Cleanroom & Facility Standards

OriginBio's manufacturing facilities operate under internationally recognized quality management systems and are certified to GMP, HACCP, and ISO standards. Our production operations are designed to comply with the stringent requirements of global markets, including the United States and European Union.

With advanced manufacturing equipment, validated production processes, and comprehensive quality assurance systems, our facilities provide OEM and ODM manufacturing services for numerous international health supplement brands.

Advanced GMP Manufacturing Facilities

Our production site features over 10,000 square meters of Class 100,000 (ISO 8 equivalent) cleanroom facilities, specifically designed for the manufacturing of dietary supplements, including capsules, tablets, gummies, powders, softgels, and liquid products.

The cleanroom environment is continuously monitored and maintained to ensure product safety, consistency, and regulatory compliance throughout the production process.

Cleanroom Specifications

· Class 100,000 Cleanroom (ISO 8 Equivalent)

· Airborne Particle Count: ≤ 3.52 million particles/m³

· Controlled Temperature & Humidity Systems

· HEPA Filtration Air Purification

· Dedicated Material & Personnel Flow Management

Cross-Contamination Prevention

To ensure product integrity and consumer safety, our facilities implement strict contamination control procedures, including:

· Scientifically designed pressure differential zoning

· Dedicated equipment cleaning and sanitation procedures

· Comprehensive allergen management programs

These measures effectively minimize the risk of cross-contamination and maintain the highest manufacturing standards.

Dual Disinfection Protection

Our production environment utilizes a dual sterilization system combining:

· Ozone Disinfection

· Ultraviolet (UV) Sterilization

This multi-layered sanitation approach provides comprehensive environmental protection and helps maintain a clean and hygienic manufacturing environment.