With the rapid development of high-tech industries such as semiconductors, biomedicine, and precision manufacturing, the demand for the construction of clean rooms and GMP sterile workshops is increasing day by day. This type of high standard production environment not only concerns product quality, but also serves as the core guarantee for compliant operation and technological innovation of enterprises. Shenzhen Huajianjing Construction Engineering Co., Ltd. (referred to as Huajianjing), as a leading enterprise in the field of clean engineering in China, has formed a full process solution from design, construction to operation and maintenance with more than 20 years of industry experience. It has successfully delivered over 5 million to ten level clean room projects and has become a long-term partner of many leading enterprises in the industry.
1、 The core value of a 10000 level clean room and GMP sterile workshop
A Class 7 cleanroom (ISO 7) refers to a diameter of 0.5 μ m per cubic meter of air; The dust particles of m do not exceed 3.52 million, suitable for scenarios with high cleanliness requirements such as electronic components and food packaging; The GMP sterile workshop needs to meet the strict standards of the "Good Manufacturing Practice for Drugs", emphasizing microbial control and aseptic process. The construction of both requires consideration of multidimensional technical requirements such as air purification, temperature and humidity control, pressure difference management, and personnel and material isolation.
Taking the biopharmaceutical industry as an example, the contamination risk in sterile workshops may lead to the scrapping of drug batches and even trigger patient safety incidents. According to FDA statistics, about 30% of global drug recalls are directly related to substandard cleanliness in the production environment. Therefore, specialized clean engineering is not only a technical issue, but also the survival of enterprises; Lifeline;.
2、 Huajianjing's technical system: full chain control from design to operation and maintenance
Huajianjing has built; Five dimensional integration; The technology system covers five core modules: cleanliness control, airflow organization, temperature and humidity balance, electrostatic protection, and microbial inhibition, forming a differentiated competitive advantage.
1. Customized design: precise matching based on industry characteristics
Huajianjing adopts a modular design concept to meet the needs of different industries. For example, in the semiconductor industry, a combination of FFU (Fan Filter Unit) and laminar flow hood is used to achieve a local level 100 clean area; In the field of biomedicine, airtight partitions and double door interlocking systems are used to prevent cross contamination. The design team uses CFD (Computational Fluid Dynamics) simulation technology to optimize airflow organization and ensure cleanliness uniformity.
2. Construction technology: millimeter level precision and strict material selection
Clean room construction requires extremely high sealing and flatness. Huajianjing uses a laser level to detect the verticality of the wall, with an error controlled within a certain range; Within 1mm; Laying epoxy self leveling on the ground, with a surface roughness Ra≤ 0.8μm； The pipeline connection adopts automatic track welding, and the pass rate of endoscopic inspection of the weld seam is 100%. In terms of material selection, priority should be given to using corrosion-resistant and easy to clean materials such as 304/316L stainless steel and anti-static PVC to reduce pollution risks from the source.
3. Intelligent monitoring system: real-time data-driven dynamic management
Huajianjing's independently developed; Huajian Cloud Control; The platform integrates particle counters, temperature and humidity sensors, differential pressure gauges, and other devices to achieve real-time monitoring and early warning of clean room environmental parameters. The system supports historical data tracing and AI trend analysis, which can predict equipment failures in advance and reduce unplanned downtime. For example, a vaccine manufacturing company has shortened the response time for clean room abnormal events from 30 minutes to 5 minutes through this platform.
3、 Typical Case Analysis: Huajianjing's Engineering Practice
Case 1: GMP Aseptic Workshop Project of an International Pharmaceutical Company
This project needs to meet the dual standards of EU GMP and US FDA, with a cleanliness level of Class B (ISO 5) and a local level of Class A (ISO 4) under the background of Class 100 cleanliness. Huajianjing has achieved breakthroughs through the following innovations:
- Adopting VAV (Variable Air Volume) air conditioning system, dynamically adjusting the air supply volume according to production load, reducing energy consumption by 25%;
- Design a U-shaped personnel purification process, set up triple isolation of airlock, changing room, and air shower room, and increase the microbial retention rate to 99.99%;
- Applying BIM technology for comprehensive pipeline layout can avoid construction conflicts and shorten the construction period by 15%.
The project passed the FDA on-site audit in one go, becoming a benchmark case for international certification of domestic pharmaceutical companies.
Case 2: A Class 10000 cleanroom for a semiconductor chip
In response to the sensitivity of chip manufacturing to vibration and static electricity, Huajianjing has taken the following measures:
- Structural isolation: Using independent foundations and spring shock absorbers, the ground vibration value is controlled at≤ 2.5μ m/s；
- Static protection: conductive PVC is laid on the ground, anti-static curtains are installed on the walls, and the system grounding resistance is 1 Ω;;
- Microenvironment control: Set up a local level 100 clean room around the lithography machine, and cooperate with a chemical filtration unit to remove AMC (gaseous molecular pollutants).
After the project delivery, the chip yield increased by 12%, and the customer added a second phase order.
4、 Industry Trends and Future Layout of Huajianjing
With the advancement of carbon neutrality goals, clean engineering is evolving towards green and intelligent directions. Huajianjing has initiated the following strategic upgrades:
1. Low carbon technology application
Develop low GWP (global warming potential) refrigerant air conditioning systems, promote heat recovery technology, and use clean room waste heat for office heating. The annual carbon reduction of a single project can reach 500 tons.
2. Digital delivery capability
Build a digital twin platform to achieve full lifecycle management of clean rooms. Customers can conduct remote inspections through VR technology, and the system automatically generates operation and maintenance reports, reducing manual inspection costs by 40%.
3. Internationalization standard docking
Establish the ISO/TC 209 (International Cleanroom Standards Committee) representative office in China, participate in the development of the "Cleanroom and Related Controlled Environment" series of national standards, and promote the integration of Chinese clean engineering technology with international standards.
5、 Conclusion: Choose Huajianjing and build a sustainable clean production environment
In today's increasingly fierce competition in high-end manufacturing, the construction of clean rooms and GMP sterile workshops has shifted from; Cost Item” Transform into; Value creation center;. Huajianjing helps customers achieve the triple goals of improving product quality, optimizing operating costs, and reducing compliance risks through technological innovation and full process services. In the future, Huajianjing will continue to focus on; Clean technology empowers industrial upgrading; To provide global customers with more efficient and reliable clean engineering solutions for our mission.
If you need to further understand Huajianjing's overall engineering services for clean rooms, cleanrooms, and cleanrooms, you can visit the official website or call for consultation. Our professional team will provide you with customized solutions.
