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A modular cleanroom is a kind of cleanroom that is prefabricated and self-contained. The modular cleanroom utilizes standardized components and panels which enable quick and easy installation, reconfiguration, and building of a cleanroom with specific environmental attributes that are needed by certain industries including pharmaceuticals, electronics, and biotech industries.
The usability of modular cleanrooms ensures shorter building timelines and lower construction expenses, as well as provision of inbuilt HEPA/ULPA filters, environmental controls like temperature and humidity, and cleanroom finishes.
The Core Problem & Solution: Traditional building uses stick-built construction, whereas the modular construction is already streamlined and allows construction to proceed faster and much cheaper than with the conventional building methodologies.
Who is This For? Present different target audiences:
Facility and Project Managers: Should be given insights into the aspect of return on investment, timelines, and minimization of disruptions.
Cleanroom engineers & Designers: Should be presented with specifications, materials, layouts and regulations in a detailed manner.
Procurement & QA Departments: Should learn how to evaluate suppliers and get relevant information about costs and installation.
What You Will Get: Make a list of important conclusions and recommendations.
Authoritative Hook: "This guide is based on the experience of senior product designers at Deiiang™ like Jason Peng, taking into account the new ISO and GMP Standards, and provides a trusted framework for your next project.
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What is a Modular Cleanroom & Why Choose It?
Definition and Core Concept
Pre-fabricated, pre-tested components assembled on-site.
Key components: wall/ceiling panels, integrated fan filter units (ffus), doors, windows.
Modular vs. Traditional Construction: A Data-Driven Comparison
| Aspect | Traditional | Modular |
|---|---|---|
| Speed | 6-12 months | 8-16 weeks depending on the project (Deiiang™ project completion average 40% faster) |
| Cost | Involves a lot of start-up costs | Known for price predictability and lower cost in most cases |
Ideal Application Scenarios
Areas of pharmaceutical and biotechnology that require the use of clean rooms (which strictly follow GMP)
Industries of electronics and semiconductors that needed environmental isolation due to vibration
Manufacturing medical equipment
Processing food and beverage
Conducting scientific research
Types of Modular Cleanrooms: An Overview (TL;DR)
Steel Frame hardwall Cleanrooms
Use Areas: Heavy industry requiring employment of heavy equipment.
Advantages: Fortification and stability.
Drawbacks: Weight and danger of corrosion.
Aluminum Frame hardwall cleanrooms
Use Areas: Pharmaceutical, electronic industry, and others.
Advantages: Lightness and corrosion resistance. Deiiang™ often uses proprietary reinforced aluminum nodes for superior rigidity.
Drawbacks: Weight-bearing capabilities being lower than steel.
softwall Cleanrooms (PVC curtains)
Use Areas: Construction projects that don’t require strict regulations.
Advantages: Cost-effectiveness and speed of installation.
Drawbacks: Low level of air pressure and poor cleaning capacity.
Detailed Type Comparison: Tables & Key Takeaways
| Module | Material of construction | Load-bearing capacities | Prices per square foot |
|---|---|---|---|
| Steel Hardwall | Steel | High | $200-$400 |
| Aluminum Hardwall | Aluminum | Medium | $150-$300 |
Conclusion: For the GMP production grade process, we recommend installing aluminum hardwall modules.
Design & Engineering Parameters: A Technical Deep Dive
ISO 14644-1 cleanliness classes & Applications
| ISO Cleanliness Grade | Maximum Allowed Number of Particles in 1 m³ | Application |
|---|---|---|
| iso 5 | 3520 | Aseptic Filling |
| ISO 7 | 352000 | Pharmacy Compounding |
Airflow, Ventilation & Pressurization
air changes per Hour (ACH): Formula: ACH = (Total Airflow in m³/h) / (Room Volume in m³). Show an example of ISO 6 room calculations (e.g., 70 – 160 ACH).
Airflow Patterns: Laminar (uni-directional) and Turbulence (non-unidirectional). Diagrams are an important factor here.
Pressure Cascade Principle: Describe the principle of the pressure cascade, which operates according to the rule of positive pressure transfer through cleaner areas to less clean areas, e.g.; the pressure in ISO 5 is +15 Pa, while in ISO 7 it is about +10 Pa.
Material List & Technical Specifications (Free Excel Template)
Typical modular cleanroom materials include insulated sandwich panels (powder-coated steel or aluminum skin with a polyurethane or mineral wool core), stainless steel (304/316) used for furniture or fittings, cleanroom-grade vinyl or epoxy flooring, HEPA/ULPA filters and stainless or galvanized ducts, sealed LED lights with IP65 standards, airtight doors with viewports installed and automatic closing, softwall or clear PVC curtains installed, silicone or FDA approved sealants used, as well as ceiling frames and suspensions made of stainless steel or aluminum coated with anodic oxide layer.
Technical characteristics of cleanroom modules:
Classes of cleanliness: ISO 1-8 (most often ISO 5-8) or equivalent standards Federal STD 209E
Filters HEPA/ULPA: HEPA H13-H14 or ULPA U15-U17, efficiency at least 99.95% to 99.9995% at MPPS
air change rates: from 60 to 600 ACH depending on the cleanroom class (for ISO 7 the average is about 60-90 ACH)
Pressure difference: from 5 to 15 Pa between adjacent zones
Air temperature: about 18-24°C (64-75°F) +/- 1°C
Relative humidity: 30-60% +/- 5%
Lighting: 500-1000 lux depending on task fulfillment (the index of CRI is at least 80 and it shall not cause flickering)
Floor: ESD safe wherever it is needed, finished to the degree of smoothness Rz ≤0.8 µm
Surface: smooth, does not shed, non-corrosive and easy to clean
Electrical power/data connection: Double circuits for vital loads with isolated grounding for sensitive equipment
If you want to have the complete bill of materials or specifications of a certain iso class, please mention the required one and the size of the room.
BOM Categories:
Structure of cleanroom: panels, frame, ceiling grid
Glazing: windows, doors (sliding, rolling), pass-through windows
HVAC: FFU, air ducts, valves, insulation, etc.
Step-by-Step Construction & Installation Process
Step 1: Preparatory steps (Weeks 1-2)
Site readiness: even floor and utility stubs (for water, electricity and data).
Step 2: Main construction (Weeks 3-8)
Frame installation
Panel installation
Setting up windows and doors
Step 3: Installation qualification (Weeks 9-12)
IQ (Installation Qualification): Checking installation compliance with the project.
OQ (Operating Qualification): Testing operating efficiency with regard to airflow, pressure and amount of recovery.
Standards, Regulations & Compliance
International Standards (ISO)
Regional & Industry-Specific Regulations
Pharmaceutical: EU and US FDA GMP
Medical Devices: ISO 13485
Risk Management & Common Construction Challenges
Absence of leaks at the joint between panels (which can be fixed with the use of appropriate gaskets and trained installers).
Deviation in properly placing of the return air grill.
Some critical products such as HEPA filters can take time to be delivered, which can be evaded by collaboration with company such as Deiiang™, which is able to deliver products on time.
Operations, Maintenance & Lifecycle Management
Operations & Maintenance: In terms of Operations and Maintenance, every day there should be mopped floors and pressure differential checked. Moreover, quarterly maintenance includes HEPA testing and kalibration of sensors, and annual re-certification of cleanrooms.
Lifecycle Management: A well-maintained cleanroom can remain operating for more than 20 years, having an advantage of being reconfigured with minimum loss and cost in terms of initial investment.
Preventive Maintenance Schedule
Daily: Mopped floors and pressure differential checked.
Quarterly: HEPA testing and kalibration of sensors.
Annually: Re-certification of cleanrooms.
Case Studies & Project Portfolio
Case Study 1: Pharmaceutical Company A
Challenge: Build an ISO 5 (class 100) biologics filling suite in 6 months.
Deiiang™ Solution: Custom aluminum hardwall cleanroom with integrated FFU ceiling.
Result: The project took 22 weeks to finish, with PQ approval on the first try.
Cost Estimation & ROI Analysis
Supplier Selection
Analyze suppliers’ experience, in-house engineering capacity, certification of quality (e.g. ISO 9001), and positive references from clients.
Tender Process
Prepare a complete RFP (Request for Proposal), with technical specifications and project deadlines defined clearly. During negotiations, address warranty conditions, after-sale support, and skip suppliers whose contracts are ambiguous or who have previously gone over budget.
Initial Cost Breakdown
Pie chart: materials (50%), labor (25%), equipment/FFUs (15%), commissioning/testing (10%).
Operational Cost Drivers
Fuel consumption (HVAC is the biggest), filter replacements, re-certification.
How to Select a Supplier & Manage the Tender Process
First, define requirements: ISO class, room dimensions, process flow, HVAC (ACH, pressure, temperature/humidity), utilities, validation (IQ/OQ/PQ), timing, estimated budget, and legal regulations.
Check vendors’ qualifications (experience, certification (ISO 9001), financial capacity, local installation/service, references); ask for materials samples and history.
Compose a brief RFP with drawings, specifications, acceptance tests, lead time, warranty, etc. Rate offers, check locations, negotiate prices/(milestones, payments), and deliver goods through one manager reporting to one contract liability.
Supplier Evaluation Checklist
Experience & References
In-house Engineering Capability (i.e. Deiiang™'s engineering staff)
Quality Certifications (ISO 9001)
Conclusion & Next Steps
Highlight the following benefits: speed, capability of adapting to market changes, cost efficiency, and compliance.
Strong Call to Action (CTA):
"Ready to start your modular clean room project?"
"Contact a Deiiang™ specialist for a free consultation and initial plan!"
"Download the accurate Material List and Project Specifications Template!"
References & Further Reading
iso 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration.
EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EudraLex - Volume 4).
FDA Recommendations for the Industry.
faq(Frequently Asked Questions)
What is just a modular cleanroom?
A modular cleanroom is also a controlled environment that is built up by pre-made parts such as wall sections, ceiling grids, doors, windows, and filtration equipment. The advantage of its modular construction is the speed of construction, the ease of increase of size, and the flexibility of the layout compared to ordinary construction.
Which standards are used in the construction of modular cleanrooms?
The ISO-14644 standard is used most often, as it is used for the classification of the airborne particles in the area, for testing, and cleanroom operation. The pharmaceutical industry might also have to comply with the GMP requirements such as EU GMP Annex 1 or other FDA standards. Other regulations will also be required in different industries, such as workplace safety, fire protection, and electrical safety regulations.
What information is needed before starting the process of designing a modular cleanroom?
The team of designer must define: The required class for cleanliness; Process of manufacturing and possible contaminations; Personnel and goods flow; Temperature and humidity conditions; Pressure differentials; Basic electric loads and utility connections; Legal requirements that should be satisfied; Future possibility of expansions.
How long does it take to create a modular cleanroom?
Creating a small or medium-sized modular cleanroom takes several weeks if the design is approved, the equipment is delivered, and the construction process starts. The total time in other cases can reach several months to complete the whole process. The time of doing the project depends on many factors: size, customized design, utility connections, conditions of the site, etc.
What are the materials used for the panels of mobile cleanrooms?
Common materials of the panels surface include powder-coated steel, aluminum, stainless steel, and polymers and others. The core materials may include aluminum honeycomb or mineral wool. The choice will depend on the cleanability, fire resistance, and strength characteristics.
How does HVAC design influence cleanroom operation?
The design of HVAC plays an important role in controlling the concentration of the particles in the air, the direction of airflow, and humidity. It is important to consider the use of the HEPA filter, rate of renewal of air, and many other factors.
