Construction of Medical Syringe Cleanroom, Renowned Purification Company Huajianjing Crafted with Ingenuity

# 医用注射器Clean WorkshopConstruction：Huajian Jing匠心筑造，助力企业一次过审、快速Put into Production

Behind the seemingly simple production process of a medical syringe, from polypropylene pellets to finished products, lies a set of precise and clean environments silently guarding it. As a Class II sterile medical device, the production of syringes must be completed in a Class 100000 (ISO 8) clean room, while key processes such as filling and assembly require local Class 100 (ISO 5) laminar flow protection. This is not only a mandatory requirement of regulations, but also a solemn commitment to the safety of every patient's life.

1、 Regulations are like iron, standards are the lifeline

According to the "Quality Management Specification for Medical Device Production" and YY0033 "Sterile Medical Device Production Management Specification", the production environment of medical syringes is divided into general production area, D-level clean area, C-level clean area, and local A-level clean area under C-level background. Among them, the sealing process, as the core link directly exposed by the product, must be carried out under local hundred level protection. The latest implementation of GB/T 51466-2025 "Construction and Acceptance Standards for Cleanrooms in the Pharmaceutical Industry" provides the most authoritative technical basis for construction acceptance.

Core environmental parameters are uncompromising: the static pressure difference between clean and non clean areas must be 10Pa, and between areas of different cleanliness levels it must be 5Pa; Temperature control between 18 ℃~26 ℃, relative humidity between 45%~65%; Floating bacteria≤ 100 CFU/m³ Settling bacteria≤ 10 CFU/4h. If any indicator is not met, it means that the product cannot pass the on-site verification of the drug regulatory bureau and cannot be marketed.

2、 Huajianjing: Crafting a benchmark for cleanliness at the 10000 level with ingenuity

It is precisely under such strict standards that Shenzhen Huajian Dust Treatment Technology Co., Ltd. (Huajian Jing) has become the preferred brand for the construction of medical syringe clean workshops in the Pearl River Delta region, thanks to its more than 15 years of craftsmanship in the field of medical purification.

The core team of Huajianjing all have experience in medical device purification design and construction, familiar with the full set of regulations and standards such as the National Medical Products Administration's "Medical Device Production Quality Management Specification", YY0033, ISO14644, ISO14698, etc. They can intervene from the early stage of the project, assist customers in product risk analysis, determine cleanliness levels, plan compliance layouts, directly interface with the quality department of the enterprise and the drug regulatory bureau's verification personnel, and fully implement key elements such as layout, separation of personnel and logistics, pressure difference control, anti-static, and document system in the design phase.

At the construction level, Huajianjing adopts a 50mm antibacterial color steel plate enclosure structure, and all internal corners are made of R≥ 50mm circular arc shape to prevent dust accumulation due to airflow vortices; Laying epoxy self leveling on the ground, seamless and resistant to disinfectant flushing as a whole; The air purification system is equipped with three levels of filtration: primary efficiency, medium efficiency, and high efficiency (HEPA) to ensure that the cleanliness of the final air supply meets the standard accurately. The air conditioning system achieves quantitative control of pressure gradient, and the clean area maintains a positive pressure of no less than 10Pa in the buffer zone, forming an indestructible system; Air barrier;.

3、 Once approved, quickly seize the market opportunity

Data is the most powerful proof. Huajianjing has successfully built thousands of clean spaces at levels 100, 1000, 10000, and 100000, including over 150 medical device projects with a certification pass rate of up to 100%. The company has its own team and equipment, and construction is not outsourced. Service points are set up in Shenzhen, Guangzhou, Dongguan, and Foshan, with a response time of 2 hours, technical diagnosis provided within 4 hours, and personnel arranged to arrive at the site within 24 hours.

In the medical device industry, compliance is the bottom line, certification is the threshold, production is the goal, and the market is competition. Choosing Huajianjing is not only about choosing a clean workshop, but also about choosing a sustainable and stable product quality assurance capability. From requirement analysis to final delivery, the entire process is compliant and controllable throughout the entire chain; — Make every syringe that leaves the production line withstand the strictest inspection.

在这个空间里，连空气都被精心Filter。因为在医疗领域，干净，就是生命线。