Changsha Vaughn Environmental Protection Technology Co., Ltd

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Medical device water is an indispensable high-clarity sanitary water in medical device production, implantable medical devices, and hospitals. It is mainly used for sanitary treatment such as cleaning. During the water treatment process, it must meet the water quality standards for injection water and pass relevant tests. . The Vaughan system comprehensively designs sampling points and data monitoring during the design. Through the management panel, you can easily view the system water quality data and management system, combined with the daily water quality monitoring of the sampling points, to achieve stable operation and water quality safety.

Design Basis:

1. According to the detailed water quality report provided by the user, "tailor-made".
2. Sterile and implantable medical devices "Inspection and Evaluation Standards".
3. The latest version of "Chinese Pharmacopoeia".
4. Water quality standards for purified water and water for injection.

Design Features:
1. Modular design of the entire system, three-dimensional simulation design and installation.
2. The wiring of each unit is completed in the factory, reducing the installation and commissioning time.
3. Comply with cGMP, ISPE / FDA guidelines, and comply with EU CE certification requirements.
4. The pipeline is made of 304 / 316L material; sanitary and non-hygienic design.
5. Normal temperature type / hot water disinfection type.
6. Stainless steel pipeline trend diagram Welding spot arrangement, welding record, endoscope inspection.
7. The pipeline inlet section has a corresponding slope and no dead angle design.
8, integrated control system and integrated instrument system, etc., convenient operation and management.

Prevent the growth of microorganisms:
The details of the treatment of the purified water system and injection water system used in medical devices often determine the safety and reliability of the system. During the production process of NetDerui, the dead angle of the system is eliminated by design, welding, surface treatment, etc. The water produced by the system is stable and reliable, and it is produced and processed strictly in accordance with the technological requirements and design drawings.

Quality Assurance System:
1. Standard operating procedures for piping and fittings and cleaning
2. Standard specification operation process of automatic welding machine
3. Standard operating procedure for pipeline cleaning
4. Standard operating procedures for pipeline pressure test standards
5. Pipeline pickling passivation standard specification operation process
6. Standard operating procedures for system disinfection standards

Complete verification service:
Vaughan Environmental Protection can provide all verification documents, including the implementation of PQ draft.
1. Design confirmation (DQ)
2. Installation confirmation (IQ)
3. Operation confirmation (OQ)

general Service:

1. FAT acceptance test
Provide detailed FAT factory acceptance test report.
2. Related training services
System operation management, daily operation management standard mechanism, etc.
3. After-sales service
(1) Quick response service for customer problem feedback, put forward solutions in 30 minutes, and arrive at the site for free repair within 24 hours at the fastest
(2) 7X24 hours free consultation service for life
(3) Free follow-up guidance for life, reminder service for replacement of equipment consumables