrical components, including sensors, control systems, and alarms, are properly connected and functioning.
1.6 Perform a visual inspection to confirm that the equipment is installed according to the manufacturer’s instructions and that all components are intact.
1.7 Complete the IQ documentation, including checklists, equipment manuals, and relevant installation records, ensuring that all information is recorded and signed off by responsible personnel.
2. Operational Qualification (OQ):
2.1 Verify that all operational controls, such as fill volume, fill speed, tube feed rate, and sealing pressure, are properly set and calibrated.
2.2 Conduct a dry run of the automatic tube filling machine to verify that it operates without issues. Monitor key parameters such as filling volume, tube alignment, and sealing consistency.
2.3 Test all control systems, ensuring that the start/stop, tube feeding, filling, capping, and sealing mechanisms work correctly.
2.4 Inspect the filling process to ensure that the correct amount of product is filled into each tube and that the tubes are sealed properly.
2.5 Verify that the system handles different tube sizes and types correctly, with proper sealing and labeling.
2.6 Document the results of the OQ, noting any deviations or issues encountered and corrective actions taken.
3. Performance Qualification (PQ):
3.1 Conduct the filling process using product or simulated product (e.g., inert solution) and monitor performance under typical production conditions.
3.2 Perform sampling during the filling cycle to measure the fill volume in each tube. Ensure that the fill volume is consistent and meets predefined specifications.
3.3 Verify that the tube capping and sealing process produces tubes that are leak-free and secure.
3.4 Conduct a visual inspection to ensure that the filled tubes are correctly labeled and that no damage occurs during the filling or sealing process.
3.5 Measure the throughput of the machine and ensure that it operates within the required production rates without compromising quality.
3.6 Document the results of the PQ, including fill volume data, sealing integrity, labeling accuracy, and any process deviations. Ensure that all records are signed and reviewed by responsible personnel.
4. Documentation and Reporting:
4.1 Record all data during the IQ, OQ, and PQ processes, including batch records, equipment logs, process parameters, and inspection results for fill accuracy, sealing integrity, and labeling accuracy.
4.2 Ensure that all forms, reports, and certificates are completed and signed by responsible personnel.
4.3 Perform statistical analysis on the collected data to assess the consistency and reliability of the filling process. This analysis should confirm that the machine operates consistently within predefined parameters and meets the acceptance criteria for product quality.
4.4 Prepare a final qualification report, summarizing the results of the IQ, OQ, and PQ, including any deviations, corrective actions, and conclusions regarding the automatic tube filling machine’s performance.
5. Requalification:
5.1 Requalify the tube filling machine if significant changes are made to the equipment, such as replacing major components, relocating the machine, or modifying the filling system.
5.2 Periodically perform requalification to ensure that the equipment continues to perform as expected and remains in compliance with regulatory requirements.
5) Abbreviations
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- QA: Quality Assurance
- SOP: Standard Operating Procedure
6) Documents
- IQ/OQ/PQ Protocol
- Equipment Manufacturer Specifications
- Installation and Setup Reports
- Calibration Records
- Filling Process Records
- Tube Sealing and Capping Logs
- Deviation and Corrective Action Reports
7) Reference
- FDA Guidance for Industry: Equipment Qualification
- International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ISO 9001: Quality Management Systems – Requirements
- USP Chapter 1151: Pharmaceutical Dosage Forms
8) SOP Version
Version 1.0 – Effective Date: DD/MM/YYYY
Annexure
Template 1: IQ/OQ/PQ Test Record
| Date | Time | Operator Initials | Test Type (IQ/OQ/PQ) | Test Results | Comments |
|---|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | IQ/OQ/PQ | Pass/Fail | Comments |
Template 2: Fill Volume Log
| Batch No. | Test Date | Fill Volume (mL) | Deviation (%) | Pass/Fail | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Volume in mL | Deviation Percentage | Pass/Fail | Operator Name |
Template 3: Tube Sealing and Capping Log
| Batch No. | Test Date | Sealing Integrity (Pass/Fail) | Tube Capping Accuracy (Pass/Fail) | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Pass/Fail | Pass/Fail | Operator Name |