LUMINARA BIOTECH

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.

210+
Employees
11
R&D Staff

Factory Photo Coming Soon

24,000m² Cleanroom Facility

Company Milestones

2024

Luminara Biotech founded in Ningbo Qianwan New District

2024

24,000m² Class 100,000 cleanroom facility completed

2025

ISO 22716, GMPC, and SMETA 6.0 certifications obtained (Bureau Veritas)

2026

US FDA registration completed (FEI: 3043644807)

2026

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.

24,000m²
Total Area
Class 100,000 cleanroom
≤3.52M/m³
Particle Count
Full-area purification coverage
316L Steel
Pipeline
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.

Step 01

Raw Material Intake

Supplier qualification audit + full physicochemical testing with raw material traceability archives.

Step 02

Process Control

Real-time monitoring of critical control points: temperature, pH, viscosity, and fill volume.

Step 03

Finished Product Testing

Microbial limits, physicochemical indicators, accelerated stability, and packaging compatibility.

Step 04

Environmental Monitoring

Daily monitoring of airborne particles, settling bacteria, and planktonic bacteria.

Step 05

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.

Schedule a Visit