A clean room plays a vital role in industries where even the smallest particle, microbe, or airborne contaminant can affect product quality, research integrity, or manufacturing safety. From pharmaceuticals and semiconductors to biotechnology and aerospace, clean rooms are the foundation of controlled environment operations.
As a trusted clean room equipment manufacturer, Rayshen Environmental Pvt. Ltd. provides high-performance solutions designed to meet strict ISO and GMP standards.

This guide explains what a clean room is, how it is classified, and what core components are needed to ensure contamination-free performance.

What Is a Clean Room?

A clean room is a controlled environment where temperature, humidity, airborne particles, airflow, and pressure levels are maintained within strict limits.
The primary goal of a clean room is to minimize contamination caused by:

• Dust
  
  
• Microorganisms
  
  
• Aerosols
  
  
• Chemical vapors
  
  
• Skin flakes
  
  
• Fabric fibers
  
  

Clean rooms use advanced filtration technologies—especially HEPA and ULPA filters—along with controlled airflow systems to ensure a contamination-free workspace. At Rayshen Environmental Pvt. Ltd., each clean room solution is engineered to maintain stable environmental conditions for sensitive operations.

Why Clean Rooms Are Important

Many sectors depend on clean rooms because uncontrolled contaminants can:

• Damage microelectronic circuits
  
  
• Compromise pharmaceutical products
  
  
• Alter laboratory test results
  
  
• Trigger chemical reactions
  
  
• Reduce equipment reliability
  
  
• Lead to costly product recalls
  
  

A professionally designed clean room ensures:

• Consistent product quality
  
  
• Compliance with industry standards
  
  
• Controlled microbial and particulate count
  
  
• Stable manufacturing conditions
  
  
• Safe research environments
  
  

For industries such as pharmaceuticals, medical devices, and semiconductor manufacturing, clean rooms are not optional—they’re mandatory.

Clean Room Classifications

Clean rooms are classified based on the number and size of particles allowed per cubic meter or cubic foot of air. The two most commonly used standards are:

1. ISO 14644-1 Clean Room Classification

ISO standards are globally recognized and classify clean rooms from ISO Class 1 to ISO Class 9.

• ISO Class 1 – The cleanest level, used for nanotechnology and microelectronics
  
  
• ISO Class 5 – Common for pharmaceutical filling areas
  
  
• ISO Class 7–8 – Often used for general manufacturing and packaging
  
  

The lower the class number, the cleaner the environment.

For example:

• ISO Class 5 allows only 3,520 particles (≥0.5µm) per cubic meter.
  
  
• ISO Class 8 allows 3,520,000 particles (≥0.5µm) per cubic meter.
  
  

2. Federal Standard 209E (FS 209E)

Although outdated, many industries still reference FS 209E terminology such as:

• Class 100
  
  
• Class 1,000
  
  
• Class 10,000
  
  

These classifications correlate roughly with ISO classes. For example:

• FS 209E Class 100 ≈ ISO Class 5
  
  
• FS 209E Class 10,000 ≈ ISO Class 7
  
  

Rayshen Environmental Pvt. Ltd. provides clean room equipment tailored to both ISO and FS 209E standards, ensuring full compliance for regulated industries.

Key Components of a Clean Room

A fully functioning clean room requires multiple systems working together. Below are the core components that ensure clean, controlled, and safe conditions.

1. HEPA or ULPA Filtration

Air filtration forms the backbone of a clean room.

• HEPA filters remove 99.97% of particles ≥0.3 microns
  
  
• ULPA filters remove 99.999% of particles ≥0.12 microns
  
  

These filters capture dust, microbes, and aerosols, ensuring a continuous supply of clean air.
Rayshen provides high-efficiency HEPA systems designed for demanding clean room operations.

2. Air Flow and FFUs (Fan Filter Units)

A Fan Filter Unit (FFU) combines a fan and filtration system to distribute ultra-clean air across the room. FFUs maintain:

• Laminar airflow
  
  
• Uniform air pressure
  
  
• Proper air exchange rates
  
  

They are widely used in modular clean rooms, pharmaceutical facilities, and electronics manufacturing.

3. Air Showers

Air showers act as contamination control checkpoints. They use high-velocity air jets to remove loose particles from personnel and materials entering the clean room. This process reduces the introduction of contaminants and protects the sterile environment.

4. Pressure Control

Proper pressure levels ensure contaminants do not infiltrate clean areas.

• Positive pressure – Used in pharmaceutical and electronics spaces
  
  
• Negative pressure – Used in biosafety and infectious control labs
  
  

Pressure sensors and airlocks ensure clean room integrity.

5. Temperature and Humidity Control

Clean rooms maintain stable environmental conditions because sensitive processes can be affected by:

• Heat fluctuations
  
  
• Moisture
  
  
• Static electricity
  
  
• Condensation
  
  

HVAC systems are engineered to maintain exact temperature and humidity levels to protect product reliability.

6. Clean Room Equipment and Furniture

To avoid contamination, all equipment must be clean-room compatible, typically made from stainless steel or non-particle-shedding materials. Examples include:

• SS tables and benches
  
  
• Storage racks
  
  
• Pass boxes
  
  
• Air shower systems
  
  
• SS sinks
  
  
• Laminar flow units
  
  

Rayshen Environmental Pvt. Ltd. manufactures multiple types of clean room equipment that comply with GMP and ISO standards.

How a Clean Room Works

The functioning of a clean room can be summarized in a few important steps:

1. Air Filtration

Outside air is filtered through pre-filters and HEPA/ULPA filters before entering the room.

2. Controlled Airflow

Laminar air passes from the ceiling to the floor in straight, uniform streams, pushing contaminants downward.

3. Pressure Stabilization

Positive pressure traps contaminants outside, while negative pressure traps harmful particles inside specific rooms.

4. Continuous Monitoring

Sensors monitor:

• Particle counts
  
  
• Pressure differentials
  
  
• Temperature
  
  
• Humidity
  
  

Any deviation is corrected instantly to maintain compliance.

Applications of Clean Rooms

Clean rooms are widely used in industries such as:

• Pharmaceuticals
  
  
• Biotechnology
  
  
• Semiconductor manufacturing
  
  
• Aerospace
  
  
• Automotive electronics
  
  
• Food and beverage processing
  
  
• Medical devices
  
  

Each sector requires a different clean room classification based on risk level and product sensitivity.

Why Choose Rayshen Environmental Pvt. Ltd. for Clean Room Solutions?

Rayshen Environmental Pvt. Ltd. specializes in designing and supplying high-quality clean room equipment, including:

• HEPA filter modules
  
  
• FFUs
  
  
• Air showers
  
  
• Laminar airflow units
  
  
• SS clean room furniture
  
  
• Pass boxes
  
  
• Clean room consumables
  
  

Our solutions ensure:

• ISO & GMP compliance
  
  
• Long-lasting durability
  
  
• Low maintenance
  
  
• Maximum contamination control
  
  
• Energy-efficient performance
  
  

Conclusion

A clean room is a highly controlled environment where air quality, temperature, humidity, and pressure are maintained within strict standards. Clean rooms are essential for industries that demand contamination-free operations, high-quality manufacturing, and regulatory compliance.

With reliable equipment from Rayshen Environmental Pvt. Ltd., organizations can build high-performance clean rooms that meet modern industry requirements while ensuring safety, precision, and consistency.