Installation Qualification (IQ) is a critical part of validating a purified water system, ensuring it meets the specifications required for its intended use. The following is a step-by-step process for performing Installation Qualification for a purified water system.
- Define User Needs: The first step is to define user needs. Determine the purified water system's intended usage and the needed output quality. The parameters should include flow rate, temperature, conductivity, and microbiological quality.
- Create an IQ Plan: Make an intelligence strategy that contains the scope, objectives, and acceptance criteria. The IQ strategy should also contain information on the necessary equipment and supplies for the IQ procedure.
- Check the Installation Specifications: Check sure the purified water system was installed according to the manufacturer's instructions. Check that all components are properly placed and that all connections are tight and leak-free. Examine the equipment installation instructions to check that all criteria have been satisfied.
- Verify System Performance: Perform a preliminary system performance test to ensure that the purified water system is operating as intended. Test the water quality, flow rate, and temperature of the system.
- Create Standard Operating Procedures (SOPs) for the purified water system: Create Standard Operating Procedures (SOPs) for the purified water system. These SOPs should contain protocols for system startup, shutdown, and maintenance. They should also include cleaning and sanitizing protocols for the system.
- Perform Performance Qualification (PQ): Once the purified water system installation is complete, do a PQ. Operational and environmental testing should be included in the PQ. The operational testing should validate the system's performance, and the environmental testing should validate that the system is running in a clean environment.
- Record the IQ Process: The whole IQ process should be documented, including all test findings, SOPs, and equipment installation documents. These papers should be sorted and maintained in a secure document management system.
- Review and Approve IQ papers: Go over all IQ papers, including the IQ plan, SOPs, and test results, and provide your approval. Personnel with the necessary credentials and expertise should evaluate the materials.
- Perform a Risk Assessment: Evaluate the purified water system for any dangers or risks. The risk assessment should involve an evaluation of the system's intended usage, important components, and any dangers associated with the system's operation.
- Develop a Preventive Maintenance Program: Develop a preventive maintenance program for the purified water system. The program should include a schedule for regular maintenance activities, such as cleaning and calibration, and should be documented in the SOPs.
In conclusion, performing an IQ for a purified water system is a critical step in ensuring the system meets the user's requirements and is operating safely and efficiently. By following the steps outlined above, organizations can ensure that their purified water system is validated and ready for use.
ALSO READ: Validation Master Plan
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