Documentation and validation for high purity water systems
Maintaining integrity and consistency
As a high purity water system OEM, Filter & Water Technologies is tasked with providing comprehensive documentation tailored to each customer’s specific needs. In addition, we aid customer QC/QA departments in developing and executing validation protocols, and provide comprehensive turnkey validation packages for new water systems.
Documentation
As the significance of water quality in production grows, so does the demand for supportive documentation. The availability of such documentation, along with adherence to operational procedures, ensures the preservation of water quality and, in turn, the consistency of products relying on it.
Documentation may include a Technical Equipment Specification, Equipment Functional Specification, Water Quality Specification, or a System Operational Description. Additionally, pretesting of the Water System, in the form of a Factory Acceptance Test (FAT), might be required. Detailed Standard Operating Procedures, covering System Start-Up, Shutdown, Sanitization, and Filter Replacement, are often provided to facilitate Third Party Commissioning of Systems.
Validation
Validation of high purity water systems holds increasing importance for analytical laboratories, biotechnology, and pharmaceutical firms. Whether obtaining an ASTM or CSLI Reagent Grade Water System, or a USP Purified Water System, many facilities now adopt validation principles to ensure dependable analytical results and product manufacturing.
Commonly followed protocols include:
- User Requirement Specification (URS)
Describing business needs for system requirements before its creation. - Design Qualification (DQ)
Demonstrating the proposed design’s alignment with URS specifications before construction or procurement. - Installation Qualification (IQ)
Showing proper installation of equipment and documentation. - Operational Qualification (OQ)
Confirming equipment functions according to manufacturer’s specifications. - Performance Qualification (PQ)
Demonstrating consistent, intended performance through ongoing testing and maintenance.
Let's talk high purity water systems
We are a tested team of high purity water experts devoted to building and maintaining state-of-the art systems for America’s leading industries.
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