Standard Operating Procedure for Qualification of Chillers and Cold Storage Units
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying chillers and cold storage units used in pharmaceutical manufacturing and storage areas. This SOP ensures that the chillers and cold storage units are properly installed, calibrated, and operate according to the required specifications. The qualification process verifies that these systems maintain the required temperature and humidity control for storing temperature-sensitive materials and products, while ensuring compliance with regulatory and safety standards.
2) Scope
This SOP applies to the qualification of chillers and cold storage units used in pharmaceutical manufacturing and storage areas, such as warehouses, refrigeration rooms, and storage chambers for raw materials, intermediates, and finished products. The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new chillers and cold storage units and those that have undergone significant repairs, upgrades, or relocations. The qualification ensures that the chillers and cold storage units maintain the required storage conditions to preserve the integrity and quality of temperature-sensitive products.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the chillers and cold storage units 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 chillers and cold storage units operate 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 chillers and cold storage units meet all performance criteria.
Maintenance Personnel: Ensures that the chillers and cold storage units are 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 chillers and cold storage units:
1. Installation Qualification (IQ):
1.1 Review the chiller and cold storage unit specifications and manufacturer manuals to ensure that the equipment meets the necessary installation requirements.
1.2 Verify that all required utilities (e.g., electrical power, refrigeration gas, water, compressed air) are available and meet the specifications required for operation.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, and space.
1.4 Confirm that all mechanical components are correctly installed, including compressors, evaporators, condensers, temperature and humidity sensors, and control panels.
1.5 Ensure that all electrical components, including controllers, alarms, sensors, and data loggers, are correctly connected and functioning.
1.6 Perform a visual inspection to confirm that the chiller and cold storage units are 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 temperature, humidity, pressure, and system alarms, are properly set and calibrated.
2.2 Conduct a dry run of the chiller and cold storage unit to verify that they operate without issues. Monitor key parameters such as temperature, humidity, and airflow.
2.3 Test all control systems, ensuring that the cooling, heating, humidity regulation, and alarm systems work correctly.
2.4 Inspect the chiller and cold storage units to ensure that they maintain the required temperature and humidity levels and perform within the acceptable range.
2.5 Verify that the system operates effectively across the required temperature range for the specific storage conditions (e.g., refrigeration, freezing, or controlled room temperature).
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 operation of the chiller and cold storage unit under typical storage conditions to monitor performance during routine use.
3.2 Verify that the chiller and cold storage units consistently maintain the required temperature and humidity levels for the specified storage conditions.
3.3 Measure and record temperature and humidity at multiple locations within the storage area to ensure uniformity and compliance with specifications.
3.4 Perform performance testing to verify that the system can handle varying load conditions, such as fluctuations in heat load or door openings.
3.5 Verify that the chiller and cold storage units operate effectively under varying operational conditions, including changes in environmental factors or system load.
3.6 Document the results of the PQ, including temperature and humidity measurements, system performance data, and any 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 system logs, temperature and humidity measurements, performance data, and inspection results.
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 chiller and cold storage units. This analysis should confirm that the system operates consistently within predefined parameters and meets the acceptance criteria for temperature and humidity control.
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 chiller and cold storage units’ performance.
5. Requalification:
5.1 Requalify the chiller and cold storage units if significant changes are made to the equipment, such as replacing major components, relocating the system, or modifying the refrigeration or control systems.
5.2 Periodically perform requalification to ensure that the system 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
- Chiller and Cold Storage Unit Manufacturer Specifications
- Installation and Setup Reports
- Calibration Records
- Temperature and Humidity 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 1116: Temperature Control in Pharmaceutical Manufacturing
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: Temperature and Humidity Log
| Batch No. | Test Date | Temperature (°C) | Humidity (%) | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Temperature | Humidity | Operator Name |
Template 3: Performance Test Log
| Batch No. | Test Date | Performance Test Description | Test Results | Pass/Fail | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Test Description | Test Results | Pass/Fail | Operator Name |