Hotline：15150275957
Your location： Home/a> > NEWS > News
Purified water equipment |
| Publisher: Suzhou Huanke Pharmaceutical Equipment Technology Co., Ltd Time：2023-03-03 21:20:13 Number of clicks：475 Close |
Pharmaceutical water is an important raw and auxiliary material in the process of pharmaceutical production. Under the guidance of the new GMP, the quality of water and products is guaranteed. In practical application, we should also make great efforts in optimizing equipment, reasonable storage and distribution, online monitoring and standardized operation to ensure the safe and stable supply of pharmaceutical water and provide a strong guarantee for the whole pharmaceutical production process.
1. Documents required for installation confirmation There is an approved flow chart, system description and design parameters; Water treatment equipment and pipeline installation and debugging records; Verification records of instruments and meters; Equipment operation manual and standard operation and maintenance procedures. 2. Main contents of installation confirmation Confirm the installation according to the production requirements, focusing on checking whether the pipelines of purified water and water for injection equipment are qualified, whether the equipment as a whole and the produced water are qualified, checking the calibration of instruments and the preparation of operation and maintenance procedures. (1) Installation confirmation of preparation device Installation confirmation of the preparation device refers to checking whether the installation conforms to the design and specifications by comparing the design drawings and supplied technical data after the equipment is installed. The preparation devices mainly include mechanical filter, activated carbon filter, electrodialysis, mixed bed, water pump, distilled water machine, etc. The items to be inspected include the installation and connection of electricity, steam, compressed air, instruments, water supply and filters. (2) Installation confirmation of distribution system ① Materials of pipes and valves Confirm whether the materials of pipes and valves required by the design are adopted. Generally, pipes are made of 316L material, and valves are made of 316L diaphragm valves. ② Pipeline connection and pressure test If hot-melt argon arc welding is used, the inner wall should be smooth, and the welding quality should be checked, the number of welded joints should be recorded, and X-rays should be taken. If it is a jacketed pipe, the inner pipe should be photographed first. Usually, automatic argon arc hot-melt welding machine is adopted, and the welding parameters are verified before welding. After the connection is completed, use deionized water for pressure test. The pressure test is 1.5 times of the working pressure, and no leakage is qualified. ③ Cleaning, passivation and disinfection of pipelines. The cleaning, passivation and disinfection of pipelines can roughly follow the following steps: circulating pre-washing, circulating cleaning with alkali solution, washing with purified water, passivating, washing with purified water again and sterilizing with pure steam. Circulating pre-flushing: link the pipeline to be passivated with the water storage tank, water pump and flowmeter into a circulating path, inject enough deionized water at normal temperature into the storage tank, circulate it with the water pump, open the drain valve after 15 minutes, and discharge it circularly. Circulating cleaning of alkali liquor: sufficient chemical pure reagent of sodium hydroxide, add hot water not lower than 70℃, prepare alkali liquor according to the ratio of 1:100, circulate it with a water pump, and open the drain valve after 30 minutes.
Passivation: Prepare 8: 100 acid solution with purified water and pure nitric acid, circulate at 49-52°C for 60 minutes and then discharge. Flushing purified water again: add purified water into the storage tank, circulate it with a water pump, and discharge it circularly. When the resistivity of the water outlet is consistent with that of the water in the storage tank, open the drain valve and keep it for more than 30 minutes. Pure steam disinfection: introduce clean steam into the whole pipeline system and rinse at least 15 minutes at each point of use. The above cleaning, passivation and disinfection processes and their parameters shall be recorded and archived. (3) Calibration of instruments and meters Instruments and meters in purified water equipment must be calibrated regularly to control the allowable error. Commonly used instruments include: conductivity meter, time controller, flowmeter, temperature controller, pressure gauge and various instruments for analyzing water quality. |
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
Scan and add WeChat
Sweep