Sendary：High-quality purified water equipment starts from system design

净得瑞

2023.11.04 09:00

209

Purified water has a very high degree of cleanliness and contains very few impurities. It can be used as a preparation component, also can be used to clean equipment and instruments, and for in vitro diagnosis. It is an important component in GMP quality management and verification of pharmaceutical enterprises. Therefore, in the view of Sundry, the essence of maintaining the quality of the purified water system is to control the possible pollution sources in the pharmaceutical production process through a good system design to ensure the quality of the produced water.

It is reported that Net Derui has been dedicated to the comprehensive service of water system for 15 years, professionally providing purified water equipment and implementing efficient operation, covering the whole process of system design, manufacturing, installation, verification, training, etc., committed to the standardized manufacturing of water system, and adhering to high quality to continuously bring value to customers.

Fig. 1 Purified Water Equipment Shown to Customers by Sendary

In order to ensure that the demands of the enterprise are met to the maximum extent, Net Derui conducts comprehensive URS analysis for the enterprise, fully understands the process demands of the enterprise, and strictly controls each link of the purified water system, so that the produced purified water always meets the quality requirements. Starting from the system design, lay a foundation for building a high-quality purified water system.

Based on professional level and rich experience, water quality requirements, process selection, installation requirements, operation requirements and verification requirements are mainly considered in the design of purified water system. First determine the use of purified water and then determine the quality standard to be met. For example, a pharmaceutical enterprise needs a set of purified water system complying with GMP in China; Secondly, in terms of process selection, the method adopted by the enterprise to prepare, store and distribute purified water shall be mainly confirmed; In terms of installation requirements, the GEP and ASEM BPE and other specifications are mainly used for high-quality installation. All purified water equipment of Net Derui shall be constructed by professional construction teams with more than 10 years of working experience, in strict accordance with the operation instructions and installation procedures, and shall be inspected layer by layer to implement strict quality control; In terms of operation requirements, production, maintenance and GMP requirements shall be taken into consideration; For the verification requirements, the content and standard of the document shall be determined according to the declaration object.

Fig. 2 Netpays attention to product quality

Based on the hygiene of drug production, microorganism is easy to cause pollution to the raw materials, production environment and finished products of drugs, which is an important factor causing production failure and unqualified products. GMP in China clearly requires that the purified water equipment shall control microorganism. Therefore, when designing the system, Net Derui shall fully consider the microbial factors, such as flow rate, dead angle, gradient and welding, so as to reduce the microbial load of the system.

It is reported that, in combination with the actual situation of the enterprise, Net Derui designed a complete set of purified water treatment process to meet the preparation requirements of purified water for in vitro diagnosis of pharmaceutical enterprises, hospitals and laboratories. The integrated purified water system is composed of 304 stainless steel or 316L stainless steel, and the disinfection and sterilization devices, such as ultraviolet sterilization device, ozone sterilization device or pasteurization method, are arranged in front of the water point to meet the quality index requirements of the pharmaceutical enterprises for microbial control. In addition, the system adopts automatic control mode, with intelligent display screen with one touch start function, which is more convenient for operation. The system can automatically alarm and send the alarm to the communication equipment of relevant personnel, further improving the system safety coefficient.

The purified water system of Sundry is manufactured according to GMP standards, the process design is determined according to the raw water quality and water production requirements, and the complete GMP verification service is provided for the customer, "said the relevant responsible person of Sundry.

In recent years, the purified water equipment industry has made great progress in both product and service, providing important guarantee for the development of pharmaceutical industry in China. Net Derui attaches importance to system design, constantly improves the quality and service level of purified water equipment, wins the recognition and support of the pharmaceutical industry, and establishes a good reputation in the industry.