Renowned purification company Huajianjing has rich experience in the construction of clean workshops for implantable Class III instruments

# 植入类三类器械Clean WorkshopConstruction：Huajian Jing以Class 10,000标准筑牢合规底线

In the medical device industry, a clean room is never simple; Decoration Engineering; But it is a lifeline that concerns the survival of the enterprise. Especially for implantable Class III medical devices -; — High risk products such as vascular stents, pacemakers, artificial joints, and drug implants must meet cleanliness standards of Class 10000 (ISO 7) or even Class 100 (ISO 4) in their production environment. Any deviation in one parameter may mean that they cannot be certified, put into production, or sold. In the medical device industry highland of the Pearl River Delta, Shenzhen Huajian Dust Treatment Technology Co., Ltd. (Huajian Jing) has become a benchmark choice for construction with a cleanliness standard of 10000 levels, thanks to nine years of deep cultivation and more than 150 medical device projects.

Ten thousand level cleanliness is the bottom line and the hard threshold. According to the mandatory requirements of the National Medical Products Administration, the production area of sterile medical devices must achieve a cleanliness level of 10000, which means that every cubic meter of air contains 0.5 μ m; The number of dust particles in m does not exceed 3.52 million, and the number of planktonic bacteria is 100 CFU/m/sup3; Settling bacteria≤ 10 CFU/4h. At the same time, the pressure difference between the clean area and the non clean area must be 10Pa, 5Pa between different cleanliness levels, and the temperature should be controlled at 18 ℃‐ 26 ℃, relative humidity 45%‐ 65%, anti-static voltage≤ 100V. Behind this series of numbers is the cross constraint of multiple regulations such as YY0033 "Sterile Medical Device Production Management Specification", GMP Appendix, ISO14644 and ISO14698. The core team of Huajianjing has all the experience in medical device purification design and construction. From the design stage, they have fully implemented the separation of people and logistics, changing and disinfection routes, and pressure gradient layout, directly benchmarking the on-site inspection requirements of the drug regulatory bureau, and eliminating the risk of rework from the source.

The standardized construction system makes it inevitable to meet the 10000 level standard. Huajianjing has a construction team of 100 people, who are certified and strictly adhere to the regulations; Team self inspection, project re inspection, and final inspection by the director; Three level acceptance system. The enclosure structure is made of 50mm antibacterial color steel plate, with rounded corners R≥ 50mm， Seamless splicing; The ground is made of epoxy self leveling, resistant to 75% alcohol, anti-static, and seamlessly treated; The doors and windows are made of medical sealed clean doors with double-layer insulated glass and airtight sealing strips. Ventilation system according to initial efficiency G4→ Medium efficiency F8→ Efficient H13 three-level filtration configuration, with a ventilation rate of 15 times/h in the 10000 level area, combined with PLC intelligent pressure difference control, to ensure that all parameters pass the inspection in one go. As the true evaluation of the person in charge of an electronic technology enterprise in Shenzhen:; With the replacement of Huajianjing, the entire process from design to acceptance was smooth, with zero budget overruns and various indicators far exceeding expectations. " This reputation is most strongly confirmed by its repeat purchase rate of over 80% among its loyal customers.

From construction to certification, a one-stop closed loop is the real power. The biggest fear for medical device companies is not the inability to build a good workshop, but the inability to pass the audit once it is built. Huajianjing provides full process compliance services: free on-site inspection and testing of solutions, strictly designed according to YY0033; After the completion of construction, cooperate with third-party CMA authoritative testing to issue a complete set of reports on cleanliness, microbiology, and pressure difference; More importantly, we provided full assistance in coordinating with the drug regulatory bureau for on-site verification, simulated inspections, on-site guidance, and problem rectification. The pass rate of evidence collection in the Pearl River Delta region is as high as 100%, and the fastest completion time for evidence collection is 30 days. After the project is delivered, Shenzhen will respond within 2 hours and visit the site 24 hours a day. Regular inspections will be conducted on pressure differentials, filters, and anti-static systems. Before the flight inspection, simulation self inspection services will also be provided, truly achieving the goal of; One cooperation, lifelong protection;.

Clean Workshop是品质的基石，更是合规的入场券。Huajian Jing以150余个Medical DevicesProject的硬核战绩证明：选对Purification EngineeringService商，就是选对了快速Put into Production与市场先机。对于正在Planning植入类三类器械Class 10,000Clean Workshop的企业而言，Huajian Jing无疑是值得信赖的首选伙伴。