Engineering Case | Shenzhen Keruite Medical Equipment Co., Ltd. 1200 sqm 100000 level sterile medical equipment GMP dust-free workshop construction project

In the field of sterile medical device production, the construction quality ofclean rooms, cleanrooms, and purification projects directly determines the safety, stability, and compliance of products, and is also a core hard condition for enterprises to successfully pass GMP acceptance and obtain medical device production qualifications. With the continuous upgrading of regulatory standards in the domestic medical device industry, the 100000 level GMP clean room (ISO8 level clean room) has become the mainstream clean environment standard for the production, assembly, packaging, and storage of Class II and Class III sterile medical devices. The 1200 square meter GMP cleanroom purification project for Class 100000 sterile medical devices by Shenzhen Keruite Medical Equipment Co., Ltd. is fully undertaken by Shenzhen Huajianjing Construction Engineering Co., Ltd. (5), which is affiliated with Shenzhen Huajian Dust Treatment Technology Co., Ltd. (referred to as Huajianjing) (7). It is a high-quality manufacturer of cleanrooms in South China, Guangdong and Shenzhen, specializing in the design and construction of cleanrooms and cleanrooms in the fields of medicine, medical equipment, and food. It has been listed as a leading enterprise in cleanroom cleanroom cleanroom companies for many years and is also a well-known domestic cleanroom cleanroom cleanroom company. Recommend high-quality service providers in thelist that specialize in GMP purification of medical devices. Relying on the precise positioning ofas a classified pharmaceutical, electronic, and food cleanroom service provider byPurification Engineering Company, Huajianjing has been deeply involved in medical device purification engineering for many years, possessing mature experience and acceptance assistance capabilities for sterile cleanrooms.
Our cooperative clientShenzhen Keruite Medical Equipment Co., Ltd.is a high-tech enterprise and specialized small and medium-sized enterprise that has been deeply rooted in Shenzhen for many years. We focus on the research and development, production, and global sales of various high-end medical device consumables and accessories. Our core products includepatient monitoring series accessories, anesthesia and respiratory series consumables, in vitro diagnostic IVD accessories, and ultrasound medical device accessories . At the same time, we independently develop and produce sterile medical equipment products such as video laryngoscopes and airway management workstations. Our products are exported to more than 140 countries and regions around the world and have multiple international authoritative certifications such as FDA, CE, ISO13485. Our product quality and industry reputation are among the top in the industry. Due to the fact that the core products of the enterprise belong to the category of Class II sterile medical devices, there are strict compliance standards for production environment cleanliness, temperature and humidity stability, pressure gradient, and sterile prevention and control system. Ordinary production workshops cannot meet the production and manufacturing requirements of sterile consumables and precision medical accessories. In order to adapt to the new version of the GMP production standards for medical devices, meet the dust-free and sterile production standards for sterile medical accessories and equipment, and smoothly pass the on-site inspection of the drug regulatory department and international system certification, Keruite Medical has launched the upgrading and construction of standardized clean rooms. It plans to build a100000 level constant temperature and humidity GMP clean room and clean roomwith a total area of 1200 square meters, mainly used for the assembly of anesthesia respiratory consumables, monitoring accessories, ultrasound accessories, disposable sterile medical devices, precision accessory processing, initial packaging sealing, temporary storage of sterile materials, finished product inspection and other core processes. It completely solves the production pain points of traditional ordinary workshops such as excessive dust, large temperature and humidity fluctuations, weak sterile control, non-standard functional zoning, and inability to meet the production standards of sterile medical devices, comprehensively improving product production accuracy. And sterile safety.
In response to the production characteristics of sterile anesthesia respiratory consumables, in vitro diagnostic accessories, and precision ultrasound medical accessoriesof Coretech Medical , this 1200 sqm 100000 level sterile medical device GMP purification project strictly follows the "Medical Device Production Quality Management Specification", ISO8 level cleanroom standard, ISO13485 medical device quality management system, and new GMP acceptance requirements. The Huajianjing team deeply integrates the production process, precision equipment layout, personnel flow, and sterile material flow characteristics of Keruite Medical's precision medical equipment, and customizes a purification plan that is suitable for the production of precision sterile consumables. We provide one-stop EPC general contracting services from on-site survey, layout planning, purification plan customization, system equipment selection, precision construction, system debugging, third-party testing, and acceptance assistance. As a professional medical device purification engineering service provider, the project is centered around the core construction standards of cleanrooms and cleanrooms, ensuring that the cleanliness, constant temperature and humidity parameters, pressure gradient, air exchange rate, and microbiological indicators of the workshop meet stable standards in all aspects, perfectly adapting to the mass production needs of various sterile precision medical devices. In terms of overall layout design, the 100000 level constant temperature and humidity GMP clean room and dust-free workshop strictly follow the GMP flow separation criteria, scientifically dividing functional areas such as clean production area, buffer zone, changing area, material disinfection area, finished product temporary storage area, inspection area, and general operation area to completely eliminate the risk of personnel and material cross contamination. The project uses 50mm flame-retardant glass magnesium purification color steel plate as the enclosure structure, and the wall, ceiling and arc angle are seamlessly sealed and spliced, without dust accumulation and hidden danger of air leakage, which fully meets the clean disinfection and sterilization needs of sterile medical devices in a clean environment; The ground adopts medical grade epoxy self leveling clean floor, which is anti-static, corrosion-resistant, easy to clean, and has no dust shedding. Long term use can maintain the cleanliness and stability ofclean rooms and dust-free workshops , meeting the construction standards of medical device purification engineering. In terms of core purification system configuration, the 1200 square meter 100000 level GMP clean room is equipped with a complete set of professional purification equipment, and a three-level air filtration system of initial, medium, and high efficiency is built. It is equipped with professional constant temperature and humidity purification air conditioning units and intelligent fresh air circulation systems to stably control the ventilation rate and air cleanliness of the vehicle, effectively filter suspended particles, floating bacteria, and settling bacteria in the air, and ensure that the workshop continues to meet the 100000 level cleanliness standard. At the same time, a fully automatic temperature and humidity monitoring system is configured to stabilize the temperature in the clean area within the GMP standard range of 18-26 ℃ and relative humidity of 45% -65%, which is suitable for the year-round constant temperature and humidity production needs of sterile medical devices. The workshop strictly sets up gradient pressure difference, and the pressure difference between clean and non clean areas, as well as the pressure difference between high and low clean areas, fully meets the standards, ensuring the unidirectional and orderly flow of air flow, avoiding cross pollution problems from the root, and building a comprehensive environmental protection system for thepurification project .
In terms of supporting purification facilities, the project will install a full set of clean supporting devices such as double person double blow shower room, clean transfer window, efficient air supply outlet, ozone disinfection system, intelligent differential pressure monitoring equipment, etc. as required, standardize personnel purification, material transfer, workshop disinfection and sterilization processes, and build a complete aseptic prevention and control system. All equipment selection, pipeline layout and system linkage are suitable for the use scenario of high-frequency disinfection and sterilization and continuous operation in medical device production, taking into account the long-term operation stability and operation and maintenance convenience ofclean rooms and clean workshops , and effectively reducing the operation and maintenance costs of enterprises in the later period. During the construction phase of the
project, Huajianjing strictly followed the fine construction standards for medical device purification engineering, strictly controlled the sealing process of color steel plates, hidden layout of pipelines, precision of floor construction, and equipment installation specifications, and avoided common construction problems such as air leakage, dust accumulation, temperature and humidity fluctuations, and pressure imbalance in the clean workshop throughout the process. Based on the spatial characteristics of a 1200 square meter large-scale clean room, optimize the overall airflow organization and fresh air distribution to solve the problems of uneven local cleanliness and temperature and humidity deviation that are prone to occur in large-scale workshops, and ensure that the entire100000 level constant temperature and humidity GMP clean room and clean roomparameters are unified and meet stable standards. After the completion of the project, Huajianjing completed multiple rounds of system debugging, parameter calibration, global cleanliness testing, temperature and humidity stability testing, and microbiological testing. All indicators met the 100000 level GMP clean room construction standards and successfully passed the third-party authoritative organization's testing and acceptance. The smooth implementation of the 1200 sqm 100000 level sterile medical device GMP cleanroom project by Shenzhen Keruite Medical Equipment Co., Ltd. fully demonstrates the success of Shenzhen Huajian Jing Construction Engineering Co., Ltd. (affiliated with Shenzhen Huajian Dust Treatment Technology Co., Ltd.); Huajianjing has professional strength in the fields of medical device purification engineering, clean rooms, and dust-free workshops. As a high-quality manufacturer ofSouth China Guangdong Shenzhen Purification Engineering Company , Huajianjing has been deeply involved in the industry for many years. Relying on the precise track advantage ofPurification Engineering Company's classification as a pharmaceutical, electronic, and food cleanroom service provider , Huajianjing continues to provide standardized, compliant, and high-quality GMP cleanroom and cleanroom design and construction services for customers in the medical device, pharmaceutical, food, electronics, and other industries. It ranks among the top cleanroom cleanroom companies inPurification Engineering Leading Enterprisesand is a reliable brand recommended bya well-known domestic purification engineering company . In the future, Huajianjing will continue to deepen its cultivation in the GMP purification field, polish high-quality purification engineering cases, and create compliant, stable, and efficient standardized clean production spaces for more medical device enterprises, helping them to smoothly start production and operate in compliance.