Precision Manufacturing for Advanced Wound Care
Empowering global healthcare with nearly 30 years of medical-grade manufacturing excellence, automated cleanrooms, and stringent international compliance.
State-of-the-Art Cleanroom Infrastructure
Quality medical dressings begin with an uncompromising production environment. Roosin Medical operates specialized Class 100,000 (ISO Class 8) cleanrooms equipped with intelligent environmental monitoring systems to strictly control particulates, microbial counts, temperature, and humidity.
Key Highlights:
ISO Class 8 (100,000-Class) Clean Workshops
Full laminar flow ventilation and continuous environmental air monitoring ensure strict sterile bioburden control.
Automated Production Lines
High-speed integrated lines for coating, laminating, high-precision die-cutting, and automated sealing minimize human intervention.
Dedicated Sterile Validation
Advanced Ethylene Oxide (EO) sterilization chambers and rigorous microbial testing capabilities ensuring lot-to-lot sterility assurance.
Core Manufacturing Capabilities & Technology
From raw polymer synthesis to final multi-layer sterile dressings, Roosin Medical combines material science with precision engineering to manufacture high-performance wound care products.
Medical-Grade Silicone & Foam Lamination：State-of-the-art polyurethane (PU) foaming and perforated gentle silicone gel coating technology, providing superior fluid absorption without causing skin trauma upon removal.
Biopolymer & Alginate Processing：Specialized non-woven carding and needle-punching lines for calcium alginate, silver-impregnated fibers, and biological composite matrices for high-exudate wound management.
Hydrocolloid & Hydrogel Formulations：Proprietary hot-melt coating and cross-linked polymer casting lines ensuring optimal moisture vapor transmission rate (MVTR) and prolonged adhesion.
High-Speed Die-Cutting & Complex Layering：Rotary die-cutting systems with multi-station visual inspection cameras, capable of custom shapes, island designs, and bordered borderless configurations.
End-to-End Quality Control & Traceability
Roosin Medical operates under a certified ISO 13485 Quality Management System (QMS). Every batch of products undergoes a multi-stage Quality Control protocol ensuring zero-defect clinical reliability.
Quality Assurance Workflow:
IQC (Incoming Quality Control): 100% rigorous chemical, physical, and biocompatibility verification of all incoming polymers, films, and packaging materials.
IPQC (In-Process Quality Control): Continuous automated inline sensor monitoring and manual periodic dimensional, adhesion, and MVTR testing during production.
FQC & OQC (Final & Outgoing Inspection): Seal-integrity testing (dye penetration/burst test), sterile validation, bioburden assay, and outer carton drop tests.
Full Lifecycle Traceability: Digital MES batch tracking from raw material lot numbers to warehouse logistics, ensuring complete documentation compliance.
