Fully Compliant USP <797> & USP <800> Cleanroom Systems

Introduction

Are you looking for a reliable USP <797> and USP <800> compliant cleanroom system? These standards govern pharmaceutical compounding, ensuring safety and sterility in environments where medications are prepared. USP <797> addresses non-hazardous compounding, while USP <800> focuses on hazardous drugs, both requiring stringent control over particulate and microbial contamination.

As a leading provider of cleanroom solutions, Farclean delivers turnkey projects that meet or exceed these regulations, incorporating advanced features like specialized cleanroom doors and modular wall panels for seamless integration.

What Are USP <797> and USP <800> Standards?

USP <797> and USP <800> are critical guidelines set by the United States Pharmacopeia for compounding pharmacies and laboratories. They mandate:

Controlled airflow and filtration systems
Regular monitoring of particulate and microbial levels
Design criteria for ISO Class 7 or higher as per ISO 14644-1
Adherence to FDA cGMP (21 CFR Part 211) and EU GMP Annex 1 for pharmaceutical manufacturing
Use of high-efficiency particulate air (HEPA) or ULPA filtration

These standards ensure that compounding environments minimize risks, maintain product integrity, and protect both patients and personnel.

Why Choose a Professional USP <797> & USP <800> Compliant Cleanroom System?

✔ 1. Strict Regulatory Compliance

A professional system ensures full adherence to USP <797>, USP <800>, ISO 14644-1 (ISO Class 3-8), ISO 14644-4, and international regulations like FDA cGMP and EU GMP Annex 1. This guarantees your operations meet global pharmaceutical safety requirements.

✔ 2. Advanced Filtration and Airflow Control

Our cleanrooms feature precise HEPA H14 filtration and independent zone pressure management, enabling:

Duplication of ISO Class 5 or 7 environments for sterile compounding
Low-noise, energy-efficient operation for comfortable workflow
Integration with smart monitoring systems for real-time compliance checks

✔ 3. Enhanced Biosafety and Worker Protection

Farclean systems incorporate robust design elements, such as our custom cleanroom doors and modular wall panels, to contain hazardous materials and reduce exposure per EU GMP and FDA guidelines.

✔ 4. Modular and Flexible Design

Our solutions are scalable, allowing expansion with additional cleanroom doors and wall panels for facilities ranging from small clinics to large compounding pharmacies.

Applications for USP <797> & USP <800> Compliant Cleanrooms

Pharmaceutical compounding pharmacies
Hospital pharmacies and outpatient clinics
Radiopharmaceutical and oncology labs (for USP <800>)
Biological research facilities
Diagnostic laboratories
Medical device compounding sites
Regulatory agency testing labs

Farclean – Your Trusted USP <797> & USP <800> Cleanroom Partner

Farclean specializes in fully compliant cleanroom systems designed for pharmaceutical compounding, leveraging our expertise in turnkey projects. Our Suzhou facility ensures high-quality construction, fast delivery, and strong support for OEM/ODM needs.

Main Features:

ISO Class 6 or better air purity aligned with ISO 14644-1 standards
FDA cGMP and EU GMP Annex 1 certification
User-friendly, low-maintenance materials
Customizable layouts with advanced cleanroom doors
Modular wall panels for quick assembly
Integration with HEPA filtration systems for particle control
Robust construction for hazardous environments

Advantages of Farclean USP Compliant Systems

Reduced risk of contamination ensuring high product quality
Improved compliance and audit success for regulatory inspections
Better protection against hazardous drug exposure per USP <800> standards
Enhanced operational efficiency and cost savings
Long-term durability with easily replaceable components like specialized cleanroom doors

Conclusion

For your USP <797> and USP <800> requirements, Farclean offers comprehensive, compliant cleanroom systems that prioritize safety, efficiency, and regulatory adherence. Our modular wall panels and cleanroom doors ensure easy installation and adaptability for any pharmaceutical setting.

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