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.

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
Phase | Duration | Key Deliverables |
---|---|---|
Flooring Installation | 2-3 weeks | Antistatic epoxy, seamless joints |
HVAC System | 4-6 weeks | HEPA filtration, air flow validation |
Electrical Work | 3-4 weeks | Cleanroom 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.

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 Type | Frequency | Acceptance Criteria |
---|---|---|
Particle Count | Daily | ≤352,000 particles/m³ (≥0.5μm) |
Airflow Velocity | Weekly | 0.3-0.5 m/s |
Pressure Differential | Daily | 10-15 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.

Fig.2 - iso 14644-1 CleanRoom Classification Chart
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 Protocols
Standards: NFPA fire safety guidelines
Strict electrical, fire, and evacuation protocols are a must.
Protocol | Frequency | Responsible Party |
---|---|---|
Fire Drill | Monthly | Safety Officer |
Electrical Inspections | Bi-weekly | Certified Electrician |
PPE Compliance Check | Daily | Site 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 Measure | Implementation | Effectiveness |
---|---|---|
Noise Reduction | Quiet equipment, restricted hours | Complaints reduced by 75% |
Traffic Management | Designated routes, signage | Local traffic flow improved |
Community Updates | Monthly newsletters, meetings | Trust 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.