Strict Validation and Confirmation Purified Water Equipment

Strict Validation and Confirmation

Installation Qualification (IQ): After the equipment is installed, a comprehensive inspection and confirmation of the equipment installation status is required, including whether the installation position, pipeline connection and electrical connection of the equipment meet the design requirements, and whether the technical data of the equipment is complete.

 Operational Qualification (OQ): After the installation qualification is passed, conduct operational qualification. Through no-load and load operation tests of the equipment, verify whether the equipment can operate stably under different operating conditions and whether various parameters meet the set requirements, such as pressure, flow rate, temperature and resistivity.

 Performance Qualification (PQ): Performance qualification is carried out after the operational qualification is passed. By continuously producing multiple batches of purified water and conducting comprehensive detection and analysis of its water quality, it is confirmed whether the equipment can continuously and stably produce purified water that meets the quality standards. It is usually required to conduct verification for at least three consecutive batches, and the water quality of each batch should meet the specified quality standards.

Improved Monitoring and Management System

Online Monitoring: Purified water equipment in the pharmaceutical industry usually needs to be equipped with a complete online monitoring system to monitor key water quality parameters of purified water in real time, such as resistivity, conductivity, microbial content and endotoxin. Once the water quality parameters exceed the set range, the system can immediately issue an alarm so that operators can take timely measures.

Data Recording and Traceability: The equipment should have data recording and storage functions, and can automatically record the operating parameters of the equipment, water quality monitoring data and other information. These data should be traceable for query and analysis when needed, providing a basis for quality control and traceability of drug production. The data retention period should usually meet the requirements of Good Manufacturing Practice (GMP), generally not less than the validity period of the drug plus a certain period of time.

Equipped with Cleaning and Disinfection Functions

Automatic Cleaning System: Purified water equipment needs to be equipped with an automatic cleaning system to regularly clean the equipment to remove dirt, microorganisms and other impurities on the inner surface of the equipment. The cleaning process usually includes water washing, alkali washing, acid washing and other steps, which can be automatically carried out according to the set program to ensure the consistency of cleaning effect.

Disinfection Methods: To effectively kill microorganisms in water and remove endotoxins, purified water equipment in the pharmaceutical industry often adopts disinfection methods such as pasteurization, ultraviolet disinfection and ozone disinfection. These disinfection methods should be able to comprehensively and effectively disinfect the equipment and pipelines without affecting the quality of purified water. For example, pasteurization kills microorganisms by heating purified water to a certain temperature (such as about 80℃) and maintaining it for a period of time.

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