GMP Validation Consulting Service

Project Background：

A core technology-driven Class III medical device enterprise specializing in collagen products for chronic non-healing wound treatment in trauma repair, requiring top-tier cleanrooms, process validation, quality control and sterility assurance supported by a rigorous GMP system.

AUSTAR Solution：

Qualifications for HVAC, cleanroom, water/gas systems, moist/dry heat sterilizers, VHP sterilizers, washing-drying-filling-capping facilities and lyophilizers, plus airflow visualization study, aseptic gowning and hand disinfection interval validation.

AUSTAR Value & Client Benefits：

• Compliant with NMPA Medical Device GMP (Latest Edition) and ISO 13485

• Phased consulting for targeted, cost-effective "sterility assurance" validation