Introduction: As a Class II medical device, the quality of the core component, the micro-mesh atomizing plate, of a medical nebulizer is directly related to the safety and effectiveness of patient treatment, and must comply with stringent medical-grade standards. Shenzhen Liandaqi Precision Ceramics Co., Ltd. (hereinafter referred to as "Liandaqi") is rooted in the Huike Industrial Park in Shiyan, Shenzhen. Relying on the foundation of precision manufacturing industry, it has established a full-process quality control system from raw material screening to finished product delivery. Through standardized and normalized production, it ensures that every medical micro-mesh atomizing plate meets medical safety and performance requirements, providing reliable core component support for medical nebulizer manufacturers.
1. Raw material control: laying a solid foundation for medical quality from the source
The quality of medical micro-net atomizing tablets begins with the rigorous selection of high-quality raw materials. Lian Daqi adheres to the principle of "medical-grade material selection and full-batch testing", establishes a dedicated raw material supply chain, and prevents unqualified materials from entering the production process from the source. The core control points are as follows:
1. Piezoelectric ceramic material: High-purity alumina ceramic raw materials with a purity of over 99.9% are selected. After undergoing third-party biocompatibility testing, no harmful substances are released, meeting the GB/T 16886 Biological Evaluation Standards for Medical Devices, ensuring no safety hazards when in contact with medicinal solutions. Additionally, each batch of piezoelectric ceramics undergoes testing for resonant frequency, mechanical strength, and acid-alkali resistance. Unqualified raw materials are directly eliminated to ensure stable driving performance.
2. Microporous steel sheet: Made of medical-grade 316L stainless steel, it possesses excellent corrosion resistance and wear resistance. It is compatible with various liquid medications such as saline solution, antibiotics, and traditional Chinese medicine preparations, preventing material corrosion and performance degradation caused by long-term exposure to the liquid. The thickness of the steel sheet is strictly controlled at 0.1–0.15mm, with a flatness error of ≤0.005mm, laying a precision foundation for subsequent microporous processing.
3. Auxiliary materials: Both sealing glue and coating materials are made of medical-grade eco-friendly materials, free from odor and volatilization. They have undergone high-temperature sterilization testing to ensure that no harmful impurities are generated during the atomization process, meeting the safety requirements of medical equipment.
II. Production process control: precision manufacturing, fully traceable
Leveraging the precision manufacturing strengths of the Huike Industrial Park in Shiyan, Shenzhen, Liandaqi has established a Class 10,000 clean production workshop and implemented the ISO 13485 medical device quality management system, achieving standardization and traceability throughout the entire production process. The core control links include:
1. Precision machining control: Utilizing automated laser drilling equipment, coupled with an independently developed intelligent calibration system, real-time monitoring of micro-hole machining precision is achieved. Hourly sampling inspection is conducted to measure hole diameter, number of holes, and distribution uniformity, ensuring that the hole diameter error is ≤±0.05μm and the uniformity of hole distribution is ≥95%. The precision bonding process is employed for the bonding of piezoelectric ceramics and steel sheets, with a bonding error of ≤0.01mm, thus avoiding fluctuations in atomization effect caused by uneven vibration transmission.
2. Assembly and sealing control: Automated assembly equipment is employed to minimize manual operation errors. Strict control is maintained over sealing performance during the assembly process, and the assembly undergoes air tightness testing (pressure ≥ 0.3 MPa, no air leakage) to prevent liquid leakage. Additionally, vibration testing is conducted on the assembled atomizing plate to ensure that the resonant frequency remains stable within the range of 103–108 ± 3 kHz, with uniform vibration output.
3. Sterilization and Cleanliness Control: The finished atomizing tablets undergo high-temperature and high-pressure sterilization (121°C, 30 minutes) to eliminate all microorganisms and meet the sterility requirements for medical settings. After sterilization, they are vacuum-packed to prevent contamination during transportation and storage. Additionally, they are labeled with the production batch, production date, and expiration date to ensure full traceability.
III. Finished product inspection and control: Conduct multi-dimensional testing to prevent unqualified products from leaving the factory
Lian Daqi has established rigorous finished product testing standards, requiring each atomizing chip to undergo multi-dimensional testing before leaving the factory. The testing covers three major categories: performance, safety, and durability. The core testing contents are as follows:
1. Performance testing: Emphasis is placed on core indicators such as atomized particle size (with a proportion of particles in the range of 2–5μm being ≥70%), atomization rate (≥0.3mL/min), drug residual rate (<0.8mL), and resonant frequency. Professional testing equipment is employed to ensure precise data, and test reports are retained for each batch.
2. Safety testing: Conduct biocompatibility tests (including cytotoxicity, sensitization, and irritation), acid and alkali resistance tests (no corrosion or performance degradation after soaking for 72 hours), and high-temperature aging tests (continuous operation at 80°C for 24 hours with stable performance), to ensure the safety and reliability of the product in clinical use.
3. Durability testing: Through tens of thousands of vibration fatigue tests, it is ensured that the vibration output fluctuation value of the atomizing plate remains below 3% after long-term use. Micro-hole anti-clogging tests are conducted, simulating long-term clinical usage scenarios, to ensure no issues such as micro-hole clogging or performance degradation, with a service life of ≥500 hours.
IV. Quality control advantages: Assisting manufacturers in passing medical device certification
Lian Daqi's comprehensive quality control system not only ensures the quality of its own products but also provides comprehensive support for medical nebulizer manufacturers. Firstly, it provides complete testing reports, biocompatibility reports, and production qualification certificates, assisting manufacturers in quickly passing the registration and certification of Class II medical devices. Secondly, it achieves consistent control over product batches, with performance errors between batches being ≤5%, ensuring stable product quality for manufacturers. Thirdly, it establishes a quality traceability system, allowing for quick tracing back to the production process in case of quality issues, enabling timely resolution and reducing risks for manufacturers.
Conclusion: Medical-grade quality stems from the rigorous control of every detail. Based in the Huike Industrial Park in Shiyan, Shenzhen, LianDaQi has established a full-process quality control system from raw materials to finished products, with ISO 13485 quality management system as its core. With professionalism and rigor, we create micro-net atomizing tablets that meet medical standards. In the future, LianDaQi will continue to optimize the quality control process, enhance product stability and consistency, provide more reliable core components for the medical nebulizer industry, and contribute to the high-quality development of the industry, safeguarding patients' respiratory health.