Huuao Pharmaceutical Gmp Clean Room Professional Iso Iv Solution Clean Rooms Pharmaceutical Modular Cleanroom Project

Huaao Pharmaceutical GMP Cleanroom Solutions

Huaao provides professional, integrated GMP cleanroom systems and turnkey project management designed for the stringent requirements of the pharmaceutical industry. Our solutions comply with ISO 14644 standards (including ISO Class designations) to ensure product safety, efficacy, and regulatory compliance.

The core function of a GMP cleanroom is to create and maintain a rigorously controlled environment that prevents contamination of medicinal products throughout their manufacturing lifecycle. This is essential for:

Product Protection:Shielding sterile pharmaceuticals, injectables, and active ingredients from microbial, particulate, and cross-contamination.
Regulatory Compliance:Adhering to global GMP regulations (e.g., FDA, EU Annex 1, WHO), which mandate validated and monitored environmental conditions.
Process Integrity:Ensuring batch consistency and quality by eliminating environmental variables that could compromise manufacturing processes.

This critical environment is achieved through a meticulously integrated system:
1.  Airtight, Cleanable Structure:The modular walls and ceiling, with smooth, non-shedding surfaces, form a sealed envelope.
2.  Advanced Ventilation (HVAC):The heart of the system. It provides HEPA-filtered air, precisely controls temperature and humidity, and maintains validated airflow patterns and room pressurization to protect critical zones.
3.  Qualified Utilities:Integrated cleanroom-grade flooring, ESD-safe materials, and specialized lighting support contamination control.
4.  Continuous Validation:The environment is proven and monitored through commissioning and qualification (IQ/OQ/PQ), ensuring it consistently meets specified ISO classes and GMP requirements for sterile production.

Key Specifications

Product Features

• Lightweight construction for fast installation

• Excellent heat and sound insulation properties

• Customizable dimensions and specifications

• Factory-direct manufacturing with OEM/ODM services

Cleanroom Performance

Our modular cleanroom solution maintains ISO Class 6-8 air cleanliness standards through precision-engineered HVAC systems with HEPA/ULPA filtration, controlling temperature, humidity, and particulate levels to meet pharmaceutical-grade requirements.

Technical Specifications

Key Advantages

• Premium materials from top suppliers (Baosteel, Lantian)

• High-quality core materials and adhesives

• Large production capacity (40,000㎡)

• Established manufacturer with 800 employees across 6 factories

• World-first automated production line for superior quality

Applications

Ideal for pharmaceutical manufacturing, medical device production, semiconductor facilities, healthcare environments, food processing plants, and cosmetic production facilities where controlled environments are critical.

Project Photos

Manufacturing Facilities

Frequently Asked Questions