Standard Operating Procedure for Qualification of Ampoule and Vial Washing Machines
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying ampoule and vial washing machines used in the pharmaceutical manufacturing of sterile products. This SOP ensures that the washing machines are correctly installed, operated according to specifications, and perform effectively under typical production conditions. The qualification process verifies mechanical, electrical, and operational parameters to ensure that the washing process meets the required regulatory and quality standards, including cleaning efficiency, container integrity, and adherence to aseptic conditions.
2) Scope
This SOP applies to the qualification of ampoule and vial washing machines used in pharmaceutical manufacturing for cleaning containers such as ampoules, vials, and pre-filled syringes. The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new washing machines and those that have undergone major repairs, upgrades, or relocations. The qualification ensures that the washing machine operates effectively, providing consistent cleaning performance and meeting the necessary standards for sterile product production.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the ampoule and vial washing
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the washing machine are carried out in compliance with this SOP and meet all regulatory requirements. QA is 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 washing 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 washing machine meets all performance criteria.
Maintenance Personnel: Ensures that the washing 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 ampoule and vial washing machines:
1. Installation Qualification (IQ):
1.1 Review equipment specifications and manufacturer manuals to ensure that the ampoule and vial washing machine meets the necessary requirements for installation.
1.2 Verify that all required utilities (e.g., electrical power, water supply, steam, compressed air) are available and meet the specifications required for proper 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 washing chambers, rotating brushes, nozzles, spray arms, and drainage systems.
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 water temperature, spray pressure, agitation speed, and cycle time, are properly set and calibrated.
2.2 Conduct a dry run of the washing machine to verify that it operates without issues. Monitor key parameters such as spray pressure, water temperature, and uniformity of washing.
2.3 Test all control systems, ensuring that the start/stop, water flow, agitation, and cycle controls work correctly.
2.4 Inspect the washing process to ensure that the ampoules and vials are effectively cleaned and free of contaminants.
2.5 Verify that the washing machine produces a consistent and uniform cleaning action, ensuring that no containers are left uncleaned.
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 washing process using a batch of empty ampoules or vials, or simulated products (e.g., inert substances) to monitor performance under typical production conditions.
3.2 Verify that the washing machine cleans the containers effectively by checking for any remaining contaminants such as particles, residues, or films.
3.3 Conduct visual inspections of the cleaned containers to ensure that they are free from contaminants, stains, and visible defects.
3.4 Measure the efficiency of the washing process by conducting microbiological testing of the containers before and after cleaning to ensure that the sterilization process is effective.
3.5 Verify that the machine operates at the required throughput and meets production schedules without compromising cleaning performance.
3.6 Document the results of the PQ, including cleaning efficiency data, visual inspection results, 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 container cleanliness, contamination levels, and cycle times.
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 washing process. This analysis should confirm that the washing machine operates consistently within predefined parameters and meets the acceptance criteria for cleanliness and sterilization.
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 washing machine’s performance.
5. Requalification:
5.1 Requalify the washing machine if significant changes are made to the equipment, such as replacing major components, relocating the machine, or modifying the washing 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
- Washing Process Records
- Microbiological Testing 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: Cleaning Efficiency Log
| Batch No. | Test Date | Container Inspection (Pass/Fail) | Microbial Testing Results (Pass/Fail) | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Pass/Fail | Pass/Fail | Operator Name |
Template 3: Washing Machine Performance Log
| Batch No. | Test Date | Spray Pressure (Bar) | Water Temperature (°C) | Cycle Time (minutes) | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Pressure | Temperature | Time | Operator Name |