Validation 

“Validation - to establish the soundness, accuracy or legitimacy of something.”

 

The validation of high purity water systems has become increasingly important to analytical laboratory, biotechnology and pharmaceutical companies.  Whether purchasing an ASTM or CSLI Reagent Grade Water System or a USP Purified Water or Water For Injection System, many have adopted the principles of validating their respective water systems to ensure consistent results of their analytical tests and/or manufacturing of products.  Many follow documented protocols and procedures such as:

 

User Requirement Specification (URS) - Describes the business needs for what the user requires from the system. User Requirement Specifications are written early in the validation process, typically before the system is created.

 

Design Qualification (DQ) - Demonstrates that the proposed design will satisfy all the requirements that are defined and detailed in the User Requirement Specification (URS).  Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorized.

 

Installation Qualification (IQ) - Demonstrates that the process or equipment meets all specifications, is installed correctly and all required components and documentation needed for continued operation are installed and in place.

 

Operational Qualification (OQ) - Demonstrates that all facets of the process or equipment are operating properly and in accordance with manufacturers specifications.

 

Performance Qualification (PQ) - Demonstrates that the process or equipment performs as intended in a consistent manner over time.  Typically involves a predetermined frequency of analytical testing coinciding with a scheduled preventive maintenance of the system.

 

Filter & Water Technologies can assist your QC/QA department with authoring and execution of validation protocols or provide a complete turnkey validation package for your new water system.    

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