Quality & Manufacturing

GMP-Aligned Workflow and Certified Cleanroom Standards

Yanhua Bio maintains certified cleanroom facilities with comprehensive quality-control documentation, ensuring batch consistency, sterility, and compliance for institutional partners.

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Certified Cleanroom Testing Results

Our cleanroom facilities are tested by the Guangzhou Institute of Microbiology (CNAS L0823 accredited), meeting GB 50457-2019 pharmaceutical cleanroom design standards.

Test Parameter	Standard Limit	Test Result	Status
0.5μm Suspended Particles	≤ 352,000 /m³	250,530–255,477 /m³	✓ Compliant
5μm Suspended Particles	≤ 2,900 /m³	1,413–1,767 /m³	✓ Compliant
Planktonic Bacteria	≤ 100 CFU/m³	8–12 CFU/m³	✓ Compliant
Sedimentation Bacteria	≤ 50 CFU/4h	0–1 CFU/4h	✓ Compliant
Temperature	20–24°C	23.9°C	✓ Compliant
Relative Humidity	45–60%	57.3%	✓ Compliant
Illuminance	≥ 200 Lx	458 Lx	✓ Compliant
Noise Level	≤ 60 dB	59.6 dB	✓ Compliant
Air Changes per Hour	20–40 /h	22 /h	✓ Compliant
Pressure Differential	≥ 10 Pa	24 Pa	✓ Compliant

Report No. JJ20220527 | Testing Institution: Guangzhou Institute of Microbiology Co., Ltd. (CNAS L0823, ilac-MRA) | Test Date: April 21–23, 2022 | Cleanroom Class: C (10,000 level)

Quality-Control Focus Areas

Area	Partner Review Focus
Sterility and endotoxin	Documentation and testing approach for institutional evaluation.
Particle characterization	Particle-size, concentration, and batch-consistency discussion.
Activity-related evaluation	Research-use evaluation items and technical documentation.
Storage and transport	Handling, cold-chain (2–8°C), and documentation requirements for partner review.

Documentation Available for Partners

Company Profile

Overview of Yanhua Bio and its platform direction.

QC Checklist

Suggested quality-control items for partner evaluation.

Technical Dossier

Platform, workflow, and collaboration materials for qualified partners.

Manufacturing Standards

Non-toxic and non-harmful: Free from toxic or harmful substances.

Sterile: No viable microorganisms detected.

Virus-free: No viral contamination.

Endotoxin-free: Endotoxin levels within safe limits.

Hormone-free: No hormonal substances.

Allergen-free: Suitable for all body types.

Cold-chain storage: 2–8°C throughout storage and transport.

Important Note: Yanhua Bio’s China-based qualifications and manufacturing documentation must be reviewed according to each target country’s regulatory requirements before any local clinical, commercial, import, or promotional activity.

Discuss a Partnership With Yanhua Bio

For scientific, institutional, and partnership inquiries, our international team can share the appropriate technical and collaboration materials.

Contact Yanhua Bio