Material selection standards and pipeline cleaning methods for ultra-pure water equipment in pharmaceutical factories-Yuanlai Water Treatment

font: Big Middle Small

Material selection standards and pipeline cleaning methods for ultra-pure water equipment in pharmaceutical factories

Released Date: Nov 19,2015 Article Source: Yuanlai Water Treatment

Pharmaceutical factory ultrapure water equipment must be strictly implemented in accordance with GMP standards. The relevant material selection and installation standards are as follows: 1. The design, selection and installation of pharmaceutical ultrapure water equipment should meet production requirements, be easy to clean, or be convenient for production operation and maintenance, and be able to prevent errors and reduce pollution. 2. The surfaces of the equipment in direct contact should be smooth, flat, easy to clean, corrosion-resistant, and not undergo chemical changes or adsorption. The lubricants, coolants and other substances used in the equipment must not cause contamination to or to the containers. 3. The main fixed pipelines connected to the equipment should be marked with the names and flow directions of the materials inside the pipelines. 4. The preparation, storage and distribution of purified water and water for injection should be capable of preventing the growth and contamination of microorganisms. The materials used for storage tanks and conveying pipelines should be corrosion-resistant

　　The ultra-pure water equipment in pharmaceutical factories must be strictly in accordance withGMPThe relevant material selection and installation standards for the standards implemented are as follows:

Pure water equipment

　　1The design, selection and installation of pharmaceutical ultrapure water equipment should meet production requirements, be easy to clean, or be convenient for production operation, maintenance and upkeep, and be capable of preventing errors and reducing contamination.

　　2The surface of the equipment in direct contact should be smooth, flat, easy to clean, corrosion-resistant and not undergo chemical changes or adsorption. The lubricants, coolants and other substances used in the equipment must not cause contamination to or to the containers.

　　3The main fixed pipelines connected to the equipment should be marked with the names and flow directions of the materials inside the pipelines.

　　4The preparation, storage and distribution of purified water and water for injection should be capable of preventing the growth and contamination of microorganisms. The materials used for storage tanks and conveying pipelines should be corrosion-resistant. The design and installation of pipelines should avoid dead corners and blind pipes. The cleaning and cycle of storage tanks and pipelines should be specified. The vent of the water for injection storage tank should be equipped with a hydrophobic filter that does not shed fibers. The storage of water for injection can be adopted80oCThe above insulation65oCThe above insulation cycle or4oCStore the following.

　　5Instruments, meters, measuring tools, weighing instruments, etc. used for production and inspection should meet the requirements of production and inspection in terms of their scope of application and precision, have obvious qualification marks, and be calibrated regularly.

　　6The ultra-pure water production equipment in the pharmaceutical industry should have clear status marks and be regularly maintained, serviced and verified. The operations of equipment installation, maintenance and upkeep must not affect the quality of the products.

　　7Unqualified equipment should be moved out of the production area if possible. Before being moved out, there should be clear signs.

　　Cleaning method for the pipeline of the purified water equipment system: Use chemically pure sodium hydroxide2KgAdd drinking water200L,It is prepared in a stainless steel mixing bucket1%Heat the sodium hydroxide cleaning solution of a certain concentration70-80℃Inject it into the purified water tank, start the purified water delivery pump, and the system will circulate30After a few minutes, open the water release valves at each usage point(Join with a bucket)While supplies last. Flush the system with circulating drinking water60After a few minutes, flush the system with purified water in a circulating mannerpH6-7Stop.

　　During the operation of the equipment, maintenance and upkeep all require dedicated management and record-keeping. In case of any malfunction, the cause should be identified and promptly resolved to ensure that production efficiency and quality are not affected.

　　If you encounter any problems as mentioned above, please consult Beijing Yuanlai Water Treatment Equipment Co., LTD., which focuses on the water treatment industry15In this year, you can trust us!

Keywords: Water Softening Equipment Automatic Water Softener Reverse Osmosis Equipment Manufacturer of Water Treatment Equipment

Prev : Classification and water quality standards of laboratory ultrapure water equipment

Next : 7 Factors to Consider when Selecting a water pump

Recommend products

: EDI ultra-pure water system

Yuan LaiEDIThe ultra-pure water equipment uses electro-deionization technology.EDIElectrodeionization is a water purification method that combines the dual advantages of electrodialysis and ion exchange. It does not require acid-base chemical regeneration and can continuously and stably prepare high-purity ultrapure water. Under the action of a direct current electric field, ion separation in water is completed. At the same time, water is electrolyzed to generate hydrogen ions and hydroxide ions, achieving automatic regeneration of the resin without the need to stop the machine for manual regeneration. The pre-treatment combined with reverse osmosis can prevent oxidized substances from damaging the resin, ensuring stable effluent quality and widely meeting the high-standard water usage requirements of various industries.

: Non-negative pressure water supply equipment

The non-negative pressure water supply equipment can be directly connected to the municipal water supply network, making full use of the residual pressure of the original network for superimposed water supply. Fully enclosed operation does not require the construction of a domestic water tank, eliminating secondary pollution. Intelligent variable frequency voltage stabilization, energy-saving, quiet and easy installation, it is the preferred equipment for secondary water supply in high-rise residential buildings and commercial buildings.

: Constant pressure water supply equipment

Constant pressure water supply equipment is widely used in central air conditioning, floor heating, industrial closed-loop water circulation, and boiler systems. It integrates automatic pressure stabilization, automatic water replenishment, automatic exhaust, pressure relief and buffering functions. It stabilizes the pressure in the pipeline network, eliminates abnormal sounds caused by air blockage, and prevents damage from negative pressure and water shortage in the pipeline. It is an essential supporting equipment for HVAC and circulating water systems.