Clean Room Construction Standards
Building controlled environments for medical facilities, pharmaceutical manufacturing, and precision industries. ISO classifications, HVAC requirements, and regulatory compliance explained.
ISO Clean Room Classifications
ISO 14644-1 defines clean room classifications by maximum particle counts. Most Tampa Bay medical facilities require ISO 5-8 environments.
| ISO Class | Max Particles/m³ | US Fed Std | Typical Application | Air Changes |
|---|---|---|---|---|
| ISO 1 | 10 (0.1 µm) | N/A | Extreme semiconductor manufacturing | 500-700+ ACH |
| ISO 2 | 100 (0.1 µm) | N/A | Advanced semiconductor clean rooms | 500-700+ ACH |
| ISO 3 | 1,000 (0.1 µm) | Class 1 | Semiconductor manufacturing, nanotechnology | 500-600 ACH |
| ISO 4 | 10,000 (0.1 µm) | Class 10 | Microelectronics, some pharmaceuticals | 400-500 ACH |
| ISO 5Common | 100,000 (0.1 µm) | Class 100 | Aseptic pharmaceutical, hospital pharmacies, surgical suites | 240-480 ACH |
| ISO 6Common | 1,000,000 (0.1 µm) | Class 1,000 | Optical manufacturing, hospital isolation rooms | 90-180 ACH |
| ISO 7Common | 352,000 (0.5 µm) | Class 10,000 | General pharmaceutical, medical device assembly | 30-60 ACH |
| ISO 8Common | 3,520,000 (0.5 µm) | Class 100,000 | Medical packaging, general manufacturing | 15-25 ACH |
Highlighted rows indicate classifications most common in Tampa Bay medical and pharmaceutical projects.
Critical Construction Elements
Every component of a clean room must be designed for contamination control and cleanability.
Wall Systems
Non-shedding, cleanable surfaces with minimal seams
Ceiling Systems
Grid or flush systems supporting HEPA integration
Flooring Systems
Seamless, chemical-resistant, ESD-safe surfaces
HVAC Systems
Precise temperature, humidity, and pressure control
Air Filtration
HEPA/ULPA filters meeting classification requirements
Pressure Control
Maintain pressure differentials between zones
HVAC Requirements by Classification
Environmental control is the heart of clean room functionality. These are typical requirements for medical and pharmaceutical applications.
| Classification | Temperature | Humidity | Pressure | Air Pattern |
|---|---|---|---|---|
| ISO 5 (Aseptic) | 68°F ± 2°F | 30-60% RH | +0.05" WC min | Unidirectional (laminar) |
| ISO 6 (Pharmaceutical) | 68°F ± 4°F | 30-65% RH | +0.04" WC min | Non-unidirectional |
| ISO 7 (General) | 68°F ± 5°F | 30-70% RH | +0.03" WC min | Non-unidirectional |
| ISO 8 (Support) | 68°F ± 5°F | 30-70% RH | +0.02" WC min | Mixed |
Florida Climate Considerations
Tampa Bay's high humidity (often 80%+ outdoor) creates significant dehumidification loads for clean room HVAC systems. Systems must be sized for peak humidity conditions while maintaining precise indoor control. This often requires dedicated makeup air handling with desiccant or refrigerant dehumidification stages.
Regulatory Frameworks
Clean room construction must comply with industry-specific regulations. FCS builds to these standards for Tampa Bay medical and pharmaceutical clients.
FDA 21 CFR Parts 210/211
Pharmaceutical manufacturing
cGMP for drug products; aseptic processing guidance
Build to FDA inspection standards; documentation packages
USP <797>
Compounding sterile preparations
ISO classifications for compounding areas; beyond-use dating
Hospital pharmacy clean rooms; hood placement
USP <800>
Hazardous drug handling
Negative pressure containment; decontamination
Oncology pharmacies; chemotherapy compounding
ISO 14644
Clean room classification
Particle count testing; classification verification
Design to target classification; commissioning support
USP <797> 2023 Updates
The revised USP General Chapter <797> takes effect November 1, 2023, with significant changes to beyond-use dating, air quality requirements, and personnel training. Hospital pharmacies planning clean room construction or renovation should design to the updated standards. FCS stays current with all regulatory changes affecting medical facility construction.
Frequently Asked Questions
Related Medical Construction Resources
Ready to Build Your Clean Room?
Florida Construction Specialists has built clean rooms for hospital pharmacies, medical device manufacturers, and research facilities throughout Tampa Bay. Let's discuss your project requirements.