Hardwall Cleanrooms

What is a hardwall clean room?

A hardwall clean room is a controlled environment designed to prevent the contamination of sensitive processes, equipment, and products. Constructed with rigid, solid walls, these rooms provide stability and are equipped with advanced filtration systems, environmental controls, and strict cleanliness standards. They are ideal for industries like pharmaceuticals, biotechnology, and electronics, where the integrity of products must be safeguarded against contaminants.

Description:

A hardwall clean room features durable and solid walls, as opposed to flexible, soft walls used in other types of clean rooms. It ensures a stable environment by controlling air quality, temperature, humidity, and particle contamination levels. The sealed structure provides better control over cleanliness, making it suitable for high-precision industries.

Key Features:

Hardwall clean rooms typically include high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters to maintain air purity. The environment within the clean room is carefully regulated through HVAC systems that control air flow, temperature, and humidity. Hardwall clean rooms can meet various cleanliness standards such as ISO 14644-1 and are designed for industries that require stringent conditions.

How does a hardwall clean room differ from a softwall clean room?

1.Structural Differences:

The primary distinction between a hardwall and softwall clean room lies in their construction. Hardwall clean rooms have rigid, solid walls, providing greater structural stability and better control over environmental conditions. In contrast, softwall clean rooms use flexible curtains or panels, which are easier to modify but offer less contamination control.

2.Contamination Control:

Hardwall clean rooms provide superior contamination control. The solid walls are less likely to allow air leakage, making it easier to maintain positive pressure and reduce particle contamination. Softwall rooms, while easier to assemble, can be prone to more contamination risks due to the flexibility of their walls.

3.Flexibility and Cost:

While hardwall clean rooms are often more expensive and less flexible in design changes, they are ideal for applications requiring high cleanliness standards. Softwall clean rooms are more cost-effective and flexible, suitable for temporary needs or industries with less stringent requirements.

4.Applications:

Hardwall clean rooms are typically used in industries that demand strict regulatory compliance, such as pharmaceuticals, medical device manufacturing, and aerospace. Softwall clean rooms are often preferred in less regulated environments or where flexibility and portability are important.

Can hardwall clean rooms be customized for specific applications?

• Customization Options:Yes, hardwall clean rooms can be highly customized for various applications.

• Design Flexibility:Custom design features such as specific air filtration systems, wall materials, and size can be incorporated to meet application needs.

• Size Adjustments:Hardwall clean rooms can be built in different sizes to fit particular processes or equipment.

• Compliance Specifications:Customization helps meet industry regulations, ensuring the clean room meets specific cleanliness standards.

• Material Selection:Materials such as stainless steel, aluminum, and specialized coatings can be chosen based on chemical or physical requirements.

• Technology Integration:Advanced monitoring and automation systems can be integrated into the design to provide real-time data and ensure consistent environmental control.

Hardwall clean rooms are highly versatile, making them ideal for specific applications that require customization for cleanliness, compliance, and technological integration.

What kind of air filtration systems are used in hardwall clean rooms?

HEPA Filters:

Hardwall clean rooms commonly use High-Efficiency Particulate Air (HEPA) filters to trap particles as small as 0.3 microns, ensuring the air remains contaminant-free.

ULPA Filters:

Ultra-Low Penetration Air (ULPA) filters are used in the most stringent environments, capturing even smaller particles with an efficiency of 99.999% for particles as small as 0.12 microns.

How to ensure compliance with cleanroom regulations in a hardwall clean room?

Ensuring compliance with cleanroom regulations such as ISO 14644-1 or GMP standards is essential for industries that require stringent cleanliness. This involves designing the room according to the necessary class, continuous monitoring, and adherence to procedures.

Regular Monitoring and Validation:

Regular air quality checks, temperature, and humidity monitoring are crucial. Validation of systems like filtration and airflow ensures compliance with cleanliness levels. Monitoring equipment should be calibrated regularly to maintain accurate readings.

Training and Procedures:

Employees should be trained in proper cleanroom protocols, including gowning procedures, cleaning, and equipment handling. Strict adherence to these protocols helps minimize contamination risks.

Documentation:

Maintaining detailed records of testing, cleaning, and maintenance activities is essential for compliance audits and regulatory inspections.

Maintenance and Audits:

Scheduled maintenance of HVAC and filtration systems ensures continued operation. Regular audits help verify the clean room’s performance and adherence to regulations.

What is the installation process for a hardwall clean room?

1.Planning and Design:

The installation of a hardwall clean room begins with comprehensive planning, where the requirements for the cleanroom are defined based on the industry and application. The clean room design layout, size, filtration systems, and environmental control systems are specified.

2.Site Preparation:

The site must be prepared to meet structural and environmental needs. This may include reinforcing the floor, electrical work, and installing plumbing if required.

3.Construction Phase:

Construction typically involves assembling prefabricated walls, floors, and ceilings, followed by the installation of air handling systems, filtration units, and HVAC systems.

4.Final System Setup:

Once the structure is in place, the air filtration and HVAC systems are calibrated, and environmental controls are integrated to ensure proper functioning.

5.Certification and Testing:

After installation, the clean room undergoes thorough testing to verify that it meets the required cleanroom ISO class and regulatory standards. This includes particle count tests, airflow checks, and pressure differential tests.

6.Commissioning:

Once everything is verified, the clean room is commissioned for use, and all necessary documentation is completed for compliance purposes.

7.Relevant International Standards:

Installation processes must adhere to international standards such as ISO 14644, which defines cleanroom classifications, and GMP (Good Manufacturing Practice) for pharmaceutical or food industry applications.

How do you control temperature and humidity in a hardwall clean room?

• HVAC Systems:The primary method of controlling temperature and humidity in a hardwall clean room is through the HVAC system, which regulates air flow and environmental conditions。

• Sensors and Automation:Sensors continuously monitor temperature and humidity levels, with automated systems adjusting settings to ensure they stay within the required parameters.

• Regular Calibration:Calibration of temperature and humidity sensors is crucial to maintain the accuracy of readings and ensure the system responds correctly to changes in environmental conditions.

• Maintenance of Cleanroom Equipment:Routine maintenance of HVAC equipment, such as cleaning filters and checking for system leaks, ensures continued efficient operation and the ability to control environmental conditions effectively.

• Data Logging:Data logging systems track temperature and humidity over time, helping to identify trends or potential issues before they become critical.

• Airflow Considerations:Proper airflow design, in combination with the HVAC system, helps to maintain consistent temperature and humidity throughout the cleanroom.

Are hardwall clean rooms suitable for pharmaceuticals?

Pharmaceutical Needs:

Yes, hardwall clean rooms are highly suitable for pharmaceutical applications, where contamination control is critical for drug safety and efficacy.

Regulatory Compliance:

Hardwall clean rooms meet strict regulatory requirements such as those outlined by the FDA and EMA, which mandate specific environmental conditions for drug production.

Sterile Manufacturing:

These rooms are essential for the manufacturing of sterile products, as they can maintain the necessary particle count and microbial levels.

Controlled Environment:

Hardwall clean rooms provide an environment where temperature, humidity, and airflow are precisely controlled, which is vital for pharmaceutical production processes.

Quality Assurance:

The cleanroom environment helps ensure product consistency and quality, reducing the risk of contamination and defects.

The high level of control and cleanliness provided by hardwall clean rooms makes them essential for the pharmaceutical industry, where even the smallest contaminants can compromise the product's safety and quality.

What are the advantages of hardwall clean rooms over modular options?

Hardwall clean rooms are known for their superior durability and high-level containment capabilities compared to modular options. They are ideal for industries requiring stringent contamination control, such as pharmaceuticals, electronics, and biotechnology. Their permanent structure and solid walls make them more suitable for long-term operations.

1.Increased Containment and Durability

Hardwall clean rooms are more robust than modular clean rooms due to their rigid structure, which ensures better containment of particulate matter and contamination. The solid walls and ceilings create a stable and secure environment, crucial for industries where even minute contamination can affect the quality and safety of products. This level of durability is particularly advantageous in industries like semiconductor manufacturing, pharmaceutical production, and aerospace, where environmental control is critical.

2.Better Airflow and Control

Hardwall clean rooms offer superior control over airflow, pressure, and temperature. The walls are typically designed to support a higher level of filtration, which helps in creating a more stable and consistent air flow. This is essential for maintaining the cleanroom's classification standards, such as ISO 14644, and reducing the chances of contamination. The rigid design also allows for more precise control of particle count in the air, which is essential for critical manufacturing processes.

3.Long-Term Investment

Hardwall clean rooms provide a long-term solution for facilities that require high levels of cleanliness. The solid walls are easier to maintain, and the overall structure is more resilient to wear and tear. Although the initial investment is higher than modular clean rooms, the long-term benefits of reduced maintenance and longer lifespan make hardwall clean rooms a more economical choice over time.

4.Customization and Flexibility

Unlike modular options, which can be limited in terms of size and structural changes, hardwall clean rooms offer more flexibility when it comes to customization. These rooms can be designed to meet specific regulatory requirements, include specialized air filtration systems, and accommodate a variety of layouts. This makes them a better choice for industries that need a tailor-made environment to suit precise operational needs.

Hardwall clean rooms offer substantial advantages over modular options in terms of durability, containment, airflow control, and long-term cost efficiency. These benefits make them an ideal choice for industries with stringent environmental and contamination control requirements.

How do you choose a hardwall clean room supplier?

• Select a supplier with proven expertise in designing and constructing hardwall clean rooms tailored to your industry’s needs.

• Ensure the supplier follows international standards such as ISO 14644 to ensure high-quality design and functionality.

• Choose a supplier capable of offering customization to meet your specific operational requirements and space limitations.

• Research the supplier's reputation through customer feedback and past project successes to ensure reliability and performance.

• Consider the total cost of ownership, including maintenance services and post-installation support, to ensure a cost-effective solution in the long run.

What common challenges are faced during the construction of a hardwall clean room?

Design and Planning Complexity

Designing a hardwall clean room that meets all necessary cleanliness standards and is functional for specific industries can be a complex task. Detailed planning is needed to balance airflow, temperature, and pressure controls while ensuring compliance with industry regulations.

Material Selection

Choosing the right materials for the walls, flooring, and ceilings is critical for ensuring a long-lasting, cleanable surface that prevents contamination.

Meeting Regulatory Standards

Compliance with strict international cleanroom standards such as ISO 14644 or GMP (Good Manufacturing Practices) is a significant challenge. It requires thorough knowledge of the standards and the ability to implement them in the room's design and construction. 

Installation and Integration

Integrating advanced filtration systems, air handling units, and other essential components during installation requires precision. Any mistakes in installation can result in contamination or inefficient airflow.

Cost Control and Budgeting

Hardwall clean room construction can be costly, particularly if there are unexpected delays or changes in design during the project. Proper budgeting and cost estimation are essential to keep the project on track financially.

Relevant International Standards:

• ISO 14644-1: Classification of air cleanliness

• ISO 14644-4: Design, construction, and operation of cleanrooms

• GMP (Good Manufacturing Practices)

How do you maintain cleanliness in a hardwall clean room?

Hardwall clean rooms require regular cleaning schedules to prevent particle buildup on walls, ceilings, and floors. Routine inspections are also necessary to detect any potential sources of contamination.

Only approved cleaning agents should be used in clean rooms to avoid contamination. Cleaning staff should be trained on the correct procedures and materials to ensure cleanliness is maintained without compromising air quality.

Maintaining cleanliness in a hardwall clean room involves regular cleaning, proper material handling, and routine inspections. A structured maintenance plan helps to keep the environment compliant with cleanroom standards.

What are the typical ISO classifications for hardwall clean rooms?

ISO 1 to ISO 9 Classifications：Clean rooms are classified according to their level of air cleanliness, based on the number of particles of a certain size that are present in the air. ISO 1 represents the highest level of cleanliness, suitable for critical applications like semiconductor manufacturing.

ISO 14644-1 Standards：ISO 14644-1 provides detailed classification criteria for cleanrooms, with ISO 5 and ISO 7 being common classifications for many hardwall clean rooms, especially in biotechnology and pharmaceutical industries.

Applications and Suitability：ISO classifications are important to match the clean room's cleanliness level with the requirements of the industry, ensuring proper control over contaminants for sensitive processes.

How is airflow managed in a hardwall clean room?

In hardwall clean rooms, the airflow is designed to create a unidirectional stream of air, which moves from clean areas to less clean areas, ensuring minimal contamination. The airflow is managed using high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters.

Airflow management also involves controlling the pressure difference between different zones within the clean room. Positive pressure is often maintained to prevent the entry of contaminated air from adjacent spaces.

What industries commonly use hardwall clean rooms?

• Common Industries

  Hardwall clean rooms are widely used in industries like pharmaceuticals, biotechnology, semiconductor manufacturing, aerospace, and food production, where contamination control is crucial.

• Industry-Specific Needs

  Each industry requires specific air cleanliness levels and environmental conditions, making hardwall clean rooms an ideal solution for meeting these stringent requirements.

What is the cost of building a hardwall clean room?

The cost of building a hardwall clean room depends on factors such as room size, air filtration systems, and compliance with industry standards. On average, costs can range from $5000 to $2,0000 per square meter.

Customization, cleanroom classification, and location can all influence the final cost of construction. Proper planning can help manage these expenses efficiently.

How do you design a hardwall clean room?

Designing a hardwall clean room involves understanding the specific needs of the industry, complying with cleanliness standards, and optimizing airflow, pressure, and temperature controls. Proper material selection, layout planning, and integration of necessary equipment are essential for achieving the desired cleanroom performance. 

The first step in cleanroom design is to understand the operational requirements of the industry. Different industries have varying standards for cleanliness, which influence the overall design and infrastructure.

Designing a hardwall clean room requires a balance of industry-specific needs, regulatory compliance, and technical expertise to create a space that meets cleanliness and operational requirements.