Our excellent production facility is designed to meet the most stringent regulatory and quality standards for Class II medical dressings. Spanning over 10,000 m² of ISO 8 and ISO 7 cleanroom environments, our manufacturing halls feature unidirectional airflow systems, HEPA‑filtered laminar flow benches, and fully automated gowning areas to minimize contamination risk. Every stage of production—from raw material receipt and inspection to the final packaging and sterilization—is conducted under real‑time digital monitoring. Our facility is GMP‑certified and audited regularly by third‑party bodies to ensure full compliance with FDA, ISO 13485, and CE directives, enabling us to offer private‑label partners absolute confidence in both product integrity and regulatory readiness.
Our equipment display showcases the cutting edge of medical‑grade dressing technology. High‑precision coating machines apply hydrogel, alginate, and non‑woven layers uniformly at speeds exceeding 50 m/min, while automated die‑cutting units guarantee dimensional accuracy within ±0.1 mm. Integrated sterilization tunnels—employing both gamma irradiation and EO gas methods—ensure batch‑level sterility assurance values (SAL) of 10⁻⁶. Downstream, our fully automated labeling, sealing, and cartoning lines adapt seamlessly to bespoke branding requirements and packaging formats. Adjacent to the production area, our in‑house quality‑control laboratory is equipped with HPLC, FTIR spectroscopy, and microbiological testing suites, providing comprehensive verification of physicochemical properties and biocompatibility before any shipment, thus reinforcing our commitment to excellence in private‑label medical dressing manufacturing.
Medical Device Equipments
