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Relying on this extensive manual, professionals aiming at creating their own modular hardwall cleanroom systems will have the opportunity to learn everything they need to know about them. This includes technical specifications, the requirements they must comply with, general costs, and procurement issues as relevant.
What Is a Modular Hardwall Cleanroom?
modular hardwall cleanrooms are pre-made constructions that involve rigid wall panels and are used for the eventual containment of contamination-sensitive activities. They are sometimes said to be more effective than soft wall constructions since they provide better operational conditions but are at the same time quicker to install than those built in the traditional way.
Hardwall Cleanroom
Comparison: Hardwall vs Softwall vs Traditional Construction
| Aspect | Hardwall | Soft Wall | Traditional |
|---|---|---|---|
| Durability | 15-20 years | 5-8 years | 20+ years |
| Installation Time | 4-12 weeks | 2-4 weeks | 6-18 months |
| Cost per m² | $2,000-$4,000 | $800-$1,500 | $3,000-$6,000 |
| ISO Class | ISO 1-8 | iso 5-8 | ISO 1-8 |
| Flexibility | High (rearranging possible) | Very high | Low (permanent) |
When to Choose Hardwall vs Softwall or Site-built
Choosing between the various types of cleanrooms mentioned in this manual is to be done according to one’s specific needs and financial possibilities. Here are the common situations when modular hardwall cleanrooms can be used beneficially.
Decision Matrix
| Situation | Recommended Variants | Key Factors |
|---|---|---|
| Pharmaceutical ISO 5/7 | Hardwall | Conformity to regulations, durability, precise control over the environment |
| Semiconductor Packing | Hardwall | Protection from ESD, isolation from shocks, resistance to chemicals |
| Aerospace Large Assembly | Hardwall | Safety of the construction, control over the vibrations, ability to carry large parts |
| Long-term production | Hardwall or Traditional | Durability of construction, expenses for maintenance, stability of work |
| R&D Laboratory | Soft wall | Flexibility, lower costs, temporary construction |
Case Example: Pharmaceutical ISO 7 Facility
One of the large pharmaceutical corporations has chosen modular hardwall cleanrooms for the new vaccine production plant. The grounds for the decision were as follows: 12-months faster deployment as opposed to traditional construction, a 25% cost reduction, and possibility to meet EU GMP Annex 1 standards for Grade B classification.
Standards & Compliance
Modular hardwall cleanroom constructions should conform to international standards in order to guarantee performance, safety, and compliance with the laws and regulations set for the industry where such cleanrooms are used.
Some of the Standards Applicable to Modular Hardwall Cleanrooms
Recommendation for Contract
The contract should include requirement for FAT/SAT testing according to ISO 14644 with minimum 95% confidence level for sample counts. Minimum sampling points should be specified.
Core Technical Specs & Performance Parameters
Panel Specifications
| Type of Panel | Thickness | Core Material | R-value | Applications |
|---|---|---|---|---|
| Aluminum Base Panels | 50mm, 75mm, 100mm | Aluminum Honeycomb | R16 to R24 | Aerospace, high cleanliness |
| Composite Panel | 40mm, 60mm | Purple or IRS foam | R22 to R28 | Pharmaceuticals, electronics |
| Fire-rated Panels | 60mm, 80mm | Mineral wool | R13 to R19 | Healthcare, laboratories |
ISO Classification & Particle Limitations
| ISO Class | Maximum Particles/m³ (≥0.5 μm) | Recommended ACH | Pressure Differential |
|---|---|---|---|
| ISO 5 | 3,520 | 240 to 480 | PP +15 to +30 |
| ISO 6 | 35,200 | 90 to 180 | PP +10 to +25 |
| ISO 7 | 352,000 | 30 to 70 | PP +5 to +20 |
air changes Per Hour Calculation
Airflow (m³/s) = (Volume of Room × ACH) / 3600
Example Calculation: 500 m² ISO 7 Clean Room with 3-meter Height 50 Air Changes a Hour
Volume = 500 m² × 3 m = 1500 m³
Airflow = (1500 × 50) / 3600 = 20.83 m³/s
Required HVAC output: ∼75,000 m³/h (20.83 × 3600)
Temperature & Humidity Control
Normal information for modular hardwall cleanrooms include:
- Temperature stability: ±1°C to ±2°C
- Relative humidity: ±5% RH control
- Common settings: 21°C ±2°C, 45% ±5% RH
Materials, Construction Details & Node Drawings
Materials Comparison
| Materials | TML (%) | CVCM (%) | Benefits | Disadvantages |
|---|---|---|---|---|
| Powder coated steel | <0.1 | <0.01 | Strong, inexpensive | Heavier than aluminum |
| Anodized aluminum | <0.05 | <0.005 | Lightweight and great for aerospace | Costly |
| Stainless steel | <0.001 | <0.001 | Cheap and easy to clean | Most expensive |
Construction Details
Wall Section Detail
Ceiling Integration
ESD Flooring System
HVAC, Filtration & Airflow Design
Replacement of Filters
Types of filters:
- Secondary Filters F7/F9: (95-99% efficiency) - ｒｅｐｌａｃｅ every 1-2 years
- Final Filters HEPA H13/H14: (99.97-99.995% efficiency) - ｒｅｐｌａｃｅ every 3-5 years
- ULPA Filters U15-U17: (99.9995% and above efficiency) - Used in ISO Class 1-3 applications
Airflow Patterns
Fully Laminar Air Flow
Used in ISO Class 1-5 applications, unidirectional airflow
Turbulent Mixing
Used in ISO Class 6-8 applications - low-cost
Pressure Cascade Example
Examples of pressure differences in multi-room installations:
- Core iso class 5 room – 30 Pa
- Gowning iso class 7 room – 20 Pa
- Air Lock iso class 8 room – 15 Pa
- Corridor – 10 Pa
CFD Analysis of Airflow Patterns
Installation, Transport & Lift Considerations
Typical Schedule of Installation
Week 1-2: Preparation of site, incomplete installation utilities
Week 3-5: Assembly of construction, installation of panels
Week 6-7: Integration of HVAC systems and electrical systems
Week 8-9: Finishing and installation of filters
Week 10-12: Commissioning, start of usage, and validation
Transport & Logistics
- Common dimensions of panels: from 1200mm x 2400mm to 1200mm x 3600mm
- Max shipping dimensions: 13.6m x 2.5m x 2.9m (standard container)
- Weight: from 25 kg/m² to 40 kg/m² according to the type of panels
- Capacity of crane required on the building site will vary from 2 to 10 tons based on the type of module
Validation & Commissioning (IQ/OQ/PQ)
Validation Protocol Structure
| Phase | Activities | Deliverables |
|---|---|---|
| IQ | Documentation check, installation check | Provisions |
| OQ | Operational test, performance verification | Results of experimentation and calibration data |
| PQ | Process simulation and normal operation | Monitoring data collection |
Particle Counters Sampling Plan
As per ISO 14644-1:
- Number of sampling points minimum: √A (rounded)
- Volume of sampling minimum: for ISO Class 5 – 20 dr and plus according to other classes
- Height of sampling: 0.8-1.2 m (working height)
- Level of confidence: minimum 95%
Operation, Maintenance & Lifecycle Costs
Maintenance Chart
| Component | Frequency | Activity | Estimated Cost |
|---|---|---|---|
| Pre-filters | 6-12 months | Replacement | $200-$500 |
| HEPA filters | 3-5 years | Replacement | $3,000-$8,000 |
| Pressure monitoring | Annual | Calibration | $500-$1,000 |
| ESD flooring | Quarterly | Resistance testing | $200-$400 |
5-Year Total Cost of Ownership Comparison
| Cost Component | Modular Hardwall | Traditional Construction |
|---|---|---|
| Initial CAPEX | $750,000 | $1,200,000 |
| Annual OPEX | $45,000 | $60,000 |
| Energy Costs (5yr) | $125,000 | $150,000 |
| Maintenance (5yr) | $75,000 | $100,000 |
| Total 5-year TCO | $1,175,000 | $1,750,000 |
Procurement & RFP Checklist
Essential RFP Requirements
- Detailed technical specifications with performance guarantees
- Comprehensive FAT/SAT protocols
- BIM models and as-built documentation
- CFD analysis reports for airflow validation
- Warranty terms and service level agreements
- Training programs for operations staff
- Spare parts inventory recommendations
- Financial stability documentation
Supplier Evaluation Matrix
| Criterion | Weight | Scoring (1-5) | Notes |
|---|---|---|---|
| Technical Compliance | 30% | Meets all specification requirements | |
| Project Experience | 25% | Similar scale and industry projects | |
| Cost Competitiveness | 20% | Total cost of ownership | |
| Service & Support | 15% | Local support, response times | |
| Quality Certifications | 10% | ISO, GMP, industry-specific |
Common Pitfalls & Red Flags
Vague Scope of Delivery
Suppliers who cannot provide detailed scope documentation, including exact specifications, deliverables, and exclusion lists, often lead to project cost overruns and delays.
No Factory Acceptance Test (FAT)
Reputable suppliers always conduct FAT to verify system performance before shipment. Avoid suppliers who cannot provide comprehensive FAT protocols.
Lack of BIM/CFD Capabilities
Modern cleanroom projects require Building Information Modeling and Computational Fluid Dynamics analysis for optimal design and performance validation.
Insufficient Local Support
Suppliers without local service networks cannot provide timely maintenance and emergency support, risking production downtime.
Use of TML/CVCM non-compliant materials
The requirement of meeting ASTM E595 outgassing rules (TML<1.0%, CVCM <0.1%) applies to materials used in aerospace and semiconductor industries.
Quick Audit Checklist
- Document describing the scope of supply
- Detailed FAT/SAT document
- Comprehensive BIM and CFD reports
- Local network of services
- Material certificates of compliance
- References and case studies from clients
- Quality management system certificates
- Financial stability papers
Case Studies & Photo Gallery
Pharmaceutical iso 7 cleanroom
Industry: Pharmaceuticals
Area: 350 sq. m.
ISO Class: 7 (Grade B)
Time: 14 weeks
Challenge: Adherence to the EU GMP Annex 1 regulations within a limited period of time
Solution: modular cleanroom with hardwalls and monitoring functions
Assembly Process of Aero Space Parts
Industry: Aerospace
Area: 600 sq. m.
ISO Class: 6
Time: 18 weeks
Challenge: Control of vibrations for delicate measuring instruments
Solution: Dedicated isolation systems
Semiconductor Packaging
Industry: Semiconductors
Area: 250 sq. m.
ISO Class: 5
Time: 12 weeks
Challenge: Protection against electrostatic discharge and resistance to chemical attack
Solution: Conductive flooring and chemical-resistant modules
The process of cleanroom installation in brief
Questions and Answers
What ISO classes are achievable in hardwall cleanrooms?
If designed properly, modular hardwall cleanrooms may be able to achieve ISO Class 1, 2, 3, 4, 5, 6, 7, 8 with ISO Class 5 being most common in medical, aerospace, and semiconductor industries.
What is the time that takes to install hardwall cleanroom?
The installation duration may vary from 4 to 12 weeks based on the complexity and size of the project as against 6 months to 18 months needed in traditional construction methods. This time includes site preparation, installation, HVAC connection, and commissioning.
How do you bring large machines into cleanroom construction?
In order to bring bigger equipment into modular cleanrooms, you can design large doors of cleanroom modules as large as 4m x 4m, employ removable sections of walls, overhead cranes, and structural members.
What is the period of replacement of filters?
HEPA filters function for around 3 to 5 years depending on applications whereas pre-filters must be changed every 6-12 months based on the environment and application. ULPA filters for high critical applications need to be replaced within short periods.
Can modular cleanrooms be made larger?
Yes, the main purpose of modular cleanrooms includes the possibility to increase and decrease their size or even change their configuration according to production processes with minimum time losses.
What is meant by energy consumption?
Energy consumption is primarily linked to HVAC systems. 500 m² ISO 7 cleanroom consumes 60-100 kW depending on temperature/humidity level, filtration class, and working hours. Modular hardwall cleanrooms can be constructed using special vibration isolation systems, which typically perform better than their conventional counterparts so that for applications in aerospace and semiconductor industries, it is possible to achieve a natural frequency of less than 8 Hz.
Warranty period for hardwall cleanrooms
Standard warranty period is 2-5 years for construction parts and 1-2 years for mechanical systems. Extended warranties are available for certain critical components, such as HEPA filters and control systems.
Next Steps & Contact
Interested in our modular hardwall cleanrooms? We have a team of experts who can assist you in the procurement process.
Contact us
Phone: 1234567890
Email: info@cleanroom.com
Technical Support: support@cleanroom.com
Address: 123 Cleanroom Way, California
Requests
Resources & Reading
Standards & Guidelines
- ISO 14644-1:2015 - Cleanrooms and controlled environments. Part 1 Classifying Cleanrooms
- ISO 14644-2:2015 - Cleanrooms and controlled environments. Part 2 Monitoring evidence of cleanroom performance
- iso 14644-3:2019 - Cleanrooms and controlled environments. Part 3 Test methods
- iso 14644-4:2022 - Cleanrooms and controlled environments. Part 4 Design and Construction
- ISO 14698-1:2003 - Cleanrooms and controlled environments. Biocontamination control - Part 1 General principles
- ASTM E595-15 - Standard test method for total mass loss and volatiles amount
- IEC 61340-5-1 - Electrostatics – Part 5 Electrostatic protection of electronic devices
- EU GMP Annex 1 – Manufacture of sterile medicinal products
- FDA guidance – Sterile products obtained via aseptic processing
Resources
- Whyte W. Cleanroom Technology: Fundamentals of Design, Testing and Operation
- ASHRAE Handbook - HVAC Applications (Clean Spaces chapter)
- ICCCS best practices for cleanroom operation
- NASA Handbook for Outgassing Materials in Space Applications
