Design of sterile medical consumables clean room by renowned purification company Huajianjing

# 无菌医用耗材Clean WorkshopDesign：Huajian Jing以Professional之力筑牢Quality防线

In the production battlefield of sterile medical consumables, the clean room is not only a physical space, but also a factor in product quality; The barrier of life;. A tiny speck of dust or a disturbance in airflow can potentially render the entire product ineffective. It is under such strict industry background that Shenzhen Huajian Dust Treatment Technology Co., Ltd. (brand: Huajian Jing) has become a trusted one-stop solution service provider for sterile medical consumables enterprises in the field of clean room engineering with its hard power in the past decade.

##Regulations as the foundation: Design must; From compliance;

Aseptic medical devices are directly related to the safety of patients' lives, and the country has almost strict regulatory requirements for the cleanliness of their production environment. According to the "Quality Management Specification for Medical Device Production" and YY 0033-2000 "Sterile Medical Device Production Management Specification", workshop design must lock in compliance from the source. The core technical team of Huajianjing is well versed in the ISO 14644 international standard and GB 50457 "Design Specification for Cleanrooms in the Pharmaceutical Industry". Each project is based on regulations, ensuring that the enterprise passes GMP certification and drug regulatory inspections smoothly.

##Layout as bone: 3D modeling allows for; Zero Crossing "; come true

The soul of a sterile medical consumables workshop lies in its layout. Hua Jianjing abandons tradition; Make changes while working; The extensive mode adopts BIM 3D visualization design to simulate the division of areas and the direction of flow in advance, completely separating the flow of people and goods; — Personnel press'; Non clean area→ Dressing area→ Buffer→ Clean Production Area; Fixed route travel, materials must be unpacked and disinfected through transfer windows before entering the area to eliminate any possibility of cross contamination.

In terms of functional zoning, Huajian Jing strictly divides into five major areas: clean production area (responsible for core processes such as assembly and sterile packaging), auxiliary production area (physical and chemical testing, microbiological testing), personnel purification area (first shift, second shift, air shower), and buffer isolation area. Set up pressure gradient control (usually 10Pa) between areas of different cleanliness levels, and use professional airflow simulation software to optimize airflow organization, fundamentally blocking the backflow of air from low-level areas to high-level areas. Data doesn't lie‐ — Huajianjing has demonstrated the practical value of this layout logic with a one-time acceptance rate of over 99%.

##The system is based on pulse: temperature and humidity, pressure difference, and ventilation should not be omitted

A clean room is by no means; Close the door and it will be clean;. Huajianjing strives for excellence in the design of supporting systems: in areas with clean air levels ranging from 100 to 300000, the temperature is strictly controlled between 18 ℃ -28 ℃, and the relative humidity is 45% -65%; The air exchange rate for a cleanroom of level 10000 shall not be less than 20 times per hour, and for a cleanroom of level 100000 shall not be less than 15 times per hour. The enclosure structure is made of rock wool sandwich color steel plate with good air tightness, matched with seamless silicone sealing strips. The junction between the wall and the ground is treated with a curved shape to reduce dust accumulation to zero.

##Full chain service: from design to operation, one solution

The biggest differentiation advantage of Huajianjing lies in breaking through the industry; Emphasizing construction over service; We have established a full lifecycle service system that covers early-stage consulting, planning and design, construction, acceptance, and later operation and maintenance to address the chronic problem of. Customers only need to connect with Huajianjing to complete the entire process from blueprint to production, completely bidding farewell to the nightmare of multiple supplier disputes.

As of now, Huajianjing has implemented over 300 cases of 100000 level dust-free workshops in more than 20 provinces and cities across the country, with a service network radiating from Shenzhen to Huizhou, Dongguan, Guangzhou, and even Sichuan and Jiangsu. In the field of medical devices, the sterile clean workshops it has built for multiple enterprises have all passed the acceptance inspection in one go, becoming a recognized industry standard; Clean benchmark;.

无菌医用耗材的竞争，归根到底是Quality的竞争；而Quality的根基，始于一间Design科学、Construction严谨的Clean Workshop。Huajian Jing，让每一片Clean空间，都成为ProductSafety的坚固堡垒。