Cleanroom design standards

Cleanroom design Standards

Classification of Cleanrooms

Cleanrooms are classified based on the maximum allowable number of particles per cubic meter. The most commonly referenced classifications include ISO 1 through ISO 9, with ISO 1 being the cleanest. For example, ISO 5 allows a maximum of 3,520 particles (0.5 micrometers or larger) per cubic meter.

• ISO 1: < 10 particles/m³ (0.5 µm)

  ISO 5: ≤ 3,520 particles/m³ (0.5 µm)

• ISO 7: ≤ 352,000 particles/m³ (0.5 µm)

Airflow and Filtration Systems

Proper airflow is vital for maintaining cleanroom standards. Cleanrooms should have a minimum of 20 air changes per hour, depending on the classification. High-Efficiency Particulate Air (HEPA) or Ultra-Low Penetration Air (ULPA) filters are required to meet specific levels of cleanliness.

• Minimum of 20 air changes/hour for ISO 7 and ISO 8.

• HEPA filters capture up to 99.97% of particles ≥ 0.3 µm.

• ULPA filters capture up to 99.999% of particles ≥ 0.12 µm.

Environmental Control

Maintaining strict environmental controls is essential in cleanroom design. Temperature should generally be kept between 20-25°C, while relative humidity should be maintained between 30-60%. These conditions help prevent static electricity and microbial growth.

• Ideal temperature: 20-25°C.

• Relative humidity: 30-60%.

• Strict monitoring ensures compliance and operational efficiency.

Materials and Surfaces

The choice of materials in cleanroom construction is crucial. Surfaces should be non-porous and easy to clean. Common materials include stainless steel, epoxy flooring, and glass. These materials help minimize particle generation and facilitate effective cleaning procedures.

• ISO 14644: International standard for cleanrooms and controlled environments.

• ISO 9001: Quality management systems standard that includes cleanroom practices.

• GMP (Good Manufacturing Practices): Guidelines for ensuring products are consistently produced and controlled.

• ISO 13485: Standards for quality management systems specifically for medical devices.

• FDA 21 CFR Part 210/211: Regulations for pharmaceutical manufacturing and quality control.

Is ISO 7 or 8 Better?

1. Cleanliness Standards

ISO 7 and ISO 8 are cleanliness classifications defined by the iso 14644-1 standard. ISO 7 has stricter limits on particle counts, making it more suitable for sensitive processes.

2. Suitability for Applications

ISO 7 is ideal for industries like pharmaceuticals and biotechnology, where contamination control is critical. ISO 8 is often used in less critical environments, such as food processing.

3. Cost and Maintenance

Maintaining an ISO 7 Cleanroom typically requires more resources, which can increase operational costs. Conversely, ISO 8 rooms are less costly to maintain, making them attractive for certain businesses.

Which ISO Form is Most Commonly Used?

• Popularity in Industries

ISO 14644-1 is the most commonly used CleanRoom standard across various industries, including pharmaceuticals, Electronics, and healthcare. Its framework ensures that environments meet specific cleanliness requirements.

• Versatility of ISO Standards

ISO 14644-1 offers flexibility, allowing businesses to select suitable classifications based on their operational needs. This adaptability contributes to its widespread adoption in different sectors.

• Global Recognition

The ISO standards are internationally recognized, facilitating compliance and operational consistency across borders. This recognition makes ISO 14644-1 a preferred choice for companies operating globally.

What ISOShould a Fully Functional Clean Room Be?

Critical Manufacturing Needs

A fully functional cleanroom typically requires at least ISO7 to ensure minimal contamination. This is crucial for industries like pharmaceuticals and aerospace, where precision is essential.

Flexibility for Different Applications

Depending on the specific application, some facilities may opt for ISO6 or lower. However, ISO7 generally offers a balance between operational efficiency and cleanliness.

Compliance and Certification

Choosing the right ISO class also involves understanding regulatory requirements. Companies must ensure their cleanroom meets applicable standards for certification and operational compliance.

Which ISO is Best for Higher Quality?

ISO 9001 Overview

ISO 9001 is widely regarded as the benchmark for quality management systems. It focuses on continuous improvement and customer satisfaction, making it ideal for organizations aiming for high-quality outputs.

Industry-Specific ISO Standards

While ISO 9001 is general, industry-specific standards (like ISO 13485 for medical devices) can enhance quality in particular sectors. These standards provide tailored guidelines to meet unique industry challenges.

Customer Expectations

In many industries, customers expect products to meet specific ISO standards. Adopting the appropriate ISO classification demonstrates a commitment to quality, which can differentiate a company from its competitors.