How do you choose a hardwall clean room supplier?

How Do You Choose a Hardwall Clean Room Supplier?

Choosing a hardwall clean room supplier is a critical decision that can significantly impact your facility’s operational efficiency and compliance with industry standards. Here are some essential factors to consider when selecting a supplier.

1. Experience and Expertise

When evaluating potential suppliers, consider their industry experience and expertise. A supplier with over 10 years in the cleanroom industry is likely to have a better understanding of specific requirements, including compliance with ISO 14644 standards, which outlines CleanRoom Classifications based on particle levels. Suppliers with extensive experience often have a portfolio of successful projects, which can provide insights into their capabilities.

2. Compliance with International Standards

Ensure that the supplier adheres to international standards relevant to cleanroom environments. Key standards include iso 14644-1 for cleanroom classification and iso 14644-2 for monitoring. A reliable supplier should not only comply with these standards but also demonstrate a commitment to continuous improvement and quality assurance processes.

3. Customization Capabilities

Every cleanroom application has unique requirements. A good supplier should offer customizable solutions tailored to your specific needs. Whether it’s a cleanroom for pharmaceuticals, electronics, or biotechnology, the supplier should be able to provide options that meet your operational and regulatory requirements. Aim for a supplier that can deliver a cleanroom with specific dimensions, airflow patterns, and filtration systems aligned with your processes.

4. Quality of Materials and Construction

The quality of materials used in the construction of a hardwall cleanroom is vital for maintaining cleanliness and minimizing contamination. Look for suppliers that utilize high-quality, durable materials with low particulate emissions. For example, materials that comply with ASTM standards, such as ASTM E84 for surface burning characteristics, can enhance the integrity of your cleanroom environment.

5. Installation and Support Services

Installation is a critical phase that can affect the long-term performance of your cleanroom. Select a supplier that provides comprehensive installation services, ensuring that the cleanroom is set up correctly and efficiently. Additionally, consider their post-installation support, including maintenance services and training for your staff on cleanroom protocols.

6. Cost and Value Proposition

While cost is an important factor, it should not be the sole determinant in your decision-making process. Assess the value proposition of the supplier, taking into account factors such as the quality of materials, level of customization, and after-sales support. A supplier offering a well-constructed cleanroom that meets all regulatory requirements is often worth the investment, evencost analysis. By meticulously evaluating these aspects, organizations can ensure they choose a supplier that not only meets their cleanroom requirements but also enhances their operational efficiency and compliance with industry standards.

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

• ISO 9001- Standard for quality management systems, ensuring consistent quality in products and services.

• ASTM E2391- Guide for the design and construction of cleanrooms.

• FDA 21 CFR Part 210/211- Regulations for pharmaceutical manufacturing requirements.

• IEC 61000-3-2- Standard for electromagnetic compatibility, ensuring cleanroom equipment does not interfere with other electronic devices.

How Are Cleanrooms Classified?

Cleanroom Classification Standards

Cleanrooms are classified according to the level of airborne particulate contamination. The most widely recognized standard is ISO 14644, which categorizes cleanrooms based on the maximum allowable particle count in the air.

ISO Classifications

ISO classifications range from Class 1, which allows only 12 particles per cubic meter, to Class 9, allowing 35,200,000 particles. Each class has specific requirements for particle size and concentration, impacting the cleanroom’s design and operational protocols.

Federal Standard 209E

In addition to ISO standards, Federal Standard 209E was previously used in the U.S. It classified cleanrooms as Class 1 to Class 100,000 based on particle counts. However, this standard has been largely replaced by ISO classifications.

Cleanroom design Considerations

The classification affects the design of the cleanroom, including the choice of materials, HVAC systems, and filtration methods. Higher-class cleanrooms require more stringent controls and advanced technologies to maintain cleanliness.

What Are the Requirements for a Clean Room?

• Air Quality Control

Cleanrooms must maintain specific air quality standards, including controlled levels of airborne particles, temperature, and humidity. Effective air filtration systems, such as HEPA or ULPA filters, are essential for achieving these standards.

• Positive Pressure Environment

Most cleanrooms operate under positive pressure to prevent contamination from outside environments. This is achieved by maintaining higher air pressure inside the cleanroom compared to adjacent areas.

• Strict Protocols

Operational protocols must be strictly followed, including gowning procedures, equipment cleaning, and material transfer methods. Personnel must be trained on these protocols to minimize contamination risks.

What Materials Can Be Used in a Clean Room?

1. Wall and Ceiling Materials

Cleanroom walls and ceilings are typically constructed from non-porous materials such as fiberglass reinforced plastic (FRP) or painted steel. These materials are easy to clean and resistant to contamination.

2. Flooring Options

Cleanroom flooring must be seamless and non-porous. Common options include vinyl, epoxy, or polyurethane flooring, which provide durability and ease of cleaning while minimizing particle generation.

3. Sealing and Adhesives

Sealing materials and adhesives used in cleanrooms should be low outgassing and compatible with cleanroom environments. Silicone or polyurethane sealants are often preferred to ensure that joints remain airtight and contaminant-free.

Is PVC Allowed in a Cleanroom?

1. PVC Characteristics: Polyvinyl chloride (PVC) is a common material known for its durability and versatility. However, its use in cleanrooms is often debated due to potential outgassing and particle generation under certain conditions.

2. Cleanroom Compatibility: While PVC can be used in some cleanroom applications, it must meet specific cleanliness standards. Non-outgassing, low-particulate-grade PVC is preferable to minimize contamination risks.

3. Alternatives to PVC: Materials such as high-density polyethylene (HDPE) or polypropylene are often recommended as safer alternatives to PVC. These materials are less likely to release harmful particles or gases, making them more suitable for modular cleanroom environments.

What Are the OSHA Requirements for Clean Rooms?

General Safety Standards

OSHA mandates that cleanrooms must comply with general safety standards to protect workers. This includes ensuring that air quality is maintained and preventing the accumulation of hazardous substances.

Personal Protective Equipment (PPE)

OSHA requires the use of appropriate personal protective equipment in cleanrooms. This includes gloves, gowns, masks, and face shields to reduce contamination risk and protect employees from exposure.