About Luminara Biotech
Defining standards through scale, earning trust through quality.
Our Story
Founded in 2024, Luminara Biotech (Zhejiang) Co., Ltd. is a large-scale ODM manufacturing enterprise integrating the development, production, and sales of cleaning, personal care, and oral care products. Located in the Qianwan New District of Ningbo with proximity to one of the world’s busiest ports.
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24,000m² Cleanroom Facility
Company Milestones
Luminara Biotech founded in Ningbo Qianwan New District
24,000m² Class 100,000 cleanroom facility completed
ISO 22716, GMPC, and SMETA 6.0 certifications obtained (Bureau Veritas)
US FDA registration completed (FEI: 3043644807)
Annual formulation capacity reaches 45,000 tons, 450 million units filling capacity
Manufacturing Facility
Our 24,000m² Class 100,000 cleanroom facility features full-area purification, constant temperature and humidity control, positive pressure air filtration, and 316L stainless steel pipeline transmission for zero human contact processing.
Quality Management
ISO 22716 Good Manufacturing Practices with full-chain traceability. From raw material intake through finished product inspection, every critical control point is monitored in real time. Quality issues located within 2 hours.
Raw Material Intake
Supplier qualification audit + full physicochemical testing with raw material traceability archives.
Process Control
Real-time monitoring of critical control points: temperature, pH, viscosity, and fill volume.
Finished Product Testing
Microbial limits, physicochemical indicators, accelerated stability, and packaging compatibility.
Environmental Monitoring
Daily monitoring of airborne particles, settling bacteria, and planktonic bacteria.
Full Traceability
Complete chain from raw material to finished product. Quality issues located within 2 hours.
Certifications
Our quality commitment is validated by internationally recognized certifications.
ISO 22716
GMPC
SMETA 6.0
FDA
Visit Our Facility
Experience our 24,000m\u00B2 cleanroom facility firsthand. Schedule a factory tour today.
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