HEPA filters help to achieve laminar flow by forcing the air to move through the filter in a straight line with uniform velocity and direction, which can dramatically reduce contamination.

Choosing the Right Softwall Cleanroom for Your Business

Softwall cleanrooms are unlike traditional cleanrooms which have rigid walls. They are constructed with flexible materials like vinyl and polyurethane that can be easily moved and adjusted to create different configurations. Their flexibility and versitility provide a cost effective and timely solution for companies needing to quickly adapt to changing business needs.

Factors to Consider When Choosing a Softwall Cleanroom

• Project requirements: Consider the specific needs of the project, including the number of personnel, equipment, and materials that need to be accommodated.
• Industry standards: Make sure that the cleanroom meets relevant industry standards, such as ISO 14644 and any necessary FDA or cGMP guidelines.
• Contamination control: Ensure that the cleanroom is designed to prevent the entry of contaminants from outside the workspace and to control contamination from personnel and equipment.
• Budget: Set a realistic budget for the cleanroom project, taking into account not only the initial cost but also ongoing maintenance and operating expenses.

Define Your Project Requirements:

In order to decide which cleanroom is right for your business, start by evaluating the number of personnel, equipment, and materials that will be involved.

Choosing the Right Size and Layout

The size of the cleanroom will depend on the specific requirements of the project — including the number of personnel, equipment, and materials that need to be accommodated — and the size of the conditioned space that will house the softwall cleanroom. The layout of the cleanroom should be designed to ensure efficient workflow and to minimize the risk of contamination.

Selecting the Appropriate Air Filtration System

The air filtration system is a critical component of the softwall cleanroom in order to maintain the appropriate ISO classification. HEPA filters are recommended to achieve these goals with their number and locations varying for different ISO standards. This will also impact airflow rate and pressure cascades across cleanrooms and antechambers (positive vs. negative pressure).

Laminar Flow and HEPA Filters

Laminar flow refers to the unidirectional movement of air in a cleanroom, where the air moves in a straight line with uniform velocity, and is an essential aspect of maintaining a clean and sterile workspace in a softwall cleanroom. The unidirectional flow of air ensures that particles and other contaminants are not re-circulated within the workspace, reducing the risk of contamination and helps to prevent fluctuations in temperature and humidity that can negatively impact the quality of products or research results.

Laminar flow is achieved via high efficiency particulate air (HEPA) filters. HEPA filters are designed to remove particles from the air as small as 0.3 microns with a 99.97% efficiency rate, ensuring the air is clean and free of contaminants. By removing particles from the air, HEPA filters help to achieve laminar flow by forcing the air to move through the filter in a straight line with uniform velocity and direction.

It's important to note that HEPA filters must be installed, operated, and maintained correctly to ensure their effectiveness. Regular filter replacements and maintenance are essential to maintain laminar flow and proper filter operation.

Deciding on Positive or Negative Pressure

Choosing between positive and negative pressure depends on the specific needs of the project. Positive pressure is recommended when the goal is to prevent contamination from entering the cleanroom, while negative pressure is recommended when the goal is to contain contaminants within the workspace.

Positive Pressure:

Positive pressure cleanrooms maintain a higher air pressure inside the cleanroom than the outside environment, which prevents contaminants from entering the workspace. This type of cleanroom is typically used for manufacturing or processing applications where the product needs to be protected from outside contaminants.

Negative Pressure:

Negative pressure cleanrooms maintain a lower air pressure inside the cleanroom than the outside environment. This type of cleanroom is typically used for applications where hazardous materials are handled, such as in pharmaceutical or biotech industries. Negative pressure cleanrooms prevent hazardous materials from escaping into the surrounding environment via filtering and protect workers from exposure.

Choosing The Right One:

The choice between a positive or negative pressure cleanroom depends on the specific application. Positive pressure cleanrooms are used for product protection, while negative pressure cleanrooms are used for worker protection. By understanding the requirements and standards of cleanrooms, companies can choose the appropriate type of cleanroom for their operations and ensure that their workspace remains clean and sterile. Contact ICS if you have questions about choosing the right cleanroom for your business.

Contamination Control

Contamination control is an essential requirement for softwall cleanrooms. The use of gowning procedures, sterile gloves, and other protective equipment can help to prevent contamination from personnel. The cleanroom must also be designed to prevent the entry of contaminants from outside the workspace.

Lighting and Power

Lighting should be designed to ensure adequate visibility while minimizing the risk of creating shadows that can harbor contaminants or glare that can disrupt operations. Sufficient power outlets and electrical capacity must also be included in the cleanroom design to accommodate equipment and lighting needs.

Cost and Maintenance

The cost of the softwall cleanroom project includes not only the initial purchase and installation but also ongoing maintenance and operating expenses. Consider the cost of filters, protective gear, and any other necessary equipment, along with regular cleaning to maintain certification standards. Also, consider the ease of maintenance and the availability of technical support from the cleanroom manufacturer.

Meeting Your Industry Standard

What ISO standard do you need?

ISO 14644 is the most commonly used standard for cleanrooms. It defines the maximum allowable particle concentration and size within a cleanroom space on a 9 level classification system, ranging from Class 1 to Class 9 based on the number of particles per cubic meter of air. Adhering to ISO standards is essential for maintaining a clean and sterile workspace and meeting specific industry requirements. Other ISO standards used in cleanroom operations include ISO 14698 for biocontamination control and ISO 10648 for air cleanliness classification, along with FDA and cGMP guidelines for various industries. Following these standards ensures that cleanrooms meet industry-specific requirements and provide an appropriately controlled environment.

Conclusion

A softwall cleanroom is a flexible and cost-effective type of controlled environment used in manufacturing and scientific research. They use flexible vinyl curtains to maintain a controlled environment by controlling the flow of air and preventing contaminants from entering the workspace. Adhering to ISO standards is essential for maintaining a clean and sterile workspace, and HEPA filters must be installed, operated, and maintained correctly to ensure their effectiveness. When considering a softwall cleanroom, factors such as size, layout, air filtration system, contamination control, lighting, and power must be taken into account to ensure the cleanroom meets industry standards and project needs.

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