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Red Yeast Rice Manufacturing Process | How Top Manufacturer Ensure Purity

Patented strain library × Dual-mode sterilization × Full industry chain quality control, establishing global TOP-level red yeast rice production standards

Get Customized Production Solution
Certified in 56 countries
Activity retention rate >98%
Zero cross-contamination records

Irradiation Sterilization (Recommended for solid products)

Application: Red yeast rice/capsule powder

Advantage: Co-60 gamma ray penetration sterilization

Data: Active ingredient retention rate 98.2%

Dry Sterilization (Recommended for liquid extracts)

Application: Fermentation broth/functional extracts

Advantage: 56℃ low-temperature steam inactivation

Data: Protein denaturation rate ≤0.05%

"Serving 23 EU health brands | Complies with ISO 11137/WHO sterilization standards"

Single-Technology Control: Zero Cross-Contamination, 99.6% Batch Pass Rate

Modular Design

300-500L units prevent cross-contamination. ±0.5℃ control boosts Monacolin K yield 30%, limits citrinin to ＜0.01ppm (vs traditional 0.2-0.5ppm).

Bio-Sensors

256-point lasers track density (±0.1g/L). HPLC checks Monacolin K every 2h (±2%).

Auto-Isolation

8s response seals faulty Technology (＜0.2% impact). Backup units activate, blockchain tracks 57 params.

Traditional Technology: 95.2% → Our system: 99.6%
2024 SGS audit | ISO 22000 compliant
37 pharma partners | Monacolin K SD 15%→2.3% | Citrinin ＜0.05%

Full Industry Chain Purity Control System Pharmaceutical-grade Purity Control

Establish a full-chain purity control system covering raw material cultivation, strain breeding, production processes, and terminal testing, achieving pharmaceutical-grade standards of active substance purity ≥99.5% and total impurities ≤0.02%, exceeding both EU EFSA and US FDA requirements.

Raw Material Interception System

2023 intercepted low-purity materials 41 tons, 3.8% of total procurement

Strain Stability

Growth rate fluctuation 2.3% (initial generation 18%)

Soil Control

Cadmium content 0.3mg/kg (National standard 1.0mg/kg)

Irrigation Water Standard

Lead/Arsenic/Mercury content ＜0.001ppm

Purity Foundation in Material Cultivation Material Cultivation Standard

In self-owned cultivation bases in Wuchang, Heilongjiang and Niigata, Japan, japonica rice cultivation fully complies with NON-GMO certification standards, with each rice grain passing 456 pesticide residue screenings and zero-tolerance heavy metal detection.

Purity Evolution in Strain Breeding Strain Optimization

Proprietary patented strain Monascus purpureus MR-99 (Preservation No. CCTCC M2024078) undergoes 15 generations of directional domestication, with Monacolin K proportion in metabolites stabilized at 98.5%-99.2%.

Gene Editing Technology

Citrinin undetected (＜0.001ppm)

Growth Stability

Fluctuation rate compressed to 2.3%

Detection Accuracy

0.001ppm level (Industry 0.01ppm)

Global Certifications

ISO22000:2018 & FDA GRAS certifications

Terminal Verification of Purity Quality Assurance

Finished products pass three detection checkpoints: HPLC mass spectrometry, nanoscale laser particle size analyzer, blockchain certification system. 2024 SGS blind test shows total impurities 0.018%.

25-Year Pioneer in Monascus Technology
Exported to 56 Countries ∙ Quadruple International Certifications

1999
China's first Monascus export certification
2012
Established fully automated GMP workshop
2020
Passed FDA on-site audit
2024
Launched global supply chain AI management system
▋ Production Standards
ISO22000 · HACCP
▋ Religious Compliance
HALAL · Kosher
▋ Safety Certifications
FDA-GRAS · SGS
▋ Sustainability
Ecovadis Silver
Serving: Pfizer raw material supplier (US) | Meiji Pharmaceutical (Japan) | Sanofi (France) | Novartis (Switzerland) | Bayer (Germany) | AstraZeneca (UK)

Company Introduction

TWIN HORSE is a national high-tech enterprise specializing in the research and development, manufacturing, and sales of red yeast rice-based health foods and pharmaceutical raw material intermediates, integrating science, industry, and trade.

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Contact Us

Telephone：+86 18258802770

E-Mail：j[email protected]

Address：No.1, East Industry&Trade Development Zone, Shouchang Town, Jiande City,Hangzhou City,Zhejiang Province, China

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