Build a Reliable GMP-Compliant Pharmacy Cleanroom with Dersion

Pharmaceutical manufacturers, hospital pharmacies, and sterile compounding facilities face increasing pressure to ensure drug safety, regulatory compliance, and operational efficiency. A well-designed GMP-compliant pharmacy cleanroom is the foundation for success, but traditional construction methods often involve long timelines, high costs, and complex compliance challenges.

Dersion provides modular pharmacy cleanroom solutions that address these challenges with fast deployment, modular flexibility, and globally proven GMP/ISO compliance.

Why a Pharmacy Cleanroom Matters

A pharmacy cleanroom is a controlled environment that limits:

• Airborne particles and microbial contamination

• Temperature and humidity fluctuations

• Pressure differentials and airflow inconsistencies

These cleanrooms are essential for:

• Sterile drug compounding

• Injectable and IV solution preparation

• Oncology and hazardous drug handling (CSTD)

• Hospital central pharmacies

• GMP pharmaceutical production and packaging

The goal: prevent contamination, protect operators, and ensure consistent drug quality while meeting regulatory requirements from FDA, EU GMP, USP, and ISO standards.

Common Industry Pain Points

Facilities in the US, Europe, and the Middle East often encounter:

• Long construction timelines disrupting ongoing operations

• Difficulty passing GMP, USP, or FDA inspections

• Rigid cleanroom layouts that cannot adapt to future expansion

• High energy consumption and lifecycle costs

• Complex coordination between HVAC, engineering, and construction teams

Dersion’s modular approach solves these challenges.

Dersion’s Modular Pharmacy Cleanroom Advantages

1. Rapid Installation & Minimal Disruption

• Pre-fabricated modules reduce on-site construction time

• Ideal for hospitals and active pharmaceutical facilities

2. Fully GMP & ISO Compliant

• Designed to meet ISO 14644, EU GMP, FDA cGMP, USP 797/800 standards

• Ensures smooth regulatory inspections with documented airflow, pressure, and cleanliness control

3. Flexible & Scalable Design

• Easily expanded or relocated to meet future operational growth

• Supports multiple zones: ISO Class 5, 6, and 7 areas

4. Intelligent Environmental Control

• Automated monitoring of temperature, humidity, pressure, and air quality

• Data logging and alarms improve audit readiness and operational reliability

5. Cost-Efficient & Sustainable

• High material reuse and energy-efficient systems

• Reduced lifecycle costs compared with traditional construction

6. Global Experience & One-Stop Service

• Over 20 years of cleanroom engineering experience

• Provides design, manufacturing, installation, and technical support worldwide

• Successfully delivered projects for hospitals, pharmaceutical companies, and biotech labs

Key Design Considerations Dersion Addresses

• 1.Optimized Layout & Workflow: Clear separation of personnel, materials, and waste to avoid cross-contamination

• 2.Pressure & Airflow Control: Positive pressure in sterile areas, negative pressure in cytotoxic rooms

• 3.Cleanroom-Grade Materials: Smooth, non-porous surfaces and rounded corners for easy cleaning

• 4.Validation & Documentation: IQ/OQ, airflow reports, and material compliance certificates ensure audit readiness

By integrating these features, Dersion cleanrooms reduce regulatory risk while improving operational efficiency.

Applications Across Healthcare & Pharma

• 1.Hospital central pharmacies and compounding rooms

• 2.Sterile drug preparation and filling areas

• 3.Pharmaceutical manufacturing facilities

• 4.Biotech and life science laboratories

• 5.Medical device controlled environments

Conclusion

A reliable GMP-compliant pharmacy cleanroom requires more than ISO-classified spaces — it demands precision engineering, regulatory-compliant design, intelligent monitoring, and long-term operational flexibility.

With Dersion’s modular cleanroom solutions, pharmaceutical and healthcare facilities can achieve rapid deployment, compliance assurance, and sustainable operations, all backed by over two decades of international cleanroom expertise.

Contact Dersion today for a free pharmacy cleanroom layout design and professional consultation.