Modular Cleanroom Construction-The Ultimate Guide to Design & Build

Introduction

What is a Modular Cleanroom? 

A modular cleanroom is a prefabricated, self-contained controlled environment composed of standardized panels and components that can be quickly assembled, reconfigured, or expanded to provide defined levels of airborne particulate and contamination control for industries like pharmaceuticals, electronics, and biotech;

it offers flexibility, lower build time and cost, and typically includes integrated HEPA/ULPA filtration, environmental controls (temperature, humidity, pressure), and cleanroom-grade finishes to meet regulatory and cleanliness standards.

The Core Problem & Solution: Contrast the long timelines, high costs, and inflexibility of traditional stick-built construction with the speed, cost-effectiveness, and adaptability of modular methods.

Who is This For? Directly address the key personas:

• Project Managers & Facility Owners: Focus on ROI, timeline, and minimizing business disruption.
• Cleanroom designers & Engineers: Deep dive into technical specs, engineering parameters, and compliance.
• Procurement & QA/Regulatory Staff: Highlight supplier vetting, cost templates, and adherence to GMP/ISO standards.

What You Will Learn: A bulleted list of key takeaways (e.g., "Compare cleanroom types in 5 minutes," "Download a free material checklist," "Calculate your ACH requirements").

Authoritative Hook: "This guide, compiled with insights from Deiiang™'s senior product designers like Jason Peng and referencing key ISO and GMP Standards, provides a trusted framework for your next project."

Introduction: 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

Ideal Application Scenarios

• Pharmaceuticals & Biotechnology (GMP compliance)
• Semiconductor & Electronics Manufacturing (Vibration control)
• Medical Device Assembly
• Food & Beverage Processing
• Research Laboratories

Types of Modular Cleanrooms: An Overview (TL;DR)

Steel Frame hardwall Cleanrooms

Best for: Heavy industrial use, high structural load requirements (e.g., supporting heavy equipment).

Pros: Extreme durability, high stability.

Cons: Heavier, potential for corrosion if not treated.

Aluminum Frame hardwall Cleanrooms

Best for: Most pharmaceutical and electronics applications.

Pros: Lightweight, high corrosion resistance, sleek appearance. Deiiang™ often uses proprietary reinforced aluminum nodes for superior rigidity.

Cons: Lower load-bearing vs. steel.

softwall Cleanrooms (Clear PVC Curtains)

Best for: Low-budget projects, temporary areas, ISO 7/8 classification, packaging areas.

Pros: Lowest cost, extremely fast installation.

Cons: Poorer air pressure integrity, less durable, difficult to clean thoroughly.

Detailed Type Comparison: Tables & Key Takeaways

Analysis by Deiiang™ Experts: For a GMP-grade filling line, an aluminum hardwall cleanroom is typically recommended due to its balance of durability, cleanability, and compliance, whereas a softwall solution might be sufficient for a secondary packaging area.

Design & Engineering Parameters: A Technical Deep Dive

ISO 14644-1 Cleanliness Classes & Applications

Airflow, Ventilation & Pressurization

Air Changes per Hour (ACH): Formula: ACH = (Total Airflow in m³/h) / (Room Volume in m³). Provide example calculations for an ISO 6 room (e.g., 70-160 ACH typical).

Airflow Patterns: Laminar (unidirectional) vs. Turbulent (non-unidirectional); diagrams are crucial here.

Pressure Cascade Design: Explain the principle of positive pressure cascading from cleaner to less clean zones. Example: +15 Pa in ISO 5 -> +10 Pa in ISO 7.

Material List & Technical Specifications (Free Excel Template)

Typical modular cleanroom materials include insulated sandwich panels (powder-coated steel or aluminum skins with polyurethane or mineral wool core), stainless steel (304/316) for furniture and fittings, cleanroom-grade vinyl or epoxy flooring, HEPA/ULPA filters and stainless or galvanized ductwork, sealed LED lighting with IP65 rating, airtight doors with vision panels and automatic closers, softwall or clear PVC strip curtains where used, silicone or FDA-approved sealants, and stainless or anodized aluminum ceiling grids and supports.

Key technical specifications (brief):

• Cleanliness classes: ISO 1–8 (commonly ISO 5–8) or Federal STD 209E equivalents

• HEPA/ULPA filters: HEPA H13–H14 or ULPA U15–U17, efficiency ≥99.95%–99.9995% at MPPS

• Air changes: 60–600+ ACH depending on class; typical ISO 7 ≈ 60–90 ACH

• Pressure differentials: 5–15 Pa between adjacent zones

• Temperature: typically 18–24°C (64–75°F) ±1°C

• Relative humidity: 30–60% ±5%

• Lighting: 500–1000 lux depending on task, CRI ≥80, flicker-free

• Flooring: ESD-safe where required, Rz finish ≤0.8 µm for smoothness

• Surfaces: smooth, non-shedding, corrosion-resistant, easy to clean

• Power/data: redundant circuits for critical loads, isolated grounding for sensitive equipment

If you need a full bill of materials or a spec sheet for a specific ISO class, tell me the target class and room size.

BOM Categories:

• Structure: Panels, Framing, Ceiling Grid
• Glazing: Windows, Doors (sliding, rapid roll), Pass-throughs
• HVAC: FFUs, Ductwork, Dampers, Insulation

Step-by-Step Construction & Installation Process

Phase 1: Pre-Construction (Weeks 1-2)

Site readiness: Level floor, utility stubs (power, water, data).

Phase 2: Main Construction (Weeks 3-8)

1. Frame Erection
2. Panel Installation
3. Door/Window Fitting

Phase 3: Commissioning & Validation (Weeks 9-10)

IQ (Installation Qualification): Verify installation per design.

OQ (Operational Qualification): Test functionality (airflow, pressure, recovery).

Standards, Regulations & Compliance

International Standards (ISO)

• ISO 14644 (Parts 1-5, 7, 8, 9, 14, 15)
• ISO 14698 (Biocontamination control)

Regional & Industry-Specific Regulations

• Pharmaceutical: EU & US FDA GMP, PIC/S
• Medical Devices: ISO 13485

Risk Management & Common Construction Challenges

• Leaks and poor sealing at panel joints (Solution: Use high-quality gaskets and trained installers).
• Airflow short-circuiting (Solution: Proper return air grille placement).
• Supply chain delays for critical components like HEPA filters (Solution: Partner with suppliers like Deiiang™ with robust logistics).

Operations, Maintenance & Lifecycle Management

Operations & Maintenance: Daily and weekly tasks include surface cleaning and pressure differential checks. Quarterly maintenance involves HEPA filter integrity testing and sensor calibration, while annual re-certification ensures ongoing compliance with ISO standards.

Lifecycle Management: A well-maintained hardwall modular cleanroom can have a lifespan of 20+ years. Its key advantage is easy reconfiguration or expansion, protecting your initial investment and adapting to future needs with minimal downtime and waste. A strategic spare parts plan is crucial for minimizing operational disruptions.

Preventive Maintenance Schedule

• Daily/Weekly: Surface cleaning, pressure checks.
• Quarterly: HEPA filter leak testing, sensor calibration.
• Annually: Full performance re-certification.

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: Project completed in 22 weeks, passed PQ on first attempt.

Cost Estimation & ROI Analysis

Supplier Selection

Evaluate suppliers based on their experience, in-house engineering capability, quality certifications (like ISO 9001), and strong client references.

Tender Process

Create a detailed RFP (Request for Proposal) with clear technical specifications and project timelines. During negotiations, focus on warranty terms, after-sales service, and avoid suppliers with vague contracts or a history of cost overruns.

Initial Cost Breakdown

Pie chart: Materials (50%), Labor (25%), Equipment/FFUs (15%), Testing/Commissioning (10%).

Operational Cost Drivers

Energy consumption (HVAC is the largest), filter replacements, re-certification.

How to Select a Supplier & Manage the Tender Process

Start by defining requirements: ISO class, room size, process flow, HVAC (ACH, pressure, temp/humidity), utilities, validation (IQ/OQ/PQ), timeline, budget, and regulatory standards.

Prequalify vendors for industry experience, certifications (ISO 9001), financial stability, local installation/service, references, and request sample materials and case studies.

Issue a clear RFP with drawings, performance specs, acceptance tests, lead times, warranties, and itemized bids; score proposals, conduct site visits, negotiate milestones/holdbacks, and manage delivery with one contact, regular reviews, and documented IQ/OQ/PQ.

Supplier Evaluation Checklist

• Experience & References
• In-house Engineering Capability (e.g., Deiiang™'s design team)
• Quality Certifications (ISO 9001)

Conclusion & Next Steps

Summarize the key benefits: Speed, Flexibility, Cost Control, and Compliance.

Strong Call to Action (CTA):

"Ready to specify your modular cleanroom project?"

"Contact a Deiiang™ expert today for a free consultation and preliminary design."

"Download our comprehensive Material Checklist and Project Specification Template to get started."

References & Further Reading

1. iso 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration.
2. EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EudraLex - Volume 4).
3. FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing.