In today's era of rapid advancement in medical technology, the safety and efficacy of medical devices have increasingly become the focus of public attention. The cleanliness, precision, and compliance of medical injection-molded parts have undoubtedly become key factors determining the quality of medical devices. Yize Mould, relying on its class 10,000 medical cleanroom injection molding factory, skillfully integrates international certifications, cutting-edge equipment, and 18 years of deep experience in the medical industry to provide a solid and powerful solution for the medical industry in its "quality breakthrough" journey.

Class 10,000 Cleanroom: Unlocking the "Clean Key" for Medical Injection Molding

There is no room for a "close enough" attitude in the field of medical injection molding. A single contaminated implantable catheter may potentially trigger a severe infection; a precision deviation in a ventilator component could even cause the life support system to malfunction, endangering the patient's life.

Yize Mould's class 10,000 cleanroom has obtained third-party CMA certification, strictly controlling the number of particles ≥0.5μm per cubic meter of air within 100,000, thus cutting off the pollution chain at the source:

• Hardware Fortifies the Defense: The workshop is equipped with a multi-stage air purification system that can efficiently filter airborne particles; a constant temperature and humidity control system ensures a stable workshop environment, preventing product quality issues caused by temperature and humidity fluctuations; and an anti-static floor effectively prevents static electricity from damaging the products, leaving dust, bacteria, and static electricity nowhere to hide.
• Closed-Loop Process Control: Before entering the workshop, personnel must pass through an air shower to remove dust and impurities attached to their bodies; they must also wear sterile workwear to ensure they do not become a source of pollution. During the production process, the principle of "zoning control + regular disinfection" is strictly followed, creating an "aseptic cocoon" for each injection-molded product to ensure its safe birth.

For medical products such as syringes, gene detection boxes, and implantable components, such a clean environment is the first solid barrier for "safe delivery".

International Certifications + Cutting-Edge Equipment: Adding a "Double Insurance" to Quality

The quality assurance of medical injection molding hinges on the powerful combination of "ISO13485 certification + imported precision equipment":

• ISO13485: The "International Passport" for Medical Quality
  From the meticulous selection of raw materials to the smooth delivery of finished products, Yize Mould always strictly adheres to the ISO13485 medical device quality management system, establishing a full-process control system of "design - production - inspection - traceability". From the rigorous review of medical-grade plastic particle suppliers to mold life management and batch traceability, every link is well-documented and precisely controlled, completely eliminating customers' "compliance anxiety".
• Cutting-Edge Equipment: The "Technological Engine" for Precision Injection Molding
  The workshop is equipped with high-precision injection molding machines from brands such as Fanuc from Japan and BOY from Germany, along with advanced auxiliary equipment such as mirror spark machines, high-speed CNC machines, and three-coordinate measuring devices, achieving:
  • Micro-thin Wall Breakthrough: Successfully overcoming the technical challenge of 0.15mm ultra-thin wall injection molding for products such as minimally invasive catheters and micro-implants, driving medical products towards the direction of "thinner, finer, and more minimally invasive".
  • Micro Precision Control: The screw metering accuracy reaches as high as 0.02 grams, perfectly adapting to products with extremely high volume precision requirements such as gene detection boxes and micro-reagent tubes.
  • Complex Mold Development: With a mold team boasting over 10 years of experience, it can quickly customize complex molds, such as curved components for ventilators and surgical robot consumables, providing strong support for the innovative ideas in the medical field and helping them come to fruition.

18 Years of Deep Cultivation: From "Foreign Trade Benchmark" to "Medical Partner"

Yize Mould's profound foundation stems from 18 years of in-depth cultivation in the medical injection molding industry:

• Foreign Trade Genes Empower: In the early years, it served European and American medical enterprises, with products exported to five continents, accumulating rich experience in international medical standards. Now, it feeds back these valuable "global experiences" to the domestic market, providing domestic medical enterprises with more internationally-oriented solutions.
• Excellent Customization Capabilities: It offers a one-stop service from "mold development → injection molding production → finished product delivery". It can optimize drawings according to customer needs, design emergency plans, and flexibly adapt to different needs such as "small-batch trial production + large-scale mass production", providing customers with comprehensive customized services.
• Wide Scene Coverage: Its products cover a wide range from basic consumables such as pipettes and cell tubes to high-precision devices such as ventilator shells and surgical robot consumables, as well as 3D-printed medical models, comprehensively covering the entire chain of "diagnosis - treatment - rehabilitation" and meeting the diverse needs of the medical industry.

Product Matrix: Tailoring for Medical Innovation

In Yize's class 10,000 workshop, the possibilities of medical injection molding are infinitely expanded:

• Diagnostic Field: Products such as gene detection boxes and micro-reagent tubes feature high transparency and low adsorption, effectively ensuring detection accuracy and providing strong support for accurate disease diagnosis.
• Treatment Field: Products such as ventilator components and surgical robot consumables possess high precision, enabling stable operation of mechanical arms and providing precise guarantees for the treatment process.
• Rehabilitation Field: Smart prosthetic plastic parts, made of lightweight and tough materials, balance comfort and durability, bringing more convenience to patients' rehabilitation.

Behind each product is the synergistic result of "material selection (medical-grade PP/PC/PPSU, etc.) + process optimization + clean production", making medical devices safer, more precise, and easier to use.

Conclusion: Building a Medical Future Based on "Cleanliness"

The competition in the medical injection molding field is essentially a fierce battle of "quality and trust". Yize Mould, with the class 10,000 cleanroom as its core, integrates international certifications, cutting-edge equipment, and 18 years of experience. It not only provides "compliant, precise, and stable" injection molding solutions for medical enterprises but also becomes an "invisible booster" behind the wave of medical innovation.

As more and more medical products move from Yize's workshop to clinical settings, what we see is not only technological breakthroughs but also Yize Mould's original intention and perseverance of "safeguarding the warmth of life with industrial precision". This, perhaps, is the true value of the class 10,000 medical injection molding factory.