Engineering Case | Mil Medical Technology (Shenzhen) Co., Ltd. Two storey Total 5000 sqm Class II Medical Device GMP Cleanroom Purification Project

在二类Medical Devices研发生产行业，Cleanroom, Cleanroom, Purification EngineeringThe construction standards directly determine product quality, sterile safety, and are also the core prerequisite for enterprises to complete medical device GMP audits and obtain production licenses. With the continuous improvement of the domestic medical device regulatory system, a large number of enterprises engaged in the production of interventional consumables and medical device components need to establish compliant and stable constant temperature and humidityClean room, cleanroomThis timeMill Medical Technology (Shenzhen) Co., Ltd. Two floors totaling 5000 square meters, GMP cleanroom purification project for Class II medical devices, byShenzhen Huajianjing Construction Engineering Co., LtdGeneral contracting construction, the company is affiliated withShenzhen Huajian Dust Treatment Technology Co., Ltd. (referred to as Huajian Jing)It is a local city in Shenzhen with strong comprehensive strength in the South China regionPurification EngineeringService provider, deeply involved in the fields of medical equipment, precision optoelectronics, and biological laboratoriesClean room, cleanroomOverall design and construction, with rich project experience in planning clean spaces for multi-level factories, can meet the construction needs of medical device enterprises for multi-level zoning and multi process collaborative production.
Cooperation ClientsMil Medical Technology (Shenzhen) Co., LtdLocated in Shenzhen, it is a high-tech enterprise specializing in the research and development, production, and sales of Class II minimally invasive medical devices. The enterprise focuses on the research and development of consumables for minimally invasive diagnosis and treatment, medical catheter components, disposable interventional assistive devices, and surgical accessories. The products are widely used in minimally invasive surgery, rehabilitation medicine, outpatient diagnosis and treatment, and other scenarios. Enterprises attach great importance to sterile control of products. Multiple disposable medical consumables belong to Class II sterile medical devices that come into contact with human tissues. The products are supplied to the domestic market while also laying out overseas trade channels, and need to meet the dual requirements of the domestic "Medical Device Production Quality Management Specification" and ISO13485 quality management system. With the continuous growth of enterprise orders and the expansion of product lines, the existing production site space is insufficient and functional zoning is chaotic, making it difficult to achieve zoning control for research and development, production, and inspection. To expand production scale and establish a standardized sterile production environment, Mill Medical plans to create a two-story clean production space, with a building area of 2500 square meters per floor and a total area of 5000 square metersClean room, cleanroomDivided into functional areas of different cleanliness levels, used for key processes such as medical catheter assembly, consumables packaging, precision machining of components, temporary storage of sterile products, and physical, chemical, and microbiological testing.
target, aim at, address, focus on, in response toDisposable minimally invasive consumables, medical catheter components, Class II sterile medical devicesThe production process and construction difficulties of the multi story factory building are strictly planned in accordance with GB50457 "Design Specification for Cleanrooms in the Pharmaceutical Industry", ISO14644 cleanliness standards, and medical device GMP specifications for a total purification project of 5000 square meters. The project is reasonably divided into multiple levels: 100000 level (ISO8) and 10000 level (ISO7)Clean room, dust-free workshopProduction area, distinguishing between production assembly area, inspection area, raw material storage area, and auxiliary functional area. The Huajianjing technical team has conducted multiple on-site surveys of building structures, load-bearing conditions, and floor pipeline routes. Combining with the layout of multiple medical consumables production lines, equipment placement locations, personnel and material transfer routes of Mill Medical, they have customized a multi story integrated purification solution for the factory building. They provide one-stop EPC general contracting services including site survey, planar process layout, purification HVAC system design, enclosure structure construction, purification equipment installation, system linkage debugging, third-party cleanliness testing, and GMP acceptance guidance. As a professional in the field of medical devicesPurification EngineeringService provider, the entire project revolves around the requirements of aseptic productionClean room, cleanroomThe core standards of constant temperature and humidity, pressure difference control, and cross contamination prevention have been implemented.
In terms of overall layout design, there are two layersClean room, cleanroomIndependently planned and coordinated with each other, each floor strictly follows the GMP principle of separating personnel and logistics, and sets up separate dressing buffer channels, material outsourcing disinfection rooms, and transfer buffer areas to avoid pollutants from entering the clean production area. The wall and ceiling of the clean area are built with flame retardant purified color steel plate, and all internal and external corners are seamless sealed with arc transition to eliminate dust dead corners, which is convenient for daily cleaning and disinfection and sterilization in the workshop; The ground adopts medical grade anti-static epoxy self leveling flooring, which is resistant to disinfectant corrosion, not easy to dust, and provides long-term protectionClean room, dust-free workshopGround cleanliness conditions. Based on the characteristics of two independent clean spaces, the high and low clean areas are physically isolated, and independent pressure difference control systems are set up in layers to avoid mutual interference of airflow between upper and lower floors.
In terms of core purification system, the entire setclean roomUnified configuration of primary efficiency, medium efficiency, and high-efficiency HEPA three-level air filtration systems, matching corresponding air exchange rates according to different production process cleanliness levels, and continuously controlling the number of suspended particles and airborne bacteria in the air. Each floor is independently equipped with a constant temperature and humidity purification air conditioning unit. The temperature in the clean area is stably controlled at 18-26 ℃, and the relative humidity is maintained at 45% -65%, effectively preventing medical silicone tubing and plastic consumables from getting damp, aging, and breeding microorganisms. Standardized gradient pressure difference is set up in each functional clean area, and the airflow continues to flow from the high clean area to the low clean area, preventing dust and bacterial backflow pollution and building a solid systemPurification EngineeringFundamentals of Aseptic Environment. The workshop is equipped with an all-weather online monitoring system, which collects real-time data on particle concentration, temperature and humidity, and pressure difference, facilitating daily production and operation management of the enterprise.
The clean supporting facilities are configured according to the production standards for Class II sterile medical devices, including multi person double air shower rooms, embedded clean transfer windows, high-efficiency air supply outlets, partitioned ozone disinfection systems, and pressure differential monitoring instruments. Personnel entering the clean assembly area need to complete multi-level changing and air shower dust removal; Medical catheters and plastic components are disinfected and transported through transfer windows. All air ducts and water and electricity pipelines are concealed to reduce dust accumulation points; Equipment selection takes into account noise control during operation, adapts to the working environment of precision instrument assembly and inspection, and balancesClean room, dust-free workshopLong term stable operation, effectively reducing later operation and maintenance costs.
Compared to single story workshops, the construction of multi story large-scale clean rooms is more difficult, requiring coordination of floor load-bearing, air duct installation, vertical pipeline layout, sound insulation between upper and lower floors, and non-interference of airflow. Huajianjing construction team optimizes the layout of vertical air ducts and the organization of airflow on each floor, balancing the distribution of fresh air volume in each area of each floor; Strictly control the sealing of color steel plates, air tightness of air ducts, and floor construction standards throughout the construction process, and strictly prevent common problems such as air leakage and inadequate sealing. After the completion of the project, multiple rounds of system linkage debugging were carried out in layers, and suspended particle detection, 24-hour temperature and humidity stability testing, settling bacteria and planktonic bacteria sampling were completed in different zones. All indicators met the design GMP cleanliness standards and successfully passed the acceptance of third-party authoritative testing institutions.
Mil Medical Technology (Shenzhen) Co., Ltd. has two floors totaling 5000 square meters of Class II medical device GMPClean room, cleanroomThe purification engineering project has been successfully completed and delivered, fully supporting the large-scale production of Class II sterile medical devices such as disposable minimally invasive consumables and medical catheter components for enterprises. At the same time, it meets the requirements of domestic drug regulatory GMP verification and overseas ISO13485 system audit, fully reflectingShenzhen Huajian Jing Construction Engineering Co., Ltd. (affiliated with Shenzhen Huajian Dust Treatment Technology Co., Ltd. and Huajian Jing)In multi-layer medical devicesPurification engineering, clean room, dust-free workshopProfessional strength in overall project planning and construction.
asHigh quality manufacturer of purification engineering in Shenzhen, South ChinaHuajianjing focuses on constant temperature and humidity in the medical device, biopharmaceutical, precision optics, and food industriesClean room, cleanroom总包Engineering，Own多层厂房、大面积Clean FactoryRich落地案例。未来Huajian Jing持续打磨Medical DevicesPurification EngineeringSolutions，为Shenzhen及大湾区众多Medical Devices企业打造合规Stable、适配量产需求的标准化Clean生产空间，助力医疗企业顺利取证、扩大国内外市场规模。