A CleanSpace Guide to Cleanroom Classifications

A Cleanspace Guide to Cleanroom Classifications

If you want to build a cleanspace, there’s a critical choice from the start – modular or standard construction. While both options serve the same purpose of maintaining pristine conditions, they differ in their approach and advantages. In this article, we’ll dive into the fascinating realm of cleanroom classifications and explore the unique qualities that set modular cleanrooms apart from their traditional counterparts. 

Cleanroom classifications constitute a vital framework within the field of controlled environments, serving as a standardized system for categorizing and defining the cleanliness and contamination control levels of cleanrooms. 

These classifications are essential for ensuring product quality, safety, and regulatory compliance across various industries, including pharmaceuticals, electronics manufacturing, aerospace, and healthcare. Here is a comprehensive overview of cleanroom classifications:

Purpose and Importance:

• Cleanroom classifications, designed to minimize airborne particles, microorganisms, and other pollutants, are established to quantify and control particulate contamination levels within cleanrooms.
• The primary purpose of cleanroom classifications is to provide a common language and set of criteria to assess and compare cleanroom environments, ensuring consistency and reliability in controlled environments across industries.

Classification Standards:

• The two most commonly referenced standards for cleanroom classifications are ISO 14644-1 and Federal Standard 209E (FS 209E), though ISO 14644-1 has largely superseded FS 209E.
• ISO 14644-1 provides an international system for cleanroom classification, defining cleanliness levels based on airborne particle counts.

ISO 14644-1 Classification:

• ISO 14644-1 classifies cleanrooms on a scale from ISO Class 1 (the cleanest) to ISO Class 9 (the least clean).
• Each ISO class corresponds to a specific maximum allowable particle count per cubic meter, with ISO Class 1 allowing the fewest particles and ISO Class 9 allowing the highest.
• The classification considers particles of various sizes, with smaller particles having stricter limits than larger ones.

Particle Size and Count:

• Cleanroom classifications typically specify limits for particles of different sizes, often measured in micrometers (µm).
• The most critical particle size range is usually between 0.1 µm and 5.0 µm, as these particles are most likely to impact sensitive processes and products.
• Particles outside this range may have separate limits defined for specific applications.

Monitoring and Compliance:

• Continuous monitoring of airborne particle counts is essential to ensure compliance with the designated cleanroom classification.
• Cleanrooms have particle counters and air sampling systems to assess and maintain cleanliness levels.
• Regular validation and certification processes are conducted to verify that cleanrooms meet the specified classification requirements.

Practical Applications:

• Cleanroom classifications are widely used in pharmaceuticals, microelectronics, biotechnology, healthcare, aerospace, and more industries.
• The choice of cleanroom classification depends on the specific requirements of the processes and products being handled within the cleanroom.

Cleanroom Design and Maintenance:

• Achieving and maintaining a specific cleanroom classification involves meticulous design, construction, and operation.
• Factors such as air filtration, temperature, humidity, air pressure differentials, and personnel gowning protocols contribute to the final cleanroom classification.

Evolving Standards:

• Cleanroom standards, including ISO 14644-1, are subject to periodic revisions to align with technological advancements and evolving industry needs. Staying up-to-date with the latest standards is crucial for compliance.

Cleanroom classifications are a fundamental component of cleanroom design and operation, serving as a standardized system to assess and communicate the cleanliness and contamination control levels of controlled environments. Understanding these classifications is imperative for industries where precision, quality, and safety are paramount, ensuring that products and processes are conducted in environments that meet the necessary cleanliness standards.

The Professional Team Need to Comply with Cleanroom Standards

Ensuring compliance with cleanroom standards requires the expertise and collaboration of a diverse team of professionals. The composition of this team may vary depending on the specific industry, cleanroom classification, and the complexity of the cleanroom facility. Additionally, companies like www.cleanspaceus.com can provide valuable support in achieving and maintaining cleanroom standards. 

Below, we outline the professionals typically required and how such companies can assist:

Cleanroom Design and Construction Professionals:

• Cleanroom Design Engineers: These professionals specialize in designing cleanroom facilities that meet the required standards. To ensure compliance, they consider factors such as layout, airflow, filtration, and materials.
• Architects and Contractors: Architects and construction teams are responsible for constructing the physical cleanroom structure per the design specifications, including installing HVAC systems and other critical components.

Cleanroom Validation and Certification Experts:

• Validation Engineers: Experts perform testing and qualification procedures to ensure the cleanroom meets the specified cleanliness and performance criteria. They conduct particle count testing, air velocity measurements, and temperature and humidity checks.
• Certification Bodies: Independent certification bodies may be engaged to verify compliance with cleanroom standards. They issue certificates of compliance once the cleanroom passes all required tests.

HVAC and Environmental Control Specialists:

• HVAC Engineers: These professionals design and maintain the heating, ventilation, and air conditioning (HVAC) systems critical to controlling temperature, humidity, and air quality within the cleanroom.
• Environmental Control Technicians: Technicians oversee the day-to-day operation of HVAC systems and ensure that cleanroom ecological conditions remain within specified ranges.

Cleanroom Operations and Quality Control Personnel:

• Cleanroom Managers: Cleanroom managers oversee day-to-day operations, scheduling, and protocol adherence. They ensure personnel compliance with gowning and entry procedures.
• Quality Assurance Specialists: Quality control professionals monitor processes within the cleanroom to ensure product quality and adherence to cleanroom standards.

Cleanroom Training and Education Providers:

• Cleanroom Training Organizations: These organizations offer specialized training and education programs for cleanroom personnel, covering gowning, aseptic techniques, and cleanroom behavior.

Companies Providing Cleanroom Solutions:

Cleanspace specializes in cleanroom solutions and can be a valuable partners in achieving and maintaining cleanroom standards with the following services:

• Consultation: We can provide expert consultation on cleanroom design, construction, and compliance.
• Cleanroom Products: Cleanspace offers a range of cleanroom equipment and products, including furniture, HVAC components, and filtration systems.
• Maintenance and Support: Rely on us to provide ongoing maintenance services to ensure that cleanrooms continue to meet standards over time.

A multidisciplinary team of professionals, including cleanroom design and construction experts, validation and certification specialists, HVAC engineers, cleanroom managers, and quality control personnel, is crucial for achieving and maintaining compliance with cleanroom standards. 

Cleanspace and Cleanroom Compliance

We offer expertise and resources to support cleanroom compliance efforts, from initial design to ongoing maintenance and product supply. Collaborating with such companies can streamline the process of adhering to cleanroom standards and ensure the long-term success of cleanroom operations.