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GMP Modular Cleanroom Requirements Guide for Pharmaceutical Startups

Created on 01.26
Modular cleanrooms are an ideal solution for pharmaceutical startups looking to rapidly establish compliant production environments, balancing construction speed with GMP standards.

Core GMP Cleanroom Requirements

Air Cleanliness Classification

Class
Particle Limit (≥0.5μm/m³)
Application Scenario
ISO 5
3,520
Aseptic filling, core operation area
ISO 7
352,000
Solution preparation, preparation area
ISO 8
3,520,000
Gowning room, material buffer

Cleanroom with air shower and control panel on blue floor.

Key Design Elements

Wall Materials: Smooth, easy to clean, non-shedding, disinfectant-resistant
Recommended: Stainless steel, FRP, antimicrobial coated panels
Airflow Control
Pressure differential: Maintain 10-15 Pa gradient between adjacent areas
Airflow direction: Clean → Less clean → Non-clean
Air changes: 20-60 times/hour depending on classification
Monitoring System
Real-time monitoring of particles, temperature, humidity, pressure
Regular microbial testing
Traceable data recording

Advantages of Modular Solutions

Construction Efficiency

Time Saving: Completion in 3-6 months (traditional requires 9-18 months)
Flexible Expansion: Phased expansion as business grows
Cost Control: 30-40% reduction in upfront investment

Compliance Support

Pre-validated component systems
Standardized documentation templates
Complete qualification package (DQ/IQ/OQ/PQ)

Implementation Recommendations

Budget Optimization Strategies

Precise Classification: High-grade for core areas, lower-grade for auxiliary areas
Module Combination: Hardwall main workshop + softwall auxiliary areas
Reserved Interfaces: Space reserved for future upgrades

Avoiding Common Issues

Ensure sufficient HVAC capacity margin
Plan separation of personnel and material flow
Establish change control processes
Select suppliers with pharmaceutical experience

Key Points for Supplier Selection

✅ Pharmaceutical project case studies
✅ Provision of complete qualification documents
✅ Understanding of latest GMP requirements
✅ Ability to provide local technical support
✅ Quality management system certification
Need a specific solution? Our pharmaceutical cleanroom experts can provide customized design consultation covering the entire process from planning to qualification.
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