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ISO 7 cleanroom-Design Construction Commissioning Standards

  • Author:Jason Peng

  • Cleanroom Engineering Technology Manager of Deiiang Company.

    Product R&D Manager of GDC Inc. Cleanroom Equipment Manufacturing Company.

    Executive Director of Guangdong Cleanroom Industry Association of China.

    Engaged in R&D of related products for 15 years, with rich relevant technical experience

  • 2025-06-19  |  Visits:
#ISO7Cleanroom      #CleanroomConstruction      #QualityControl      #ConstructionSafety      #CivilizedConstruction

What is  ISO 7 Cleanroom?

An ISO 7 cleanroom, also known as a Class 10,000 cleanroom, is a controlled environment where the concentration of airborne particulates is maintained at a specified level to minimize contamination.

It allows a maximum of 352,000 particles per cubic meter of air for particles that are 0.5 micrometers or larger. These cleanrooms are typically used in industries such as pharmaceuticals, biotechnology, and Electronics manufacturing, where maintaining a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors is critical.

Schedule: The Backbone of Your Project

The project timeline is the guiding force behind any successful ISO 7 cleanroom construction. Meticulous planning and realistic scheduling are essential to avoid costly delays and ensure smooth execution.

Typical-ISO-7-Cleanroom-Construction-Phases.jpg

Fig.1 - Typical ISO 7 Cleanroom Construction Phases

Design Phase

Timeline: 6-8 weeks for moderate complexity, up to 3 months for complex projects

Underestimating this stage is a common pitfall. In 99.99% of past projects, insufficient planning led to significant delays.

Pre-construction

Key Focus: Site readiness and material logistics

Improper soil compaction caused a 10-day delay in one project. Just-in-time delivery reduced storage costs by 23% in a recent project.

Construction & Commissioning

Phased Approach: flooring, HVAC, electrical work, and validation

PhaseDurationKey Deliverables
Flooring Installation2-3 weeksAntistatic epoxy, seamless joints
HVAC System4-6 weeksHEPA filtration, air flow validation
Electrical Work3-4 weeksCleanroom lighting, power distribution

Completing HVAC before electrical work reduced rework by 15% in a biotech project. Commissioning and validation are non-negotiable for ISO certification.

Quality Control: Uphold the Standards

divtaining strict quality control is essential to ensure your ISO 7 cleanroom meets international standards and performs as expected.

Material Selection

Key Criteria: Cleanliness and durability

In a pharmaceutical project, choosing HEPA filters with 99.99% efficiency (ISO 29463-3 compliant) significantly improved air quality and particle control.

HEPA-filter.png

Inspections & Testing

Frequency: At least 2 inspections per week

Following IEST guidelines, regular air quality testing reduced failed certifications by 10%. Early issue detection saves both time and money.

Test TypeFrequencyAcceptance Criteria
Particle CountDaily≤352,000 particles/m³ (≥0.5μm)
Airflow VelocityWeekly0.3-0.5 m/s
Pressure DifferentialDaily10-15 Pa

Compliance Standards

Adherence to ISO 14644-1 is non-negotiable. Quality control from the start ensures your cleanroom meets strict particle count requirements for ISO 7 classification.

Safety: Protect Your Team

Safety should be a top priority in any cleanroom construction project. A comprehensive safety plan protects workers and ensures smooth project execution.2222222

Safety Training

Certification: Certified safety professional oversight

Thorough training on cleanroom protocols and safety procedures is essential. After implementing stricter PPE policies, one project saw a 30% reduction in minor injuries.

Safety Training Session.png

Safety Protocols

Standards: NFPA fire safety guidelines

Strict electrical, fire, and evacuation protocols are a must. 

ProtocolFrequencyResponsible Party
Fire DrillMonthlySafety Officer
Electrical InspectionsBi-weeklyCertified Electrician
PPE Compliance CheckDailySite Supervisor

Safety Management

Having a dedicated safety officer is invaluable for monitoring compliance and handling incidents promptly. Safety is not just a requirement—it's the foundation of a successful project.

Civilized Construction: Manage the Site Smartly

divtaining a clean and organized construction site is crucial to minimize contamination risks and ensure a smooth transition to a functional ISO 7 cleanroom.

Site Organization

Zoning: Separate materials and waste zones

designated zones reduced cross-contamination incidents by 30%. A clean site is essential for minimizing future contamination risks.

Project Management

Professional Team: The professional management team can improve efficiency by promptly handling problems and summarizing methods through on-site follow-up and regular meetings, which can effectively shorten the construction period and save construction costs.


Community Considerations

Being mindful of the community is important. In a residential project, implementing noise-reducing measures during sensitive hours improved community relations significantly.

Community MeasureImplementationEffectiveness
Noise ReductionQuiet equipment, restricted hoursComplaints reduced by 75%
Traffic ManagementDesignated routes, signageLocal traffic flow improved
Community UpdatesMonthly newsletters, meetingsTrust and transparency enhanced

Constructing an ISO 7 cleanroom requires a combination of meticulous planning, strict quality control, uncompromising safety measures, and smart site management. 

By focusing on these key areas—schedule, quality, safety, and civilized construction—you can ensure a smooth project that results in a high-quality, compliant cleanroom. 

With 15 years of experience and 43 successful projects, Jason Peng has found that attention to detail in these areas is what makes the difference between a good CleanRoom project and an excellent cleanroom project.

Cleanroom Insiders Expert Team

Deiiang's expert team specializes in designing and constructing state-of-the-art cleanrooms tailored to meet diverse industry needs. With a focus on innovation and compliance, we deliver pristine environments that ensure operational excellence and product integrity.

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