GMP Cleanroom Construction: 8 Core Indicators

Author:Jason Peng
Cleanroom Engineering Technology Manager of Deiiang Company.

Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

Executive Director of Guangdong Cleanroom Industry Association of China.

Engaged in R&D of related products for 15 years, with rich relevant technical experience
2025-06-07 | Visits:

From Design to Acceptance - Ensuring Compliance with FDA, EMA, and WHO Standards

Core Indicators

99.9%

Air Purity

120

RPN Threshold

10+

Regulatory Standards

The construction process

In the Pharmaceutical industry, the integrity of GMP Cleanrooms is non-negotiable—it's the cornerstone of drug safety and regulatory compliance. This guide breaks down the construction process into 8 critical indicators, blending technical precision with practical insights to ensure your project meets FDA, EMA, and WHO standards.

Cleanroom Construction Process Diagram

gmp cleanroom construction workflow from design to validation

FDA

EMA

WHO

ISO 14644

GMP Annex 1

8 Core Indicators

Pre-Design: Risk Assessment & Regulatory Alignment

Start with comprehensive gap analysis against GMP Annex 1 and ISO 14644. Map contamination control zones using process flow diagrams.

Determine the cleanliness level based on industry requirements.
Determine the size of the clean area based on production capacity requirements.
Determine the planning of clean functional areas in accordance with industry standards.

Design Phase: Material & System Optimization

Prepare construction drawings for each sub-project of the cleanroom.

Determine the type, specifications, and model of cleanroom Building Materials.
For cleanroom building structures,
HVAC systems,
electrical systems,
fire protection systems,
low-voltage monitoring systems

Construction Execution: Clean Practices & Monitoring

Implement rigorous "clean construction" protocols throughout the build process.

Control construction quality
Pay attention to construction safety
Control construction progress

HVAC Commissioning: Air Quality Assurance

HVAC systems are the heart of your cleanroom and demand rigorous testing.

Use PAO method to detect HEPA filter leaks (≤0.01μg/L)
Validate ULPA filters with DOP testing (leakage ≤0.001%)
Ensure particle counts stay below 290,000 particles/m³ @0.5μm

Personnel Flow: Minimizing Behavioral Contamination

Optimize gowning procedures and airlock efficiency to minimize contamination risks.

Fluorescent particle testing for gowning procedures
Airlock pressure differentials within ±0.5Pa
Passage times ≤30 seconds for individuals
Annual training with 90% passing grade

Dynamic Performance Testing: Real-World Simulation

Simulate worst-case scenarios during commissioning to validate system performance.

72-hour full-load tests
Backup systems activation within 10 seconds
Restore normal conditions in 30 minutes
Ensure TOC residues remain below 10ppm

Documentation: Building an Audit Trail

Comprehensive documentation is your compliance insurance during audits.

Compile Design History Report (DHR) with all ECRs
Validation Summary Report with 95% pass rate for OQ/PQ tests
Adhere to 21 CFR Part 11 for Electronic records
Timestamp and encrypt critical data pages

Post-Acceptance: Continuous Compliance

Compliance doesn't end at acceptance - implement ongoing monitoring and maintenance.

Install online particle counters (sampling every minute)
Conduct quarterly internal GMP audits
Annual ISO 14644 re-certifications
Sign 10-year maintenance contracts

Key validation stages and testing methodologies

Key validation stages and testing methodologies

Precision Builds Trust

Constructing a GMP cleanroom is a meticulous process, but focusing on these 8 core indicators streamlines the journey. Whether you're a project manager or a quality control expert, prioritizing technical accuracy, documentation rigor, and ongoing monitoring ensures your cleanroom stands up to the world's toughest regulatory scrutiny.