GMP Requirements for Pharmaceutical Cleanrooms: Design, HVAC & Compliance Guide

Introduction: GMP and Pharmaceutical Cleanroom Compliance

GMP (Good Manufacturing Practice) requirements play a critical role in pharmaceutical cleanroom design and operation. Cleanrooms used in pharmaceutical manufacturing must control airborne particles, microorganisms, temperature, humidity, and pressure to ensure product quality and patient safety.

Failure to meet GMP cleanroom requirements may result in regulatory non-compliance, audit findings, or production interruptions. Therefore, pharmaceutical cleanrooms must be designed, built, and operated in accordance with recognized international standards such as EU GMP, FDA cGMP, WHO GMP, and ISO 14644.

1. GMP Cleanroom Classification Requirements

Pharmaceutical cleanrooms are commonly classified using EU GMP Grades and ISO 14644-1 cleanliness classes.

Key GMP Compliance Points

• Particle limits defined for both at-rest and operational states

• Strict separation between different cleanroom grades

• Pressure cascade from higher to lower cleanliness areas

 Cleanroom Classification Standards

2. GMP Requirements for Cleanroom Layout and Zoning

Proper cleanroom layout is essential to prevent cross-contamination and mix-ups.

GMP Layout Principles

• Logical and unidirectional flow of personnel and materials

• Dedicated airlocks for personnel and material transfer

• Segregated areas for raw materials, processing, and packaging

• Controlled weighing and dispensing rooms

GMP inspections frequently identify layout and zoning issues as root causes of non-compliance.

DERSION Approach
DERSION provides GMP-oriented cleanroom layout design during the early project stage to ensure audit-ready zoning before construction.

3. GMP HVAC Requirements for Pharmaceutical Cleanrooms

HVAC systems are fundamental to GMP compliance in pharmaceutical cleanrooms.

Core HVAC Parameters

• Air change rates: typically 20–60 ACH

• Temperature control: generally 18–26°C

• Relative humidity: typically 45–65% RH

• Pressure differentials: 10–15 Pa between adjacent areas

• HEPA filtration: H13 or H14 filters for critical areas

Common HVAC Configurations

• MAU + AHU combined systems

• Terminal HEPA filtration

• Redundant HVAC design for critical operations

 GMP Cleanroom HVAC Design

4. GMP Requirements for Cleanroom Construction Materials

All materials used in pharmaceutical cleanrooms must support cleanliness and ease of sanitation.

GMP-Approved Materials

• Modular cleanroom wall panel systems

• Smooth, non-porous ceiling and wall finishes

• Epoxy or PVC cleanroom flooring

• Flush-mounted doors, windows, and lighting

• Rounded corners to eliminate dust accumulation

Modular cleanroom systems are widely used due to faster installation and easier GMP validation.

5. Personnel and Operational GMP Controls

Personnel are the primary source of contamination in pharmaceutical cleanrooms.

Key GMP Operational Requirements

• Defined gowning procedures by cleanroom grade

• Personnel training and access control

• Written SOPs and documentation

• Behavior controls within cleanroom areas

Effective gowning room design and airflow management are essential to maintain GMP conditions.

6. GMP Cleanroom Validation and Qualification

Pharmaceutical cleanrooms must be validated throughout their lifecycle.

Validation Stages

• Design Qualification (DQ)

• Installation Qualification (IQ)

• Operational Qualification (OQ)

• Performance Qualification (PQ)

Typical Validation Tests

• Airflow visualization

• Particle count testing

• HEPA integrity testing

• Pressure differential verification

 Cleanroom Validation & Qualification

7. Common GMP Compliance Challenges

Selecting an experienced cleanroom manufacturer significantly reduces compliance risk.

8. DERSION’s GMP Pharmaceutical Cleanroom Solutions

DERSION is a professional manufacturer and solution provider specializing in GMP-compliant pharmaceutical cleanrooms.

• 20+ years of cleanroom engineering experience

• Modular cleanroom manufacturing in a 20,000㎡ smart factory

• CE, ISO, UL certified systems

• One-stop solutions from design to delivery

• Support for FDA, EU GMP, and WHO GMP compliance

DERSION assists pharmaceutical manufacturers in building cleanrooms that meet regulatory expectations and operational requirements.

Conclusion

Understanding and implementing GMP requirements is essential for pharmaceutical cleanroom compliance. From classification and HVAC design to materials and validation, each element contributes to product quality and regulatory approval.

DERSION provides structured, compliant, and scalable pharmaceutical cleanroom solutions for global clients.