GMP-Compliant Modular Cleanrooms for Pharmaceutical Manufacturing

Pharmaceutical cleanrooms are critical controlled environments designed to protect product quality, ensure patient safety, and meet strict global regulatory requirements. From formulation and filling to packaging and inspection, every pharmaceutical process relies on a cleanroom system that delivers consistent cleanliness, airflow stability, and full GMP compliance.

DERSION provides modular pharmaceutical cleanroom solutions engineered for ISO and GMP compliance, fast delivery, and long-term operational flexibility. Our cleanrooms support pharmaceutical manufacturers worldwide in building reliable, inspection-ready production environments.

What Is a Pharmaceutical Cleanroom?

A pharmaceutical cleanroom is a controlled environment that limits airborne particles, microorganisms, and contaminants during drug manufacturing and packaging processes. These cleanrooms are designed according to ISO 14644 classifications and GMP guidelines, with strict control over airflow, pressure, temperature, and humidity.

Pharmaceutical cleanrooms are commonly applied in:

• 1.Solid dosage manufacturing (tablets, capsules)
• 2.Liquid and oral drug production
• 3.Aseptic filling and sterile processing
• 4.Pharmaceutical packaging and labeling
• 5.Quality control and laboratory areas

Pharmaceutical Cleanroom ISO Classifications

Cleanroom classification is determined by product exposure risk and process criticality.

• ISO Class 5–6: Aseptic filling, sterile drug processing, critical open-product operations
• ISO Class 7: Pharmaceutical packaging, liquid preparation, controlled filling areas
• ISO Class 8: Solid dosage manufacturing, secondary packaging, ancillary areas

Local high-clean zones are often used within lower-class cleanrooms to balance compliance and operating cost.

GMP Requirements for Pharmaceutical Cleanrooms

Pharmaceutical cleanrooms must comply with global GMP regulations, including EU GMP, FDA cGMP, and WHO GMP. Core GMP requirements include:

• 1.Defined cleanroom zoning and pressure cascades
• 2.Documented material and personnel flow
• 3.Validated HVAC and filtration performance
• 4.Qualified cleanroom materials and finishes
• 5.Environmental monitoring and documentation

DERSION cleanrooms are designed to support smooth GMP audits and regulatory inspections.

HVAC & Airflow Design for Pharmaceutical Cleanrooms

HVAC systems play a central role in pharmaceutical cleanroom performance.

Key design principles include:

• 1.HEPA-filtered air supply (≥99.97% at 0.3 μm)
• 2.Controlled air change rates
• 3.Stable temperature and humidity control
• 4.Positive pressure differentials between clean zones
• 5.Energy-efficient MAU + AHU configurations

Proper HVAC design ensures contamination control while optimizing long-term energy consumption.

Cleanroom Layout, Zoning & Process Flow

Effective pharmaceutical cleanroom design minimizes contamination risks through optimized layout planning:

• 1.Dedicated personnel and material airlocks
• 2.One-way flow for materials and waste
• 3.Clear separation of clean and non-clean areas
• 4.Gowning rooms with pressure gradients

Process-driven layouts improve operational efficiency and inspection readiness.

Modular Pharmaceutical Cleanroom Advantages

Compared with traditional construction, modular pharmaceutical cleanrooms offer clear advantages:

Faster Delivery

Factory-prefabricated modules significantly reduce on-site construction time, enabling pharmaceutical projects to go live weeks or months faster.

Lower Total Cost of Ownership

Modular systems reduce labor costs, minimize material waste, and improve HVAC energy efficiency.

High Compliance

All systems are designed in accordance with ISO, GMP, CE, and UL standards.

Scalability & Flexibility

Cleanrooms can be expanded, upgraded, or reconfigured as production needs evolve.

Pharmaceutical Cleanroom Applications

DERSION pharmaceutical cleanroom solutions support a wide range of applications:

• 1.Aseptic filling cleanrooms
• 2.Pharmaceutical packaging cleanrooms
• 3.Sterile and non-sterile production areas
• 4.QC laboratories and support rooms

Each solution is customized to meet specific regulatory and operational requirements.

Why Choose DERSION as Your Pharmaceutical Cleanroom Partner?

With over 20 years of cleanroom manufacturing experience, DERSION provides:

• 1.GMP-compliant modular cleanroom systems
• 2.In-house design and factory prefabrication
• 3.Faster delivery compared to traditional builds
• 4.Scalable solutions for future expansion
• 5.One-stop turnkey service from design to after-sales support

Explore Related Cleanroom Solutions

• 1.Pharmaceutical Packaging Cleanroom Requirements
• 2.Aseptic Filling Cleanroom Design
• 3.Medical Device Cleanroom Solutions
• 4.Cosmetic Industry Cleanroom Solutions

Contact DERSION

Looking for a GMP-compliant pharmaceutical cleanroom solution?

Contact DERSION to discuss your pharmaceutical cleanroom project requirements and receive a tailored solution proposal.