1. Overview

In industries that demand strict control over quality and purity such as pharmaceuticals, food, electronics, and cosmetics, the concept of a “cleanroom” has become a mandatory requirement in the production process. However, not all cleanrooms are the same—each industry requires a specific set of standards to meet the necessary level of cleanliness, ensure product safety, and comply with legal regulations.
Therefore, understanding cleanroom standards such as ISO 14644, GMP, HACCP, FS209E... and selecting the right one for each industry is a prerequisite for businesses to operate effectively, avoid wasted investment, and achieve both domestic and international quality certifications.

This article will help you:

  • Understand the nature of the most common cleanroom standards today;

  • Analyze how to choose the correct cleanroom standard based on industry specifics;

  • Avoid common mistakes in the design, construction, and operation of cleanrooms.

2. Overview of Cleanroom Standards

To build a compliant cleanroom environment, businesses must rely on internationally recognized standards and legal frameworks. Each standard has its own requirements for cleanliness levels, microbiological control, particulate matter, building materials, personnel, and operational processes. Understanding these standards allows you to choose the most suitable solution for each application field.

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2.1. Common Cleanroom Standards

Below are the most widely used systems of standards:

ISO 14644 (Latest version: ISO 14644-1:2015)

  • International standard for classifying cleanrooms based on airborne particle counts.

  • Divides cleanrooms into 9 levels from ISO Class 1 to ISO Class 9 (ranging from extremely stringent to less strict cleanliness levels).

  • Widely applied in electronics, pharmaceuticals, healthcare, and precision component manufacturing.

GMP – Good Manufacturing Practice

  • A mandatory standard for pharmaceuticals and cosmetics production.

  • Requires cleanrooms to comply with hygiene, environmental control, raw materials, equipment, and production processes.

  • Popular variations: WHO-GMP, EU-GMP, PIC/S GMP, ASEAN GMP.

FS209E (U.S. Standard – no longer updated)

  • Previously common, especially in the electronics industry.

  • Though replaced by ISO 14644, it is still referenced by some companies.

HACCP (Hazard Analysis and Critical Control Points)

  • Applied in the food industry, focusing on controlling biological, chemical, and physical hazards in production.

  • Does not classify cleanrooms by particle count but emphasizes control over microorganisms, humidity, and general hygiene.

National Standards – TCVN

  • In Vietnam, the Ministry of Health and the Ministry of Industry and Trade have issued standards equivalent to GMP and ISO, adapted to local contexts.

  • Example: TCVN 8664:2011 (pharmaceutical cleanrooms).

2.2. Criteria for Cleanroom Classification

Standards usually classify cleanliness levels based on the following factors:

Criteria

Description
Number of particles/m³

Determined by particle size (0.1µm, 0.3µm, 0.5µm, 1µm...)
Pressure differential

Maintain positive pressure to prevent external contamination
Temperature & Humidity

Controlled according to product characteristics and production process
Airflow

Unidirectional (laminar flow) or mixed (turbulent flow)
Microbiological control

Critical in pharmaceuticals, food, and medical devices
Air change rate (ACH)

Number of times the air in the room is completely replaced per hour (depending on class level)

3. How to Choose Cleanroom Standards by Industry

The selection of cleanroom standards should not be based on the assumption that “the higher the cleanliness level, the better.” Instead, it must depend on product characteristics, production processes, contamination risks, and legal requirements for each industry. Below is a detailed analysis of four common sectors:

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3.1. Pharmaceutical Industry – Mandatory GMP Compliance

The pharmaceutical industry has the strictest requirements for cleanliness, especially for sterile products such as injectables, infusions, eye drops, and vaccines.

Applicable standards:

  • EU-GMP / WHO-GMP / PIC/S GMP

  • ISO 14644 is used to verify particle counts corresponding to each Grade (A, B, C, D).

Cleanroom grades under GMP Annex 1:

Area Cleanliness Level

Purpose
Grade A ISO Class 5

Sterile filling, packaging, handling of open containers
Grade B ISO Class 6

Background area for Grade A
Grade C ISO Class 7

Preparation of raw materials, compounding
Grade D ISO Class 8

Support areas with lower sterility requirements

Notes:

  • Strict microbiological control, particulate control, laminar airflow, and positive pressure are required.

  • Compliance must be ensured from layout design, HVAC, and construction materials to personnel training.

3.2. Food Industry – Focus on Microbiological and Allergen Safety

Cleanrooms in the food industry do not require the extremely high levels of cleanliness as in pharmaceuticals, but must ensure microbiological safety, dust control, pest prevention, and strict separation of processing flows.

Applicable standards:

  • HACCP, ISO 22000, Food GMP, TCVN 5603:2008

  • ISO 14644 is referenced at ISO Class 7–8 levels.

Typical zones:

  • Raw material receiving and pre-processing

  • Cooking and sterilization

  • Packaging and storage

Notes:

  • Design must ensure clear separation of clean and dirty areas.

  • Surfaces must be easy to clean and resistant to mold and moisture.

3.3. Electronics Industry – Extremely High Requirements for Dust and Static Control

Products such as semiconductors, microchips, displays, sensors, and hard drives are highly sensitive to fine particles and static electricity—even a single dust particle may cause product failure.

Applicable standards:

  • ISO 14644-1 is mandatory

  • Common classifications: ISO Class 5–6 (equivalent to Class 100–1000 under FS209E)

Technical requirements:

  • Ionizers and static discharge systems

  • ESD (Electrostatic Discharge) flooring

  • HVAC systems ensuring stable pressure, humidity, and temperature

Notes:

  • Personnel must wear ESD-protective garments (ESD suits).

  • Cleanbenches or mini-environments are often used to optimize operational costs.

3.4. Cosmetics Industry – Combination of GMP and ISO

Although less stringent than pharmaceuticals, the cosmetics industry still requires cleanrooms that comply with standards to ensure product quality, prevent cross-contamination, and meet regulatory licensing requirements.

Applicable standards:

  • Cosmetic GMP (ISO 22716), ASEAN GMP

  • Typically apply Grade C or D depending on the zone (compounding, filling, packaging)

Common zones:

  • Raw material weighing and compounding

  • Filling and packaging

  • Storage of raw materials and semi-finished products

Notes:

  • Importing countries such as the EU and South Korea strictly require GMP compliance.

  • Traceability records and quality control documentation are critically important.

4. Comparative Table of Cleanroom Standards by Industry

The table below summarizes cleanroom standards to help businesses quickly understand:

  • Which industry requires which standards

  • The corresponding cleanliness levels

  • Technical features to consider when designing cleanrooms

Industry Main Standards

Common Cleanliness Levels

 Key Features
Pharmaceuticals EU-GMP, WHO-GMP, ISO 14644

Grade A–D (ISO Class 5–8)

 Strict microbiological control; laminar flow and sterilization requirements
Food HACCP, ISO 22000, Food GMP

ISO Class 7–8

Clean/dirty zoning; control of temperature, humidity, and cross-contamination risks
Electronics ISO 14644, FS209E (reference) ISO Class 5–6

Fine particle and ESD control; highly stable humidity and pressure
Cosmetics Cosmetic GMP, ASEAN GMP, ISO 22716 Grade C–D (ISO Class 7–8)

Control in compounding/filling areas; easier implementation but strong traceability required

Notes when reading the table:

  • ISO Class 5 = Grade A (under GMP), ISO Class 6 = Grade B, etc.

  • Differences among industries lie not only in cleanliness levels but also in specific requirements such as microbiological control, dust control, surface materials, personnel, and traceability systems.

5. Common Mistakes When Choosing Cleanroom Standards

During the process of investing in and building cleanrooms, many companies—especially those new to the field—often make mistakes in selecting standards. This leads to costly consequences, failure to obtain certification, or misalignment with actual production needs.
Below are the most common errors to avoid:

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5.1 Choosing Standards That Are Too High for Actual Needs

Some businesses assume that “the higher the cleanliness, the better,” and therefore invest in systems achieving ISO Class 5 or GMP Grade A for the entire facility.

Consequence: design, equipment, operation, and maintenance costs may increase two to three times without bringing real benefits, resulting in wasted investment.
Example: Regular cosmetics production only requires Grade C–D, but some companies invest up to Grade A as in sterile pharmaceuticals.

5.2 Failing to Assess Industry and Product Characteristics

Each industry has different contamination risks: microbiological, fine particles, chemicals, static electricity, etc.
Without thoroughly analyzing production processes and risks, companies may select inappropriate standards.
Example: The electronics industry requires dust and ESD control but mistakenly applies microbiological standards such as GMP.

5.3 Lack of Consultation from Experts or Professional Providers

Self-implementation of design or hiring inexperienced contractors often results in layout errors, incorrect HVAC selection, or use of non-compliant materials.
This leads to failure in achieving ISO/GMP certification despite investment.

5.4 Confusion Between Different Standard Systems

Many businesses do not clearly distinguish between ISO Classes and GMP Grades, leading to incorrect application or validation methods.
Example: ISO Class 5 (particle control) ≠ GMP Grade A (microbiological control), but both criteria must be evaluated together.

5.5 Poor Design Leading to Inefficient Operation

  • No clear separation of personnel, material, and airflow routes

  • Lack of airlocks, air showers, or buffer zones → pressure loss, cross-contamination

  • Results in validation failure or wasted operational energy

Proposed Solutions:

  • Always begin with risk assessment and real production process evaluation

  • Consult with professional cleanroom design and construction companies following international standards

  • Apply the principle of “adequate – correct – optimized,” avoiding the trend of “the higher, the better”

6. Conclusion

Selecting and correctly applying cleanroom standards by industry not only ensures product quality but is also crucial for achieving international certifications, expanding markets, and enhancing brand reputation. In today’s context—where more industries are facing strict production environment requirements—understanding standards such as ISO 14644, GMP, HACCP, ISO 22000, etc. is indispensable.

However, each sector—pharmaceuticals, food, electronics, and cosmetics—has its own particularities. Therefore, businesses need to:

  • Accurately assess contamination risks and product requirements

  • Choose standards that are adequate, correct, and suitable, avoiding wasteful investments

  • Consult cleanroom experts to optimize design, construction, and validation

If you are looking for a solution to build a cleanroom that meets international standards, contact VCR—a provider of comprehensive cleanroom solutions, from consulting and design to construction and equipment supply—tailored to each industry.

7. Frequently Asked Questions

What are the most common cleanroom standards today?
The two most common are ISO 14644 (particle classification) and GMP (Good Manufacturing Practice). Depending on the industry, one or both may be applied.

Which standards should the pharmaceutical industry follow?
Pharmaceuticals must comply with EU-GMP or WHO-GMP, with cleanroom classification by Grades A, B, C, and D.

What do ISO Classes 5, 6, 7… mean?
These are cleanliness levels under ISO 14644, based on the number of particles per cubic meter of air. The lower the ISO Class, the stricter the cleanliness requirements.

Which standards apply to cleanrooms in the electronics industry?
Electronics typically require ISO Class 5–6, with strict controls on ultra-fine dust and electrostatic discharge (ESD).

Does the cosmetics industry require GMP?
Yes. Cosmetics must comply with Cosmetic GMP (ISO 22716) or ASEAN GMP, especially for products applied to skin, lips, or those intended for export.

How can a company know which cleanroom level it needs?
It requires assessment of the production process, contamination risk level, and legal requirements in the industry. Consulting cleanroom experts is recommended.

Can ISO and GMP be applied together?
Yes. ISO 14644 is often used to measure particle counts in GMP cleanrooms, supporting more accurate environmental evaluation.

Is investing in a standard-compliant cleanroom costly?
Costs depend on cleanliness level, area, equipment, and applicable standards. If the correct standard is chosen, costs will be reasonable and effective.

Do cleanrooms need periodic validation?
Yes. Cleanrooms must undergo periodic validation every 3–6 months for dust, microbiology, temperature, pressure, etc., to maintain compliance.

Does VCR provide cleanroom design and construction services?
Yes. VCR specializes in design, construction, consulting, and equipment supply for cleanrooms in pharmaceuticals, food, electronics, and cosmetics—meeting international standards.

Diep VCR

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