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Why Cleanroom Classifications Matter for Your Facility?

Nov 28,2025

When planning a controlled environment, cleanroom classifications may feel overwhelming at first, but they’re essentially a “cleanliness map” from ISO 1 to ISO 9: ISO 1–3 are ultra-high-end levels, ISO 4–5 support high-precision and sterile core processes, ISO 6–7 cover pharmaceutical and electronics manufacturing needs, and ISO 8–9 are used for general controlled spaces. At Wonclean, we aim to make these levels easier to understand and easier to choose.

ISO Class

Maximum Particles ≥0.1 μm (/m³)

Maximum Particles ≥0.5 μm (/m³)

Typical Applications

ISO 1

10

2

Advanced nanotechnology, quantum experiments, ultra-precision optics

ISO 2

100

24

High-precision semiconductors, nanotechnology labs

ISO 3

1,000

237

Precision optics manufacturing, microelectronics processing

ISO 4

10,000

2,370

Aseptic pharmaceutical filling, core biological laboratories

ISO 5

100,000

23,700

Microelectronics manufacturing, high-precision optoelectronics

ISO 6

1,000,000

237,000

Medical device assembly, semiconductor packaging

ISO 7

10,000,000

2,370,000

Most pharmaceutical production areas, critical laboratories

ISO 8

100,000,000

23,700,000

Material weighing, general electronics assembly, support areas

ISO 9

1,000,000,000

237,000,000

Packaging, warehousing, supportive controlled areas


Understanding Cleanroom Classifications in Real Projects


When you actually start working with cleanroom classifications, you’ll quickly see that they’re not just technical definitions—they directly influence airflow planning, pressure control, energy consumption, and compliance success. ISO defines particle limits, but for you, the real question is: “Will this level support my process requirements?”

ISO classification chat


Industries by Cleanroom Classifications


ISO 1–3: Extreme Cleanliness Levels

Within the strictest cleanroom classifications (ISO 1–3), air must be “clean beyond imagination.”

Industries:

  • Nanotechnology
  • Quantum experiments
  • Advanced semiconductor processing
  • Ultra-precision optics manufacturing


ISO 4–5: High-Precision & Core Sterile Production

In this range of cleanroom classifications (ISO 4–5), particle and microbial control is absolutely essential.

Industries:

  • Aseptic pharmaceutical filling
  • Core biotech laboratories
  • Micro-electronic processing
  • High-precision optoelectronics


ISO 6: The Balanced Level for Precision + Efficiency

Many real cleanroom classifications projects choose ISO 6 because it’s clean enough without extreme cost.

Industries:

  • Medical device assembly
  • Semiconductor packaging
  • Non-sterile biopharma areas
  • Precision instrument production


ISO 7: The Mainstream Pharmaceutical Level

Among cleanroom classifications, ISO 7 is considered the “workhorse level” for pharma.
Industries:

  • Most biopharmaceutical production areas
  • Chemical pharmaceutical mixing and compounding
  • Medical device clean packaging
  • Critical laboratory clean zones


ISO 8–9: General Controlled Area Levels

In the foundational cleanroom classifications (ISO 8–9), the goal is stable, controlled, particle-limited environments.

Industries:

  • Material weighing and storage
  • General electronics assembly
  • Support rooms around cleanrooms
  • Packaging & auxiliary materials storage


Choosing Cleanroom Classifications Without Overbuilding


One of the biggest worries in cleanroom classifications is choosing a level that’s “too high” or “not high enough,” which is why understanding actual process requirements is essential. A single sentence must contain all long-tail terms—iso 5 cleanroom, iso 6 cleanroom, iso 7 cleanroom, iso 8 cleanroom—and the entire design must satisfy cleanroom standards ISO 14644 GMP compliance to avoid validation issues later.


Cleanroom Classifications Are the Start of Every Good Facility


No matter which level of cleanroom classifications you’re planning, the goal is always the same: a stable, safe, and scalable production environment. ISO 1–3 serve ultra-high-tech fields, ISO 4–5 support sterile and precision manufacturing, ISO 6–7 cover most pharmaceutical and electronics applications, and ISO 8–9 handle supporting and general controlled areas. Wonclean’s role is helping you choose the level that truly fits—without under- or over-designing.


 
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