About Cleanrooms

Who need a Cleanroom?

In many industries, maintaining controlled conditions during production is essential to ensure product quality, compliance, and functionality. Here are some common reasons why controlled environments, often known as cleanrooms, are required:

• Customer or Product-Specific Requirements: Some clients may require products to be manufactured under strict conditions to guarantee purity and precision.
• Product Sensitivity: Certain products, particularly in high-precision or sensitive fields, require consistent and highly controlled environments to function as intended.
• Industry Standards and Regulations: Industries often have strict standards mandating specific conditions in production environments. These may include national, regional, or international standards that require adherence to specific cleanliness levels and environmental controls.

Regardless of the reason, understanding the requirements for cleanroom standards is crucial for compliance and optimal production outcomes.

What Cleanrooms Control

Cleanrooms go beyond simple cleanliness; they regulate multiple environmental variables to suit the needs of sensitive processes and products. Commonly controlled factors include:

• Airborne Contaminants: Cleanliness is fundamental to prevent particle contamination that could compromise quality.
• Temperature and Humidity: Consistent control over temperature and humidity ensures that sensitive materials remain stable and functional.

The specific controls depend on the processes performed and the standards that must be met within the cleanroom. Industries and Applications Utilizing Cleanrooms

Cleanrooms are essential in various sectors where contamination could impact product quality, safety, or functionality. Here are some common industries and applications:

• Pharmaceuticals and Biotechnology: For the production of sterile drugs and biologics.
• Medical Devices and Hospitals: Ensuring sterility and safety in device manufacturing and healthcare settings.
• Food and Beverage: To prevent contamination and maintain product integrity.
• Electronics and Semiconductors: Protecting fine electronic components from damage by dust and static.
• Micromechanics, Nanotechnology, and Optics: Precise control for manufacturing at microscopic and atomic levels.
• Aerospace, Defense, and Optics: Ensuring components meet rigorous industry and regulatory standards.
• Universities, Laboratories, and R&D: For controlled research environments.
• Toxic and Hazardous Materials: Containing dust, toxins, or other contaminants within designated rooms.

If you’re uncertain whether your production requires cleanroom conditions, feel free to reach out to us for guidance. We’ll help you navigate the standards and determine the best approach for your production needs.

Cleanroom conditions

Cleanrooms are meticulously controlled environments designed to minimize contamination and maintain optimal conditions for sensitive production processes. Various factors are carefully regulated to achieve the required cleanliness levels. Here’s an overview of the essential conditions maintained in a cleanroom:

1. Airborne Particle Control

• Filtration: High-Efficiency Particulate Air (HEPA) and Ultra-Low Penetration Air (ULPA) filters remove particles from the air. HEPA filters can capture 99.97% of particles as small as 0.3 microns.
• Airflow Patterns: Laminar (unidirectional) or turbulent (multi-directional) airflow systems keep particles moving out of critical areas, reducing the chance of contamination.

2. Temperature and Humidity Control

• Temperature: Precise temperature control minimizes equipment overheating and ensures materials maintain their integrity. Optimal temperatures vary by industry but are generally kept between 18°C to 23°C (64°F to 73°F).
• Humidity: Controlled humidity prevents static buildup and helps preserve product quality. Common humidity levels range from 30% to 60%, depending on product and process needs.

3. Air Pressure

• Positive or Negative Pressure: Cleanrooms often use positive pressure (air flows out) to prevent outside contaminants from entering. In some cases, like handling hazardous materials, negative pressure (air flows in) is used to contain contaminants within the room.

4. Lighting and Electromagnetic Interference

• Lighting: Cleanrooms require high-quality, uniform lighting that doesn’t produce particles. LED lighting is commonly used due to its low particle emission and energy efficiency.
• EMI Control: In electronic manufacturing cleanrooms, shielding against electromagnetic interference (EMI) is essential to protect sensitive components.

5. Strict Protocols for Personnel and Equipment

• Gowning and Personal Protective Equipment (PPE): Personnel wear gowns, gloves, masks, and sometimes full suits to minimize particle introduction. Gowning procedures are strictly regulated.
• Cleaning Protocols: Regular cleaning and disinfection protocols prevent particle buildup and maintain cleanliness levels.
• Restricted Equipment: Only specific equipment, designed for low particle emissions, is allowed inside a cleanroom.

6. Monitoring and Compliance

• Cleanroom conditions are monitored continuously to ensure compliance with standards such as ISO 14644 and industry-specific guidelines (e.g., USP, FDA, EU GMP). This monitoring includes particle counts, pressure differentials, and environmental parameters.

By carefully controlling these conditions, cleanrooms create a stable and contamination-free environment, ensuring product integrity and meeting regulatory standards across diverse industries.

If you’d like to learn more about cleanroom conditions and how they apply to your industry, please feel free to reach out. Our team is here to guide you through the regulatory landscape and help you achieve compliance with confidence.

Cleanroom qualification

Cleanrooms are specialized environments requiring stringent cleanliness and control to meet regulatory and operational standards. ISO 14644 is the most widely recognized international standard for cleanroom classification and qualification.

However, several other industry-specific standards and guidelines also govern cleanroom requirements based on the products or processes involved. Here’s an overview of cleanroom qualifications, including ISO and additional standards.

ISO 14644: The Foundation of Cleanroom Standards

The ISO 14644 series provides a framework for classifying and qualifying cleanrooms according to air cleanliness, particle count, and environmental controls:

• ISO 14644-1: Specifies the classification of air cleanliness by particle concentration, ranging from ISO Class 1 (the cleanest) to ISO Class 9.
• ISO 14644-2: Details requirements for monitoring and maintaining compliance with specified cleanliness levels.
• ISO 14644-3: Outlines test methods for cleanroom performance, including airflow, filter integrity, and particle counting.
• ISO 14644-4: Addresses cleanroom design, construction, and start-up protocols.

These standards are essential for industries like pharmaceuticals, biotechnology, and electronics, where even tiny particles can compromise product quality or safety.

Industry-Specific Cleanroom Standards

While ISO standards form the baseline, additional regulations are often required for industry-specific applications:

• Pharmaceuticals: Cleanrooms involved in drug production or compounding must adhere to the EU Good Manufacturing Practices (GMP), classified as Grades A through D. In the United States, USP standards (particularly USP <797> and <800>) provide guidelines for sterile compounding in healthcare settings.
• Medical Devices: The FDA and EU Medical Device Regulations (MDR) set additional cleanliness and contamination controls specific to device production.
• Aerospace and Defense: Cleanrooms used for high-precision components must follow stringent guidelines from NASA and other agencies, often incorporating custom particle limits for unique aerospace requirements.
• Food and Beverage: Cleanrooms involved in food processing may need to meet HACCP standards for contamination control, in addition to ISO 14644.

Qualification and Requalification Processes

Cleanroom qualification includes testing for airflow, particle counts, filter integrity, and environmental controls. This process typically involves Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases. Regular requalification ensures that cleanrooms continue to meet these stringent requirements over time, adjusting for any modifications or environmental shifts.

The Importance of Cleanroom Standards

By adhering to ISO 14644 and other industry standards, cleanrooms provide reliable, contamination-free environments critical for product integrity and regulatory compliance. These qualifications protect product quality, ensure safety, and uphold industry reputation, making them fundamental to operations across high-stakes sectors.



For more details on achieving cleanroom compliance or understanding specific industry guidelines, consulting a cleanroom specialist can be invaluable.

See table for appoximal comparision.

Air change per hour (ACH)

Air purity is achieved by passing the air through HEPA and ULPA filters.

The more often the air passes through HEPA filters, the fewer particles remain in the room air.

The air volume filtered in one hour divided by the room volume gives the number of air changes per hour (ACH)

For GMP (A, B, C, D) cleanrooms, it is a rule of thumb to use:

• 5-10 ACH in GMP D rooms
• 10-15 ACH in GMP C rooms
• 20-25 ACH in GMP B rooms with Laminar Air Flow
• 30-35 ACH in GMP A rooms with Laminar Air Flow

Below table with some rule of thumb for ACH for fine electronics (dust)

HVAC & ACH

HVAC calculations requires a mix of technical skills, understanding of the particle-generating potential of the process and experience.

It is crucial that you talk to a HVAC specialist who has experience with cleanrooms.

ISO 14644-1:2015 does not specify ACH for each cleanroom class because it depends on many factors. It can only tell you the result to aim for: the maximum concentration limits for particles.

However, the ISO purity level (ISO 8, ISO 7, ISO 6 and ISO 5) gives a hint about the required ACH range.

A cleanroom with activities that generate few particles versus one that generates many airborne particles, even though both are ISO 7, does not require the same ACH.

Various recommendations ACH ranges and intervals can be found on the Internet.

This can be summarised to the following rule of thumb for fine electronics, etc. (dust)

• ACH 10-30 for ISO 8
• ACH 30-65 for ISO 7
• ACH 80-150 for ISO 6
• ACH 200-450 for ISO 5.

For EU GMP A-D, it is a rule of thumb to use:

• ACH 5-10 for GMP D
• ACH 10-15 for GMP C
• ACH 20-25 for GMP B
• ACH 30-35 for GMP A

If there is a significant generation of particles in the process, or many

people in the room, the higher number is selected in the range of the area.

Note that the ACH above is only a rule of thumb!

ACH must be calculated by an HVAC engineer based on experience and understanding of the particle generating potential of the specific processes.

We are always ready to assist you.

Note

The above information provides a foundational understanding of cleanroom classifications, including the distinctions between ISO 5, ISO 6, ISO 7, and ISO 8 cleanrooms per ISO 14644-1.

Please keep in mind that this summary is for educational purposes only, and the descriptions here are simplified to aid in understanding the basics of cleanroom standards.

For expert guidance or specific assistance with your cleanroom project, please don’t hesitate to reach out to us. Our team is here to answer questions and support you in designing a cleanroom that meets your unique requirements.