Zhejiang Xinghe Medical Device's 10,000-level cleanroom officially put into use, leading high-end manufacturing of sterile instruments with intelligent upgrades

Publication Time:

2025-02-16

In October 2024, Zhejiang Xinghe Medical Device Co., Ltd. announced that its new 10,000-level cleanroom, with a total investment exceeding 30 million yuan, has officially commenced operation. The cleanroom covers an area of 1200 square meters and adopts a laminar flow purification system. Its air cleanliness reaches Class 7 (10,000-level) as per ISO 14644-1, with certain operating areas achieving Class 5 (100-level).

In October 2024, Zhejiang Xinghe Medical Device Co., Ltd. announced the official launch of its new 10,000-level cleanroom, with a total investment exceeding 30 million yuan. The 1200-square-meter cleanroom utilizes a laminar flow purification system, achieving an air cleanliness level of Class 7 (10,000-level) as per ISO 14644-1, with local operating areas reaching Class 5 (100-level). Equipped with German-imported fully automatic injection molding machines, Swiss precision laser welding equipment, and an AI vision detection system, the cleanroom focuses on producing disposable laparoscopic anastomosis devices, tissue forceps, and other Class III high-risk sterile instruments. Monthly production capacity has increased to 500,000 sets, representing a more than 50% increase over the previous production line.

In terms of quality management, the cleanroom incorporates a MES (Manufacturing Execution System), enabling full digital traceability from raw material entry to finished product shipment. Each batch of products must pass 18 key quality control checkpoints, including ethylene oxide sterilization validation and particulate contamination detection. According to third-party test reports, the initial contamination rate of products from the new cleanroom is less than 1/5 of the industry average, and the sterility assurance level meets the EU EN ISO 11737 standard. The company has collaborated with Shanghai Zhongshan Hospital, Zhejiang University Affiliated Hospitals, and other institutions on clinical validation. Its new generation of laparoscopic anastomosis devices has reduced the instrument failure rate in radical gastrectomy by 0.3 percentage points compared to imported brands.

The company's general manager stated at the launch ceremony: “This upgrade not only meets the National Medical Products Administration's regulations for Class III medical device production but also lays the foundation for undertaking international orders. In 2024, we plan to obtain FDA 510(k) certification and enter the North American market.” Industry analysts point out that with the advancement of domestic substitution policies, Xinghe Medical's production capacity breakthrough is expected to capture more than 10% of the domestic market share in the minimally invasive surgical instruments field.

Xinghe Medical releases intelligent sensing anastomosis device, minimally invasive surgery enters the era of precise quantification

None