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Introduction of purified water system equipment
Publisher: Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd Time：2023-03-03 21:08:33 Number of clicks：449 Close

The following will combine the verification purpose of design qualification (DQ), installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) with the verification items, explain the equipment status, and formulate the operation control standards of the water production system.


(1) Design confirmation is the evidence to prove that the purified water system is designed in accordance with GMP requirements, and is the basis for subsequent confirmation (such as installation confirmation, operation confirmation, performance confirmation). Design and functional descriptions are included in the design confirmation file. The design description is a detailed and accurate description of how the user needs will be met by the water system supplier, and the functional description describes how the system is expected to be implemented, but the documentation needs to be reviewed and approved by the user. The main inspection items confirmed by the design of the purified water system include but are not limited to the applicability of the system selection, technical parameters, drawings and other documents and the applicability of process maintenance and cleaning, so as to ensure that the contents of the user's needs are responded to and implemented.


(2) The purpose of installation confirmation is to make the purified water system comply with the installation specifications, and the filing management of product-related materials and documents must meet the requirements. The purification water system installation confirmation and verification project generally includes two aspects: one is to check the system documents according to the information provided and equipment to ensure that the verification documents are complete; The second is to check the installation of the equipment according to the process flow and installation drawings. Verification includes but is not limited to PID drawing inspection, material polishability confirmation, key component confirmation, instrument calibration, welding documents, dead angle slope, pressure test, pickling passivation and electrical inspection.


(3) The purpose of operation confirmation is to ensure that the functions and control functions of the equipment in the operating state comply with the specifications. Operation confirmation is a no-load test of each part and integrity of the equipment after installation to ensure that the equipment operates accurately within the performance requirements and meets the specified technical indicators. Purified water system verification includes but is not limited to riboflavin test, operation function, production parameters, human-machine interface, disinfection, alarm test, user authority, audit trail, emergency stop test and power failure recovery test.


(4) The purpose of performance confirmation is to ensure that the equipment can adapt to the production conditions under actual use conditions and meet the quality requirements of pharmaceutical processes. The performance confirmation of the purified water system is divided into three stages: the first stage is the chemical analysis and microbial detection of water, sampling each major component of the water system, investigating the function of each functional section of the system, formulating the appropriate operating scope and final operation, maintenance and cleaning procedures, to ensure that the quality and quantity of water produced and transported meet the requirements, usually lasting 2~4 weeks; The second stage is the continuation of the first stage, but the sampling and inspection methods confirmed in the next stage are used for subsequent stage water quality monitoring, the sampling frequency is reduced compared to the first stage, and the second stage of purified water can be used for production, this stage lasts 2~4 weeks; The purpose of the third stage of performance confirmation is to prove that the purified water system has good long-term operation performance, and to ensure that the potential seasonal changes are evaluated and treated, which takes at least 1 year, after which the water quality and system operation should be evaluated in stages.


After a series of verifications, the equipment verification documents were obtained, and the results were statistically analyzed and confirmed, and sorted into reports
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Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd.     
Suzhou Chenglang Cleaning Equipment Co., Ltd. Contact: Zhang Gong Tel：15150275957 Email：285145232@qq.com Company website： http://www.szhuanke.com Add：No. 366, Jinxian Road, Jinjiaba Town, Wujiang District, Suzhou City, Jiangsu Province Su ICP No. 2022043966-1

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